447P - Quality of life in patients with EGFR-mutated lung cancer receiving gefitinib vs gefitinib plus pemetrexed and carboplatin chemotherapy

Background

The addition of chemotherapy to Gefitinib improved outcomes in non-small cell lung cancer (NSCLC) with sensitizing EGFR mutations in this trial, these results have already been published. Here we analysed the quality of life (QoL) data of patients in this study to determine the impact of the addition of chemotherapy to Gefitinib on QoL.

Methods

This was a phase III randomized trial in treatment-naive patients with advanced NSCLC with an EGFR-sensitizing mutation and ECOG PS of 0 -2 receiving first-line palliative therapy. Patients were randomized 1:1 to receive either gefitinib 250 mg PO once a day (Gef) or gefitinib 250 mg PO once a day with Pemetrexed (500 mg/m2) + Carboplatin (AUC5) IV every 3 weeks for 4 cycles, followed by maintenance pemetrexed (gefitinib plus chemotherapy [Gef+C]). The primary endpoint was PFS; QoL was a key secondary endpoint. QoL was assessed using the EORTC QLQ C-30 and LC 13 questionnaires and their validated translations. QoL was collected at 2 monthly intervals [60 (+/-15) days]. The mean QoL scores for both arms were plotted and compared between the two arms at each time point using the Mann-Whitney Test. Sensitivity analysis was performed. The mixed linear model analysis is used to study the impact of treatment arms and time on QoL scores while considering participant variability.

Results

In the linear mixed model analysis (LMA), there was no significant impact on the global health status (QL) scores between the 2 arms (p= 0.5007). However, there was a significant change in the global health status scores in both arms over time (p= 0.0420). In the LMA there were no significant differences in the other function scales between the 2 arms. The scores for the symptoms scale had significantly improved for pain (p = 0.0351), dyspnoea (p = 0.0483), diarrhea (p = 0.0243), sore mouth (p = 0.0283), pain in the arm or shoulder (p = 0.0315), pain in other parts (p = 0.0273) improved over time in the Gef+C arm as compared Gef arm.

Conclusions

The addition of chemotherapy to Gefitinib improved survival outcomes (PFS an dOS) without a significant adverse impact on quality of life.

Clinical trial identification

CTRI/2016/08/007149.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Tata Memorial Center Research Administration Council and unrestricted educational grants from Dr. Reddy’s Laboratories, Fresenius Kabi India, Alkem Laboratories, Natco Pharma, BDR Pharmaceuticals, and Lung Cancer Consortium India.

Disclosure

All authors have declared no conflicts of interest.