Phase II trial of 5-fluorouracil/leucovorin/gemcitabine/cisplatin as second-line treatment in patients with metastatic or recurrent colorectal carcinoma: a cancer therapeutics research group study.

摘要: Abstract Background Second-line treatment of relapsed or metastatic colorectal cancer (CRC) after failure with a fluoropyrimidine is composed oxaliplatin in combination an irinotecan-containing regimen. Cisplatin and gemcitabine are synergistic preclinical studies, as 5-fluorouracil (5-FU) combined either agent. Fixed-rate infusional more effective than bolus administration animal models. Patients Methods A 2-stage phase II trial was conducted to assess the efficacy (the primary endpoint response rate) safety regimen consisting 5-FU 400 mg/m2 intravenous at middle 60-minute infusion leucovorin 100 mg/m2, followed by 800 over 80 minutes, cisplatin 20 15 minutes. Treatment repeated weekly for 3 weeks 1-week rest. advanced CRC were eligible if they had experienced fluoropyrimidine-based therapy. Results Nineteen patients enrolled. The median age 60 years; men 4 women. Twelve colon 7 rectal cancer. Sites metastasis follows: liver (n = 10), lung 8), skin 1), non-regional lymph nodes 1). All Eastern Cooperative Oncology Group performance status 0/1. total 44 cycles chemotherapy delivered (median, 2 cycles; range, 1–5 cycles). One patient exhibited partial (5%), 8 stable disease (42%), 5 progression (26%); another nonevaluable (26%). time survival 36 weeks. Grade 3/4 toxicities diarrhea dyspnea pneumonia neutropenia 2), thrombocytopenia Conclusion Despite acceptable toxicity reasonable overall survival, 5-FU/leucovorin/gemcitabine/cisplatin does not seem improve current standard therapy second-line whom first-line fluoropyrimidine-containing has failed.