Health-related quality of life (HRQoL) with paclitaxel plus ramucirumab (PTX-RAM) switch maintenance versus continuation of first-line fluoropyrimidine and oxaliplatin (FOX) chemotherapy (ChT) in patients (pts) with advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) cancer: A secondary endpoint of the ARMANI phase 3 randomized trial.

Abstract

4060 Background: PTX-RAM switch maintenance significantly improved PFS (HR 0.61, 95%CI 0.48–0.79; p = 0.0002) and OS (HR 0.75, 95%CI 0.58–0.96; p = 0.025) versus continuation of FOX first-line ChT in the ARMANI trial, with a higher incidence of grade ≥3 treatment-related adverse events and an increased number of hospital visits. Here we present HRQoL results. Methods: ARMANI was an Italian multicenter, open-label, randomized, phase 3 trial enrolling pts with HER2-negative G/GEJ cancer who had disease control after a 3-month FOX induction ChT, and randomized to switch maintenance with PTX-RAM or the continuation of FOX. European Organisation for Research and Treatment of Cancer (EORTC) QLQC30, QLQOG25 and EuroQol EQ5D were assessed at randomization and every 8 weeks until progression. HRQoL changes over time were described by: (i) mean changes from baseline at each time point, (ii) distribution of improved/stable/worse at 8 weeks and (iii) time to QoL deterioration (TTD), defined as the time from randomization to a worsening ≥ 10 points of global QoL in EORTC QLQC30. Mean changes were compared by a linear regression model, with baseline values as covariates. Proportion of improved/stable/worse was compared by Chi square test. Kaplan-Meier and Cox proportional hazards model were used for TTD estimation. Results: Of the 280 pts randomized, 198 (71%; 109/144 with PTX-RAM and 89/136 with FOX) and 133 (48%; 81/144 and 52/136) completed baseline and 8-weeks assessment of EORTC and EQ5D, respectively. Mean baseline scores of global HRQoL were 66.90 (standard deviation [SD] 20.71) with PTX-RAM and 70.97 (SD 19.39) with FOX. Global QoL at 8-weeks assessment was better with PTX-RAM versus FOX both in terms of mean changes from baseline (+2.17 vs -8.51, delta 10.68, p = 0.015) and in terms of proportion of improved/stable/worse (improved 24.7% vs 4.2%, stable 56.2% vs 64.6%, worse 19.2% vs 31.3%, p = 0.009). TTD was significantly longer for PTX-RAM versus FOX (median TTD 7.6 vs 3.8 months, HR 0.52, 95%CI 0.33-0.82; p = 0.005). Mean changes from baseline after 8 weeks for functional scales and symptoms of QLQC30 and QLQOG25 showed significant improvement for PTX-RAM vs FOX for role functioning (p = 0.006), nausea/vomiting (p = 0.002), pain (p = 0.016), appetite loss (p = 0.03) and dysphagia (p = 0.028); hair loss was worse with PTX-RAM (p = 0.024). VAS score from EQ5D was not significantly different between the two treatments for all the assessments. Conclusions: In pts with HER2-negative advanced G/GEJ cancer, PTX-RAM switch maintenance, beyond a significant benefit in PFS and OS, showed significant benefit in terms of HRQoL, reducing symptoms and delaying global QoL deterioration. Clinical trial information: NCT02934464 .