LAUSR

Abstract Background Previous studies have developed risk stratification schemas to assess chemotherapy toxicity. However, it is controversial which geriatric assessment variables should be used to assess the individual risk of severe toxicity from chemotherapy in elderly patients. Methods Patients aged ≥70 years with advanced non-small cell lung cancer (NSCLC) treated at 24 National Hospital Organization institutions completed a pre-1st-line chemotherapy assessment, including the following: patient characteristics, treatment variables, laboratory test values, and geriatric assessment variables. Patients were followed through one cycle of chemotherapy to assess grade 3 (severe) to grade 5 (death) adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. We also analyzed clinical outcomes of all patients. Results In total, 348 advanced NSCLC patients with a median age of 76 years (range, 70 to 95 years) joined this prospective study. In all patients, the best objective response rate and disease control rate were 35.6% and 81.0%, respectively. Severe adverse events ≥grade 3 occurred in 136 patients (39.1%). Functional status (performance status, daily life independence level, and Barthel index; p = 0.0037, 0.0023, and 0.0214, respectively, between the ≥grade 3 cohort and the grade 0-2 cohort) and laboratory test results (anemia, albumin, and lactate dehydrogenase; p = 0.0497, 0.0171, and 0.0060 respectively, between the ≥grade 3 cohort and the grade 0-2 cohort) affected the occurrence of severe non-hematologic adverse events. For hematologic adverse events, body mass index, Charlson comorbidity, daily life independence level, recognition status, treatment variables, and anemia were involved with the occurrence of severe adverse events (p = 0.0488, 0.0333, 0.0358, 0.0276, Conclusions Geriatric assessment variables and several laboratory test values independently predicted vulnerability to chemotherapy in elderly patients with advanced NSCLC. Clinical trial identification UMIN000010384. Legal entity responsible for the study The National Hospital Organization in Japan. Funding The National Hospital Organization in Japan. Disclosure All authors have declared no conflicts of interest.