The DOI matches its Crossref record; 24 of the 24 references it cites were found in a registry or an index.
Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): a randomised, multicentre, non-inferiority trial
Open accessAbstract
Background Patients with HPV-positive oropharyngeal squamous cell carcinoma (OPC) have high survival rates when treated with radiotherapy plus cisplatin. Whether replacement of cisplatin with cetuximab, an antibody against the epidermal growth factor receptor, can preserve high survival rates and reduce treatment toxicity is unknown. Methods In a randomized, non-inferiority, multicenter trial, patients with locoregionally-advanced p16-positive OPC were stratified by American Joint Committee on Cancer T (T1-T2 vs. T3-T4) and N (N0-N2a vs. N2b-N3), Zubrod Performance Status (0 vs. 1), and tobacco smoking history (≤ vs. >10 pack-years) and randomized 1:1 to radiotherapy plus cetuximab 400 milligrams per square meter of body surface area (mg/m2), followed by 250 mgs/m2 for seven weekly doses or cisplatin 100 mgs/m2 for two doses, 21 days apart. The sample size was 800 eligible patients. The primary endpoint was overall survival (OS) with non-inferiority margin 1.45 (hazard ratio). Findings From June 2011 through July 2014, 849 patients (805 eligible; 399 cetuximab; 406 cisplatin) were randomized at 182 centers in the United States and Canada. With median follow-up 4·5 years, radiotherapy plus cetuximab did not meet the non-inferiority criterion for OS. Estimated 5-year OS was 77·9% (95% confidence interval [CI] 73·4-82·5) in cetuximab group versus 84·6% (95%CI=80·6-88·6) in cisplatin group (hazard ratio [HR], 1·45, 1-sided 95% upper CI, 1·94; non-inferiority p=0·5056; 1-sided log-rank p=0.0163). PFS was significantly lower in cetuximab group than in cisplatin group (HR 1·72, 95%CI=1·29-2·29; 5-year rates, 67·3% vs. 78·4%), and LRF was significantly higher (HR 2·05, 95%CI=1·35-3·10; 5-year rates, 17·3% vs. 9·9%). The rate of moderate-to-severe toxicity that was acute (77·4% vs. 81·7%, p=0·1586) and late (16·5 vs. 20·4%, p=0·1904) was similar in the cetuximab and cisplatin groups, respectively. Interpretation For patients with HPV-positive OPC, radiotherapy plus cetuximab demonstrated inferior OS and PFS compared to radiotherapy plus cisplatin; toxicity rates were similar (NCT01302834). Funding National Cancer Institute USA, Eli Lilly and The Oral Cancer Foundation
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Human Papillomavirus and Survival of Patients with Oropharyngeal Cancer
Ang, K. K., Harris, J., Wheeler, R., Weber, R., Rosenthal, D. I., Nguyen-Tân, P. F., Westra, W. H., Chung, C. H., Jordan, R. C., Lu, C., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa0912217 · Cited by 6,566
Self-citationRadiotherapy plus Cetuximab for Squamous-Cell Carcinoma of the Head and Neck
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Self-citationThe Analysis of Failure Times in the Presence of Competing Risks
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Machiels, J.-P., René Leemans, C., Golusinski, W., Grau, C., Licitra, L., & Gregoire, V. (2020) · Annals of Oncology · doi:10.1016/j.annonc.2020.07.011 · Cited by 916
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Self-citationContemporary radiotherapy: present and future
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The Use of HPV16-E5, EGFR, and pEGFR as Prognostic Biomarkers for Oropharyngeal Cancer Patients
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Jelinek, M. J., Foster, N. R., Zoroufy, A. J., Schwartz, G. K., Munster, P. N., Seiwert, T. Y., de Souza, J. A., & Vokes, E. E. (2021) · Oral Oncology · doi:10.1016/j.oraloncology.2020.105171 · Cited by 20
Metadata
- Authors
- Gillison, M. L., Trotti, A. M., Harris, J., Eisbruch, A., Harari, P. M., Adelstein, D. J., Jordan, R. C. K., Zhao, W., Sturgis, E. M., Burtness, B., Ridge, J. A., Ringash, J., Galvin, J., Yao, M., Koyfman, S. A., Blakaj, D. M., Razaq, M. A., Colevas, A. D., Beitler, J. J., Jones, C. U., Dunlap, N. E., Seaward, S. A., Spencer, S., Galloway, T. J., Phan, J., Dignam, J. J., & Le, Q. T.
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2019-01
- Volume
- 393
- Issue
- 10166
- Pages
- 40-50
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2901263658
- Cited by
- 1,304
- References
- 24
- FWCI
- 112.42
- Type
- journal article
- Language
- en
- Open access
- green
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- Gillison, M. L., Trotti, A. M., Harris, J., Eisbruch, A., Harari, P. M., Adelstein, D. J., Jordan, R. C. K., Zhao, W., Sturgis, E. M., Burtness, B., Ridge, J. A., Ringash, J., Galvin, J., Yao, M., Koyfman, S. A., Blakaj, D. M., Razaq, M. A., Colevas, A. D., Beitler, J. J., . . . Le, Q. T. (2019). Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): a randomised, multicentre, non-inferiority trial. The Lancet. https://doi.org/10.1016/s0140-6736(18)32779-x
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