e19150 Background: AAs with lung cancer (LC) have shorter survival than Caucasians (Cs). Despite a higher LC incidence among AAs than Cs (74.7 vs 64.4/100,000), AAs are underrepresented in clinical trials. There are no reports of randomized LC prospective trials reporting AA results. In POINTBREAK, we enrolled AAs at the same rate as the US incidence of NSCLC in AAs. We report efficacy/safety of AAs in both arms and efficacy/safety of AA and C within the Pem Arm. Methods: Data from AAs and Cs enrolled in POINTBREAK were analyzed. AAs in both arms were evaluated in a pre-specified analysis. Hazard ratio and p-values were derived from a multivariate Cox-PH model by adjusting stratification factors. Results: Of 939 randomized pts, 94 were AA and 805 were C. Demographics were comparable between AA/intent-to-treat populations (%): 56/53 male, 65/52 ≤65 years, 87/88 ever smoker, 86/90 stage IV, 43/44 Eastern Cooperative Oncology Group performance status 0. The table shows efficacy results. Among AAs, drug-related grade 3/4 adverse events (AEs) include (Pem Arm %/Pac Arm %): anemia (7.3/0), thrombocytopenia (9.8/4.0), fatigue (4.9/4.0), neutropenia (31.7/44.0), febrile neutropenia (0/4.0). Within Pem Arm, drug-related grade 3/4 AEs (AA%/ C%) were anemia (7.3/15.9), thrombocytopenia (9.8/25.5), fatigue (4.9/11.5), neutropenia (31.7/25.3), febrile neutropenia (0/1.6). Conclusions: Median OS for Pem Arm was not superior to Pac Arm in AAs. Within Pem Arm, there were no significant differences between AAs and Cs for efficacy outcomes. Both regimens were tolerable in AAs. Clinical trial information: NCT00762034. [Table: see text]
Cost simulation for the US of febrile neutropenia hospitalization due to pegfilgrastim on-body injector failure compared to single-injection pegfilgrastim and daily injections with reference and biosimilar filgrastim in lung cancer