Palliative first-line chemotherapy of patients with metastatic colorectal cancer with 5-FU/FA as a 24h-inf. (AIO schedule) combined with weekly Irinotecan and bi-weekly Bevacizumab (BV): Interim analysis of a prospective evaluation

Abstract

15099 Background: BV is a humanized monoclonal antibody that targets vascular endothelial growth factor and downregulates angiogenesis. Since 2005 BV is licensed for the first-line treatment of patients (pts.) with metastatic colorectal cancer (CRC). The most effective treatment schedule applied in combination with BV which provides the lowest grade of toxic side effects is still unknown to date. Here, we report on the interim analysis of metastatic CRC pts., who have been treated with palliative first-line chemoth. based on 5-FU/FA as a 24h- inf. (AIO) combined with a weekly application of Irinotecan and bi-weekly BV. Methods: Prospective evaluation of 21 pts. in the framework of an application monitoring based on the tumor registry data of the Dept. of Int. Med. 1; start: 1.2.2005; palliative chemoth.: BV (5mg/kg i.v. as 0,5h-inf.; d1,15,29 qd57) and Irinotecan (80 mg/m2 i.v. as 1h-inf.; d1,8,15,22,29,36 qd57) followed by 5-FU (2,000 mg/m2 i.v. as 24h-inf.; d 1,8,15,22,29,36 qd57) and FA (500 mg/m2 i.v. as 24h-inf.; d1,8,15,22,29,36 qd57) via a miniature pump system. Results: Last date of evaluation: Nov/30/07; localisation: colon: 47.6%, rectum: 47.6%, unknown: 4.8%; histology: adenocarcinoma: 90.4%, signet-ring cell carcinoma: 4.8%, undifferentiated carcinoma: 4.8%; grading G2/G3: 81/19%; metastases: liver: 81%, peritoneum: 28.6%, lungs: 38.1%; median age: 54 years; men/women: 52.4/47.6%; ECOG 0/1/2: 42.8/52.4/4.8%; chemoth. appl.: total number: 386; higher grade toxicity (grade 3+4): anemia: 4.8%, diarrhea: 14.3%, hypertonia: 14.3%, pain: 4.8%, alopecia: 4.8%, intestinal fistula: 4.8%, thrombembolic events: 19%; response: CR: 9.5%, PR: 19%, SD: 66.7%, not evaluable: 4.8%; tumor control (CR, PR, SD): 95.2%; secondary metastatic resection: R0: 23.8%, R2: 14.3%, RX: 4.8%. Conclusion: Combination chemoth. with weekly Irinotecan and bi-weekly BV followed by 5-FU/FA as a 24h-inf. (AIO) on an out-patient basis is an effective palliative treatment schedule with solely low grade toxicity. Final results remain to be seen. No significant financial relationships to disclose.