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©2011 Baishideng Publishing Group Co., Limited. All rights reserved.
Cetuximab plus irinotecan in pretreated metastatic colorectal cancer patients: The ELSIE study
Robert Lim, Yan Sun, Seock-Ah Im, Ruey-Kuen Hsieh, Tsz Kok Yau, Anthony Bonaventura, Arkom Cheirsilpa, Regina Esser, Matthias Mueser, Suresh Advani
Robert Lim, Department of Hematology-Oncology, National University Hospital, 119074 Singapore, Singapore
Yan Sun, Department of Medical Oncology, Cancer Hospital and Institute, Chinese Academy of Medical Science, Beijing 100021, China
Seock-Ah Im, Division of Hematology-Oncology, Department of Internal Medicine, Seoul National University Hospital, Seoul 110-744, South Korea
Ruey-Kuen Hsieh, Department of Oncology-Hematology, Mackay Memorial Hospital, Taipei 104, Taiwan, China
Tsz Kok Yau, Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong, China
Anthony Bonaventura, Department of Medical Oncology, Calvary Mater Newcastle Hospital, Waratah, New South Wales, 2298, Australia
Arkom Cheirsilpa, National Cancer Institute, Bangkok, 10400, Thailand
Regina Esser, Global Clinical Development Unit Oncology, Merck KGaA, Darmstadt, 64293, Germany
Matthias Mueser, Medical Affairs Oncology Asia Pacific, Merck Serono, 609927 Singapore, Singapore
Suresh Advani, Jaslok Hospital and Research Centre, Mumbai 400026, India
Author contributions: Lim R, Sun Y, Hsieh RK, Mueser M and Esser R designed the study; Lim R, Sun Y, Im SA, Hsieh RK, Yau TK, Bonaventura A, Cheirsilpa A and Advani S recruited patients to the study; Sun Y, Im SA, Hsieh RK, Yau TK, Bonaventura A, Cheirsilpa A, Esser R and Advani S performed the research; Sun Y, Im SA, Hsieh RK, Yau TK, Bonaventura A, Cheirsilpa A and Advani S collected data; Lim R, Hsieh RK, Mueser M and Esser R analyzed the data; Lim R, Bonaventura A, Mueser M and Esser R wrote and edited the manuscript; all authors gave final approval to manuscript submission.
Supported by Merck KGaA, Darmstadt, Germany
Correspondence to: Dr. Robert Lim, Department of Hematology-Oncology, National University Hospital, 5 Lower Kent Ridge Road, 119074 Singapore, Singapore. robert_lim@nuhs.edu.sg
Telephone: +65-67724616 Fax: +65-67775545
Received: November 15, 2010
Revised: November 22, 2010
Accepted: November 29, 2010
Published online: April 14, 2011
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/m2 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.
