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07.08.2018 | Original Article

Phase II study of trastuzumab with modified docetaxel, cisplatin, and 5 fluorouracil in metastatic HER2-positive gastric cancer

Zeitschrift:
Gastric Cancer
Autoren:
Sebastian Mondaca, Matthew Margolis, Francisco Sanchez-Vega, Philip Jonsson, Jamie C. Riches, Geoffrey Y. Ku, Jaclyn F. Hechtman, Yaelle Tuvy, Michael F. Berger, Manish A. Shah, David P. Kelsen, David H. Ilson, Kenneth Yu, Zoe Goldberg, Andrew S. Epstein, Avni Desai, Vincent Chung, Joanne F. Chou, Marinela Capanu, David B. Solit, Nikolaus Schultz, Yelena Y. Janjigian
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1007/​s10120-018-0861-7) contains supplementary material, which is available to authorized users.

Abstract

Background

Trastuzumab with cisplatin and fluoropyrimidine is the standard treatment in metastatic HER2-positive gastric or gastroesophageal (GE) junction adenocarcinoma; however, there is limited data on the efficacy of trastuzumab in combination with a three-drug regimen in this setting. We examined the efficacy and safety of modified docetaxel, cisplatin and 5 fluorouracil (mDCF) plus trastuzumab in a single-arm multicenter phase II trial.

Methods

Previously untreated patients with HER2-positive metastatic gastric or GE junction adenocarcinoma were treated with mDCF and trastuzumab every 2 weeks. The primary endpoint was 6-month progression-free survival (PFS); secondary endpoints included objective response rate, overall survival (OS), and toxicity.

Results

We enrolled 26 patients with metastatic HER2-positive gastric or GE junction adenocarcinoma between February 2011 and June 2015. The median age of patients was 62 years; 96% had a Karnofsky performance status equal to or greater than 80%. With a median follow-up of 25.4 months, the 6-month PFS was 73% (95% CI 51–86%). The objective response rate was 65%, the median PFS was 13 months (95% CI 6.4–20.7) and the median OS was 24.9 months (95% CI 14.4–42.5). Grade 3/4 toxicities included neutropenia (42%), fatigue (23%), and hypophosphatemia (15%). There were no episodes of febrile neutropenia.

Conclusion

The combination of mDCF and trastuzumab is effective and safe in patients with metastatic HER2-positive gastric or GE junction adenocarcinoma and can be considered as an option for selected patients. This trial is registered at ClinicalTrials.gov, number NCT00515411.

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Zusatzmaterial
Supplementary material 1 (DOCX 27 KB)
10120_2018_861_MOESM1_ESM.docx
Literatur
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