Abstract 447P
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.
Resources from the same session
250P - Impact of adjuvant chemo(radio)therapy in stage I/II testicular seminoma
Presenter: Mahmoud Eleisawy
Session: Poster Display
Resources:
Abstract
251P - LDH isozyme as a prognostic factor for patients with metastatic clear cell renal cell carcinoma (mCRCC)
Presenter: Hayato Takeda
Session: Poster Display
Resources:
Abstract
252P - Risk factors for recurrence after curative nephrectomy in non-metastatic renal cell carcinoma: A retrospective cohort study
Presenter: Kristine Tejada
Session: Poster Display
Resources:
Abstract
253TiP - WUTSUP-02-II-Neo-Dis-Tis: Investigating the efficacy and safety of neoadjuvant tislelizumab plus disitamab vedotin with adjuvant tislelizumab in upper urinary tract carcinoma: A phase II multi-center study
Presenter: Yige Bao
Session: Poster Display
Resources:
Abstract
254TiP - Prospective observational trial of cabozantinib plus nivolumab in Japanese patients with advanced or metastatic renal cell carcinoma: JACUMET trial
Presenter: Yuji Miura
Session: Poster Display
Resources:
Abstract
264P - Interim results from a phase I study of AMG 509 (xaluritamig), a STEAP1 x CD3 XmAb 2+1 immune therapy in patients with metastatic castration-resistant prostate cancer (mCRPC)
Presenter: Chia-Chi Lin
Session: Poster Display
Resources:
Abstract
266P - Clinical application and potential impact of liquid biopsy on the management of Chinese patients with metastatic castration-resistant prostate cancer (mCRPC): A territory-wide prospective analysis
Presenter: Wai Kay Philip Kwong
Session: Poster Display
Resources:
Abstract
267P - Exploring homologous recombination deficiency threshold for predicting response to PARP inhibitor in prostate cancer
Presenter: Diwei Zhao
Session: Poster Display
Resources:
Abstract
268P - Comparisons of on new-onset prostate cancer in type 2 diabetes mellitus exposed to the SGLT2I and DPP4I: A population-based cohort study
Presenter: Hou In Chou
Session: Poster Display
Resources:
Abstract
269P - Prostate cancer harboring low COMT expression correlates with a poor prognosis and response to enzalutamide
Presenter: Shigekatsu Maekawa
Session: Poster Display
Resources:
Abstract