Modified docetaxel, cisplatin, and fluorouracil (mDCF) is less toxic than DCF, even when supported with granulocyte colony-stimulating factor (GCSF), and is associated with improved efficacy, a new study published online ahead of print in the Journal of Clinical Oncology has shown.1
Although DCF is a standard first-line 3-drug chemotherapy regimen for patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma, it is associated with significant toxicity. Therefore, researchers sought to evaluate the safety and efficacy of a mDCF regimen.
For the study, researchers enrolled 85 previously untreated patients with metastatic gastric or GEJ adenocarcinoma.
Participants were randomly assigned to receive either mDCF (5-FU 2,000 mg/m2 IV every 48 hours, docetaxel 40 mg/m2 IV on day 1, cisplatin 40 mg/m2 IV on day 3, every 2 weeks) or DCF (docetaxel 75 mg/m2, cisplatin 75 mg/m2, and 5-FU 750 mg/m2 IV over 5 days with GCSF, every 3 weeks).
Results showed that 6-month progression-free survival was 63% (95% CI: 48-75) for mDCF compared with 53% (95% CI: 34-69) for DCF. Median overall survival was 18.8 months and 12.6 months with mDCF and DCF, respectively (P=0.007).
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In regard to safety, grade 3 to 4 toxicity was experienced by 54% of patients in the mDCF group within the first 3 months and 76% of patients in the same treatment arm over the course of treatment. Those rates were 71% and 90%, respectively, in the DCF group. The DCF arm was therefore closed early due to toxicity.
“mDCF should be considered a standard first-line option for patients with metastatic gastric or GEJ adenocarcinoma,” the authors concluded.
- Shah MA, Janjigian YY, Stoller R, et al. Randomized multicenter phase II study of modified docetaxel, cisplatin, and fluorouracil (DCF) versus DCF plus growth factor support in patients with metastatic gastric adenocarcinoma: a study of the US Gastric Consortium [published online ahead of print October 5, 2015]. J Clin Oncol. doi: 10.1200/JCO.2015.60.7465.