Baek-Yeol Ryoo1, Philippe Merle2, Amit S Kulkarni3, Ann-Lii Cheng4, Mohamed Bouattour5, Ho Yeong Lim6, Valeriy Breder7, Julien Edeline8, Yee Chao9, Sadahisa Ogasawara10, Thomas Yau11, Marcelo Garrido12, Stephen L Chan13, Bruno Daniele14, Josephine M Norquist3, Erluo Chen3, Abby B Siegel3, Andrew X Zhu15,16, Richard S Finn17, Masatoshi Kudo18. 1. Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. 2. Croix-Rousse Hospital, Hospices Civils de Lyon, Lyon, France. 3. Merck & Co., Inc., Kenilworth, New Jersey. 4. National Taiwan University Cancer Center, Taipei City, Taiwan. 5. Beaujon Hospital, Assistance Publique-Hôpitaux de Paris, Clichy, France. 6. Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea. 7. N. N. Blokhin National Medical Research Center of Oncology, Moscow, Russia. 8. Centre Eugene Marquis, Rennes, France. 9. Taipei Veterans General Hospital, Taipei City, Taiwan. 10. Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba, Japan. 11. The University at Hong Kong, Hong Kong, People's Republic of China. 12. Pontifical Catholic University of Chile, Santiago, Chile. 13. State Key Laboratory of Translational Oncology, Department of Clinical Oncology, The Chinese University of Hong Kong, Sha Tin, Hong Kong. 14. Hospital of the Sea, Napoli, Italy. 15. Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, Massachusetts. 16. Jiahui International Cancer Center, Jiahui Health, Shanghai, China. 17. David Geffen School of Medicine at University of California Los Angeles, Los Angeles, California. 18. Kindai University School of Medicine, Osaka, Japan.
Abstract
BACKGROUND:Health-related quality of life (HRQoL) is an important outcome measure and prognostic indicator in hepatocellular carcinoma (HCC). KEYNOTE-240 (NCT02702401) assessed the efficacy and safety of pembrolizumab plus best supportive care (BSC) versus placebo plus BSC in patients with HCC who previously receivedsorafenib. This study presents the results of a prespecified exploratory analysis of patient-reported outcomes. METHODS: Patients completed the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) and its HCC supplement (EORTC QLQ-HCC18) electronically at baseline; at weeks 2, 3, 4, 6, 9, 12, and 18; and then every 9 weeks until 1 year or end of treatment, and at the 30-day safety follow-up visit. RESULTS: The HRQoL population included 271 and 127 patients randomly assigned to pembrolizumab and placebo, respectively. From baseline to week 12, changes in both scores were similar between pembrolizumab and placebo; global health status/QoL scores were stable. The proportions of patients who improved, remained stable, or deteriorated across all functional domain and symptom scores were generally similar between pembrolizumab and placebo. Time to deterioration was similar between the 2 arms based on the prespecified analysis of EORTC QLQ-HCC18 domains of abdominal swelling, fatigue, and pain. CONCLUSION:Pembrolizumab preserved HRQoL during treatment for advanced HCC. Combined with efficacy and safety results from KEYNOTE-240, these findings support a positive benefit/risk profile for pembrolizumab in a second-line treatment setting for patients with HCC who previously receivedsorafenib.
RCT Entities:
BACKGROUND: Health-related quality of life (HRQoL) is an important outcome measure and prognostic indicator in hepatocellular carcinoma (HCC). KEYNOTE-240 (NCT02702401) assessed the efficacy and safety of pembrolizumab plus best supportive care (BSC) versus placebo plus BSC in patients with HCC who previously received sorafenib. This study presents the results of a prespecified exploratory analysis of patient-reported outcomes. METHODS:Patients completed the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) and its HCC supplement (EORTC QLQ-HCC18) electronically at baseline; at weeks 2, 3, 4, 6, 9, 12, and 18; and then every 9 weeks until 1 year or end of treatment, and at the 30-day safety follow-up visit. RESULTS: The HRQoL population included 271 and 127 patients randomly assigned to pembrolizumab and placebo, respectively. From baseline to week 12, changes in both scores were similar between pembrolizumab and placebo; global health status/QoL scores were stable. The proportions of patients who improved, remained stable, or deteriorated across all functional domain and symptom scores were generally similar between pembrolizumab and placebo. Time to deterioration was similar between the 2 arms based on the prespecified analysis of EORTC QLQ-HCC18 domains of abdominal swelling, fatigue, and pain. CONCLUSION:Pembrolizumab preserved HRQoL during treatment for advanced HCC. Combined with efficacy and safety results from KEYNOTE-240, these findings support a positive benefit/risk profile for pembrolizumab in a second-line treatment setting for patients with HCC who previously received sorafenib.
Authors: Tim F Greten; Ghassan K Abou-Alfa; Ann-Lii Cheng; Austin G Duffy; Anthony B El-Khoueiry; Richard S Finn; Peter R Galle; Lipika Goyal; Aiwu Ruth He; Ahmed O Kaseb; Robin Kate Kelley; Riccardo Lencioni; Amaia Lujambio; Donna Mabry Hrones; David J Pinato; Bruno Sangro; Roberto I Troisi; Andrea Wilson Woods; Thomas Yau; Andrew X Zhu; Ignacio Melero Journal: J Immunother Cancer Date: 2021-09 Impact factor: 13.751
Authors: Evie E M Kolsteren; Esther Deuning-Smit; Alanna K Chu; Yvonne C W van der Hoeven; Judith B Prins; Winette T A van der Graaf; Carla M L van Herpen; Inge M van Oort; Sophie Lebel; Belinda Thewes; Linda Kwakkenbos; José A E Custers Journal: Cancers (Basel) Date: 2022-08-11 Impact factor: 6.575