The DOI matches its Crossref record; 5 of the 5 references it cites were found in a registry or an index.
gp100 Peptide Vaccine and Interleukin-2 in Patients with Advanced Melanoma
Open accessAbstract
BACKGROUND: Stimulating an immune response against cancer with the use of vaccines remains a challenge. We hypothesized that combining a melanoma vaccine with interleukin-2, an immune activating agent, could improve outcomes. In a previous phase 2 study, patients with metastatic melanoma receiving high-dose interleukin-2 plus the gp100:209-217(210M) peptide vaccine had a higher rate of response than the rate that is expected among patients who are treated with interleukin-2 alone. METHODS: We conducted a randomized, phase 3 trial involving 185 patients at 21 centers. Eligibility criteria included stage IV or locally advanced stage III cutaneous melanoma, expression of HLA*A0201, an absence of brain metastases, and suitability for high-dose interleukin-2 therapy. Patients were randomly assigned to receive interleukin-2 alone (720,000 IU per kilogram of body weight per dose) or gp100:209-217(210M) plus incomplete Freund's adjuvant (Montanide ISA-51) once per cycle, followed by interleukin-2. The primary end point was clinical response. Secondary end points included toxic effects and progression-free survival. RESULTS: The treatment groups were well balanced with respect to baseline characteristics and received a similar amount of interleukin-2 per cycle. The toxic effects were consistent with those expected with interleukin-2 therapy. The vaccine-interleukin-2 group, as compared with the interleukin-2-only group, had a significant improvement in centrally verified overall clinical response (16% vs. 6%, P=0.03), as well as longer progression-free survival (2.2 months; 95% confidence interval [CI], 1.7 to 3.9 vs. 1.6 months; 95% CI, 1.5 to 1.8; P=0.008). The median overall survival was also longer in the vaccine-interleukin-2 group than in the interleukin-2-only group (17.8 months; 95% CI, 11.9 to 25.8 vs. 11.1 months; 95% CI, 8.7 to 16.3; P=0.06). CONCLUSIONS: In patients with advanced melanoma, the response rate was higher and progression-free survival longer with vaccine and interleukin-2 than with interleukin-2 alone. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00019682.).
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Bassani-Sternberg, M., Bräunlein, E., Klar, R., Engleitner, T., Sinitcyn, P., Audehm, S., Straub, M., Weber, J., Slotta-Huspenina, J., Specht, K., et al. (2016) · Nature Communications · doi:10.1038/ncomms13404 · Cited by 693
Metadata
- Authors
- Schwartzentruber, D. J., Lawson, D. H., Richards, J. M., Conry, R. M., Miller, D. M., Treisman, J., Gailani, F., Riley, L., Conlon, K., Pockaj, B., Kendra, K. L., White, R. L., Gonzalez, R., Kuzel, T. M., Curti, B., Leming, P. D., Whitman, E. D., Balkissoon, J., Reintgen, D. S., Kaufman, H., Marincola, F. M., Merino, M. J., Rosenberg, S. A., Choyke, P., Vena, D., & Hwu, P.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2011-06-02
- Volume
- 364
- Issue
- 22
- Pages
- 2119-2127
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2089401318
- Cited by
- 911
- References
- 5
- FWCI
- 42.83
- Type
- journal article
- Language
- en
- Open access
- green
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- Schwartzentruber, D. J., Lawson, D. H., Richards, J. M., Conry, R. M., Miller, D. M., Treisman, J., Gailani, F., Riley, L., Conlon, K., Pockaj, B., Kendra, K. L., White, R. L., Gonzalez, R., Kuzel, T. M., Curti, B., Leming, P. D., Whitman, E. D., Balkissoon, J., Reintgen, D. S., . . . Hwu, P. (2011). gp100 Peptide Vaccine and Interleukin-2 in Patients with Advanced Melanoma. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1012863
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