The DOI matches its Crossref record; 20 of the 20 references it cites were found in a registry or an index.
Survival Outcomes in Patients With Previously Untreated BRAF Wild-Type Advanced Melanoma Treated With Nivolumab Therapy: Three-Year Follow-up of a Randomized Phase 3 Trial
Open accessAbstract
Importance: This analysis provides long-term follow-up in patients with BRAF wild-type advanced melanoma receiving first-line therapy based on anti-programmed cell death 1 receptor inhibitors. Objective: To compare the 3-year survival with nivolumab vs that with dacarbazine in patients with previously untreated BRAF wild-type advanced melanoma. Design, Setting, and Participants: This follow-up of a randomized phase 3 trial analyzed 3-year overall survival data from the randomized, controlled, double-blind CheckMate 066 phase 3 clinical trial. For this ongoing, multicenter academic institution trial, patients were enrolled from January 2013 through February 2014. Eligible patients were 18 years or older with confirmed unresectable previously untreated stage III or IV melanoma and an Eastern Cooperative Oncology Group performance status of 0 or 1 but without a BRAF mutation. Interventions: Patients were treated until progression or unacceptable toxic events with nivolumab (3 mg/kg every 2 weeks plus dacarbazine-matched placebo every 3 weeks) or dacarbazine (1000 mg/m2 every 3 weeks plus nivolumab-matched placebo every 2 weeks). Main Outcome and Measure: Overall survival. Results: At minimum follow-ups of 38.4 months among 210 participants in the nivolumab group (median age, 64 years [range, 18-86 years]; 57.6% male) and 38.5 months among 208 participants in the dacarbazine group (median age, 66 years [range, 25-87 years]; 60.1% male), 3-year overall survival rates were 51.2% (95% CI, 44.1%-57.9%) and 21.6% (95% CI, 16.1%-27.6%), respectively. The median overall survival was 37.5 months (95% CI, 25.5 months-not reached) in the nivolumab group and 11.2 months (95% CI, 9.6-13.0 months) in the dacarbazine group (hazard ratio, 0.46; 95% CI, 0.36-0.59; P < .001). Complete and partial responses, respectively, were reported for 19.0% (40 of 210) and 23.8% (50 of 210) of patients in the nivolumab group compared with 1.4% (3 of 208) and 13.0% (27 of 208) of patients in the dacarbazine group. Additional analyses were performed on outcomes with subsequent therapies. Treatment-related grade 3/4 adverse events occurred in 15.0% (31 of 206) of nivolumab-treated patients and in 17.6% (36 of 205) of dacarbazine-treated patients. There were no deaths due to study drug toxic effects. Conclusions and Relevance: Nivolumab led to improved 3-year overall survival vs dacarbazine in patients with previously untreated BRAF wild-type advanced melanoma. Trial Registration: ClinicalTrials.gov identifier: NCT01721772.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
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
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
Adverse Renal Effects of Immune Checkpoint Inhibitors: A Narrative Review
Wanchoo, R., Karam, S., Uppal, N. N., Barta, V. S., Deray, G., Devoe, C., Launay‐Vacher, V., Jhaveri, K. D., & on behalf of Cancer and Kidney International Network Workgroup on Immune Checkpoint Inhibitors (2017) · American Journal of Nephrology · doi:10.1159/000455014 · Cited by 15,320
Cook, R. J., Dickens, B. M., & Fathalla, M. F. (2003) · Oxford University Press eBooks · doi:10.1093/acprof:oso/9780199241323.003.0025 · Cited by 10,825
Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma
Larkin, J., Chiarion-Sileni, V., Gonzalez, R., Grob, J. J., Cowey, C. L., Lao, C. D., Schadendorf, D., Dummer, R., Smylie, M., Rutkowski, P., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1504030 · Cited by 8,157
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-citationOverall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma
Wolchok, J. D., Chiarion-Sileni, V., Gonzalez, R., Rutkowski, P., Grob, J.-J., Cowey, C. L., Lao, C. D., Wagstaff, J., Schadendorf, D., Ferrucci, P. F., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1709684 · Cited by 5,357
Self-citationNivolumab and ipilimumab versus ipilimumab in untreated melanoma
Postow, M. A., Chesney, J., Pavlick, A. C., Robert, C., Grossmann, K., McDermott, D., Linette, G. P., Meyer, N., Giguere, J. K., Agarwala, S. S., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1414428 · Cited by 2,781
Self-citationWeber, J. S., D’Angelo, S. P., Minor, D. R., Hodi, F. S., Gutzmer, R., Neyns, B., Höeller, C., Khushalani, N. I., Miller, W. H., Lao, C. D., et al. (2015) · The Lancet Oncology · doi:10.1016/s1470-2045(15)70076-8 · Cited by 2,725
Self-citationRibas, A., Puzanov, I. J., Dummer, R., Schadendorf, D., Hamid, O., Robert, C., Hodi, F. S., Schachter, J., Pavlick, A. C., Lewis, K. D., et al. (2015) · The Lancet Oncology · doi:10.1016/s1470-2045(15)00083-2 · Cited by 1,590
Self-citationHirsch, F. R., McElhinny, A., Stanforth, D., Ranger‐Moore, J., Jansson, M., Kulangara, K., Richardson, W., Towne, P., Hanks, D. A., Vennapusa, B., et al. (2016) · Journal of Thoracic Oncology · doi:10.1016/j.jtho.2016.11.2228 · Cited by 1,287
Schachter, J., Ribas, A., Long, G. V., Arance, A. M., Grob, J., Mortier, L., DAUD, A. I., Carlino, M. S., McNeil, C. M., Lotem, M., et al. (2017) · The Lancet · doi:10.1016/s0140-6736(17)31601-x · Cited by 1,251
Self-citationHodi, F. S., Chesney, J., Pavlick, A. C., Robert, C., Grossmann, K. F., McDermott, D. F., Linette, G. P., Meyer, N., Giguere, J. K., Agarwala, S. S., et al. (2016) · The Lancet Oncology · doi:10.1016/s1470-2045(16)30366-7 · Cited by 968
Self-citationLarkin, J., Minor, D. R., D’Angelo, S. P., Neyns, B., Smylie, M., Miller, W. H., Gutzmer, R., Linette, G. P., Chmielowski, B., Lao, C. D., et al. (2017) · Journal of Clinical Oncology · doi:10.1200/jco.2016.71.8023 · Cited by 522
Self-citationNivolumab for Patients With Advanced Melanoma Treated Beyond Progression
Long, G. V., Weber, J. S., Larkin, J., Atkinson, V. G., Grob, J., Schadendorf, D., Dummer, R., Robert, C., Márquez‐Rodas, I., McNeil, C. M., et al. (2017) · JAMA Oncology · doi:10.1001/jamaoncol.2017.1588 · Cited by 178
Self-citationWolchok, J. D., Weber, J. S., Maio, M., Neyns, B., Harmankaya, K., Chin, K. M., Cykowski, L., de Pril, V., Humphrey, R. W., & Lebbé, C. (2013) · Annals of Oncology · doi:10.1093/annonc/mdt161 · Cited by 175
Self-citationRobert, C., Ribas, A., Hamid, O., DAUD, A. I., Wolchok, J. D., Joshua, A. M., Hwu, W., Weber, J. S., Gangadhar, T. C., Joseph, R. W., et al. (2016) · Journal of Clinical Oncology · doi:10.1200/jco.2016.34.15_suppl.9503 · Cited by 108
Self-citationRobert, C., Long, G. V., Schachter, J., Arance, A. M., Grob, J., Mortier, L., DAUD, A. I., Carlino, M. S., McNeil, C. M., Lotem, M., et al. (2017) · Journal of Clinical Oncology · doi:10.1200/jco.2017.35.15_suppl.9504 · Cited by 68
Self-citation
Cited by
Sorted by citations
Fecal microbiota transplant promotes response in immunotherapy-refractory melanoma patients
Baruch, E. N., Youngster, I., Ben-Betzalel, G., Ortenberg, R., Lahat, A., Katz, L., Adler, K., Dick-Necula, D., Raskin, S., Bloch, N., et al. (2021) · Science · doi:10.1126/science.abb5920 · Cited by 1,757
Robert, C., Ribas, A., Schachter, J., Arance, A., Grob, J.-J., Mortier, L., Daud, A., Carlino, M. S., McNeil, C. M., Lotem, M., et al. (2019) · The Lancet Oncology · doi:10.1016/s1470-2045(19)30388-2 · Cited by 1,159
Self-citationHuang, A. C. C., & Zappasodi, R. (2022) · Nature Immunology · doi:10.1038/s41590-022-01141-1 · Cited by 586
Emens, L. A., Adams, S., Barrios, C. H., Dieras, V. C., Iwata, H., Loi, S., Rugo, H. S., Schneeweiß, A., Winer, E. P., Patel, S., et al. (2021) · Annals of Oncology · doi:10.1016/j.annonc.2021.05.355 · Cited by 493
Lee, K. A., Thomas, A. M., Bolte, L. A., Björk, J. R., de Ruijter, L. K., Armanini, F., Asnicar, F., Blanco-Miguez, A., Board, R., Calbet-Llopart, N., et al. (2022) · Nature Medicine · doi:10.1038/s41591-022-01695-5 · Cited by 464
Metadata
- Authors
- Ascierto, P. A., Long, G. V., Robert, C., Brady, B., Dutriaux, C., Di Giacomo, A. M., Mortier, L., Hassel, J. C., Rutkowski, P., McNeil, C., Kalinka-Warzocha, E., Savage, K. J., Hernberg, M. M., Lebbé, C., Charles, J., Mihalcioiu, C., Chiarion-Sileni, V., Mauch, C., Cognetti, F., Ny, L., Arance, A., Svane, I. M., Schadendorf, D., Gogas, H., Saci, A., Jiang, J., Rizzo, J., & Atkinson, V.
- Affiliations
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (IT)
- The University of Sydney (AU)
- Institut Gustave Roussy (FR)
- Cabrini Hospital (AU)
- Université de Bordeaux (FR)
- UOC Oncological Immunotherapy, University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy
- Inserm (FR)
- Heidelberg University (DE)
- The Maria Sklodowska-Curie National Research Institute of Oncology (PL)
- Royal Prince Alfred Hospital (AU)
- Polish Mother’s Memorial Hospital Research Institute, Lodz, Poland
- BC Cancer Agency (CA)
- Helsinki University Hospital (FI)
- Assistance Publique–Hôpitaux de Paris Dermatology and Centre d’Investigation Clinique, University Paris Diderot INSERM U976, Saint Louis Hospital, Paris, France
- Centre National de la Recherche Scientifique (FR)
- McGill University (CA)
- Melanoma Cancer Unit, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico, Padua, Italy
- University Hospital Cologne (DE)
- Instituto Nazionale Tumori Regina Elena (IT)
- Sahlgrenska University Hospital (SE)
- Hospital Clínic de Barcelona (ES)
- Herlev Hospital (DK)
- Essen University Hospital (DE)
- National and Kapodistrian University of Athens (GR)
- Bristol-Myers Squibb (United States) (US)
- The University of Queensland (AU)
- Corresponding author
- Ascierto, Paolo A.
- ORCID
- Ascierto, Paolo A.
- Long, Georgina V.
- Robert, Caroline
- Dutriaux, Caroline
- Mortier, Laurent
- Hassel, Jessica C.
- Rutkowski, Piotr
- McNeil, Catriona
- Savage, Kerry J.
- Hernberg, Micaela M.
- Charles, Julie
- Mihalcioiu, Catalin
- Mauch, Cornelia
- Cognetti, Francesco
- Ny, Lars
- Arance, Ana
- Svane, Inge Marie
- Schadendorf, Dirk
- Gogas, Helen
- Saci, Abdel
- Atkinson, Victoria
- Venue
- JAMA Oncology
- Publisher
- American Medical Association (AMA)
- Published
- 2019-02-01
- Volume
- 5
- Issue
- 2
- Pages
- 187
- ISSN
- 2374-2437 (ISSN-L)
- PMC
- PMC6439558
- OpenAlex
- W2898510820
- Cited by
- 352
- References
- 20
- Citations by year
- 2026: 18 · 2025: 26 · 2024: 31 · 2023: 46 · 2022: 47 · 2021: 65 · 2020: 83 · 2019: 33
- FWCI
- 17.20
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA Oncology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, other-oa)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Use Siena air (University of Siena) (submittedVersion)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Melanoma and MAPK Pathways
- Keywords
- BRAF wild-type melanoma, advanced melanoma, nivolumab, dacarbazine, immune checkpoint inhibitors, PD-1 inhibitors, first-line therapy, overall survival, long-term follow-up, complete response, partial response, treatment-related adverse events, immunotherapy, progression-free survival, treatment discontinuation
- MeSH terms
- Antineoplastic Agents, Immunological, Nivolumab, Adolescent, Adult, Aged, Aged, 80 and over, Dacarbazine, Double-Blind Method, Female, Humans, Male, Melanoma, Middle Aged, Skin Neoplasms, Time Factors, Treatment Outcome, Disease Progression, Antineoplastic Agents, Alkylating, Proto-Oncogene Proteins B-raf, Young Adult
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
