- Title
- Cetuximab Alone or With Irinotecan for Resistant KRAS-, NRAS-, BRAF- and PIK3CA-wild-type Metastatic Colorectal Cancer: The AGITG Randomized Phase II ICECREAM Study
- Creator
- Shapiro, Jeremy D.; Thavaneswaran, Subotheni; Tebbutt, Niall C.; Price, Timothy J.; Khasraw, Mustafa; Van Hazel, Guy A.; Waring, Paul M.; Tejpar, Sabine; Simes, John; Gebski, Val J.; Desai, Jayesh; Segelov, Eva; Underhill, Craig R.; Robledo, Kristy P.; Karapetis, Chistos S.; Day, Fiona L.; Nott, Louise M.; Jefford, Michael; Chantrill, Lorraine A.; Pavlakis, Nick
- Relation
- Clinical Colorectal Cancer Vol. 17, Issue 4, p. 313-319
- Publisher Link
- http://dx.doi.org/10.1016/j.clcc.2018.06.002
- Publisher
- Elsevier
- Resource Type
- journal article
- Date
- 2018
- Description
- Background: The Irinotecan Cetuximab Evaluation and Cetuximab Response Evaluation (ICECREAM) study assessed the efficacy of cetuximab monotherapy compared with cetuximab combined with chemotherapy for quadruple wild-type (KRAS, NRAS, BRAF, or P13KCA exon 20) metastatic colorectal cancer. Patients and Methods: Patients were enrolled in an open-label, multicenter, phase II trial and randomly assigned to cetuximab 400 mg/m2, then 250 mg/m2 cetuximab weekly, with or without irinotecan 180 mg/m2 every 2 weeks. The primary endpoint was 6-month progression-free survival; secondary endpoints were response rate, overall survival, toxicity, and quality of life. Results: From 2012 to 2016, 48 patients were recruited. Two were ineligible, and 2 were not evaluable for response. Characteristics were balanced, except gender (male, 62% vs. 72%) and primary sidedness (left, 95% vs. 68%). For cetuximab compared with cetuximab-irinotecan, progression-free survival was 14% versus 41% (hazard ratio, 0.39; 95% confidence interval, 0.20-0.78; P = .008); response rate was 10% (2 partial responses) versus 38% (1 complete, 8 partial); P = .04. Grade 3 to 4 toxicities were less with cetuximab monotherapy (23% vs. 50%); global and specific quality of life scores did not differ. Conclusion: In comparison with cetuximab alone, cetuximab plus irinotecan increases the response rate and delays progression in irinotecan-resistant RAS wild-type colorectal cancer. This echoes data from molecularly unselected patients.
- Subject
- cetuximab; chemotherapy colon cancer; irinotecan; RAS; SDG 3; Sustainable Development Goals
- Identifier
- http://hdl.handle.net/1959.13/1447205
- Identifier
- uon:43081
- Identifier
- ISSN:1533-0028
- Language
- eng
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