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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S group | platin-5FU + trastuzumab | ||
| T group | taxanes + platin-5FU + trastuzumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taxane | Drug | docetaxel or paclitaxel |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated between January 2009 and Mars 2021 were included, in 7 centers in Franche-Comte region in France.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Besancon | Besançon | Franche-Comté | 25030 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35340264 | Derived | Orillard E, Henriques J, Vernerey D, Almotlak H, Calcagno F, Fein F, Fratte S, Jary M, Klajer E, Vienot A, Borg C, Kim S. Interest of the Addition of Taxanes to Standard Treatment in First-Line Advanced HER2 Positive Gastroesophageal Adenocarcinoma in Selective Patients. Front Oncol. 2022 Mar 7;12:763926. doi: 10.3389/fonc.2022.763926. eCollection 2022. |
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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 |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C080625 | taxane |
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