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- W2272840787 abstract "Introduction: S-1 + irinotecan (IRIS) plus bevacizumab (Bev) is a standard therapy for metastatic colorectal cancer (mCRC) in Japan. However, few clinical data on its use in second line therapy are available. Methods: The study was conducted under a multicenter, single-arm, open-label prospective design. Major inclusion criteria were previously treated mCRC with an oxaliplatin containing regimen; presence of measurable lesions; age > 20 years; ECOG performance status (PS) 0–1; and adequate organ function. Patients received Bev 7.5 mg/kg d1 and IRIS (irinotecan 150 mg/m2 d1 plus S-1 80 mg/m2 bid d1-14) q3w, repeated until unacceptable toxicity or disease progression occurred. Primary endpoint was progression-free survival (PFS). A sample size of 37 was planned for a threshold PFS of 3.0 months (M) and expected value of 5.0 M, with one-sided alpha of 0.05 and beta of approximately 0.1. Results: Thirty-seven patients were enrolled from Nov. 2011 to May 2013, of whom male/female, 23/14; median age, 62.0 years (range 33-76); and PS 0/1, 33/4. Two patients did not fulfill the eligibility criteria, and one was not treated. 34 patients were assessed for response and 36 for safety: CR + PR, 7 patients; confirmed ORR, 20.6%. Response rate across all time points without confirmation was 26.5%. Median PFS was 5.6M (90% CI, 3.8-7.0M) and mOS was 16.4M (95% CI, 8.1–20.0M) The most common grade 3/4 adverse events were neutropenia 25.0%, thrombocytopenia 8.4%, anorexia 22.2%, fatigue 16.7%, hypertension 30.6%, hand-foot syndrome 0%, bleeding 5.6% and febrile neutropenia 5.6%. Conclusion: Second-line treatment with IRIS + Bev showed a promising response rate, PFS and OS, and an acceptable tolerability profile in clinical care of Japanese patients with mCRC." @default.
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- W2272840787 date "2015-06-01" @default.
- W2272840787 modified "2023-09-28" @default.
- W2272840787 title "P-244 Prospective study of S-1 + Irinotecan plus bevacizumab as second-line therapy in Japanese patients with metastatic colorectal cancer (KSCC1102)" @default.
- W2272840787 doi "https://doi.org/10.1093/annonc/mdv233.241" @default.
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