A modified chemotherapy regimen is associated with improved efficacy and less toxicity than a standard combination of docetaxel, cisplatin, and fluorouracil ("parent" DCF) for the treatment of metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, a multicenter phase II study has demonstrated.
Six-month progression-free survival (PFS) was 63% (95% CI 48%-75%) for the modified regimen versus 53% (95% CI 34%-69%) for parent DCF, and median overall survival was improved as well for the modified regimen (18.8 v 12.6 months; P=0.007), according to Manish A. Shah, MD, of Weill Cornell Medical College in New York City and colleagues.
"Whereas parent DCF is associated with significant toxicity, with a high risk of patients hospitalization because of serious adverse events, even when supported by growth factors, mDCF is better tolerated with similar efficacy," they wrote. "We therefore conclude that mDCF is the preferable three-drug therapy regimen for advanced gastric cancer. "Modified DCF (mDCF) -- the same drugs at different doses and intervals -- should be considered a potential new three-drug standard chemotherapy option for patients with advanced gastric adenocarcinoma, the researchers concluded in the Journal of Clinical Oncology.
Gastric cancer remains a prevalent worldwide malignancy with a high mortality rate, the investigators noted. Despite a modest improvement in outcome for patients with metastatic disease, survival remains poor, with the majority of patients dying within 1 year of developing metastases, they said.
Parent DCF, a standard first-line three-drug chemotherapy regimen for advanced gastric or GEJ adenocarcinoma, is associated with significant toxicity. The 6-month PFS rate for it is estimated at 43%. This regimen consists of docetaxel 75 mg/m2, cisplatin 75 mg/m2, and fluorouracil 750 mg/m2 IV over 5 days with granulocyte colony-stimulating factor, every 3 weeks.
The modified DCF regimen involved fluorouracil 2,000 mg/m2 IV every 48 hours, docetaxel 40 mg/m2 IV on day one, and cisplatin 40 mg/m2 IV on day three, every 2 weeks.
"Importantly, the reduced toxicity associated with mDCF was also associated with efficacy comparable (and possibly superior) to that of parent DCF," Shah and colleagues wrote. "When compared with DCF in this study, as well as with historical data, mDCF demonstrated remarkable efficacy, with median PFS of nearly 10 months, and median survival of more than 18 months."
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