Cetuximab plus irinotecan in pretreated metastatic colorectal cancer patients: The ELSIE study

被引:17
作者
Lim, Robert [1 ]
Sun, Yan [2 ]
Im, Seock-Ah [3 ]
Hsieh, Ruey-Kuen [4 ]
Yau, Tsz Kok [5 ]
Bonaventura, Anthony [6 ]
Cheirsilpa, Arkom [7 ]
Esser, Regina [8 ]
Mueser, Matthias [9 ]
Advani, Suresh [10 ]
机构
[1] Natl Univ Singapore Hosp, Dept Hematol Oncol, Singapore 119074, Singapore
[2] Chinese Acad Med Sci, Canc Hosp & Inst, Dept Med Oncol, Beijing 100021, Peoples R China
[3] Seoul Natl Univ Hosp, Dept Internal Med, Div Hematol Oncol, Seoul 110744, South Korea
[4] Mackay Mem Hosp, Dept Hematol Oncol, Taipei 104, Taiwan
[5] Pamela Youde Nethersole Eastern Hosp, Dept Clin Oncol, Hong Kong, Hong Kong, Peoples R China
[6] Calvary Mater Newcastle Hosp, Dept Med Oncol, Waratah, NSW 2298, Australia
[7] Natl Canc Inst, Bangkok 10400, Thailand
[8] Merck KGaA, Global Clin Dev Unit Oncol, D-64293 Darmstadt, Germany
[9] Merck Serono, Med Affairs Oncol Asia Pacific, Singapore 609927, Singapore
[10] Jaslok Hosp & Res Ctr, Bombay 400026, Maharashtra, India
关键词
Epidermal growth factor receptor; Cetuximab; Irinotecan; Metastatic colorectal cancer; Asia; GROWTH-FACTOR-RECEPTOR; PHASE-II TRIAL; FLUOROURACIL FAILURE; 1ST-LINE TREATMENT; RANDOMIZED-TRIAL; CHEMOTHERAPY; OXALIPLATIN; EXPRESSION; INFUSION; SURVIVAL;
D O I
10.3748/wjg.v17.i14.1879
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
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(2) initially, then 250 mg/m(2) 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/m(2) 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. (C) 2011 Baishideng. All rights reserved.
引用
收藏
页码:1879 / 1888
页数:10
相关论文
共 30 条
[1]  
Adenis A, 2005, J CLIN ONCOL, V23, p278S
[2]  
Baselga J, 2001, EUR J CANCER, V37, pS16
[3]   Fluorouracil, Leucovorin, and Oxaliplatin With and Without Cetuximab in the First-Line Treatment of Metastatic Colorectal Cancer [J].
Bokemeyer, Carsten ;
Bondarenko, Igor ;
Makhson, Anatoly ;
Hartmann, Joerg T. ;
Aparicio, Jorge ;
de Braud, Filippo ;
Donea, Serban ;
Ludwig, Heinz ;
Schuch, Gunter ;
Stroh, Christopher ;
Loos, Anja H. ;
Zubel, Angela ;
Koralewski, Piotr .
JOURNAL OF CLINICAL ONCOLOGY, 2009, 27 (05) :663-671
[4]   A CONFIDENCE-INTERVAL FOR THE MEDIAN SURVIVAL-TIME [J].
BROOKMEYER, R ;
CROWLEY, J .
BIOMETRICS, 1982, 38 (01) :29-41
[5]   Cetuximab Plus Irinotecan in Pretreated Metastatic Colorectal Cancer Progressing on Irinotecan: The LABEL Study [J].
Buzaid, Antonio C. ;
Mathias, Clarissa de Cerqueira ;
Perazzo, Florencia ;
Simon, Sergio D. ;
Fein, Luis ;
Hidalgo, Jorge ;
Murad, Andre M. ;
Esser, Regina ;
Senger, Stefanie ;
Lerzo, Guillermo .
CLINICAL COLORECTAL CANCER, 2010, 9 (05) :282-289
[6]   International Trends in Colorectal Cancer Incidence Rates [J].
Center, Melissa M. ;
Jemal, Ahmedin ;
Ward, Elizabeth .
CANCER EPIDEMIOLOGY BIOMARKERS & PREVENTION, 2009, 18 (06) :1688-1694
[7]   Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer [J].
Cunningham, D ;
Humblet, Y ;
Siena, S ;
Khayat, D ;
Bleiberg, H ;
Santoro, A ;
Bets, D ;
Mueser, M ;
Harstrick, A ;
Verslype, C ;
Chau, I ;
Van Cutsem, E .
NEW ENGLAND JOURNAL OF MEDICINE, 2004, 351 (04) :337-345
[8]   Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer [J].
Cunningham, D ;
Pyrhönen, S ;
James, RD ;
Punt, CJA ;
Hickish, TF ;
Heikkila, R ;
Johannesen, TB ;
Starkhammar, H ;
Topham, CA ;
Awad, L ;
Jacques, C ;
Herait, P .
LANCET, 1998, 352 (9138) :1413-1418
[9]  
FERLAY J, 2002, GLOBOCAN CANC INCIDE
[10]   Cetuximab and irinotecan/5-fluorouracil/folinic acid is a safe combination for the first-line treatment of patients with epidermal growth factor receptor expressing metastatic colorectal carcinoma [J].
Folprecht, G ;
Lutz, MP ;
Schöffski, P ;
Seufferlein, T ;
Nolting, A ;
Pollert, P ;
Köhne, CH .
ANNALS OF ONCOLOGY, 2006, 17 (03) :450-456