Abstract
ABSTRACT Background HOT0901 trial evaluated the efficacy and safety of AMR, third-generation synthetic anthracycline agent, for NSCLC patients as third-line or fourth-line chemotherapy. We conducted a subset analysis of HOT0901 to determine the outcome for elderly patients. Methods Eligible patients had a performance status 0 to 2, failure of second-line or third-line chemotherapy, and adequate organ function. Patients received AMR 35 mg/m2 intravenously on days 1-3 every 3 weeks. The primary endpoint was disease control rate (DCR: CR + PR + SD). Secondary endpoints were overall survival (OS), progression-free survival (PFS), response rate (CR + PR), and toxicity profile. Elderly patients were defined as those at least 70 years of age at the time of enrollment. The efficacy and safety data for AMR therapy was compared between the elderly and younger patients ( Results There were 14 elderly and 27 younger patients in this study. Elderly patients accounted for 34% of the study cohort. Clinical characteristics such as PS or histologic subtypes were similar between the groups. The median number of treatment cycles was 3 in elderly and 2 in younger patients. The overall response rate and DCR were 14.3% and 71.4% in elderly patients and 7.4% and 55.5% in younger patients, respectively (p = 0.42 and 0.26). Median PFS was 3.6 and 2.4 months (p = 0.70), whereas median survival time was 11.3 and 13.9 months (p = 0.67) in elderly and younger patients. The most common grade 3/4 toxicity was neutropenia (64.3 vs. 70.4%); overall, there was no major difference in the incidence of hematological and nonhematological toxicities between the groups. No treatment-related death was observed in this study. Conclusion Third-line or fourth-line AMR yielded the similar efficacy and toxicity profiles between elderly and younger NSCLC patients. Data from this post-hoc analysis encourage prospective evaluation of potential benefit of AMR in elderly NSCLC patients. Disclosure All authors have declared no conflicts of interest.
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