Capecitabine plus 3-weekly irinotecan (XELIRI regimen) as first-line chemotherapy for metastatic colorectal cancer: phase II trial results.

Abstract

BACKGROUND:

Capecitabine results in superior response rate, improved safety, and improved convenience compared with 5-fluorouracil (FU)/leucovorin (LV) in metastatic colorectal cancer (MCRC). Irinotecan in combination with 5-FU/LV has been shown to improve efficacy compared with 5-FU/LV alone in MCRC. Therefore, we evaluated the efficacy and safety of capecitabine plus irinotecan every 3 weeks (XELIRI regimen) as first-line treatment.

METHODS:

Patients with MCRC who were <65 years of age received irinotecan 250 mg/m i.v. on day 1 + capecitabine 1000 mg/m orally twice daily on days 1 to 14, every 3 weeks. Patients >or=65 years of age and those with impaired renal function or with a history of prior radiotherapy received lower doses of both agents (200 mg/m and 750 mg/m twice daily, respectively).

RESULTS:

A total of 52 patients (29 men, 23 women) were enrolled between October 2001 and August 2003. Median age was 57.5 years (range, 30-79 years); median Karnofsky performance status was 90 (range, 70-100). Treatment led to a response rate of 50% (ITT population) and a disease control rate of 71%. With a median cohort follow-up of 30.5 months, median time to progression and overall survival are 7.8 months (95% confidence interval, 5.6-10.0) and 16.8 months (95% confidence, 11.9 to not reached), respectively. Most common treatment-related grade 3/4 adverse events were neutropenia (25%), diarrhea (20%), vomiting (16%), dehydration (10%), nausea (6%), abdominal pain (6%), and hand-foot syndrome (6%).

CONCLUSION:

XELIRI is an active first-line treatment of MCRC. Implementation of upfront dose reductions for both agents in patients with risk factors for toxicity appears to have produced a safer regimen compared with previous studies of XELIRI without such dose reductions.

• Authors: Yehuda Z Patt, Fa-Chyi Lee, James E Liebmann, Dimitrios Diamandidis, S Gail Eckhardt, Milind Javle, Glen R Justice, Wayne Keiser, Joseph R Salvatore, Alice Bexon, Edward Lin
• Journal: American journal of clinical oncology (Am J Clin Oncol) Vol. 30 Issue 4 Pg. 350-7 (Aug 2007) ISSN: 1537-453X [Electronic] United States
• PMID: 17762434 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Deoxycytidine
• Capecitabine
• Irinotecan
• Fluorouracil
• Camptothecin

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Camptothecin (administration & dosage, analogs & derivatives)
• Capecitabine
• Colorectal Neoplasms (drug therapy, secondary)
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Disease-Free Survival
• Female
• Fluorouracil (administration & dosage, analogs & derivatives)
• Humans
• Irinotecan
• Male
• Maximum Tolerated Dose
• Middle Aged
• Survival Rate
• Treatment Outcome