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)

• DOI: 10.1200/jco.2004.22.90140.3567
• Publication Date: 2017-04-05T07:17:42Z
• Authors: J. Feliú; P. Escudero; F. Losa; M. Bolaños; J. M. Vicent; A. Yubero; J. Sanz-Lacalle; R. López; J. Dorta; M. González-Barón
• Keywords: Performance status

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