The DOI matches its Crossref record; 9 of the 9 references it cites were found in a registry or an index.
Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001
Open accessAbstract
BACKGROUND: Pembrolizumab demonstrated robust antitumor activity and safety in the phase Ib KEYNOTE-001 study (NCT01295827) of advanced melanoma. Five-year outcomes in all patients and treatment-naive patients are reported herein. Patients whose disease progressed following initial response and who received a second course of pembrolizumab were also analyzed. PATIENTS AND METHODS: Patients aged ≥18 years with previously treated or treatment-naive advanced/metastatic melanoma received pembrolizumab 2 mg/kg every 3 weeks, 10 mg/kg every 3 weeks, or 10 mg/kg every 2 weeks until disease progression, intolerable toxicity, or patient/investigator decision to withdraw. Kaplan-Meier estimates of overall survival (OS) and progression-free survival (PFS) were calculated. Objective response rate and PFS were based on immune-related response criteria by investigator assessment (data cut-off, September 1, 2017). RESULTS: KEYNOTE-001 enrolled 655 patients with melanoma; median follow-up was 55 months. Estimated 5-year OS was 34% in all patients and 41% in treatment-naive patients; median OS was 23.8 months (95% CI, 20.2-30.4) and 38.6 months (95% CI, 27.2-not reached), respectively. Estimated 5-year PFS rates were 21% in all patients and 29% in treatment-naive patients; median PFS was 8.3 months (95% CI, 5.8-11.1) and 16.9 months (95% CI, 9.3-35.5), respectively. Median response duration was not reached; 73% of all responses and 82% of treatment-naive responses were ongoing at data cut-off; the longest response was ongoing at 66 months. Four patients [all with prior response of complete response (CR)] whose disease progressed during observation subsequently received second-course pembrolizumab. One patient each achieved CR and partial response (after data cut-off). Treatment-related AEs (TRAEs) occurred in 86% of patients and resulted in study discontinuation in 7.8%; 17% experienced grade 3/4 TRAE. CONCLUSIONS: This 5-year analysis of KEYNOTE-001 represents the longest follow-up for pembrolizumab to date and confirms the durable antitumor activity and tolerability of pembrolizumab in advanced melanoma. CLINICAL TRIAL REGISTRY: ClinicalTrials.gov, NCT01295827.
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Cites
Improved Survival with Ipilimumab in Patients with Metastatic Melanoma
Hodi, F. S., O'Day, S. J., McDermott, D. F., Weber, R. W., Sosman, J. A., Haanen, J. B., Gonzalez, R., Robert, C., Schadendorf, D., Hassel, J. C., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa1003466 · Cited by 15,155
Self-citationPembrolizumab 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
Self-citationNivolumab in Previously Untreated Melanoma without BRAF Mutation
Robert, C., Long, G. V., Brady, B., Dutriaux, C., Maio, M., Mortier, L., Hassel, J. C., Rutkowski, P., McNeil, C., Kalinka-Warzocha, E., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1412082 · Cited by 5,519
Self-citationIFN-γ–related mRNA profile predicts clinical response to PD-1 blockade
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Self-citationTopalian, S. L., Sznol, M., McDermott, D. F., Kluger, H. M., Carvajal, R. D., Sharfman, W. H., Brahmer, J. R., Lawrence, D. P., Atkins, M. B., Powderly, J. D., et al. (2014) · Journal of Clinical Oncology · doi:10.1200/jco.2013.53.0105 · Cited by 2,222
Self-citationSchadendorf, D., Hodi, F. S., Robert, C., Weber, J. S., Margolin, K., Hamid, O., Patt, D., Chen, T.-T., Berman, D. M., & Wolchok, J. D. (2015) · Journal of Clinical Oncology · doi:10.1200/jco.2014.56.2736 · Cited by 2,141
Self-citationAssociation of Pembrolizumab With Tumor Response and Survival Among Patients With Advanced Melanoma
Ribas, A., Hamid, O., Daud, A., Hodi, F. S., Wolchok, J. D., Kefford, R., Joshua, A. M., Patnaik, A., Hwu, W.-J., Weber, J. S., et al. (2016) · JAMA · doi:10.1001/jama.2016.4059 · Cited by 1,069
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Self-citationPD-1 Blockade Expands Intratumoral Memory T Cells
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“In patients treated with pembrolizumab for advanced/metastatic melanoma, long-term responses may be maintained through prominent expansion of CD8þmemory cells [26].”
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Metadata
- Authors
- Hamid, O., Robert, C., Daud, A., Hodi, F. S., Hwu, W. J., Kefford, R., Wolchok, J. D., Hersey, P., Joseph, R., Weber, J. S., Dronca, R., Mitchell, T. C., Patnaik, A., Zarour, H. M., Joshua, A. M., Zhao, Q., Jensen, E., Ahsan, S., Ibrahim, N., & Ribas, A.
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2019-04
- Volume
- 30
- Issue
- 4
- Pages
- 582-588
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2913383852
- Cited by
- 945
- References
- 9
- FWCI
- 46.70
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Hamid, O., Robert, C., Daud, A., Hodi, F. S., Hwu, W. J., Kefford, R., Wolchok, J. D., Hersey, P., Joseph, R., Weber, J. S., Dronca, R., Mitchell, T. C., Patnaik, A., Zarour, H. M., Joshua, A. M., Zhao, Q., Jensen, E., Ahsan, S., Ibrahim, N., & Ribas, A. (2019). Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. Annals of Oncology. https://doi.org/10.1093/annonc/mdz011
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