NIVOLUMAB EXPERIENCE IN THE TREATMENT OF PRE-TREATED PATIENTS WITH METASTATIC SKIN MELANOMA
https://doi.org/10.18027/2224-5057-2018-8-3-78-85
Abstract
The appearance of anti-PD-1 drugs significantly improved prognosis of patients with metastatic skin melanoma. However, little data on the effectiveness of these drugs in the second and subsequent lines of therapy has been accumulated in the international literature. We have analyzed our experience in the use of nivolumab in the treatment of metastatic melanoma. This non-randomized, uncontrolled, continuous study included 53 patients with metastatic or unresectable melanoma, of whom 86.8 % (46) received two or more lines of systemic therapy for metastatic melanoma. The rate of objective response was 22.6 % (95 % Confidence Interval (CI) 53.3–64.4 %). The median progression-free survival was 4.37 months (95 % CI 2.27–6.47). The median overall survival was 17.9 months (95 % CI 8.89–26.99). One-, two-, three-year overall survival contained 66, 35 and 35 %, respectively. The efficacy of nivolumab in the second and subsequent treatment lines is significantly lower than showed in the results of randomized trials of the use of anti-PD-1 drugs in the first line of therapy.
About the Authors
I. V. SamoylenkoRussian Federation
Igor V. Samoylenko, MD, PhD Med, Senior Researcher, Tumor Biotherapy Department.
Moscow.
Ya. I. Zhulikov
Russian Federation
Yaroslav I. Zhulikov, 6th year student, General Medicine Faculty.
Moscow.
G. Yu. Kharkevich
Russian Federation
Galina Yu. Kharkevich, MD, PhD Med, Leading Researcher, Tumor Biotherapy Department.
Moscow.
N. N. Petenko
Russian Federation
Natalia N. Petenko, MD, PhD Med, Oncologist, Tumor Biotherapy Department.
Moscow.
L. V. Demidov
Russian Federation
Lev V. Demidov, MD, DSc Med, Professor, Head of the Tumor Biotherapy Department.
Moscow.
References
1. Robert C., Thomas L., Bondarenko I., O’Day S., Weber J., Garbe C. et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N. Engl. J. Med. 2011. Vol. 364 (26). P. 2517–2526. PMID: 1639810. DOI: 10.1056/NEJMoa1104621.
2. Mellman I., Coukos G., Dranoff G. Cancer immunotherapy comes of age. Nature. 2011. Vol. 480 (7378). P. 480–489. PMID: 22193102. DOI: 10.1038/nature10673.
3. Kaufman H. L., Kirkwood J. M., Hodi F. S., Agarwala S., Amatruda T., Bines S. D. et al. The Society for Immunotherapy of Cancer consensus statement on tumour immunotherapy for the treatment of cutaneous melanoma. Nat. Rev. Clin. Oncol. 2013. Vol. 10 (10). P. 588–598. PMID: 23982524. DOI: 10.1038/nrclinonc.2013.153.
4. Hodi F. S., O’Day S. J., McDermott D. F., Weber R. W., Sosman J. A., Haanen J. B. et al. Improved survival with ipilimumab in patients with metastatic melanoma. N. Engl. J. Med. 2010. Vol. 363 (8). P. 711–723. PMID: 20525992. DOI: 10.1056/NEJMoa1003466.
5. Schadendorf D., Hodi F. S., Robert C., Weber J. C., Margolin K., Hamid O. et al. Pooled analysis of long-term survival data from phase II and phase III trials of ipilimumab in unresectable or metastatic melanoma. J. Clin. Oncol. 2015. Vol. 33. P. 1889–1894. PMID: 25667295. DOI: 10.1200/JCO.2014.56.2736.
6. Wolchok J. D., Chiarion-Sileni V., Gonzalez R., Rutkowski P., Grob J. J., Cowey C. L. et al. Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N. Engl. J. Med. 2017. Vol. 377 (14). P. 1345–1356. PMID: 28889792. DOI: 10.1056/NEJMoa1709684.
7. Larkin J., Minor D., D’Angelo S., Neyns B., Smylie M., Miller W. H. et al. Overall Survival in Patients With Advanced Melanoma Who Received Nivolumab Versus Investigator’s Choice Chemotherapy in CheckMate 037: A Randomized, Controlled, Open-Label Phase III Trial. J. Clin. Oncol. 2018. Vol. 36 (4). P. 383–390. PMID: 28671856. DOI: 10.1200/JCO.2016.71.8023.
8. Weber J. S, D’Angelo S. P., Minor D., Hodi F. S., Gutzmer R., Neyns B. et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2015. Vol. 16 (4). P. 375–384. PMID: 25795410. DOI: 10.1016/S1470–2045(15)70076‑8.
9. Ribas A., Hamid O., Daud A., Hodi F. S., Wolchok J. D., Kefford R. et al. Association of Pembrolizumab With Tumor Response and Survival Among Patients With Advanced Melanoma. JAMA. 2016. Vol. 315 (15). P. 1600–1609. PMID: 27092830. DOI: 10.1001/jama.2016.4059.
10. Specenier P. Nivolumab in melanoma. Expert Rev. Anticancer Ther. 2016. Vol. 16 (12). P. 1247–1261. PMID: 27776441. DOI: 10.1080/14737140.2016.1249856.
Review
For citations:
Samoylenko I.V., Zhulikov Ya.I., Kharkevich G.Yu., Petenko N.N., Demidov L.V. NIVOLUMAB EXPERIENCE IN THE TREATMENT OF PRE-TREATED PATIENTS WITH METASTATIC SKIN MELANOMA. Malignant tumours. 2018;8(3):78-85. (In Russ.) https://doi.org/10.18027/2224-5057-2018-8-3-78-85