Results of a phase II open-label study of capecitabine in combination with irinotecan as first-line treatment for metastatic colorectal cancer.
BACKGROUND
Between July 2001 and September 2002, 49 eligible patients were enrolled in an open-label phase II study to assess the efficacy and safety of first-line treatment with capecitabine/irinotecan in metastatic colorectal cancer.


METHODS
Patients received capecitabine (1000 mg/m2 twice daily) on days 1-14 and irinotecan (240 mg/m2) on day 1 of a 21-day cycle. Patients enrolled had a median age of 64.5 years, and 6% of patients had an Eastern Cooperative Oncology Group performance status of 2. Fifty-seven percent of patients were male.


RESULTS
Forty-two patients were evaluable for response. There was 1 complete response (2%), 18 partial responses (43%), 20 cases of stable disease (48%), and 3 cases of disease progression (7%), for an overall response rate of 45% (95% CI, 30%-60%). The median duration of response was 5.7 months (range, 2.5-II.3 months). Median survival was 13.4 months (range, 1.2-28.8 months) and median progression-free survival was 6.2 months (range, 1.2-17.5 months). At 1 year, the estimated survival rate was 54% and the estimated progression-free survival rate was II%. The median number of cycles received was 6 (range, 1-18 cycles), and most patients (80%) required a dose modification because of diarrhea, nausea, and/or neutropenia. Grade 1/2 hand-foot syndrome occurred in 8 patients (16%). Grade 3/4 toxicities experienced by > or = 5% of patients included diarrhea (20%), neutropenia (12%), dehydration (10%), nausea (10%), anemia (6%), fatigue (6%), pain (6%), and vomiting (6%).


CONCLUSIONS
First-line capecitabine/ irinotecan is an active combination for the treatment of metastatic colorectal cancer and feasible for use in the community-based setting. Despite significant toxicity with the regimen, the treatment was manageable with dose reduction or delay and should be investigated in phase III trials.
Cartwright
Thomas
T
US Oncology Research, Inc., Houston, TX, USA. thomas.cartwright@usoncology.com
Lopez
Timothy
T
Vukelja
Svetislava J
SJ
Encarnacion
Carlos
C
Boehm
Kristi A
KA
Asmar
Lina
L
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis
D003841:Deoxycytidine; D000069287:Capecitabine; D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin