Patient-Reported Health-Related Quality of Life in KEYNOTE-604: Pembrolizumab or Placebo Added to Etoposide and Platinum as First-Line Therapy for Extensive-Stage SCLC

Hye Ryun Kim, MD, PhD; Mark M. Awad, MD, PhD; Alejandro Navarro, MD; Maya Gottfried, MD; Solange Peters, MD, PhD; Tibor Csőszi, MD; Parneet K. Cheema, MD; Delvys Rodriguez-Abreu, MD, PhD; Mirjana Wollner, MD; James Chih-Hsin Yang, MD, PhD; Julien Mazieres, MD, PhD; Francisco J. Orlandi, MD; Alexander Luft, MD, PhD; Mahmut Gümüş, MD; Terufumi Kato, MD; Gregory P. Kalemkerian, MD; Yiwen Luo, PhD; Melissa L. Santorelli, PhD, MPH; M. Catherine Pietanza, MD; Charles M. Rudin, MD, PhD

JTO Clinical and Research Reports (Nov 2023)

Patient-Reported Health-Related Quality of Life in KEYNOTE-604: Pembrolizumab or Placebo Added to Etoposide and Platinum as First-Line Therapy for Extensive-Stage SCLC

Hye Ryun Kim, MD, PhD,
Mark M. Awad, MD, PhD,
Alejandro Navarro, MD,
Maya Gottfried, MD,
Solange Peters, MD, PhD,
Tibor Csőszi, MD,
Parneet K. Cheema, MD,
Delvys Rodriguez-Abreu, MD, PhD,
Mirjana Wollner, MD,
James Chih-Hsin Yang, MD, PhD,
Julien Mazieres, MD, PhD,
Francisco J. Orlandi, MD,
Alexander Luft, MD, PhD,
Mahmut Gümüş, MD,
Terufumi Kato, MD,
Gregory P. Kalemkerian, MD,
Yiwen Luo, PhD,
Melissa L. Santorelli, PhD, MPH,
M. Catherine Pietanza, MD,
Charles M. Rudin, MD, PhD

Affiliations

Hye Ryun Kim, MD, PhD: Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea; Corresponding author. Address for correspondence: Hye Ryun Kim, MD, PhD, Yonsei Cancer Center, Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Sinchon-dong, Seodaemun-gu, Seoul 03722, South Korea.
Mark M. Awad, MD, PhD: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts
Alejandro Navarro, MD: Clinical Research Department, Vall d’Hebron Institute of Oncology (VHIO) and Oncology Department, Vall d'Hebron University Hospital, Barcelona, Spain
Maya Gottfried, MD: Oncology Department, Meir Medical Center, Kfar-Saba, Israel
Solange Peters, MD, PhD: Oncology Department, Lausanne University Hospital, Lausanne, Switzerland
Tibor Csőszi, MD: Department of Oncology, Hetenyi G Korhaz Onkologiai Kozpont, Szolnok, Hungary
Parneet K. Cheema, MD: Division of Medical Oncology, William Osler Health System, University of Toronto, Brampton, Ontario, Canada
Delvys Rodriguez-Abreu, MD, PhD: Medical Oncology Department, Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain
Mirjana Wollner, MD: Department of Medical Oncology, Rambam Medical Center, Haifa, Israel
James Chih-Hsin Yang, MD, PhD: Department of Oncology, National Taiwan University Hospital and Department of Medicine, National Taiwan University Cancer Center, Taipei, Taiwan
Julien Mazieres, MD, PhD: Department of Thoracic Oncology, Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France
Francisco J. Orlandi, MD: Region Metropolitana de Santiago, Orlandi Oncologia, Santiago, Chile
Alexander Luft, MD, PhD: Department of Oncology No. 1 (Thoracic Surgery), Leningrad Regional Clinical Hospital, St. Petersburg, Russia
Mahmut Gümüş, MD: Department of Medical Oncology, Istanbul Medeniyet University Hospital, Istanbul, Turkey
Terufumi Kato, MD: Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan
Gregory P. Kalemkerian, MD: Division of Hematology/Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan
Yiwen Luo, PhD: Biostatistics and Research Decision Sciences, Merck & Co., Inc., Rahway, New Jersey
Melissa L. Santorelli, PhD, MPH: Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts; Clinical Research Department, Vall d’Hebron Institute of Oncology (VHIO) and Oncology Department, Vall d'Hebron University Hospital, Barcelona, Spain; Oncology Department, Meir Medical Center, Kfar-Saba, Israel; Oncology Department, Lausanne University Hospital, Lausanne, Switzerland; Department of Oncology, Hetenyi G Korhaz Onkologiai Kozpont, Szolnok, Hungary; Division of Medical Oncology, William Osler Health System, University of Toronto, Brampton, Ontario, Canada; Medical Oncology Department, Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain; Department of Medical Oncology, Rambam Medical Center, Haifa, Israel; Department of Oncology, National Taiwan University Hospital and Department of Medicine, National Taiwan University Cancer Center, Taipei, Taiwan; Department of Thoracic Oncology, Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France; Region Metropolitana de Santiago, Orlandi Oncologia, Santiago, Chile; Department of Oncology No. 1 (Thoracic Surgery), Leningrad Regional Clinical Hospital, St. Petersburg, Russia; Department of Medical Oncology, Istanbul Medeniyet University Hospital, Istanbul, Turkey; Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan; Division of Hematology/Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan; Biostatistics and Research Decision Sciences, Merck & Co., Inc., Rahway, New Jersey; Center for Observational and Real-World Evidence, Merck & Co., Inc., Rahway, New Jersey; Global Clinical Development, Merck & Co., Inc., Rahway, New Jersey; Department of Medicine, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York, New York
M. Catherine Pietanza, MD: Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts; Clinical Research Department, Vall d’Hebron Institute of Oncology (VHIO) and Oncology Department, Vall d'Hebron University Hospital, Barcelona, Spain; Oncology Department, Meir Medical Center, Kfar-Saba, Israel; Oncology Department, Lausanne University Hospital, Lausanne, Switzerland; Department of Oncology, Hetenyi G Korhaz Onkologiai Kozpont, Szolnok, Hungary; Division of Medical Oncology, William Osler Health System, University of Toronto, Brampton, Ontario, Canada; Medical Oncology Department, Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain; Department of Medical Oncology, Rambam Medical Center, Haifa, Israel; Department of Oncology, National Taiwan University Hospital and Department of Medicine, National Taiwan University Cancer Center, Taipei, Taiwan; Department of Thoracic Oncology, Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France; Region Metropolitana de Santiago, Orlandi Oncologia, Santiago, Chile; Department of Oncology No. 1 (Thoracic Surgery), Leningrad Regional Clinical Hospital, St. Petersburg, Russia; Department of Medical Oncology, Istanbul Medeniyet University Hospital, Istanbul, Turkey; Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan; Division of Hematology/Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan; Biostatistics and Research Decision Sciences, Merck & Co., Inc., Rahway, New Jersey; Center for Observational and Real-World Evidence, Merck & Co., Inc., Rahway, New Jersey; Global Clinical Development, Merck & Co., Inc., Rahway, New Jersey; Department of Medicine, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York, New York
Charles M. Rudin, MD, PhD: Department of Medicine, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York, New York

Journal volume & issue: Vol. 4, no. 11
p. 100572

Abstract

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Introduction: In the phase 3 KEYNOTE-604 study (NCT03066778), pembrolizumab plus etoposide and platinum chemotherapy (EP) significantly (p = 0.0023) improved progression-free survival versus placebo plus EP in previously untreated extensive-stage SCLC (ES-SCLC). We present health-related quality of life (HRQoL) results from KEYNOTE-604. Methods: Patients with stage IV SCLC were randomized 1:1 to pembrolizumab 200 mg or placebo every 3 weeks for 35 cycles plus four cycles of EP. Secondary end points included mean change from baseline to week 18 in the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire—Core 30 (QLQ-C30) global health status/quality of life (GHS/QoL) scale and time to deterioration in the composite outcome of cough, chest pain, or dyspnea from QLQ-C30 and QLQ—Lung Cancer Module 13. Two-sided, nominal p values are reported. Results: A total of 439 patients completed at least one QLQ-C30 and QLQ—Lung Cancer Module 13 assessment (pembrolizumab + EP, n = 221; placebo + EP, n = 218). GHS/QoL scores improved from baseline to week 18: least squares mean (95% confidence interval [CI]) changes were 8.7 (5.3–12.1) for pembrolizumab plus EP and 4.2 (0.9–7.5) for placebo plus EP. Between-group differences in least squares mean scores were improved for pembrolizumab plus EP (4.4 [95% CI: 0.2–8.7], p = 0.040]). Median time to deterioration for the composite end point was not reached and 8.7 (95% CI: 5.9–not reached) months, respectively (hazard ratio = 0.80 [95% CI: 0.56–1.14], p = 0.208). Conclusions: First-line pembrolizumab plus EP therapy maintained HRQoL in patients with ES-SCLC and may be associated with greater improvement than placebo plus EP. Together with the efficacy and safety findings in KEYNOTE-604, HRQoL data support the benefit of pembrolizumab in ES-SCLC.

Published in JTO Clinical and Research Reports

ISSN: 2666-3643 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Internal medicine: Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Website: https://www.journals.elsevier.com/jto-clinical-and-research-reports/

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