Phase II study of trastuzumab with modified docetaxel, cisplatin, and 5 fluorouracil in metastatic HER2-positive gastric cancer Journal Article
| 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. |
| Article Title: | Phase II study of trastuzumab with modified docetaxel, cisplatin, and 5 fluorouracil in metastatic HER2-positive gastric cancer |
| 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. © 2018, The International Gastric Cancer Association and The Japanese Gastric Cancer Association. |
| Keywords: | docetaxel; trastuzumab; her2; gastric cancer |
| Journal Title: | Gastric Cancer |
| Volume: | 22 |
| Issue: | 2 |
| ISSN: | 1436-3291 |
| Publisher: | Springer |
| Date Published: | 2019-03-01 |
| Start Page: | 355 |
| End Page: | 362 |
| Language: | English |
| DOI: | 10.1007/s10120-018-0861-7 |
| PUBMED: | 30088161 |
| PROVIDER: | scopus |
| PMCID: | PMC6784321 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 April 2019 -- Source: Scopus |
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