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

Autor: Mondaca S; Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA., Margolis M; Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA., Sanchez-Vega F; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.; Marie-Josée and Henry R. Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA., Jonsson P; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.; Department of Epidemiology-Biostatistics, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA., Riches JC; Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA., Ku GY; Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA., Hechtman JF; Marie-Josée and Henry R. Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA., Tuvy Y; Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA., Berger MF; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.; Marie-Josée and Henry R. Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.; Physiology, Biophysics and Systems Biology Program, Weill Cornell Medical College, New York, NY, USA., Shah MA; Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA., Kelsen DP; Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA., Ilson DH; Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA., Yu K; Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA., Goldberg Z; Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA., Epstein AS; Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA., Desai A; Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA., Chung V; Department of Medical Oncology and Therapeutics Research, City of Hope Cancer Center, Duarte, CA, USA., Chou JF; Department of Epidemiology-Biostatistics, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA., Capanu M; Department of Epidemiology-Biostatistics, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA., Solit DB; Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, Room 1033, New York, NY, 10065, USA.; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.; Marie-Josée and Henry R. Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA., Schultz N; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.; Marie-Josée and Henry R. Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA., Janjigian YY; 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.
Jazyk: angličtina
Zdroj: 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.
DOI: 10.1007/s10120-018-0861-7
Abstrakt: 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.
Databáze: MEDLINE
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