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Overview of response rate published in recent oncology phase I trials
Critics have raised a fundamental ethical challenge about phase 1 cancer research. They point to an expected paucity of benefits, since approximately 5% of patients in phase 1 trials are reported to have tumor shrinkage.
Objective was to conduct a search of the literature using PubMed to identify articles about phase 1 trials that were published from January 1, 2014, through June 30, 2015. The primary end point was the response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Clinically relevant trials' characteristics were investigated as candidate factors associated with the RR: Funding source (Academic / Industrial), First-in man trial (Yes / No), Expansion cohort (Yes / No), Number of targeted organs (Single / Multiple), Therapy (Single / Combination), Treatment (MAB-Immuno / ITK / Chimioth-HT-other), Biological eligibility criterion (Yes / No), as well as the number of assessable patients, which for ease of clinical interpretation was transformed into a qualitative variable (0-25 / 26 - 50 / 51+).
The RR was described according to the individual trials' characteristics. Associations with trials's characteristics were investigated using statistical modeling.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase I | Other | Chemotherapy, ITK, Hormotherapy, Immunotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Number of reported responses (complete [CR] and partial [PR]) divided by the number of reported assessable patients | up to 6 months after treatment initiation |
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Trials based on the following eligibility criteria:
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unit of analysis = trial (analysis of aggregated data only, with the trial as the unit of analysis)
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| Name | Affiliation | Role |
|---|---|---|
| Antoine Italiano, MD-PhD | Institut Bergonié | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insitut Bergonié | Bordeaux | 33076 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29874526 | Result | Chakiba C, Grellety T, Bellera C, Italiano A. Encouraging Trends in Modern Phase 1 Oncology Trials. N Engl J Med. 2018 Jun 7;378(23):2242-2243. doi: 10.1056/NEJMc1803837. No abstract available. |
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224 trials were analyzed which included 6915 participants
| ID | Title | Description |
|---|---|---|
| FG000 | Participants Included in Phase 1 Oncology Trials | Participants included in Phase 1 Oncology Trials, published from January 1, 2014, through June 30, 2015. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Trials | Cancer Phase 1 trials |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Response Rate | Number of reported responses (complete [CR] and partial [PR]) divided by the number of reported assessable patients | Posted | Count of Participants | Participants | up to 6 months after treatment initiation |
|
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All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants Included in Phase 1 Oncology Trials | Participants included in Phase 1 Oncology Trials, published from January 1, 2014, through June 30, 2015. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Antoine Italiano | Institut Bergonié | 335 56333333 | a.italiano@bordeaux.unicancer.fr |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017321 | Clinical Trials, Phase I as Topic |
| ID | Term |
|---|---|
| D002986 | Clinical Trials as Topic |
| D000068456 | Clinical Studies as Topic |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
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| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |