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Phase II study of trastuzumab with modified docetaxel, cisplatin, and 5 fluorouracil in metastatic HER2-positive gastric cancer.
- Source :
-
Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association [Gastric Cancer] 2019 Mar; Vol. 22 (2), pp. 355-362. Date of Electronic Publication: 2018 Aug 07. - Publication Year :
- 2019
-
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.<br />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.<br />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.<br />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.
- Subjects :
- Adenocarcinoma mortality
Adult
Aged
Cisplatin administration & dosage
Cisplatin adverse effects
Docetaxel administration & dosage
Docetaxel adverse effects
Esophagogastric Junction pathology
Female
Fluorouracil administration & dosage
Humans
Male
Middle Aged
Progression-Free Survival
Receptor, ErbB-2 biosynthesis
Stomach Neoplasms mortality
Trastuzumab adverse effects
Adenocarcinoma drug therapy
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Stomach Neoplasms drug therapy
Trastuzumab administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1436-3305
- Volume :
- 22
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association
- Publication Type :
- Academic Journal
- Accession number :
- 30088161
- Full Text :
- https://doi.org/10.1007/s10120-018-0861-7