1604P - Case-Control Phase II Clinical Trial to Assess Efficacy and Safety, of the Same Antineoplastic Treatment(S) in Elderly “Fit” Compared to Adult Patients with Cancer at Different Sites

Abstract

ABSTRACT Background We designed a case-control phase II open, prospective non-randomized trial in elderly “fit” (≥65 yo) cancer patients (pts) compared to well-matched adult (45-65 yo) cancer pts to assess whether the same standard antineoplastic treatment could achieve comparable results as for efficacy and safety. Planned sample size: 125 pts per arm. Endpoints: safety, QoL, PFS, ORR, dose intensity. Patients and methods Only elderly “fit” pts at MGA were included. Inclusion criteria for elderly: histological diagnosis of cancer with either advanced disease with measurable lesions or radically resected (adjuvant setting); 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 September 2011, 254 pts were enrolled, 127 elderly and 127 adults, all evaluable for toxicity. Elderly pts clinical characteristics: M/F ratio 69/58; mean age 70.8 ± 4.5 y. Adult pts: M/F ratio, 58/69; mean age 53 ± 5.4 y. Tumor sites: colo-rectal (23.5%), head and neck (16.4%), breast (14.1%), lung (11.7%), ovarian (9.3%); prostate (6.2%), NHL (4.7%), gastric (4.7%), liver (4.7%), uterus (3.9%), pancreas (0.8%); 92.1% of pts were stage IV, 5.9% stage III and 2.0% stage II. In the elderly no grade 4 toxicity were observed, hematological and non hematological grade 3 toxicities were observed in 12.21% and 13.8% of pts, respectively. In the adults, grade 4 hematological and non hematological toxicity were observed in 3.8% and 1.9% of pts, respectively; grade 3 hematological toxicity in 23.2% and non hematological toxicities in 21.3% of pts. The difference was statistically significant (p = 0.042) in favor of the elderly. At September 2011, 234 pts were assessable for response: the ORR was 50.7% for elderly and 51.1% for adults. No differences were observed for quality of life and dose intensity between the two groups. PFS was 10.6 mo. (3-12+ mo) for elderly and 9.05 mo. (3-12+) for adults. Conclusion The promising results of this single Institution study warrant to be confirmed by a larger clinical trial. Disclosure All authors have declared no conflicts of interest.