A multicenter phase 2 clinical trial testing a combination of oxaliplatin, bolus 5-fluorouracil, leucovorin and capecitabine in patients with metastatic colorectal cancer (MCRC)

Autor: R. W. Kwong, Kyle D. Holen, D. Warren, Noelle K. LoConte, Alcee Jumonville, Jens C. Eickhoff, K. Richie, D. Mulkerin, K. Teeter, T. Dzelak
Rok vydání: 2007
Předmět:
Zdroj: Journal of Clinical Oncology. 25:14526-14526
ISSN: 1527-7755
0732-183X
Popis: 14526 Introduction: The combination of oxaliplatin (OX) with bolus and infusional 5FU has shown high activity in MCRC. Substituting capecitabine (CAPE) for 5FU in a novel high-dose schedule designed to mimic FOLFOX-6 is a feasible and well tolerated treatment (Hegeman, ASCO, 2005, #2058). A multicenter phase 2 study of this combination was performed to evaluate efficacy in first-line treatment of MCRC. Methods: Eligible patients have ECOG PS 0–2, no grade 2 or higher neuropathy, and no prior systemic treatment for metastatic cancer. Patients are treated with OX 100 mg/m2, leucovorin (LV) 20 mg/m2 and 5FU 400 mg/m2 IV bolus followed by CAPE 1500 mg/m2 PO Q8H x 6 doses, repeated every two weeks. The primary endpoint was confirmed antitumoral response. Patients were allowed to come off study to pursue surgical resection, if feasible. Results: 36 out of a planned 45 patients have been enrolled since 6/04. Survival (OS) and time to progession (TTP) data are available for all 36 patients. Toxicity and efficacy data is available for 33 patients. The median age of enrolled patients is 65.5 years (range 42–78). 16 (44%) of patients are male. 94% of patients are ECOG PS 0 or 1. Toxicity data is presented in the table . 14/33 (42%) of patients had a grade 3/4 toxicity (see table ). The response rate was 33% (95% confidence interval [CI] 18–52%): 11 patients achieved a partial response (33%), 14 (42%) had stable disease, and 8 (24%) had progressive disease. Median overall survival was 17.1 months (M) (CI 0.7+-27.5+ M). The one-year survival rate was 67%. The median TTP/TTF was 4.1 M (CI 0.3–14.3 M). Four (11%) patients have come off of the study protocol to pursue metastatectomy. Conclusion: OX, infusional 5FU, LV and CAPE is active and well tolerated in MCRC. This regimen had fewer episodes of grade 3–4 hand-foot syndrome and mucositis than prior regimens including longer durations of capecitabine. Study supported by sanofi-aventis. [Table: see text] [Table: see text]
Databáze: OpenAIRE
Externí odkaz: