Phase II study of trastuzumab with modified docetaxel, cisplatin, and 5 fluorouracil in metastatic HER2-positive gastric cancer
Open accessAbstract
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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Adding trastuzumab to platinum-based regimens was effective and safe in patients with metastatic HER2-positive gastric cancer, with an objective response rate of 65%, median progression-free survival of 13 months, and median overall survival of 24.9 months.
“The addition of trastuzumab to platinum-based regimens was found to be effective and safe in patients with metastatic HER2-positive gastric cancer (ORR: 65%, mPFS: 13 months, and mOS: 24.9 months) [69].”
From Advances in platinum-based cancer therapy: overcoming platinum resistance through rational combinatorial strategies (2025) · cites this paper as [69]
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- Authors
- Mondaca, S., Margolis, M., Sanchez-Vega, F., Jonsson, P., Riches, J. C., Ku, G. Y., Hechtman, J. F., Tuvy, Y., Berger, M. F., Shah, M. A., Kelsen, D. P., Ilson, D. H., Yu, K., Goldberg, Z., Epstein, A. S., Desai, A., Chung, V., Chou, J. F., Capanu, M., Solit, D. B., Schultz, N., & Janjigian, Y. Y.
- Affiliations
- Memorial Sloan Kettering Cancer Center (US)
- City Of Hope National Medical Center (US)
- Corresponding author
- Janjigian, Yelena Y.
- ORCID
- Venue
- Gastric Cancer
- Published
- 2018-08-07
- Volume
- 22
- Issue
- 2
- Pages
- 355-362
- ISSN
- 1436-3291 (ISSN-L)
- 1436-3305
- PMC
- PMC6784321
- OpenAlex
- W2887352196
- Cited by
- 21
- References
- 26
- Citations by year
- 2025: 4 · 2024: 3 · 2022: 5 · 2021: 4 · 2020: 3 · 2019: 2
- FWCI
- 1.69
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Gastric Cancer (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Conquer Cancer Foundation ASCO Career Development Award
- Genetech
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Gastric Cancer Management and Outcomes
- Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Keywords
- trastuzumab, cisplatin, 5-fluorouracil, HER2-positive gastric cancer, gastroesophageal junction adenocarcinoma, metastatic gastric cancer, progression-free survival, combination chemotherapy, neutropenia, hypophosphatemia, first-line therapy
- MeSH terms
- Trastuzumab, Docetaxel, Progression-Free Survival, Adenocarcinoma, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Cisplatin, Esophagogastric Junction, Female, Fluorouracil, Humans, Male, Middle Aged, Stomach Neoplasms, Erb-b2 Receptor Tyrosine Kinases
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