Associations between hematologic toxicity and health-related quality of life during first-line chemotherapy in advanced non-small-cell lung cancer: A pooled analysis of two randomized trials

Abstract

Background: Many patients experience toxicity from chemotherapy that can negatively impact their health-related quality of life (HRQoL), but side effects often go undetected by health care personnel. Hematologic toxicity (HT) is the main dose-limiting toxicity of chemotherapy. Our aim was to investigate whether patients who experienced severe HT had more negative changes in HRQoL than those who did not. If so, blood counts could represent a simple and objective method for identifying patients at risk of severely impaired HRQoL who may benefit from more supportive care during the treatment period. Methods: Data from two phase III trials of first-line chemotherapy in advanced nonsmall- cell lung cancer (NSCLC) were analyzed (n=873). Blood counts weremeasured weekly. We categorized patients as having severe (CTCAE grade 3-4) or nonsevere (grade 0-2) HT during the first chemotherapy cycle. HRQoL was reported on the EORTC QLQ-C30 and LC13 before and at the end of the cycle. The primary endpoints were changes in global quality of life, fatigue, nausea/vomiting and dyspnea (LC13). Mean differences of 5-10 points was considered to represent a small clinical difference. Results: Of the 766 patients with complete data set, 177 (23%) developed severe HT during the first chemotherapy cycle. Severe neutropenia and thrombocytopenia was observed in 149 (19%) and 67 (9%) patients, respectively, while only three (0.4%) patients had severe anemia. Changes in fatigue and nausea/ vomiting were significantly worse for patients experiencing severe compared to patients with non-severe HT (difference in mean change of 4.9 points; p=0.01, and 6.4 points; p=0.01, respectively), but this association was limited to neutropenia, not thrombocytopenia or anemia. There were no significant associations between HT and global quality of life or dyspnea (difference in mean change of 2.1 points; p=0.28, and 3.3 points; p=0.053, respectively). Conclusions: Patients developing severe HT had worse changes in two out of four HRQoL endpoints, but the association was not strong enough to use blood counts to identify patients who experience deterioration of HRQoL during chemotherapy.