Case-control phase II clinical trial to assess safety and efficacy of the same antineoplastic treatment(s) in fit elderly compared with adult patients with cancer at different sites.

Abstract

e19738 Background: We designed a case-control phase II open, prospective non-randomized trial in “fit” elderly (≥65 yo) cancer patients compared to well-matched adult (45-65 yo) cancer patients to assess whether the same standard antineoplastic treatment could achieve comparable results as for safety and efficacy. The planned sample size was 125 patients per arm. Endpoints were: safety, QoL, PFS, ORR, dose intensity. Methods: Only “fit” patients at MGA were included. Inclusion criteria for elderly: histological diagnosis of cancers with both advanced disease with measurable lesions or radically resected (adjuvant); life expectancy >3 mo.; adequate baseline functional parameters; written informed consent. Inclusion criteria for adults: the same as for elderly plus ECOG-PS 0-1. Results: At December 2010, 52 patients were enrolled, 26 elderly and 26 adults, all evaluable for toxicity. Elderly patients clinical characteristics: M/F ratio 13/13; mean age 70.5 ± 4.7 y. Adult patients: M/F ratio, 12/14; mean age 54 ± 6.1 y. Tumor sites were: colo-rectal, head and neck, NHL, gastric, uterus, breast, lung, prostate, colangiocarcinoma, pancreas, ovarian; 92.4% of patients were stage IV, 3.8% stage III and 3.8% stage II. In the elderly no grade 4 toxicity whilst nonhematological grade 3 toxicities were observed in 15.4% of patients. In the adults, grade 4 hematological and nonhematological toxicity were observed in 3.8% of patients, respectively; grade 3 hematological toxicity in 38.5% of patients and non hematological toxicities in 34.7% of patients. The difference was statistically significant (p=0.023) in favour of the elderly. At December 2010, 36 patients were assessable for response: the ORR was 55.6% for elderly and 38.9% for adults. No differences were observed as regards quality of life and dose intensity between the two groups. PFS was 10.1 mo. (3-12+ mo) for elderly and 8.57 mo. (3-12+) for adults. Conclusions: At this preliminarly planned interim-analysis, the results seem to suggest that elderly “fit” cancer patients can benefit from antineoplastic treatment both for safety and efficacy not differently from adults.