Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 3681
© 2005 American Society of Clinical Oncology

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Abstract

Capecitabine and oxaliplatin: A phase II study with a new schedule of administration in elderly patients with advanced colorectal cancer

Gradenigo Hosp, Torino, Italy

3681

Background: Oral Capecitabine (CAP) is a highly effective chemotherapy agent for treatment of advanced colorectal cancer (ACRC), demonstrating superior antitumour activity and an improved safety profile versus 5-FU/LV. CAP moreover enables chronic dosing that mimics continuous infusion 5-FU and generates 5-FU preferentially in tumor via increased expression of thymidine phosphorylase. Oxaliplatin (OHP) is a third generation platinum compound with activity against colorectal cancer. Since adding OHP to infused 5-FU/LV improves efficacy, and substituting CAP for 5-FU/LV in combination with OHP should give effective, safe and convenient treatment. On the basis of the results of XELOX trial (Van Cutsem, 2003) we tested a regimen with CAP continuously (Cunningham, 2003) in elderly patients. Methods: On January 2003 we started a mono-institutional study with the following schedule: OHP 50 mg/sqm on days 1, 8, 15, 22 every 35 and CAP 1000 mg/sqm/day continuosly. End points of the study were feasibility, response rate and toxicity. Main elegibility criteria: ACRC untreated or pretreated; age 65 years, PS ECOG 0–2; an adequate hematologic, hepatic and renal function. 27 pts (17 M, 10 F) entered the study. Median age was 71 (65–79), median PS ECOG was 1. The primary tumour was colon cancer in 23 pts and rectal cancer in 4 pts. The sites of relapse were (one or more) 21 hepatic, 4 lung, 4 peritoneum, 2 abdominal nodes. 8 patients were pretreated with a first line chemotherapy and 4 received a previous radioterapy. Results: All patients were evaluable for toxicity and 26 for response. Following the RECIST criteria we observed: 5 PR (19,2%), 9 SD (34,6%), 12 PD (46,2%); 3 pts underwent surgical resection of their relapsing disease (hepatic) and conducted to a CR; median TTP was 6.1 monhts and OS was 14.2 months. Toxicity was very low: GI/II peripheral neuropathy in 11 pts (40%), G I/II nausea-vomiting in 5 pts (18%), G I/II neutropenia in 7 pts (26%), GI/II asthenia 10 pts (35%). In one case the treatment was interrupted for toxicity (neuropathy G III after 1 course). Conclusion: This regimen is feasible, active and very safe in elderly patients with ACRC; no life threatening toxicities were registered.

No significant financial relationships to disclose.