The DOI matches its Crossref record; 22 of the 22 references it cites were found in a registry or an index.
Efficacy and safety of pembrolizumab for the treatment of advanced biliary cancer: Results from the KEYNOTE‐158 and KEYNOTE‐028 studies
Open accessAbstract
We present data from patients with advanced biliary tract cancer (BTC) receiving pembrolizumab in the KEYNOTE‐158 (NCT02628067; phase 2) and KEYNOTE‐028 (NCT02054806; phase 1b) studies. Eligible patients aged ≥18 years from both studies had histologically/cytologically confirmed incurable BTC that progressed after standard treatment regimen(s), measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Eastern Cooperative Oncology Group performance status 0/1, and no prior immunotherapy. Programmed death ligand 1 (PD‐L1)‐positive tumors were required for eligibility in KEYNOTE‐028 only. Patients received pembrolizumab 200 mg every three weeks (KEYNOTE‐158) or 10 mg/kg every two weeks (KEYNOTE‐028) for ≤2 years. Primary efficacy endpoint was objective response rate (ORR) by RECIST v1.1. Response assessed by independent central review is reported. KEYNOTE‐158 enrolled 104 patients and KEYNOTE‐028 enrolled 24 patients. Median (range) follow‐up was 7.5 months (0.6‐34.3) in KEYNOTE‐158 and 5.7 months (0.6‐55.4) in KEYNOTE‐028. In KEYNOTE‐158, ORR was 5.8% (6/104; 95% CI, 2.1%‐12.1%); median duration of response (DOR) was not reached (NR) (range, 6.2‐26.6+ months). Median (95% CI) OS and PFS were 7.4 (5.5‐9.6) and 2.0 (1.9‐2.1) months. Among PD‐L1‐expressers (n = 61) and PD‐L1‐nonexpressers (n = 34), respectively, ORR was 6.6% (4/61) and 2.9% (1/34). In KEYNOTE‐028, ORR was 13.0% (3/23; 95% CI, 2.8%‐33.6%); median DOR was NR (range, 21.5‐53.2+ months). Median (95% CI) OS and PFS were 5.7 (3.1‐9.8) and 1.8 (1.4‐3.1) months. Grade 3 to 5 treatment‐related adverse events occurred in 13.5% of patients in KEYNOTE‐158 (no grade 4; grade 5 renal failure, n = 1) and 16.7% in KEYNOTE‐028 (no grade 4/5). In summary, pembrolizumab provides durable antitumor activity in 6% to 13% of patients with advanced BTC, regardless of PD‐L1 expression, and has manageable toxicity.
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New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)
Eisenhauer, E. A., Therasse, P., Bogaerts, J., Schwartz, L. H., Sargent, D., Ford, R., Dancey, J., Arbuck, S., Gwyther, S., Mooney, M., et al. (2009) · European Journal of Cancer · doi:10.1016/j.ejca.2008.10.026 · Cited by 29,534
The National Comprehensive Cancer Network: Present and future directions
McGivney, W. T. (1998) · Cancer · doi:10.1002/(sici)1097-0142(19980515)82:10+<2057::aid-cncr14>3.0.co;2-a · Cited by 16,766
Toxicity and response criteria of the Eastern Cooperative Oncology Group
Oken, M. M., Creech, R. H., Tormey, D. C., Horton, J., Davis, T. E., McFadden, E. T., & Carbone, P. P. (1982) · AMERICAN JOURNAL OF CLINICAL ONCOLOGY · doi:10.1097/00000421-198212000-00014 · Cited by 11,647
PD-1 Blockade in Tumors with Mismatch-Repair Deficiency
Le, D. T., Uram, J. N., Wang, H., Bartlett, B. R., Kemberling, H., Eyring, A. D., Skora, A. D., Luber, B. S., Azad, N. S., Laheru, D., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1500596 · Cited by 9,377
Self-citationCisplatin plus Gemcitabine versus Gemcitabine for Biliary Tract Cancer
Valle, J., Wasan, H., Palmer, D. H., Cunningham, D., Anthoney, A., Maraveyas, A., Madhusudan, S., Iveson, T., Hughes, S., Pereira, S. P., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa0908721 · Cited by 4,406
Ajani, J. A., D’Amico, T. A., Bentrem, D. J., Chao, J., Corvera, C., Das, P., Denlinger, C. S., Enzinger, P. C., Fanta, P., Farjah, F., et al. (2019) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2019.0033 · Cited by 1,059
Increasing Incidence and Mortality of Primary Intrahepatic Cholangiocarcinoma in the United States
Patel, T. (2001) · Hepatology · doi:10.1053/jhep.2001.25087 · Cited by 1,010
Ott, P. A., Bang, Y.-J., Piha-Paul, S. A., Razak, A. R. A., Bennouna, J., Soria, J.-C., Rugo, H. S., Cohen, R. B., O’Neil, B. H., Mehnert, J. M., et al. (2019) · Journal of Clinical Oncology · doi:10.1200/jco.2018.78.2276 · Cited by 969
Self-citationNew Horizons for Precision Medicine in Biliary Tract Cancers
Valle, J. W., Lamarca, A., Goyal, L., Barriuso, J., & Zhu, A. X. (2017) · Cancer Discovery · doi:10.1158/2159-8290.cd-17-0245 · Cited by 626
Alley, E. W., Lopez, J., Santoro, A., Morosky, A., Saraf, S., Piperdi, B., & van Brummelen, E. (2017) · The Lancet Oncology · doi:10.1016/s1470-2045(17)30169-9 · Cited by 490
Cited by
Kelley, R. K., Ueno, M., Yoo, C., Finn, R. S., Furuse, J., Ren, Z., Yau, T., Klümpen, H.-J., Chan, S. L., Ozaka, M., et al. (2023) · The Lancet · doi:10.1016/s0140-6736(23)00727-4 · Cited by 1,169
Self-citationRizzo, A., Ricci, A. D., & Brandi, G. (2021) · Cancers · doi:10.3390/cancers13030558 · Cited by 259
Cholangiocarcinoma: Recent Advances in Molecular Pathobiology and Therapeutic Approaches
Khosla, D., Misra, S., Chu, P. L., Guan, P., Nada, R., Gupta, R., Kaewnarin, K., Ko, T. K., Heng, H. L., Srinivasalu, V. K., et al. (2024) · Cancers · doi:10.3390/cancers16040801 · Cited by 44
Jiang, Q., Huang, J., Zhang, B., Li, X., Chen, X., Cui, B., Li, S., & Guo, G. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.801909 · Cited by 11
Metadata
- Authors
- Piha‐Paul, S. A., Oh, D., Ueno, M., Malka, D., Chung, H. C., Nagrial, A., Kelley, R. K., Ros, W., Italiano, A., Nakagawa, K., Rugo, H. S., de Braud, F., Varga, A. I., Hansen, A., Wang, H., Krishnan, S., Norwood, K. G., & Doi, T.
- Venue
- International Journal of Cancer
- Publisher
- Wiley
- Published
- 2020-05-02
- Volume
- 147
- Issue
- 8
- Pages
- 2190-2198
- ISSN
- 0020-7136 (ISSN-L)
- 1097-0215
- OpenAlex
- W3022210979
- Cited by
- 486
- References
- 22
- FWCI
- 58.73
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Piha‐Paul, S. A., Oh, D., Ueno, M., Malka, D., Chung, H. C., Nagrial, A., Kelley, R. K., Ros, W., Italiano, A., Nakagawa, K., Rugo, H. S., de Braud, F., Varga, A. I., Hansen, A., Wang, H., Krishnan, S., Norwood, K. G., & Doi, T. (2020). Efficacy and safety of pembrolizumab for the treatment of advanced biliary cancer: Results from the KEYNOTE‐158 and KEYNOTE‐028 studies. International Journal of Cancer. https://doi.org/10.1002/ijc.33013
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