P2.03a-023 Induction-Maintenance Treatment Sequence in Non-Squamous Non-Small Cell Lung Cancer (neNSCLC): Pemetrexed vs Vinorelbine-Based Induction

Abstract

Background: Febrile neutropenia (FN) is one of the serious complications associated with cancer chemotherapy and often leads to dose reduction and change of administration schedule which may affect treatment outcomes. This post hoc analysis explored the association between FN and patient reported outcomes (PRO).Methods: PROs were collected in the trial JVCG with Lung Cancer Symptom Scale (LCSS) and EQ-5D-3L. LCSS includes 6 symptom questions (loss of appetite, fatigue, cough, dyspnea, hemoptysis, pain) and 3 global QOL items (symptom distress, difficulties with daily activities, QOL) measured on a 0-100 mm scale, with higher scores representing greater symptom burden. PROs were collected at baseline (BL, during 14days till randomization), around Day 21 in every cycle, at the timing of discontinuation and at 30-day follow up (FU). LCSS total score, global QOL total score, each global QOL item score, EQ-5D utility index and VAS score were calculated. Time to deterioration (TtD) of the LCSS and EQ-5D defined as increase from BL by 15 mm for LCSS and 15% drop for EQ-5D, respectively, was analyzed using the Kaplan-Meier method stratified by treatment-emergent FN status.Results: Of 192 patients randomized to receive ramucirumab+docetaxel or placebo+docetaxel, 80.0% were male, median age was 64.6 and 54.0% had performance status1 at BL. FN occurred in 26.0% (50/ 192). Patients compliance with LCSS and EQ-5D were approximately 97.4% and 97.9%, respectively. Patients without FN showed longer TtD than patients with FN in LCSS total score and EQ-5D VAS score. Hazard ratio (HR) (95% CI) for LCSS total score were 0.731 (0.469, 1.141), p¼0.0945 (stratified) with censoring rate of 44.0% (with FN) and 54.9% (without FN). For EQ-5D VAS score, HR were 0.802 (0.537, 1.199), p¼0.5956 with censoring rate of 32.0% (with FN) and 43.0% (without FN). No significant difference was found. Conclusion: Prevailing clinical opinion suggests that FN negatively impacts QOL. In trial JVCG, a tendency was shown that QOL of patients with FN deteriorates more rapidly than in patients without FN, consistent with current beliefs. Additional investigation is needed but prevention and management of FN may contribute to maintaining QOL.Background: Non-squamous non-small cell lung cancer (neNSCLC) is the most frequent lung cancer subtype. Prognosis of advanced disease is poor, but in recent years, the treat-to-progression strategy has emerged, demonstrating significant improvement in overall survival (OS) of maintenance regimen with pemetrexed (Pem). There are limited head-to-head clinical trial data of various treat-to-progression strategies, and a Pem-based platin doublet induction strategy has never been directly compared to vinorelbine (VNR)-based one.