The DOI matches its Crossref record; 30 of the 31 references it cites were found in a registry or an index.
Phase 1/2 Trial of Pembrolizumab and Concurrent Chemoradiation Therapy for Limited-Stage SCLC
Open accessAbstract
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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“Moreover, the results of some phase 1/2 studies (NCT02621398, NCT02434081, NCT02586207, NCT02383212, and NCT02402920) showed that α-PD-1/PD-L1 plus chemoradiotherapy was tolerable in advanced NSCLC, head and neck squamous cell carcinoma (HNSCC), and SCLC patients, with promising clinical outcomes [78–82].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [82]
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PD-1 and PD-L1 Immune Checkpoint Blockade to Treat Breast Cancer
Hartkopf, A. D., Taran, F., Wallwiener, M., Walter, C. B., Krämer, B., Grischke, E., & Brucker, S. Y. (2016) · Breast Care · doi:10.1159/000453569 · Cited by 30,989
Siegel, R. L., Miller, K. D., & Jemal, A. (2018) · CA A Cancer Journal for Clinicians · doi:10.3322/caac.21442 · Cited by 16,632
Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer
Reck, M., Rodríguez-Abreu, D., Robinson, A. G., Hui, R., Csőszi, T., Fülöp, A., Gottfried, M., Peled, N., Tafreshi, A., Cuffe, S., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1606774 · Cited by 10,089
Pembrolizumab versus Ipilimumab in Advanced Melanoma
Robert, C., Schachter, J., Long, G. V., Arance, A., Grob, J. J., Mortier, L., Daud, A., Carlino, M. S., McNeil, C., Lotem, M., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1503093 · Cited by 5,887
Durvalumab after chemoradiotherapy in stage III non–small-cell lung cancer
Antonia, S. J., Villegas, A., Daniel, D., Vicente, D., Murakami, S., Hui, R., Yokoi, T., Chiappori, A., Lee, K. H., de Wit, M., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1709937 · Cited by 4,593
Analysis of 100,000 human cancer genomes reveals the landscape of tumor mutational burden
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Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC
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Liu, D., Yang, L., Hu, M., Du, H., Chen, Y., 朱瑶瑶, Kang, J., Yuan, X., Yang, S., Xu, Q., et al. (2026) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-026-02984-y
Metadata
- 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)
- 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
- 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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