A phase II study of capecitabine (X) in elderly patients (p) as 1st line treatment for patients (pts) with advanced or metastatic colorectal cancer (MCRC)

Abstract

3567 Background: X has superior efficacy and improved safety compared to bolus 5-FU/LV in 1st line MCRC and preserves its safety advantage in pts >65 in the adjuvant setting. We investigated its use in an elderly pt population. Methods: Objectives were to determine efficacy and safety of twice daily oral X as 1st line therapy in elderly pts with histologically confirmed MCRC. Pts were not candidates for combination therapy, aged >70 years with no prior chemotherapy (except adjuvant), measurable disease (RECIST), ECOG PS ≤2 and adequate bone marrow, renal and hepatic function. They received X 1250 mg/m2 twice daily D1–14 every 3 weeks (1000 mg/m2 for moderate renal impairment). Results: 51 pts were enrolled (M/F 31/20), median age 75 (71–90), ECOG PS 0–1 86%, PS 2 14%. No comorbidity in 82%, 78% mild dependence on help (Barthel Index) and most (M/F 61%/44%) were autonomous (Lawton Index). Tumor sites were colon (n=26), rectum (n=24) or both (n=1). Median number of metastatic sites was 1 (1 site 59%, ≥ 2 sites 35%): 67% in liver and 33% lung. Previous treatment included surgery (75%), chemotherapy (24%) and radiotherapy (16%). A total of 254 cycles (median 5, range 1–8) were administered with a median relative dose intensity of 89%. All pts were evaluated for toxicity. No grade 3/4 toxicity exceeded 6% pts: thrombocytopenia 4%, neutropenia 2%, diarrhea and hand-foot syndrome 6%, dyspnea, nausea, vomiting, epigastric pain, liver, renal, cardiac, anorexia and abdominal pain all 2% pts. There was no significant difference in grade 3/4 toxicities between the overall population and those >80 years old. Intent-to-treat efficacy analysis: 2 pts achieved CR, 12 PR, 19 SD, 10 PD and 8 NE: response rate 27% (95% CI 14–40). Median TTP and OS were 8 (95% CI 5–11) and 11 (95% CI 9–13) months, respectively. Conclusions: This trial confirms that published data of 1st line X in the MCRC general population also apply to elderly pts. X is an effective and well tolerated 1st line treatment. No significant financial relationships to disclose.