Results of a Phase II Trial of Cetuximab plus Capecitabine/Irinotecan as First-Line Therapy for Patients with Advanced and/or Metastatic Colorectal Cancer
| Autor: | John E. Nugent, Robert L. Ruxer, Paul R. Kuefler, Kristi A. Boehm, Svetislava J. Vukelja, Donald A. Richards, Allen Lee Cohn, William J. Hyman, Maury Berger, Lina Asmar, Thomas H. Cartwright |
|---|---|
| Rok vydání: | 2008 |
| Předmět: |
Adult
Male Oncology medicine.medical_specialty Colorectal cancer Cetuximab Adenocarcinoma Antibodies Monoclonal Humanized Irinotecan Deoxycytidine Gastroenterology Statistics Nonparametric Capecitabine Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Aged Aged 80 and over XELIRI Intention-to-treat analysis business.industry Antibodies Monoclonal Middle Aged medicine.disease digestive system diseases Regimen Treatment Outcome Disease Progression Quality of Life Camptothecin Female Fluorouracil Colorectal Neoplasms business Progressive disease medicine.drug |
| Zdroj: | Clinical Colorectal Cancer. 7:390-397 |
| ISSN: | 1533-0028 |
| Popis: | XELIRI (capecitabine/irinotecan) is effective and well tolerated in metastatic colorectal cancer (mCRC). Cetuximab is active in mCRC alone or with chemotherapy. This study evaluated cetuximab plus XELIRI in first-line treatment of mCRC.Subjects had histologically confirmed unresectable colorectal adenocarcinoma (with T4 lesions) after preoperative chemoradiation and/or metastases. Treatment was capecitabine 1700 mg/m2 (850 mg/m2 orally twice a day on days 1-14 for 3 weeks), irinotecan 200 mg/m2 intravenously (I.V.) on day 1 every 3 weeks, and weekly cetuximab (initially 400 mg/m2 I.V. [120 minutes], subsequently 250 mg/m2 [30 minutes]).Baseline characteristics (N = 70): 43 men (61%); median age, 61.5 years; Eastern Cooperative Oncology Group performance status 0/1 = 66%/34%; 94% adenocarcinoma. Previous therapy: surgery (91%), chemotherapy (14%), or radiation therapy (7%). Responses (patients completingor = 2 cycles): complete response (5.7%), partial response (37.7%), stable disease (43.4%), and progressive disease (PD; 13.2%); 16 patients discontinued early (n = 4 allergic reaction, n = 2 withdrew consent, n = 2 death, and n = 8 other adverse events [AEs]). The overall per-protocol response rate was 43.4% (34% intent to treat [ITT]; disease control rate, 86.8%; 69% ITT). The median time to progression was 8.1 months (range,1-27.0 months), and the median time to response was 1.6 months (range, 1.1-8.4 months). The median survival was 20.5 months, and 45.7% of patients remain alive. Of the 38 deaths, 84% were because of PD. No death was treatment related. The most frequent grade 3/4 treatment-related AEs included diarrhea, neutropenia, and nausea/vomiting; 32% of patients required dose reductions. All patients are off the study primarily because of PD (34.3%) or AEs (40.0%).In summary, XELIRI plus cetuximab is a promising regimen that merits further study for first-line mCRC. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect