Cited by 101Lung Cancer Research StudiesLung Cancer Diagnosis and TreatmentHead and Neck Cancer Studies

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Phase 1/2 Trial of Pembrolizumab and Concurrent Chemoradiation Therapy for Limited-Stage SCLC

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Welsh, James W., Heymach, John V., Guo, Chunxiao, Menon, Hari, Klein, Katherine, Cushman, Taylor R., Verma, Vivek, Hess, Kenneth R., Shroff, Girish, Tang, Chad, Skoulidis, Ferdinandos, Jeter, Melenda, Comeaux, Nathan, Patel, Roshal R., Chen, Dawei, Ozgen, Tugce, Nguyen, Quynh-Nhu, Chang, Joe Y., Altan, Mehmet, Zhang, Jianjun, Papadimitrakopoulou, Vassiliki A., Simon, George R., Byers, Lauren A., Glisson, Bonnie·2020·Journal of Thoracic Oncology

DOI 10.1016/j.jtho.2020.08.022PMC PMC10600713

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Abstract

Introduction Few advancements in treating limited-stage SCLC (LS-SCLC) have been made in decades. We report here a phase 1/2 trial of concurrent chemoradiotherapy (CRT) and pembrolizumab.Methods This single-center, open-label phase 1/2 study recruited adults with LS-SCLC or other neuroendocrine tumors and good performance status (Eastern Cooperative Oncology Group ≤ 2). The primary end point was safety, as assessed by dose-limiting toxicities. Concurrent CRT consisted of etoposide and a platin with 45 Gy radiotherapy (30 twice daily). Prophylactic cranial irradiation (25 Gy, 10 fractions) was given at the physician's discretion. Pembrolizumab was started concurrently with CRT and continued for up to 16 cycles. The phase 1 portion consisted of a 3 + 3 design. Toxicity was assessed with Common Terminology Criteria for Adverse Events version 4.0. Secondary outcomes were progression-free survival, overall survival, and tumor response as measured by the immune-related response criteria.Results A total of 45 patients were screened, and 40 were enrolled. All completed radiation therapy and received greater than or equal to one cycle of pembrolizumab. A total of 27 (61%) received percutaneous coronary intervention. One dose-limiting toxicity was observed in the phase 1 portion. There were no grade 5 toxicities, but there were three grade 4 events (two neutropenia, one respiratory failure). Pneumonitis rate was 15% (three grade 2 and three grade 3). All 17 esophagitis events (42.5%) were grades 1 to 2. At median follow-up time of 23.1 months, the median progression-free survival time was 19.7 months (95% confidence interval: 8.8‒30.5) and the median overall survival time was 39.5 months (95% confidence interval: 8.0‒71.0).Conclusion Concurrent CRT and pembrolizumab for LS-SCLC was well tolerated and yielded favorable outcomes, providing a basis for randomized studies.

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Authors: Welsh, J. W., Heymach, J. V., Guo, C., Menon, H., Klein, K., Cushman, T. R., Verma, V., Hess, K. R., Shroff, G., Tang, C., Skoulidis, F., Jeter, M., Comeaux, N., Patel, R. R., Chen, D., Ozgen, T., Nguyen, Q.-N., Chang, J. Y., Altan, M., Zhang, J., Papadimitrakopoulou, V. A., Simon, G. R., Byers, L. A., & Glisson, B.
Affiliations: The University of Texas MD Anderson Cancer Center (US)
Ankara University (TR)
Corresponding author: Welsh, James W.
ORCID: Welsh, James W.
Heymach, John V.
Menon, Hari
Cushman, Taylor R.
Verma, Vivek
Hess, Kenneth R.
Shroff, Girish
Tang, Chad
Skoulidis, Ferdinandos
Jeter, Melenda
Comeaux, Nathan
Patel, Roshal R.
Chen, Dawei
Ozgen, Tugce
Nguyen, Quynh-Nhu
Chang, Joe Y.
Altan, Mehmet
Zhang, Jianjun
Papadimitrakopoulou, Vassiliki A.
Simon, George R.
Byers, Lauren A.
Glisson, Bonnie
Venue: Journal of Thoracic Oncology
Publisher: Elsevier BV
Published: 2020-12
Volume: 15
Issue: 12
Pages: 1919-1927
ISSN: 1556-0864 (ISSN-L)
DOI: 10.1016/j.jtho.2020.08.022
PMC: PMC10600713
OpenAlex: W3084355783
Cited by: 101
References: 31
Citations by year: 2026: 13 · 2025: 13 · 2024: 21 · 2023: 18 · 2022: 24 · 2021: 10 · 2020: 2
FWCI: 4.88
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 365 d)
Locations: Journal of Thoracic Oncology (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: AstraZeneca
Sierra Oncology
Genentech
GlaxoSmithKline
Johnson and Johnson
Jazz Pharmaceuticals
Eli Lilly and Company
Jounce Therapeutics
National Institutes of Health
Spectrum Pharmaceuticals
National Cancer Institute
AbbVie
Boehringer Ingelheim
F. Hoffmann-La Roche
Bristol-Myers Squibb
Merck
Novartis
Topics: Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Health Sciences › Medicine › Otorhinolaryngology › Head and Neck Cancer Studies
Keywords: pembrolizumab, limited-stage small cell lung cancer, concurrent chemoradiotherapy, etoposide, platinum-based chemotherapy, prophylactic cranial irradiation, immune checkpoint inhibitors, pneumonitis, esophagitis, progression-free survival, overall survival, neuroendocrine tumors
MeSH terms: Adult, Antineoplastic Combined Chemotherapy Protocols, Cisplatin, Humans, Lung Neoplasms, Small Cell Lung Carcinoma, Chemoradiotherapy, Antibodies, Monoclonal, Humanized

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