- Title
- Cetuximab plus irinotecan in pretreated metastatic colorectal cancer patients: the ELSIE Study
- Creator
- Lim, Robert; Sun, Yan; Im, Seock-Ah; Hsieh, Ruey-Kuen; Yau, Tsz Kok; Bonaventura, Anthony; Cheirsilpa, Arkom; Esser, Regina; Mueser, Matthias; Advani, Suresh
- Relation
- World Journal of Gastroenterology Vol. 17, Issue 14, p. 1879-1888
- Publisher Link
- http://dx.doi.org/10.3748/wjg.v17.i14.1879
- Publisher
- Beijing Baishideng BioMed Scientific
- Resource Type
- journal article
- Date
- 2011
- Description
- Aim: To evaluate the efficacy and safety of cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer (mCRC) patients from South-East Asia and Australia. Methods: In this open-label, phase II study, the main eligibility criteria were epidermal growth factor receptor-positive mCRC with progressive disease within 3 mo of an irinotecan-based regimen as the most recent chemotherapy. Patients received cetuximab 400 mg/m initially, then 250 mg/m² every week, with the same regimen of irinotecan on which the patients had progressed (4 pre-defined regimens allowed). The primary objective was evaluation of progression-free survival (PFS) at 12 wk. Secondary objectives included a further investigation of PFS, and an assessment of the overall response rate (ORR), duration of response, time to treatment failure (TTF), overall survival and the safety profile. Results: One hundred and twenty nine patients were enrolled from 25 centers in the Asia-Pacific region and of these 123 received cetuximab plus irinotecan. The most common recent irinotecan regimen used was 180 mg/m² every 2 wk which had been used in 93 patients (75.6%). The PFS rate at 12 wk was 50% (95% confidence interval (CI, 41-59) and median PFS time was 12.1 wk (95% CI: 9.7-17.7). The ORR was 13.8% (95% CI: 8.3-21.2) and disease control rate was 49.6% (95% CI: 40.5-58.8). Median duration of response was 31.1 wk (95% CI: 18.0-42.6) and median overall survival was 9.5 mo (95% CI, 7.5-11.7). The median TTF was 11.7 wk (95% CI: 9.1-17.4). Treatment was generally well tolerated. The most common grade 3/4 adverse events were diarrhea (13.8%), neutropenia (8.9%), rash (5.7%) and vomiting (5.7%). Conclusion: In patients from Asia and Australia, this study confirms the activity and safety of cetuximab plus irinotecan observed in previous studies in Europe and South America.
- Subject
- epidermal growth factor receptor; cetuximab; irinotecan; metastatic colorectal cancer; Asia
- Identifier
- http://hdl.handle.net/1959.13/1042846
- Identifier
- uon:14133
- Identifier
- ISSN:1007-9327
- Language
- eng
- Full Text
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