Improved Outcomes With Modified Docetaxel, Cisplatin, and 5-FU vs Standard Regimen Plus Growth Factor Support in Metastatic Gastric Cancer
In a phase II trial reported in the Journal of Clinical Oncology, Shah et al in the U.S. Gastric Cancer Consortium found that a modified regimen of docetaxel, cisplatin, and fluorouracil (5-FU) (mDCF) improved toxicity and survival vs a standard DCF regimen plus growth factor support as first-line treatment of metastatic gastric or gastroesophageal junction adenocarcinoma.
Study Details
In the multicenter study, 85 evaluable patients were randomly assigned to receive mDCF (n = 54) consisting of 5-FU at 2,000 mg/m2 IV over 48 hours, docetaxel at 40 mg/m2 IV on day 1, and cisplatin at 40 mg/m2 IV on day 3 every 2 weeks or DCF (n = 31) consisting of docetaxel at 75 mg/m2, cisplatin 75 mg/m2, and 5-FU at 750 mg/m2 IV over 5 days with granulocyte colony-stimulating factor every 3 weeks.
An early stopping rule for toxicity stipulated stopping for a grade 3 to 4 adverse event rate ≥70% in the first 3 months. Patients had a median age of 56 years, 72% were male, and 67% had gastric and 33% gastroesophageal junction adenocarcinoma.
Toxicity and Survival
The DCF arm was closed early due to excessive toxicity, with grade 3 or 4 adverse events occurring in 71% of patients (52% hospitalized) within 3 months and in 90% of patients over the course of treatment. In the mDCF group, grade 3 or 4 toxicity occurred in 54% (22% hospitalized) within the first 3 months and in 76% over the course of treatment.
Progression-free survival at 6 months was 63% in the mDCF group vs 53% in the DCF group, and median progression-free survival was 9.7 vs 6.5 months (P = .2). Median overall survival was 18.8 vs 12.6 months (P = .007), with 1- and 2-year survival rates of 63% vs 55% and 30% vs 12%. The objective response rate was 49% vs 33% (P = .2).
The investigators concluded: “mDCF is less toxic than parent DCF, even when supported with growth factors, and is associated with improved efficacy. mDCF should be considered a standard first-line option for patients with metastatic gastric or [gastroesophageal junction] adenocarcinoma.”
Manish A. Shah, MD, of Weill Cornell Medical College, is the corresponding author for the Journal of Clinical Oncology article.
The study was supported by sanofi-aventis. For full disclosures of the study authors, visit jco.ascopubs.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
