TY - JOUR
T1 - Cetuximab plus irinotecan in pretreated metastatic colorectal cancer patients
T2 - The ELSIE study
AU - Lim, Robert
AU - Sun, Yan
AU - Im, Seock Ah
AU - Hsieh, Ruey Kuen
AU - Yau, Tsz Kok
AU - Bonaventura, Anthony
AU - Cheirsilpa, Arkom
AU - Esser, Regina
AU - Mueser, Matthias
AU - Advani, Suresh
PY - 2011/4/14
Y1 - 2011/4/14
N2 - AIM: To evaluate the efficacy and safety of cetuximab plus irinotecan in irinotecan-refractory metastatic color-ectal cancer (mCRC) patients from South-East Asia and Australia. METHODS: In this open-label, phase 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-defned 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.
AB - AIM: To evaluate the efficacy and safety of cetuximab plus irinotecan in irinotecan-refractory metastatic color-ectal cancer (mCRC) patients from South-East Asia and Australia. METHODS: In this open-label, phase 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-defned 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.
KW - Asia
KW - Cetuximab
KW - Epidermal growth factor receptor
KW - Irinotecan
KW - Metastatic colorectal cancer
UR - http://www.scopus.com/inward/record.url?scp=79955929800&partnerID=8YFLogxK
U2 - 10.3748/wjg.v17.i14.1879
DO - 10.3748/wjg.v17.i14.1879
M3 - Article
C2 - 21528063
AN - SCOPUS:79955929800
VL - 17
SP - 1879
EP - 1888
JO - World Journal of Gastroenterology
JF - World Journal of Gastroenterology
SN - 1007-9327
IS - 14
ER -