{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,14]],"date-time":"2026-02-14T06:12:14Z","timestamp":1771049534311,"version":"3.50.1"},"reference-count":32,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2024,8,14]],"date-time":"2024-08-14T00:00:00Z","timestamp":1723593600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2024,8,14]],"date-time":"2024-08-14T00:00:00Z","timestamp":1723593600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100015990","name":"Sanofi K.K.","doi-asserted-by":"publisher","award":["SGZ\u20102017\u201011875"],"award-info":[{"award-number":["SGZ\u20102017\u201011875"]}],"id":[{"id":"10.13039\/100015990","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Intl Journal of Cancer"],"published-print":{"date-parts":[[2024,12,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Aflibercept (AFL) plus FOLFIRI prolongs overall survival (OS) in patients with metastatic colorectal cancer (mCRC). However, there is limited evidence on the efficacy and safety of AFL plus FOLFIRI previously treated with anti\u2010epidermal growth factor receptor (EGFR) agents. Therefore, we conducted a prospective open\u2010label phase II trial evaluating the efficacy and safety of AFL plus FOLFIRI in Japanese patients with mCRC failing a prior oxaliplatin\u2010based chemotherapy plus an anti\u2010EGFR agent. AFL (4\u2009mg\/kg iv) followed by FOLFIRI (irinotecan 180\u2009mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    , leucovorin 200\u2009mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    iv, bolus 5\u2010fluorouracil [5\u2010FU] 400\u2009mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    , and infusional 5\u2010FU 2400\u2009mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    \/46\u2009h) was given every 2\u2009weeks until progression or unacceptable toxicities. The primary endpoint was progression\u2010free survival (PFS) rate at 6\u2009months. Forty three patients were enrolled between November 2019 and October 2022. The primary endpoint was met: 6\u2010month PFS rate was 58.8% (90% confidence interval [CI], 45.7%\u201372.0%). Median PFS and OS were 7.3\u2009months (95% CI, 5.5\u201311.0\u2009months) and 18.8\u2009months (95% CI, 12.9\u201326.6\u2009months), respectively. The overall response rate was 20.9% (95% CI, 10.0\u201336.0%) and disease control rate was 88.4% (95% CI, 74.9\u201396.1%). The main grade\u2009\u22653 adverse events included hypertension (62.8%), neutropenia (55.8%), leukopenia (25.6%), febrile neutropenia (11.6%), fatigue (9.3%), anorexia (9.3%), proteinuria (9.3%), and diarrhea (7.0%). No deaths and no new safety signals with a causal relation to the study treatment were observed. This study suggests that AFL plus FOLFIRI shows a high response rate and a manageable safety profile in Japanese patients with mCRC who failed prior oxaliplatin\u2010based chemotherapy plus an anti\u2010EGFR agent.\n                  <\/jats:p>","DOI":"10.1002\/ijc.35116","type":"journal-article","created":{"date-parts":[[2024,8,14]],"date-time":"2024-08-14T22:56:17Z","timestamp":1723676177000},"page":"2223-2231","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["A multicenter, prospective, phase\n                    <scp>II<\/scp>\n                    trial of second\u2010line aflibercept plus\n                    <scp>FOLFIRI<\/scp>\n                    in patients with metastatic colorectal cancer refractory to an anti\u2010\n                    <scp>EGFR<\/scp>\n                    antibody:\n                    <scp>HGCSG1801<\/scp>"],"prefix":"10.1002","volume":"155","author":[{"given":"Hiroshi","family":"Nakatsumi","sequence":"first","affiliation":[{"name":"Department of Gastroenterology National Hospital Organization Hokkaido Medical Center  Sapporo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1570-6802","authenticated-orcid":false,"given":"Yoshito","family":"Komatsu","sequence":"additional","affiliation":[{"name":"Division of Cancer Center Hokkaido University Hospital  Sapporo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuaki","family":"Harada","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Hokkaido University Hospital  Sapporo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasuyuki","family":"Kawamoto","sequence":"additional","affiliation":[{"name":"Division of Cancer Center Hokkaido University Hospital  Sapporo 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