Salvage treatment with single-agent capecitabine in patients with heavily pretreated advanced colorectal cancer.

Background: Refractory and/or relapsing advanced colorectal cancer (ACRC) requires frequent and prolonged hospitalisations, with a negative impact on the patients' quality of life (QoL). The aim of this single-centre, phase II study was to investigate the efficacy and safety of capecitabine (C) as salvage therapy in patients (pts) with ACRC, heavily pretreated with various chemotherapeutic regimens, as well as radiotherapy.

Patients And Methods: A total of 28 pts were enrolled, with the following characteristics: 16 male and 12 female, median age 60 years (36-70) and median ECOG PS 1 (0-2). All pts had previously received at least 2 regimens of standard chemotherapy, including 5-FU/leucovorin, oxaliplatin and irinotecan in various combinations, while 8 pts had been offered radiotherapy. Four pts had already been treated with C. The treatment was administered at home and consisted of C at a dose of 1250 mg/m2 twice daily on days 1-14, every 3 weeks, until disease progression (PD) and for a maximum of 9 cycles. Since grade (G) 3 gastrointestinal (GI) toxicity was observed among the first 7 pts, a daily dose of 2 g/m2 was adopted in the subsequent enrolment.

Results: The disease control (DC) rate was 53% (95% CI: 33.8%-72.5%): partial response in 2 pts and disease stabilization in 13 pts. Three out of 4 pts previously exposed to C showed stable disease. A significant symptom improvement was demonstrated in all 4pts with non-measurable baseline disease. The median time to progression was 4 months (range: 2-7). Nine pts had PD while on treatment. The median overall survival times for pts with DC and PD were 6 months and 3 months, respectively. Various types of G3 haematological toxicity were observed in 4/28 pts, G3 hand-foot syndrome in 6/28 pts and G3 GI toxicity in 8/28 pts. Nevertheless, the patients' QoL and the regimen's safety profile were satisfactorily preserved.

Conclusion: Despite its methodological limitations, our trial suggests that salvage treatment of heavily pretreated ACRC with single-agent C may be considered a safe and cost-effective alternative to best supportive care.