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Assessment of health-related quality of life (HRQoL) in KEYNOTE-010: A phase 2/3 study of pembrolizumab vs docetaxel in patients with previously treated advanced NSCLC

Date

08 Oct 2016

Session

Poster Display

Presenters

Fabrice Barlesi

Citation

Annals of Oncology (2016) 27 (6): 416-454. 10.1093/annonc/mdw383

Authors

F. Barlesi1, E. Garon2, D. Kim3, E. Felip4, J. Han5, J. Kim6, M.A. Ahn7, M.J. Fidler8, M.A. Gubens9, G. Castro, Jr.10, V. Surmont11, Q. Li12, A.C. Deitz12, G. Lubiniecki12, R.S. Herbst13

Author affiliations

  • 1 Oncology, Aix Marseille University; Assistance Publique Hôpitaux de Marseille, 13385 - Marseille/FR
  • 2 Medicine, Hematology And Oncology, David Geffen School of Medicine at UCLA, Santa Monica/US
  • 3 Internal Medicine, Seoul National University Hospital, Seoul/KR
  • 4 Medical Oncology, Vall d`Hebron University Hospital Institut d'Oncologia, 08035 - Barcelona/ES
  • 5 Translational And Clinical Research, National Cancer Center, Goyang/KR
  • 6 Department Of Oncology, CHA Bundang Medical Center, CHA University, Gyeonggi-do/KP
  • 7 Medical Oncology, Samsung Medical Center, Seoul/KR
  • 8 Internal Medicine, Rush University Medical Center, Chicago/US
  • 9 Department Of Medicine, University of California San Francisco, San Francisco/US
  • 10 Internal Medicine, Instituto do Câncer do Estado de São Paulo, São Paulo/BR
  • 11 Medical Oncology, Universitar Ziekenhuis Ghent, Gent/BE
  • 12 Medical Oncology, Merck & Co, Inc, Kenilworth/US
  • 13 Medical Oncology, Yale School of Medicine, New Haven/US
More

Resources

Abstract 2638

Background

In the randomized phase 2/3 KEYNOTE-010 study (NCT01905657), pembrolizumab significantly prolonged OS compared with docetaxel in previously treated, PD-L1–positive (tumor proportion score [TPS] ≥1% and ≥50%), advanced NSCLC. Here, we report HRQoL findings from KEYNOTE-010.

Methods

Patients (pts) with PD-L1–positive NSCLC who progressed after platinum-based chemotherapy were randomized 1:1:1 to pembrolizumab 2 or 10 mg/kg Q3W or docetaxel 75 mg/kg. HRQoL was assessed using eEORTC QLQ-C30, QLQ-LC13, and eEuroQoL-5D. Analyses included mean change from baseline to wk 12 in global QoL score, functioning and symptom domains; and time to deterioration in a QLQ-LC13 composite end point of cough, dyspnea, and chest pain.

Results

Compliance was >90% at baseline and >80% at wk 12. Pts in the pembrolizumab arms (n = 131, 2 mg/kg; n = 145,10 mg/kg) reported either a numerical improvement in or less decrement of QLQ-C30 global QoL score from baseline to wk 12 versus docetaxel (n = 125); the difference in least-squares means at wk 12 was statistically significant (8.3 [95% CI, 2.42-14.26]; P = 0.006) for pembrolizumab 2 mg/kg compared with docetaxel in the PD-L1 TPS ≥50% stratum. Changes from baseline in EORTC functioning and symptom domains were numerically superior for pembrolizumab versus docetaxel; fatigue, insomnia, dyspnea, hemoptysis, alopecia, peripheral neuropathy, and sore mouth reached statistical significance. Pembrolizumab also had a smaller proportion of “deteriorated” status and a larger proportion of “stable” and “improved” status for QLQ-C30 global QoL and functional and symptom scales versus docetaxel. Pembrolizumab increased time to true deterioration in the QLQ-LC13 composite end point; statistical significance was achieved for the pembrolizumab 2 mg/kg, TPS ≥50% stratum (HR, 0.68 [95% CI, 0.48-0.96]; P = 0.030 vs docetaxel). 12-wk EQ-5D visual analog scale analyses were consistent with the results of QLQ-C30 analyses.

Conclusions

Pembrolizumab improved HRQoL and prolonged time to deterioration of lung cancer symptom scores compared with docetaxel.

Clinical trial identification

NCT01905657

Legal entity responsible for the study

Merck & Co., Inc.

Funding

Merck & Co., Inc.

Disclosure

Q. Li, G. Lubiniecki: Employee of Merck & Co, Inc. A.C. Deitz: Employee and Stockholder: Merck & Co., Inc. Corporate-sponsored research: Merck & Co., Inc. All other authors have declared no conflicts of interest.

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