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This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy.
Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast cancer and will be due to receive one of the specific chemotherapy regimens of interest.
Investigators' approach to FN risk assessment will be studied using lists of possible risk factors they may consider during their assessment. Investigators will be asked to select and rank the factors they consider the most important when assessing the overall FN risk of a subject and when making the decision whether to treat with granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based initially on their own routine clinical practise and subsequently relating specifically to each subject recruited.
This is a non-interventional study that involves no procedures outside normal care for the subjects; all data collection will be completed prior to chemotherapy administration.
Although a formal hypothesis will not be tested in this observational study, it is hypothesized that the clinical risk factors ranked as the most important when conducting FN risk assessments by investigators are aligned with international guidelines and published data. Also, that the investigator's decision to treat with G-CSF PP is influenced by clinical and non-clinical risk factors (such as distance from site, estimated subject compliance, and access to fully reimbursed G-CSF).
Study Design: Prior to identifying eligible subjects, Investigators will be registered and will record baseline information. During this Baseline Investigator Assessment investigators will be provided with two lists of risk factors. Investigators must rank selected risk factors that they consider to be the most important when assessing 1) overall FN risk (only scientific factors will be included), and 2) when deciding on whether G-CSF PP treatment will be used or not (this list will also contain non clinical factors). They will also record their own FN risk intervention threshold, which is the FN risk threshold score at which they would use G-CSF PP in their usual clinical practice.
Investigators will then prospectively and sequentially identify eligible subjects with NHL, breast or lung cancer who are due to initiate one of the permitted standard dose chemotherapy regimens listed in the protocol. The permitted chemotherapy regimens have an estimated intermediate FN risk (10%-20%) documented in published data and/or international guidelines.
For each enrolled subject, Investigators will complete a Subject Assessment prior to the start of their chemotherapy. They will be provided with the same two lists of risk factors as in the Baseline Assessment and asked to complete them based on each specific subject. Investigators must rank selected risk factors that they consider to be the most important when assessing 1) overall FN risk (only scientific factors will be included), and 2) when deciding on whether G-CSF PP treatment will be used or not. They will also document their final estimated FN risk score as a percentage based on the subject's medical history and standard of care (SOC) assessments (their routine practice for assessing this risk), and a decision as to whether G-CSF PP will be administered. Investigators will record which type of G-CSF they plan to use if one will be used.
End of Study for a subject will occur once these activities have been completed, and a prescription for the first cycle of chemotherapy has been written. The subject data collected will only be historical subject information and laboratory data from SOC assessments performed prior to beginning chemotherapy treatment. No data will be collected after the initiation of chemotherapy.
The approach to the statistical analysis will be generally descriptive in nature. The primary analysis will be conducted at two levels; investigator level and the subject level. It is expected that the opinions of investigators at a single site (that is, a department within a cancer treatment centre) will be correlated. Also, that the opinions about subjects from a single investigator will be more alike than subjects of other investigators; adjustments will be made in the analyses to account for this. Confidence intervals for the investigator level analysis and the subject level data will obtained from Multi-level Modelling (MLM) to allow for the expected intra-site and intra-investigator correlation of investigators within sites and subjects within investigator. In general, categorical data will be summarised by the number and percentage of subjects in each category. Continuous data will be summarised by mean, standard deviation, median, lower and upper quartiles, minimum and maximum values. Two-sided exact 95% confidence intervals (obtained using MLM) will be presented, where appropriate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | All patients enrolled |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall febrile neutropenia (FN) risk. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. | Baseline (prior to participant enrolment) |
| Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group | Assessed at Baseline, prior to participant enrolment. |
| Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment were collected in this study. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible subjects will have NHL, breast or lung cancer and be due to initiate one of the permitted standard dose chemotherapy regimens listed in the protocol (those with a documented intermediate FN risk of 10-20%). Subjects will be prospectively and sequentially identified by approximately 150-200 investigators during their clinics distribututed in 11 countries.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tweed Heads | New South Wales | 2485 | Australia | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26315712 | Background | Freyer G, Kalinka-Warzocha E, Syrigos K, Marinca M, Tonini G, Ng SL, Wong ZW, Salar A, Steger G, Abdelsalam M, DeCosta L, Szabo Z. Attitudes of physicians toward assessing risk and using granulocyte colony-stimulating factor as primary prophylaxis in patients receiving chemotherapy associated with an intermediate risk of febrile neutropenia. Med Oncol. 2015 Oct;32(10):236. doi: 10.1007/s12032-015-0682-z. Epub 2015 Aug 28. | |
| 25810005 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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The first patient was enrolled on 13 December 2012 and the last patient enrolled on 08 January 2014.
There were 205 registered investigators, 35 of whom did not enrol any participants and 5 who did not enrol any eligible participants and were excluded from the primary analysis set - investigators (PASI).
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Patients | Participants with cancer who were planning to receive standard dose chemotherapy regimens with a documented intermediate risk (10% to 20%) of febrile neutropenia (FN). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| At enrolment, prior to chemotherapy initiation |
| Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | At enrolment, prior to chemotherapy initiation. |
| Assessed at baseline, prior to participant enrolment. |
| Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators. | Assessed at baseline, prior to participant enrolment. |
| Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group. | Assessed at baseline, prior to participant enrolment. |
| Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group. | Assessed at baseline, prior to participant enrolment. |
| Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | For each participant, the investigator ranked the factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | At enrolment, prior to chemotherapy initiation. |
| Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | At enrolment, prior to chemotherapy initiation. |
| Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | At enrolment, prior to chemotherapy initiation. |
| Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | At enrolment, prior to chemotherapy initiation. |
| Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | At enrolment, prior to chemotherapy initiation. |
| Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | At enrolment, prior to chemotherapy initiation. |
| Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rankt the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators. | Assessed at Baseline, prior to participant enrolment. |
| Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | Assessed at Baseline, prior to participant enrolment. |
| Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | Assessed at Baseline, prior to participant enrolment. |
| Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | At enrolment, prior to chemotherapy initiation. |
| Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | At enrolment, prior to chemotherapy initiation. |
| Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | At enrolment, prior to chemotherapy initiation. |
| Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | At enrolment, prior to chemotherapy initiation. |
| Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | At enrolment, prior to chemotherapy initiation. |
| Percentage of Participants With an Investigator-assessed FN Risk at or Above the Investigator Self-reported FN-risk Intervention Threshold Who Were Planned to Receive G-CSF PP | At Baseline investigators recorded the FN risk threshold score at which they would use G-CSF PP in their usual clinical practice. For each enrolled participant, the investigator documented their final estimated FN risk score as a percentage based on the participant's medical history and standard of care assessments (their routine practice for assessing this risk), and a decision as to whether G-CSF PP would be administered in Cycle 1. | At Baseline and at enrolment, prior to chemotherapy initiation. |
| Bendigo |
| Victoria |
| 3550 |
| Australia |
| Research Site | Shepparton | Victoria | 3630 | Australia |
| Research Site | Wodonga | Victoria | 3690 | Australia |
| Research Site | Eggenburg | 3730 | Austria |
| Research Site | Graz | 8036 | Austria |
| Research Site | Leoben | 8700 | Austria |
| Research Site | Vienna | 1030 | Austria |
| Research Site | Vienna | 1090 | Austria |
| Research Site | Vöcklabruck | 4840 | Austria |
| Research Site | Moncton | New Brunswick | E1C 6Z8 | Canada |
| Research Site | Sault Ste. Marie | Ontario | P6B 0A8 | Canada |
| Research Site | Montreal | Quebec | H2W 1T8 | Canada |
| Research Site | Alès Cédex | 30103 | France |
| Research Site | Arras | 62000 | France |
| Research Site | Besançon | 25030 | France |
| Research Site | Brest | 29609 | France |
| Research Site | Créteil | 94010 | France |
| Research Site | Grenoble | 38043 | France |
| Research Site | Marseille | 13009 | France |
| Research Site | Montluçon | 03100 | France |
| Research Site | Neuilly-sur-Seine | 92202 | France |
| Research Site | Nîmes | 30900 | France |
| Research Site | Pierre-Bénite | 69495 | France |
| Research Site | Saint-Quentin | 02321 | France |
| Research Site | Toulon | 83056 | France |
| Research Site | Villefranche-sur-Saône | 69400 | France |
| Research Site | Berlin | 10317 | Germany |
| Research Site | Bonn | 53111 | Germany |
| Research Site | Fulda | 36043 | Germany |
| Research Site | Mainz | 55131 | Germany |
| Research Site | Neustadt/Sachsen | 01844 | Germany |
| Research Site | Rostock | 18107 | Germany |
| Research Site | Stralsund | 18435 | Germany |
| Research Site | Twistringen | 27239 | Germany |
| Research Site | Athens | 11522 | Greece |
| Research Site | Athens | 11525 | Greece |
| Research Site | Athens | 11527 | Greece |
| Research Site | Athens | 18547 | Greece |
| Research Site | Chania | 73300 | Greece |
| Research Site | Larissa | 41110 | Greece |
| Research Site | Nea Kifissia, Athens | 14564 | Greece |
| Research Site | Thessaloniki | 54636 | Greece |
| Research Site | Thessaloniki | 54645 | Greece |
| Research Site | Thessaloniki | 57010 | Greece |
| Research Site | Cork | Ireland |
| Research Site | Galway | Ireland |
| Research Site | Catania | 95122 | Italy |
| Research Site | Florence | 50134 | Italy |
| Research Site | Foggia | 71100 | Italy |
| Research Site | Monza (MB) | 20900 | Italy |
| Research Site | Pordenone | 33170 | Italy |
| Research Site | Reggio Calabria | 89124 | Italy |
| Research Site | Roma | 00128 | Italy |
| Research Site | Torino | 10125 | Italy |
| Research Site | Varese | 21100 | Italy |
| Research Site | Bialystok | 15-027 | Poland |
| Research Site | Bydgoszcz | 85-796 | Poland |
| Research Site | Elblag | 82-300 | Poland |
| Research Site | Gdynia | 81-519 | Poland |
| Research Site | Lodz | 90-722 | Poland |
| Research Site | Lodz | 93-509 | Poland |
| Research Site | Szczecin | 71-730 | Poland |
| Research Site | Warsaw | 02-781 | Poland |
| Research Site | Wroclaw | 50-981 | Poland |
| Research Site | Brasov | 500052 | Romania |
| Research Site | Brasov | 500152 | Romania |
| Research Site | Brăila | 810325 | Romania |
| Research Site | Bucharest | 030171 | Romania |
| Research Site | Cluj-Napoca | 400006 | Romania |
| Research Site | Cluj-Napoca | 400352 | Romania |
| Research Site | Focşani | 620165 | Romania |
| Research Site | Iași | 700483 | Romania |
| Research Site | Onești | 601048 | Romania |
| Research Site | Oradea | 410469 | Romania |
| Research Site | Piteşti | 110084 | Romania |
| Research Site | Suceava | 720237 | Romania |
| Research Site | Timișoara | 300167 | Romania |
| Research Site | Timișoara | 300239 | Romania |
| Research Site | Huelva | Andalusia | 21005 | Spain |
| Research Site | Málaga | Andalusia | 29010 | Spain |
| Research Site | Zaragoza | Aragon | 50009 | Spain |
| Research Site | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Research Site | San Cristóbal de La Laguna | Canary Islands | 38320 | Spain |
| Research Site | Ávila | Castille and León | 05004 | Spain |
| Research Site | Valladolid | Castille and León | 47005 | Spain |
| Research Site | Barcelona | Catalonia | 08003 | Spain |
| Research Site | Barcelona | Catalonia | 08035 | Spain |
| Research Site | Pamplona | Navarre | 31008 | Spain |
| Research Site | Valencia | Valencia | 46015 | Spain |
| Derived |
| Lyman GH, Dale DC, Legg JC, Abella E, Morrow PK, Whittaker S, Crawford J. Assessing patients' risk of febrile neutropenia: is there a correlation between physician-assessed risk and model-predicted risk? Cancer Med. 2015 Aug;4(8):1153-60. doi: 10.1002/cam4.454. Epub 2015 Mar 23. |
| COMPLETED |
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| NOT COMPLETED |
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Primary Analysis Set (PAS) is the set of all participants who satisfy the eligibility criteria and had at least one FN risk factor ranked by the investigator in their Subject Assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Analysis Set |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Tumor Type | Number | participants |
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| Investigator Specialty | Data provided for the Primary analysis Set-Investigators, consisting of the 165 investigators who contributed participants to the primary analysis set. | Number | investigators |
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| Number of years in oncology/hematology clinical practice | Number | investigators |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall febrile neutropenia (FN) risk. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. | Primary analysis set - investigators (PASI), which consists of investigators who contributed participants to the primary analysis set (PAS). | Posted | Number | 95% Confidence Interval | percentage of investigators | Baseline (prior to participant enrolment) | Investigators | Investigators |
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| Primary | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group | Primary analysis set - investigators (PASI), which consists of investigators who contributed participants to the primary analysis set (PAS). | Posted | Number | 95% Confidence Interval | percentage of investigators | Assessed at Baseline, prior to participant enrolment. | Investigators | Investigators |
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| Primary | Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment were collected in this study. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. | Primary analysis set which consists of all participants who satisfied the eligibility criteria and had at least one FN risk factor ranked by the investigator in their Subject Assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | At enrolment, prior to chemotherapy initiation |
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| Primary | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | Primary analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | At enrolment, prior to chemotherapy initiation. |
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| Secondary | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | Primary analysis set - investigators | Posted | Number | 95% Confidence Interval | percentage of investigators | Assessed at baseline, prior to participant enrolment. | Investigators | Investigators |
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| Secondary | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators. | Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators. | Posted | Number | 95% Confidence Interval | percentage of investigators | Assessed at baseline, prior to participant enrolment. | Investigators | Investigators |
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| Secondary | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group. | Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators. | Posted | Number | 95% Confidence Interval | percentage of investigators | Assessed at baseline, prior to participant enrolment. | Investigators | Investigators |
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| Secondary | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group. | Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators. | Posted | Number | 95% Confidence Interval | percentage of investigators | Assessed at baseline, prior to participant enrolment. | Investigators | Investigators |
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| Secondary | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | For each participant, the investigator ranked the factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | Primary analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | At enrolment, prior to chemotherapy initiation. |
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| Secondary | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | Primary analysis set; subgroup analyses were only performed on subgroups (countries) with at least 100 participants. | Posted | Number | 95% Confidence Interval | percentage of participants | At enrolment, prior to chemotherapy initiation. |
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| Secondary | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants. | Posted | Number | 95% Confidence Interval | percentage of participants | At enrolment, prior to chemotherapy initiation. |
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| Secondary | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants. | Posted | Number | 95% Confidence Interval | percentage of participants | At enrolment, prior to chemotherapy initiation. |
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| Secondary | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants. | Posted | Number | 95% Confidence Interval | percentage of participants | At enrolment, prior to chemotherapy initiation. |
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| Secondary | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants. | Posted | Number | 95% Confidence Interval | percentage of participants | At enrolment, prior to chemotherapy initiation. |
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| Secondary | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rankt the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators. | Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators. | Posted | Number | 95% Confidence Interval | percentage of investigators | Assessed at Baseline, prior to participant enrolment. | Investigators | Investigators |
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| Secondary | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators. | Posted | Number | 95% Confidence Interval | percentage of investigators | Assessed at Baseline, prior to participant enrolment. | Investigators | Investigators |
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| Secondary | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators. | Posted | Number | 95% Confidence Interval | percentage of investigators | Assessed at Baseline, prior to participant enrolment. | Investigators | Investigators |
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| Secondary | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | Primary analysis set; analysis only includes subgroups with at least 100 participants. | Posted | Number | 95% Confidence Interval | percentage of participants | At enrolment, prior to chemotherapy initiation. |
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| Secondary | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | Primary analysis set; analysis only included subgroups with at least 100 participants. | Posted | Number | 95% Confidence Interval | percentage of participants | At enrolment, prior to chemotherapy initiation. |
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| Secondary | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | Primary analysis set; analysis only included subgroups with at least 100 participants. | Posted | Number | 95% Confidence Interval | percentage of participants | At enrolment, prior to chemotherapy initiation. |
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| Secondary | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | Primary analysis set; analysis only included subgroups with at least 100 participants. | Posted | Number | 95% Confidence Interval | percentage of participants | At enrolment, prior to chemotherapy initiation. |
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| Secondary | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. | Primary analysis set; analysis only included subgroups with at least 100 participants. | Posted | Number | 95% Confidence Interval | percentage of participants | At enrolment, prior to chemotherapy initiation. |
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| Secondary | Percentage of Participants With an Investigator-assessed FN Risk at or Above the Investigator Self-reported FN-risk Intervention Threshold Who Were Planned to Receive G-CSF PP | At Baseline investigators recorded the FN risk threshold score at which they would use G-CSF PP in their usual clinical practice. For each enrolled participant, the investigator documented their final estimated FN risk score as a percentage based on the participant's medical history and standard of care assessments (their routine practice for assessing this risk), and a decision as to whether G-CSF PP would be administered in Cycle 1. | Primary analysis set, participants with investigator-assessed FN risk at or above the investigator FN-risk intervention threshold | Posted | Number | percentage of participants | At Baseline and at enrolment, prior to chemotherapy initiation. |
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Not provided
Adverse Events were not collected for this observational protocol.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Enrolled Patients | Participants with cancer who were planning to receive standard dose chemotherapy regimens with a documented intermediate risk (10% to 20%) of febrile neutropenia (FN). | 0 | 0 | 0 | 0 |
Not provided
Not provided
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D064146 | Chemotherapy-Induced Febrile Neutropenia |
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Non-Hodgkin's lymphoma (NHL) |
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| Small-cell lung cancer (SCLC) |
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| Pulmonologist |
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| Vinorelbine |
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| Age and chemotherapy agents in the backbone |
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