No abstract

Rationale: This phase III study was conducted to compare fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFOXIRI) with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first line management of metastatic colorectal carcinoma. Methods: Sixty patients with unresectable metastatic colorectal adenocarcinoma were randomly assigned to FOLFOXIRI (n = 30) or FOLFIRI (n = 30) as first line for metastatic disease. The primary end point was response rate (RR) and secondary end points were progression free survival (PFS), overall survival (OS), post chemotherapy RO surgical resection (complete resection with safety margin), and toxicity. Results: The RR was significantly higher for FOLFOXIRI arm 60% (18/30) compared to FOLFIRI (33%) (p = 0.007). The rate of progression was significantly lower for patients treated with FOLFOXIRI (11% vs. 24%; p = 0.02), 5 patients (16%) underwent radical (RO) surgery of metastases in the FOLFOXIRI arm compared with one patient (3%) in the FOLFIRI arm (p = 0.02). FOLFOXIRI resulted in an increased PFS, with median PFS of 10 month vs. 7.5 months (p = 0.0099) with an HR for progression of 2.58 (95% CI, 1.2 to 5.3). The rate of early progression (patients who progressed within six months from the treatment onset) was significantly lower in the FOLFOXIRI arm (18% vs. 45%; p < 0.0001); OS is significantly longer for FOLFOXIRI (22.6 vs. 16.7 months; p = 0.032) corresponding to an HR for death of 0.70 (95% CI, 0.50 to 0.96). Patients who received FOLFOXIRI were subjected to significantly higher incidence of adverse events; grade 2 to 3 peripheral neurotoxicity (0% vs. 20%; p < 0.001) and grade 3 to 4 neutropenia (26% vs. 53%; p < 0.001). Febrile neutropenia was comparable between the two arms (3% vs. 6%) of patients; p = 2. Conclusion: Compared to FOLFIRI regimen; FOLFOXIRI regimen has significantly higher RR, PFS, OS, and improved chance for resection of metastases, with higher but tolerable toxicity in patients with metastatic colorectal cancer.

Cetuximab combined with irinotecan when administered biweekly is safe and effective for treatment of pretreated elderly patients with mCRC.

Irinotecan and cisplatin is considered to be an effective and safe chemotherapeutic regimen when used concurrently with thoracic radiation therapy for the treatment of patients with LD-SCLC.

Objective. Comparing activity of 2 regimens combining oxaliplatin to bolus modulated fluorouracil as second line treatment in advanced pancreatic adenocarcinoma pretreated with gemcitabine-containing schedule. Methods. Forty eight patients with advanced pancreatic adenocarcinoma were randomly assigned to receive either FU 500 mg/m2 IV bolus weekly ×6 weeks plus leucovorin 500 mg/m2 IV weekly for 6 weeks during each 8-week cycle plus oxaliplatin 85 mg/m2 IV on weeks 1, 3, and 5 of each 8-week (FLOX) OR receive weekly intravenous infusions of oxaliplatin 40 mg/m2, 5-FU 500 mg/m2, and leucovorin 250 mg/m2 (3 weeks on, 1 week off). Results. Non progression(PR+SD) was found in 33.5% for first regimen and 29% for second regimen, and 37.5% had clinical benefit (FLOX regimen) compared to 50% in 3-weeks regimen. The median TTP was 3.9,4 months respectively. Median OS was 8, 9 months for both regimens. Only one case in 3-weeks arm suffered from grade IV diarrhea. Two cases > grade 2 neutropenia were observed; one in each treatment groups. Grade 3 anemia was recorded in 3 patients (2 in FLOX arm, one in 3-weeks arm). Conclusions. Both regimens showed encouraging efficacy, acceptable toxicity, and clinical benefit.