Paul Nathan1, Paolo A Ascierto2, John Haanen3, Enrique Espinosa4, Lev Demidov5, Claus Garbe6, Michele Guida7, Paul Lorigan8, Vanna Chiarion-Sileni9, Helen Gogas10, Michele Maio11, Maria Teresa Fierro12, Christoph Hoeller13, Patrick Terheyden14, Ralf Gutzmer15, Tormod K Guren16, Dimitrios Bafaloukos17, Piotr Rutkowski18, Ruth Plummer19, Ashita Waterston20, Martin Kaatz21, Mario Mandala22, Ivan Marquez-Rodas23, Eva Muñoz-Couselo24, Reinhard Dummer25, Elena Grigoryeva26, Tina C Young27, Dirk Schadendorf28. 1. Department of Medical Oncology, Mount Vernon Cancer Centre, London, United Kingdom. Electronic address: p.nathan@nhs.net. 2. Unit of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy. 3. Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands. 4. Department of Medical Oncology, Hospital Universitario La Paz, Universidad Autónoma de Madrid, Madrid, Spain. 5. N.N. Blokhin Russian Cancer Research Centre, Ministry of Health, Moscow, Russia. 6. Division of Dermatologic Oncology, Department of Dermatology, Eberhard Karls University, Tübingen, Germany. 7. Department of Medical Oncology, IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy. 8. Institute of Cancer Sciences, University of Manchester, The Christie NHS Foundation Trust, Manchester, UK. 9. Melanoma Oncology Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy. 10. First Department of Medicine, National and Kapodistrian University of Athens School of Medicine, Laiko General Hospital, Athens, Greece. 11. Division of Medical Oncology and Immunotherapy, Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy. 12. Department of Medical Sciences, Dermatologic Clinic, University of Turin, Turin, Italy. 13. Department of Dermatology, Medical University of Vienna, Vienna, Austria. 14. Department of Dermatology, University of Lübeck, Lübeck, Germany. 15. Department of Dermatology, Hannover Medical School, Skin Cancer Centre Hannover, Hannover, Germany. 16. Department of Oncology, Oslo University Hospital, Oslo, Norway. 17. Department of Oncology, Metropolitan Hospital, Athens, Greece. 18. Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Institute, Oncology Center, Warsaw, Poland. 19. Northern Institute for Cancer Research, Newcastle University, Newcastle Upon Tyne, United Kingdom. 20. Clinical Trials Unit, Beatson West of Scotland Cancer Centre, Glasgow, UK. 21. Department of Dermatology, SRH Wald Clinics, University Hospital, Gera, Germany. 22. Unit of Medical Oncology, Department of Oncology & Hematology, Papa Giovanni XXIII Hospital, Bergamo, Italy. 23. Medical Oncology Department, General University Hospital Gregorio Marañón and CIBERONC, Madrid, Spain. 24. Medical Oncology, Vall D'Hebron University, Barcelona, Spain. 25. Department of Dermatology, Universitats Spital, Zürich, Switzerland. 26. Oncology Clinical Development, Bristol-Myers Squibb, Princeton, NJ, USA. 27. Global Biometric Sciences, Bristol-Myers Squibb, Princeton, NJ, USA. 28. Department of Dermatology, University Hospital Essen, Essen, and the German Cancer Consortium, Heidelberg, Germany.
Abstract
BACKGROUND: Nivolumab has been widely studied in non-acral cutaneous melanoma; however, limited data are available in other melanoma subtypes. We report outcomes by melanoma subtype in patients who received nivolumab after progression on prior ipilimumab. PATIENTS AND METHODS: CheckMate 172 was a phase II, single-arm, open-label, multicentre study that evaluated nivolumab in patients with advanced melanoma who progressed on or after ipilimumab. Patients received 3 mg/kg of nivolumab, every 2 weeks for up to 2 years. The primary end-point was incidence of grade ≥3, treatment-related select adverse events (AEs). RESULTS: Among 1008 treated patients, we report data on patients with non-acral cutaneous melanoma (n = 723 [71.7%]), ocular melanoma (n = 103 [10.2%]), mucosal melanoma (n = 63 [6.3%]), acral cutaneous melanoma (n = 55 [5.5%]) and other melanoma subtypes (n = 64 [6.3%]). There were no meaningful differences in the incidence of grade ≥3, treatment-related select AEs among melanoma subtypes or compared with the total population. No new safety signals emerged. At a minimum follow-up of 18 months, median overall survival was 25.3 months for non-acral cutaneous melanoma and 25.8 months for acral cutaneous melanoma, with 18-month overall survival rates of 57.5% and 59.0%, respectively. Median overall survival was 12.6 months for ocular melanoma and 11.5 months for mucosal melanoma, with 18-month overall survival rates of 34.8% and 31.5%, respectively. CONCLUSIONS: The safety profile of nivolumab after ipilimumab is similar across melanoma subtypes. Compared with non-acral cutaneous melanoma, patients with acral cutaneous melanoma had similar survival outcomes, whereas those with ocular and mucosal melanoma had lower median overall survival. CLINICALTRIALS. GOV ID: NCT02156804.
BACKGROUND:Nivolumab has been widely studied in non-acral cutaneous melanoma; however, limited data are available in other melanoma subtypes. We report outcomes by melanoma subtype in patients who received nivolumab after progression on prior ipilimumab. PATIENTS AND METHODS: CheckMate 172 was a phase II, single-arm, open-label, multicentre study that evaluated nivolumab in patients with advanced melanoma who progressed on or after ipilimumab. Patients received 3 mg/kg of nivolumab, every 2 weeks for up to 2 years. The primary end-point was incidence of grade ≥3, treatment-related select adverse events (AEs). RESULTS: Among 1008 treated patients, we report data on patients with non-acral cutaneous melanoma (n = 723 [71.7%]), ocular melanoma (n = 103 [10.2%]), mucosal melanoma (n = 63 [6.3%]), acral cutaneous melanoma (n = 55 [5.5%]) and other melanoma subtypes (n = 64 [6.3%]). There were no meaningful differences in the incidence of grade ≥3, treatment-related select AEs among melanoma subtypes or compared with the total population. No new safety signals emerged. At a minimum follow-up of 18 months, median overall survival was 25.3 months for non-acral cutaneous melanoma and 25.8 months for acral cutaneous melanoma, with 18-month overall survival rates of 57.5% and 59.0%, respectively. Median overall survival was 12.6 months for ocular melanoma and 11.5 months for mucosal melanoma, with 18-month overall survival rates of 34.8% and 31.5%, respectively. CONCLUSIONS: The safety profile of nivolumab after ipilimumab is similar across melanoma subtypes. Compared with non-acral cutaneous melanoma, patients with acral cutaneous melanoma had similar survival outcomes, whereas those with ocular and mucosal melanoma had lower median overall survival. CLINICALTRIALS. GOV ID: NCT02156804.
Authors: Yian Ann Chen; Jamie K Teer; Zeynep Eroglu; Jheng-Yu Wu; John M Koomen; Florian A Karreth; Jane L Messina; Keiran S M Smalley Journal: Semin Cancer Biol Date: 2019-11-02 Impact factor: 15.707
Authors: Sanna Iivanainen; Jussi Ekstrom; Henri Virtanen; Vesa V Kataja; Jussi P Koivunen Journal: BMC Med Inform Decis Mak Date: 2021-06-30 Impact factor: 2.796