Outcomes of patients ≥65 years old with advanced cancer treated on phase I trials at MD ANDERSON CANCER CENTER. Int J Cancer 2017 Jan 01;140(1):208-215
Date
10/18/2016Pubmed ID
27599876DOI
10.1002/ijc.30417Scopus ID
2-s2.0-84994410804 (requires institutional sign-in at Scopus site) 7 CitationsAbstract
Patients ≥65 years with cancer remain underrepresented in clinical trials, particularly in phase I clinical trials. We analyzed the clinical course of patients ≥65 years treated on phase I clinical trials with particular emphasis on toxicities. We identified 347 consecutive patients ≥65 years with advanced cancer in our phase I clinic from 01/2004-12/2009 and analyzed disease characteristics, toxicities, survival and response. Overall, 251 patients received a targeted agent, of whom 241 (96%) received an investigational, non-FDA-approved drug. Clinical benefit (complete response + partial response + stable disease ≥ 6 months) was noted in 61 patients (18%). Eighty-nine patients (26%) had grade 3/4 toxicity, commonly hematologic, including 6 dose-limiting toxicities and 1 treatment-related death (<0.01%). Median overall survival from first Phase I Clinic visit was 8.8 months (95% CI: 7.8-10.6); median time to treatment failure was 1.9 months (95% CI: 1.8-2.1). Multivariable analyses revealed 4 indicators of lack of clinical benefit (liver metastases, performance status [PS] >1, prior radiation, ≥5 prior treatments; p <0.0001). Patients age 70-79 years had a greater risk of grade 3/4 toxicities when treated with combinations (≥2 drugs) compared to monotherapy (p = 0.006). Predictors of shorter time to treatment failure and overall survival included PS >1, thrombocytosis, >2 metastatic sites, and elevated lactate dehydrogenase (p <0.05). Our results suggest that phase I clinical trials are well tolerated in patients ≥65 years. Additionally, we identified risk factors that may facilitate patient selection for clinical trial participation.
Author List
Subbiah IM, Wheler JJ, Hess KR, Hong DS, Naing A, Fu S, Kurzrock R, Tsimberidou AMAuthor
Razelle Kurzrock MD Center Associate Director, Professor in the Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AgedAged, 80 and over
Antineoplastic Agents
Clinical Trials, Phase I as Topic
Drug Therapy, Combination
Drugs, Investigational
Female
Humans
Male
Neoplasm Metastasis
Neoplasms
Patient Selection
Risk Factors
Survival Analysis
Treatment Failure
Treatment Outcome
