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Gastric Cancer. 2019 Mar;22(2):355-362. doi: 10.1007/s10120-018-0861-7. Epub 2018 Aug 7.

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

Author information

1
Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA.
2
Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.
3
Marie-Josée and Henry R. Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.
4
Department of Epidemiology-Biostatistics, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.
5
Physiology, Biophysics and Systems Biology Program, Weill Cornell Medical College, New York, NY, USA.
6
Department of Medical Oncology and Therapeutics Research, City of Hope Cancer Center, Duarte, CA, USA.
7
Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA. janjigiy@mskcc.org.

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.

KEYWORDS:

Docetaxel; Gastric cancer; HER2; Trastuzumab

PMID:
30088161
DOI:
10.1007/s10120-018-0861-7

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