Atezolizumab (A)/Bevacizumab(B)/Carboplatin/Paclitaxel (CP) has been proposed as a second-line option in EGFR mutant (EGFRm) non-small lung cancer (NSCLC) patients (pts) progressing to EGFR tyrosine kinase inhibitors (TKIs) without druggable resistance targets on the basis of an exploratory analysis of the phase III trial IMpower150. A therapeutic named use program has been open in Italy (June 2019-July 2020), although this regimen has not been approved. A real-world study has been designed in order to acquire more solid data about its feasibility.
This is a retrospective-prospective observational multicenter study with the primary aim to assess the feasibility of ABCP (rate of ineligible patients/potentially candidates) according to clinicians’ selection criteria in the real-world practice of 11 Italian centres. Secondary endpoints are overall survival (OS), progression free survival (PFS), response rate (RR), disease control rate (DCR), duration of response (DoR), time to treatment failure and discontinuation (TTF and TTD), safety and quality of life (QOL).
We report preliminary data from 80 EGFRm NSCLC pts progressing to TKIs. Overall, twenty-two received the ABCP regimen, with an ineligibility rate of 80%, mostly because of poor performance status (PS) and age. After a median follow-up of 14.2 months (mos), median TTD and TTF of 8.0 and 8.7 mos, respectively, were observed. The RR was 32% and DCR was 82%, with a median DoR of 3.9 mos. The median PFS was 5.7 mos and the OS was 16.2 mos. Adverse events (AEs) occurred in 15 (68%) patients: 6 (27%) G3/G4, 1 (5%) G5 (pneumonia). The most frequent AEs were: fatigue (36.4%), hypertension (18.2%), non-febrile neutropenia (18.2%). The QOL assessment through EORTC, QLQ-C30 e QLQ-LC13 scales, showed a worsening of the global health, the person's ability and the symptoms after the first or second cycle of treatment.
This observational study included a more representative sample of patients of the clinical practice, (poor PS; comorbidities). The high rate of ineligibility confirms this combination regimen as not feasible for most patient. Median OS, PFS and the incidence of AEs are lower than in the IMpower150 trial.
University of Padova.
University of Padova and Istituto Oncologico Veneto IRCCS.
All authors have declared no conflicts of interest.