Efficacy of Combination Chemotherapy with Irinotecan (CPT-11) plus Capecitabine in Patients with Metastatic or Advanced Colorectal Carcinoma — a Dual-centre Phase II Study: the MAC-6

• Published in: Clinical oncology (Royal College of Radiologists (Great Britain)) Vol. 20; no. 2; pp. 168 - 175
• Main Authors: Choi, C.K.K, Chan, R.T.T, Tung, S.Y, Lui, L, Siu, S, Au, G.K.H, Ho, J.W.C, Law, W.L
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.03.2008
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Camptothecin - administration & dosage; Camptothecin - adverse effects; Camptothecin - analogs & derivatives; Capecitabine; Colorectal Neoplasms - drug therapy; CPT-11; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Disease-Free Survival; Drug Administration Schedule; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Fluorouracil - analogs & derivatives; Hematology, Oncology and Palliative Medicine; Humans; irinotecan; Male; metastatic colorectal cancer; Middle Aged; Neoplasm Metastasis; Radiology; Salvage Therapy; Survival Rate; metastatic colorectal cancer; irinotecan; CPT-11; Capecitabine
• ISSN: 0936-6555; 1433-2981
• DOI: 10.1016/j.clon.2007.11.008

Abstract Aims A phase II trial was initiated to evaluate the efficacy and toxicity of combination chemotherapy with irinotecan (CPT-11) plus capecitabine in patients with metastatic colorectal cancer. Patients and methods Patients received a combination of CPT-11 plus capecitabine. CPT-11 was infused intravenously on day 1 every 2 weeks and oral capecitabine was taken twice daily for 5 days every 7 days. Efficacy and toxicities were assessed. Results Between 2004 and 2005, 43 patients were enrolled. The overall response rate was 51.35%. With a median follow-up of 13 months, the median time to progression was 10 months (95% confidence interval 7.6–12.3 months); the median survival was 15 months (95% confidence interval 13.9–16.9 months). The most common grade 3 haematological and non-haematological toxicities were neutropenia (5.4%), diarrhoea (8.1%) and hand–foot syndrome (2.7%). Conclusions CPT-11 plus capecitabine with a 14 day cycle showed a comparable response with international phase II data with a 3 weekly regimen and was well tolerated as a first-line palliative chemotherapy in patients with metastatic colorectal cancer. The data should be interpreted with caution due to the limited sample size and should be further confirmed by a phase III randomised trial.