XELOX (capecitabine plus oxaliplatin) as first-line treatment for elderly patients over 70 years of age with advanced colorectal cancer

Abstract

The purpose of this phase II trial was to determine the efficacy and safety of the XELOX (capecitabine/oxaliplatin) regimen as firstline therapy in the elderly patients with metastatic colorectal cancer (MCRC). A total of 50 patients with MCRC aged X70 years received oxaliplatin 130 mg m À2 on day 1 followed by oral capecitabine 1000 mg m À2 twice daily on days 1 -14 every 3 weeks. Patients with creatinine clearance 30 -50 ml min À1 received a reduced dose of capecitabine (750 mg m À2 twice daily). By intentto-treat analysis, the overall response rate was 36% (95% CI, 28 -49%), with three (6%) complete and 15 (30%) partial responses. In total, 18 patients (36%) had stable disease and 14 (28%) progressed. The median times to disease progression and overall survival were 5.8 months (95% CI, 3.9 -7.8 months) and 13.2 months (95% CI, 7.6 -16.9 months), respectively. Capecitabine was well tolerated: grade 3/4 adverse events were observed in 14 (28%) patients: 11 (22%) diarrhoea, eight (16%) asthenia, seven (14%) nausea/vomiting, three (6%) neutropenia, three (6%) thrombocytopenia, and two (4%) hand -foot syndrome. There was one treatment-related death from diarrhoea and sepsis. In conclusion, XELOX is well tolerated in elderly patients, with respectable efficacy and a meaningful clinical benefit response. Given its ease of administration compared with combinations of oxaliplatin with 5-FU/LV, it represents a good therapeutic option in the elderly.

Randomised trial comparing biweekly oxaliplatin plus oral capecitabine versus oxaliplatin plus i.v. bolus fluorouracil/leucovorin in metastatic colorectal cancer patients: results of the Southern Italy Cooperative Oncology study 0401

“…The feasibility and activity of the XELOX regimen in elderly patients has also been investigated: a 37% response rate, with 8.5 months of median progression-free survival and 14.4 months of median survival, have been reported (Comella et al 2005). These Wndings were subsequently conWrmed by Feliu et al (2006), who reported a 36% response rate, a median progression-free survival of 5.8 months, and an overall survival of 13.2 months.…”

Grade 3/4 neutropenia is a limiting factor in second-line FOLFIRI following FOLFOX4 failure in elderly patients with metastatic colorectal cancer

“…Subsequently, irinotecan was not widely used as a second-line therapy (18). Therefore, it may be necessary to increase the proportion of elderly to whom second-line treatment is administered following disease progression.…”

Capecitabine plus oxaliplatin compared with 5-fluorouracil plus oxaliplatin in metastatic colorectal cancer: Meta-analysis of randomized controlled trials

“…The median OS was 13.2 months (95% CI 7.6-16.9 months). There were 14 (28%) patients who exhibited Grade ≥3 adverse reactions including 11 (22%) with diarrhea, 8 (16%) with asthenia, 7 (14%) with nausea/vomiting, 3 (6%) with neutropenia, 3 (6%) with thrombocytopenia and 2 (4%) with hand-foot syndrome (20). Based on the data from these trials, capecitabine and oxaliplatin may be regarded as an appropriate treatment selection for elderly patients with MCRC.…”