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Our aim was to evaluate whether second-line treatment with paclitaxel and ramucirumab was associated with improved clinical outcomes compared to other available therapies. This study involved real-world data collection, focusing on the safety and efficacy of therapeutic combinations, administered to patients with pretreated advanced gastric cancer in the Oncology Departments affiliated with the Hellenic Cooperative Oncology Group (HeCOG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who received paclitaxel - ramucirumab as second-line treatment | Patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus who had been treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG). All patients had received second-line treatment for advanced disease with paclitaxel and ramucirumab, for at least two months. |
| |
| Patients who received other regimens as second-line treatment | patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus who had been treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG). All patients had received second-line treatment for advanced disease based on international/national guidelines, except from paclitaxel and ramucirumab. All other regimens, combinations of drugs as well as monotherapy, were accepted. Patients were included in the analysis if they have received at least two months of second-line treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel and ramucirumab | Drug | Second-line treatment with paclitaxel/ramucirumab vs other regimens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | The primary endpoint of interest was the assessment of progression-free survival (PFS1), defined as the time interval from the initiation of second-line treatment to the date of discontinuation (due to any reason), first documented progression, death from any cause or last contact, whichever occurred first. | From the initiation of second-line treatment to the date of discontinuation (due to any reason), first documented progression, death from any cause or last contact, through study completion, up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | overall survival (OS), defined as the time interval from the date of disease progression to the date of death from any cause or last contact. | From the date of disease progression to the date of death from any cause or last contact, through study completion, up to 2 years. |
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Inclusion Criteria:
Exclusion Criteria:
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The study included patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus who had been treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG). All patients had received second-line treatment for advanced disease based on international/national guidelines. All regimens, combinations of drugs as well as monotherapy, were accepted. Patients were included in the analysis if they have received at least two months of second-line treatment. Patient clinicopathological characteristics and outcome data were retrospectively recorded from patient medical records. Toxicity data were retrospectively recorded from the clinicians' documentations of patient-reported symptoms and laboratory results during scheduled clinical visits or patient hospitalizations.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hellenic Oncology Cooperative Group | Athens | Greece |
Could share anonymized clinical data upon request, after approval by our institutions
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D000096662 | Ramucirumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |