First-Line Pembrolizumab Monotherapy for Advanced NSCLC With Programmed Death-Ligand 1 Expression Greater Than or Equal to 50%: Real-World Study Including Older Patients in Japan
Introduction: Pembrolizumab became available in Japan in February 2017 for first-line monotherapy of unresectable advanced and metastatic NSCLC with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) greater than or equal to 50%. This retrospective chart review study aimed to describe re...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-09-01
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| Series: | JTO Clinical and Research Reports |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666364322001217 |
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| author | Yasushi Goto, MD, PhD Atsuhisa Tamura, MD, PhD Hirotaka Matsumoto, MD Kazutoshi Isobe, MD, PhD Tomohiro Ozaki, MD Melissa L. Santorelli, PhD, MPH Kazuko Taniguchi, MS Tetsu Kamitani, MD, PhD Masato Irisawa, PhD Kingo Kanda, MPharm Machiko Abe, MS Thomas Burke, PharmD, PhD Hiroshi Nokihara, MD, PhD |
| author_facet | Yasushi Goto, MD, PhD Atsuhisa Tamura, MD, PhD Hirotaka Matsumoto, MD Kazutoshi Isobe, MD, PhD Tomohiro Ozaki, MD Melissa L. Santorelli, PhD, MPH Kazuko Taniguchi, MS Tetsu Kamitani, MD, PhD Masato Irisawa, PhD Kingo Kanda, MPharm Machiko Abe, MS Thomas Burke, PharmD, PhD Hiroshi Nokihara, MD, PhD |
| author_sort | Yasushi Goto, MD, PhD |
| collection | DOAJ |
| description | Introduction: Pembrolizumab became available in Japan in February 2017 for first-line monotherapy of unresectable advanced and metastatic NSCLC with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) greater than or equal to 50%. This retrospective chart review study aimed to describe real-world clinical outcomes of first-line pembrolizumab monotherapy, including for patients 75 years or older, who are under-represented in clinical trials. Methods: We identified patients (≥20 y old) at 23 sites initiating first-line pembrolizumab monotherapy from July 1, 2017, to December 20, 2018, for stages IIIB, IIIC, and IV NSCLC with PD-L1 TPS greater than or equal to 50% and Eastern Cooperative Oncology Group performance status of 0 to 2 or unknown. Patients with actionable genomic alterations (EGFR, ALK, ROS1, BRAF) and clinical trial participants were excluded. Time-to-event outcomes were estimated using Kaplan-Meier, with data cutoff on September 30, 2019. Results: Of 441 eligible patients (78% men), 303 (69%) were younger than 75 years and 138 (31%) were 75 years or older; median age was 70 years. With median follow-up of 13.5 months, median overall survival (OS) was not reached (NR); 12- and 24-month OS rates were 72% and 58%, respectively. For ages younger than 75 and 75 years or older, median OS was NR and 23.5 months (95% confidence interval: 16.2–NR), respectively; 12-month OS rates were 74% and 67% and 24-month OS rates were 62% and 48%, respectively. Median real-world progression-free survival was similar in the two age groups (10.1 and 9.5 mo, respectively), as was median real-world time on treatment with pembrolizumab (5.7 and 5.6 mo). Conclusions: These findings complement clinical trial results, adding real-world evidence supporting benefits of first-line pembrolizumab monotherapy for advanced NSCLC with PD-L1 TPS greater than or equal to 50%, including for patients 75 years or older. |
| first_indexed | 2024-04-11T19:56:59Z |
| format | Article |
| id | doaj.art-6c1d51a111954179b8993ec6b3e61d62 |
| institution | Directory Open Access Journal |
| issn | 2666-3643 |
| language | English |
| last_indexed | 2024-04-11T19:56:59Z |
| publishDate | 2022-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | JTO Clinical and Research Reports |
| spelling | doaj.art-6c1d51a111954179b8993ec6b3e61d622022-12-22T04:05:58ZengElsevierJTO Clinical and Research Reports2666-36432022-09-0139100397First-Line Pembrolizumab Monotherapy for Advanced NSCLC With Programmed Death-Ligand 1 Expression Greater Than or Equal to 50%: Real-World Study Including Older Patients in JapanYasushi Goto, MD, PhD0Atsuhisa Tamura, MD, PhD1Hirotaka Matsumoto, MD2Kazutoshi Isobe, MD, PhD3Tomohiro Ozaki, MD4Melissa L. Santorelli, PhD, MPH5Kazuko Taniguchi, MS6Tetsu Kamitani, MD, PhD7Masato Irisawa, PhD8Kingo Kanda, MPharm9Machiko Abe, MS10Thomas Burke, PharmD, PhD11Hiroshi Nokihara, MD, PhD12Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan; Corresponding author. Address for correspondence: Yasushi Goto, MD, PhD, Thoracic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.Center for Pulmonary Diseases, National Hospital Organization Tokyo National Hospital, Tokyo, JapanDepartment of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Hyogo, JapanDepartment of Respiratory Medicine, Toho University School of Medicine, Tokyo, JapanDivision of Medical Oncology, Kishiwada City Hospital, Osaka, JapanCenter for Observational & Real World Evidence (CORE), Merck & Co., Inc., Rahway, New JerseyMSD K.K., Tokyo, JapanMSD K.K., Tokyo, JapanMSD K.K., Tokyo, JapanMSD K.K., Tokyo, JapanMSD K.K., Tokyo, JapanCenter for Observational & Real World Evidence (CORE), Merck & Co., Inc., Rahway, New JerseyDepartment of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences, Tokushima University, Tokushima, Japan; Present Address: Respiratory Medicine, Center Hospital of the National Center for Global Health and Medicine, Tokyo, JapanIntroduction: Pembrolizumab became available in Japan in February 2017 for first-line monotherapy of unresectable advanced and metastatic NSCLC with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) greater than or equal to 50%. This retrospective chart review study aimed to describe real-world clinical outcomes of first-line pembrolizumab monotherapy, including for patients 75 years or older, who are under-represented in clinical trials. Methods: We identified patients (≥20 y old) at 23 sites initiating first-line pembrolizumab monotherapy from July 1, 2017, to December 20, 2018, for stages IIIB, IIIC, and IV NSCLC with PD-L1 TPS greater than or equal to 50% and Eastern Cooperative Oncology Group performance status of 0 to 2 or unknown. Patients with actionable genomic alterations (EGFR, ALK, ROS1, BRAF) and clinical trial participants were excluded. Time-to-event outcomes were estimated using Kaplan-Meier, with data cutoff on September 30, 2019. Results: Of 441 eligible patients (78% men), 303 (69%) were younger than 75 years and 138 (31%) were 75 years or older; median age was 70 years. With median follow-up of 13.5 months, median overall survival (OS) was not reached (NR); 12- and 24-month OS rates were 72% and 58%, respectively. For ages younger than 75 and 75 years or older, median OS was NR and 23.5 months (95% confidence interval: 16.2–NR), respectively; 12-month OS rates were 74% and 67% and 24-month OS rates were 62% and 48%, respectively. Median real-world progression-free survival was similar in the two age groups (10.1 and 9.5 mo, respectively), as was median real-world time on treatment with pembrolizumab (5.7 and 5.6 mo). Conclusions: These findings complement clinical trial results, adding real-world evidence supporting benefits of first-line pembrolizumab monotherapy for advanced NSCLC with PD-L1 TPS greater than or equal to 50%, including for patients 75 years or older.http://www.sciencedirect.com/science/article/pii/S2666364322001217Non–small cell lung cancerOlder adultsPembrolizumabReal-world progression-free survivalSurvival |
| spellingShingle | Yasushi Goto, MD, PhD Atsuhisa Tamura, MD, PhD Hirotaka Matsumoto, MD Kazutoshi Isobe, MD, PhD Tomohiro Ozaki, MD Melissa L. Santorelli, PhD, MPH Kazuko Taniguchi, MS Tetsu Kamitani, MD, PhD Masato Irisawa, PhD Kingo Kanda, MPharm Machiko Abe, MS Thomas Burke, PharmD, PhD Hiroshi Nokihara, MD, PhD First-Line Pembrolizumab Monotherapy for Advanced NSCLC With Programmed Death-Ligand 1 Expression Greater Than or Equal to 50%: Real-World Study Including Older Patients in Japan JTO Clinical and Research Reports Non–small cell lung cancer Older adults Pembrolizumab Real-world progression-free survival Survival |
| title | First-Line Pembrolizumab Monotherapy for Advanced NSCLC With Programmed Death-Ligand 1 Expression Greater Than or Equal to 50%: Real-World Study Including Older Patients in Japan |
| title_full | First-Line Pembrolizumab Monotherapy for Advanced NSCLC With Programmed Death-Ligand 1 Expression Greater Than or Equal to 50%: Real-World Study Including Older Patients in Japan |
| title_fullStr | First-Line Pembrolizumab Monotherapy for Advanced NSCLC With Programmed Death-Ligand 1 Expression Greater Than or Equal to 50%: Real-World Study Including Older Patients in Japan |
| title_full_unstemmed | First-Line Pembrolizumab Monotherapy for Advanced NSCLC With Programmed Death-Ligand 1 Expression Greater Than or Equal to 50%: Real-World Study Including Older Patients in Japan |
| title_short | First-Line Pembrolizumab Monotherapy for Advanced NSCLC With Programmed Death-Ligand 1 Expression Greater Than or Equal to 50%: Real-World Study Including Older Patients in Japan |
| title_sort | first line pembrolizumab monotherapy for advanced nsclc with programmed death ligand 1 expression greater than or equal to 50 real world study including older patients in japan |
| topic | Non–small cell lung cancer Older adults Pembrolizumab Real-world progression-free survival Survival |
| url | http://www.sciencedirect.com/science/article/pii/S2666364322001217 |
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