The DOI matches its Crossref record; 25 of the 25 references it cites were found in a registry or an index.
Long-Term Results of the Randomized Phase III Trial EORTC 18991 of Adjuvant Therapy With Pegylated Interferon Alfa-2b Versus Observation in Resected Stage III Melanoma
Open accessAbstract
Purpose: Adjuvant pegylated interferon alfa-2b (PEG-IFN-α-2b) was approved for treatment of resected stage III melanoma in 2011. Here, we present long-term follow-up results of this pivotal trial. Patients and Methods: In all, 1,256 patients with resected stage III melanoma were randomly assigned to observation (n = 629) or PEG-IFN-α-2b (n = 627) for an intended duration of 5 years. Stratification factors were microscopic (N1) versus macroscopic (N2) nodal involvement, number of positive nodes, ulceration and tumor thickness, sex, and center. Recurrence-free survival (RFS; primary end point), distant metastasis-free survival (DMFS), and overall survival (OS) were analyzed for the intent-to-treat population. Results: At 7.6 years median follow-up, 384 recurrences or deaths had occurred with PEG-IFN-α-2b versus 406 in the observation group (hazard ratio [HR], 0.87; 95% CI, 0.76 to 1.00; P = .055); 7-year RFS rate was 39.1% versus 34.6%. There was no difference in OS (P = .57). In stage III-N1 ulcerated melanoma, RFS (HR, 0.72; 99% CI, 0.46 to 1.13; P = .06), DMFS (HR, 0.65; 99% CI, 0.41 to 1.04; P = .02), and OS (HR, 0.59; 99% CI, 0.35 to 0.97; P = .006) were prolonged with PEG-IFN-α-2b. PEG-IFN-α-2b was discontinued for toxicity in 37% of patients. Conclusion: Adjuvant PEG-IFN-α-2b for stage III melanoma had a positive impact on RFS, which was marginally significant and slightly diminished versus the benefit seen at prior follow-up (median, 3.8 years). No significant increase in DMFS or OS was noted in the overall population. Patients with ulcerated melanoma and lower disease burden had the greatest benefit.
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Eggermont, A. M. M., Chiarion-Sileni, V., Grob, J.-J., Dummer, R., Wolchok, J. D., Schmidt, H., Hamid, O., Robert, C., Ascierto, P. A., Richards, J. M., et al. (2015) · The Lancet Oncology · doi:10.1016/s1470-2045(15)70122-1 · Cited by 1,262
Self-citationTargeting cytokine and chemokine signaling pathways for cancer therapy
Yi, M., Li, T., Niu, M., Zhang, H., Wu, Y., Wu, K., & Dai, Z. (2024) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-024-01868-3 · Cited by 455
Bielack, S. S., Smeland, S., Whelan, J. S., Marina, N., Jovic, G., Hook, J. M., Krailo, M. D., Gebhardt, M., Pápai, Z., Meyer, J., et al. (2015) · Journal of Clinical Oncology · doi:10.1200/jco.2014.60.0734 · Cited by 422
Metadata
- Authors
- Eggermont, A. M. M., Suciu, S., Testori, A., Santinami, M., Kruit, W. H. J., Marsden, J., Punt, C. J. A., Salès, F., Dummer, R., Robert, C., Schadendorf, D., Patel, P. M., de Schaetzen, G., Spatz, A., & Keilholz, U.
- Venue
- Journal of Clinical Oncology
- Published
- 2012-11-01
- Volume
- 30
- Issue
- 31
- Pages
- 3810-3818
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2164130643
- Cited by
- 285
- References
- 25
- FWCI
- 14.49
- Type
- journal article
- Language
- en
- Open access
- green
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- Eggermont, A. M. M., Suciu, S., Testori, A., Santinami, M., Kruit, W. H. J., Marsden, J., Punt, C. J. A., Salès, F., Dummer, R., Robert, C., Schadendorf, D., Patel, P. M., de Schaetzen, G., Spatz, A., & Keilholz, U. (2012). Long-Term Results of the Randomized Phase III Trial EORTC 18991 of Adjuvant Therapy With Pegylated Interferon Alfa-2b Versus Observation in Resected Stage III Melanoma. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2011.41.3799
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