Phase II study of cetuximab with irinotecan for KRAS wild‐type colorectal cancer in Japanese patients. Issue 2 (6th August 2015)

• Record Type: Journal Article
• Authors: Terazawa, Tetsuji; Nishitani, Hitoshi; Kato, Ken; Hashimoto, Hironobu; Akiyoshi, Kohei; Ito, Yuriko; Nakamoto, Akihiro; Iwasa, Satoru; Nakajima, Takako Eguchi; Hamaguchi, Tetsuya; Yamada, Yasuhide; Shimada, Yasuhiro
• Is Part Of: Asia-Pacific journal of clinical oncology. Volume 13:Issue 2(2017)
• Page Start: e132
• Page End: e137
• Publication Date: 2015-08-06
• Subjects: cetuximab -- efficacy -- feasibility -- Japanese patient; Oncology -- Pacific Area -- Periodicals; Cancer -- Treatment -- Pacific Area -- Periodicals; Cancer -- Pacific Area -- Periodicals; Cancer -- Treatment -- Periodicals; 616.9940095
• DOI: 10.1111/ajco.12405
• Languages: English
• ISSNs: 1743-7555

Abstract

Abstract: Aim: Cetuximab improves the prognosis for wild‐type KRAS metastatic colorectal cancer (MCRC). We evaluated the safety and efficacy of cetuximab in combination with irinotecan in Japanese patients with wild‐type KRAS MCRC refractory to irinotecan, oxaliplatin and fluoropyrimidines. Methods: Cetuximab was administered initially at a dose of 400 mg/m 2, followed by weekly infusions at 250 mg/m 2 . Irinotecan was administered every 2 weeks at 150 mg/m 2 . Primary endpoint was the incidence of grade 3/4 adverse events; secondary endpoints included overall survival (OS), progression‐free survival (PFS), response rate (RR), time to treatment failure (TTF), and TTF for irinotecan. Results: Thirty‐four patients were enrolled. Grade 3 or 4 toxicities were leucopenia (11.8%), neutropenia (23.5%), anemia (11.8%), fatigue (2.9%), anorexia (2.9%), diarrhea (14.7%) and hypomagnesemia (5.9%). Skin toxicities were as follows (any grade/grade 3): acne (94.2/8.8%), rash (55.9/0%), nail changes (75.5/8.8%) and hand‐foot syndrome (55.9/5.9%). Median PFS was 6.0 months (95%CI; 4.7–7.4). Median OS was 12.9 months (95%CI; 10.0–15.9). RR was 26.4%. Median TTF was 5.1 months and median TTF for irinotecan was 5.0 months (95%CI; 4.3–5.6). Conclusion: Cetuximab with irinotecan therapy was well tolerated in Japanese patients with wild‐type KRAS colorectal cancer refractory to irinotecan, oxaliplatin and fluoropyrimidine, thus demonstrating the feasibility of their usage.