| First-line Sunitinib plus FOLFIRI in Japanese Patients with Unresectable/Metastatic Colorectal Cancer: a Phase II Study. | |
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MedLine Citation:
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PMID: 22537162 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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This phase II, open-label, single-arm study investigated sunitinib + FOLFIRI in Japanese patients with treatment-naïve unresectable/metastatic colorectal cancer (CRC). Patients received intravenous FOLFIRI (levo-leucovorin 200 mg/m² + irinotecan 180 mg/m², followed by 5-fluorouracil (5-FU) 400 mg/m² bolus then 2,400 mg/m(2) 46-hour infusion) every 2 weeks, and oral sunitinib 37.5 mg/day on Schedule 4/2 (4 weeks on, 2 weeks off), until disease progression or treatment withdrawal. Progression-free survival (PFS) was the primary endpoint, with a target median of 10.8 months (35% improvement over FOLFIRI alone). Seventy-one patients started a median of three (range 1-11) sunitinib cycles (median relative dose intensity [RDI]: <60%). Median PFS: 6.7 months (95% CI, 4.7-9.2) by independent review, 7.2 months (95% CI, 5.4-9.5) by investigator assessment. Objective response rate (complete responses [CRs] + partial responses [PRs]) was 36.6% (independent review) and 42.3% (investigator assessment). Clinical benefit rate (CRs + PRs + stable disease) was 83.1% (independent review) and 88.7% (investigator assessment). Common all-causality, any-grade, adverse events (AEs): neutropenia and leukopenia (both 97.2%), thrombocytopenia (84.5%), diarrhea and nausea (both 78.9%), decreased appetite (74.6%), and fatigue (66.2%). Neutropenia (96%) was the most frequent grade 3/4 AE. This study was closed early due to findings from a concurrent phase III study of sunitinib + FOLFIRI in non-Japanese patients with metastatic CRC. In conclusion, median PFS for sunitinib + FOLFIRI in Japanese patients was shorter than the 10.8 month target, indicating that sunitinib did not add to the antitumor activity of FOLFIRI. |
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Authors:
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Yasushi Tsuji; Taroh Satoh; Akihito Tsuji; Kei Muro; Motoki Yoshida; Tomohiro Nishina; Michitaka Nagase; Yoshito Komatsu; Takeshi Kato; Yoshinori Miyata; Naoko Mizutani; Satoshi Hashigaki; Maria Jose Lechuga; Tadamichi Denda |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-4-27 |
Journal Detail:
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Title: Cancer science Volume: - ISSN: 1349-7006 ISO Abbreviation: - Publication Date: 2012 Apr |
Date Detail:
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Created Date: 2012-4-27 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101168776 Medline TA: Cancer Sci Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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© 2012 Japanese Cancer Association. |
Affiliation:
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Department of Medical Oncology, KKR Sapporo Medical Center Tonan Hospital, Hokkaido, Japan. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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