Interest of the Addition of Docetaxel to Standard Treatment in First-line Advanced HER2 Positive Gastroesophageal Adenocarcinoma in Selective Patients

Study Overview
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Brief Summary
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The purpose of this retrospective study is to evaluate the efficacy and the safety of trastuzumab + chemotherapies with or without taxanes among HER2-positive advanced gastroesophageal adenocarcinoma patients.

Detailed Description
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Studies have reported a beneficial role of trastuzumab combined to platin-5-FU based chemotherapy in first-line advanced HER2 positive gastroesophageal adenocarcinoma. However, the effect of taxanes combined with platin-5FU + trastuzumab (TPFT) is understudied. In this context, the aim of this study is to evaluate the efficacy and the safety of trastuzumab + chemotherapies with or without taxanes among HER2-positive advanced gastroesophageal adenocarcinoma patients.

Official Title
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Interest of the Addition of Docetaxel to Standard Treatment in First-line Advanced HER2 Positive Gastroesophageal Adenocarcinoma in Selective Patients

Conditions
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HER2-positive Gastric Cancer, Metastatic Cancer, Docetaxel, Trastuzumab

Intervention / Treatment
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* Drug: Taxane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed non-resectable locally advanced, recurrent, or metastatic adenocarcinoma of the stomach or gastro-esophageal junction; tumor samples scored as 3+ on immunohistochemistry or FISH (Fluorescence in situ Hybridization) positive (HER2:CEP17 ratio ≥2); measurable disease; treated by trastuzumab, platin (cisplatine or oxaliplatine), fluoropyrimidine (5-FU or capecitabine) +/- taxanes (docetaxel or paclitaxel), as first-line therapy for advanced gastric cancer. Exclusion Criteria: previous chemotherapy by taxane for metastatic disease, previous anti-HER2 therapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| S group<br>platin-5FU + trastuzumab | |
| T group<br>taxanes + platin-5FU + trastuzumab | Drug: Taxane<br>* docetaxel or paclitaxel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | PFS will be defined as the time interval between the date of randomization and the date of first progression (local, regional, metastatic, second cancer) or death regardless of the cause. Patients alive without progression will be censored at the time of the latest news | up to 12 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | OS will be calculated between the date of randomization and the date of death from any cause. . Alive patients or lost to follow-up at the time of the analysis will be censored at the date of last follow-up. | up to 12 years | 
| Objective Response Rate | Evaluated by RECIST criteria version 1.1 | up to 12 years | 
| disease control rate |  | up to 12 years | 
| secondary resectability of primary tumor or metastases in patients with DCR |  | up to 12 years | 
| Tolerance | graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] criteria v4.03 | up to 12 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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docetaxel, trastuzumab, Advanced HER2 Positive Gastroesophageal Adenocarcinoma