European Study Finds Capecitabine/ Oxaliplatin May Be Suitable Option for Elderly Patients With Advanced Colorectal Cancer

August 1, 2003

This special supplement to Oncology News International includes 28 reportswith updated information on clinical trials investigating capecitabine and other agents inthe treatment of advanced colorectal and breast cancers, and other solid tumors.The reports summarize selected presentations from the 39th Annual Meeting of theAmerican Society of Clinical Oncology (ASCO) and related educational symposiaheld in conjunction with ASCO.

NAPLES-The combination oforal capecitabine (Xeloda) plus oxaliplatin(Eloxatin) is safe and highly active inelderly patients with advanced colorectalcarcinoma, reported Pasquale Comella,MD, of the National Tumor Institute inNaples, Italy (ASCO abstract 2939).Dr. Comella explained the choice ofcapecitabine for the study. "Capecitabinegiven orally 2 of every 3 weeks has demonstrateda similar activity and a better toxicityprofile compared with IV leucovorin-modulated fluorouracil (5-FU) for 5days (Mayo regimen) in advanced colorectalcancer. Oxaliplatin 130 mg/m2combined with capecitabine 1,000 mg/m2bid is a safe and highly active 3-weeklyregimen (XELOX) in advanced colorectalcancer. This combination could also be asuitable option for elderly patients," hesaid."The number of elderly patients receivingpalliative chemotherapy for colorectalcarcinoma is still limited becauseof a diffuse concern about the complianceand tolerability of chemotherapy in suchpatients," Dr. Comella explained. "However,some investigators have stressed thatthe performance status, and the associatedmorbidities-more than the age of thepatients-may adversely affect outcome."Median of Six CyclesIn the first cycle, patients received oxaliplatin85 mg/m2 IV day 1, followed byoral capecitabine 1,000 mg/m2 bid fromday 2 to day 15. According to the originaldose escalation scheme, if toxicity on thefirst cycle was less than or equal to WorldHealth Organization (WHO) grade 1 toxicity, patients received a second cycle ofoxaliplatin 100 mg/m2 IV day 1, followedby oral capecitabine 1,000 mg/m2 bid,from day 2 to day 15. Then, if toxicity onthe second cycle was less than or equal toWHO grade 1, on the third and subsequentcycles, patients received oxaliplatin100 mg/m2 IV day 1, followed by oralcapecitabine 1,250 mg/m2 bid, from day 2to day 15. The median number of administeredcycles was 6 (range, 1 to 12) perpatient.Patient AssessmentsTo be eligible, patients were requiredto be over 70 years, have a life expectancyequal to or greater than 3 months, anEastern Cooperative Oncology Group(ECOG) performance status less than orequal to 2, one or more measurable lesions,and a Charlson score less than orequal to 4.The median age was 75 (range 70 to 81years). The site of the primary tumor wasthe colon in 57% of patients and the rectumin 43% of patients. Eighty percent ofpatients had previous surgery, and 23%had previous adjuvant chemotherapy.ECOG performance status was 0 in 43% of patients, 1 in 51% of patients, and 3 in6% of patients. Forty-six percent had onedisease site, 31% had two sites, and 23%had three plus sites.Of the 35 patients in the study, 6 werenot assessed for response. Response ratesamong the 29 that were assessed were: 6%complete response, 31% partial response,34% stable disease greater than 4 months,and 11% progressive disease (11%).Therefore, a temporary control of tumorgrowth was achieved in 71% of patients.The overall response rate was 37%, andthe median duration of responses was 6.9months.No patient suffered from grade 4 toxicity.Patients experienced severe diarrhea(9%), grade 3 peripheral neuropathy(11%), and mild/moderate hand-foot syndrome(11%).With a median follow-up of 10 months(range, 5.5 to 19 months), the 1-year probabilityof survival was 58%.In Summary"The combination of capecitabine withoxaliplatin (XELOX) seems to represent awell-tolerated and very active regimen forthese patients, provided that a careful,comprehensive geriatric assessment iscarried out," Dr. Comella summarized."A preliminary assessment of intrapatientdose escalation seems to suggest thata further increase of oxaliplatin dosage to130 mg/m2 could be attempted. However,the investigators recommend that thecapecitabine dosage remain at 1,000mg/m2 bid for 2 weeks."