Real-World Outcomes of Pembrolizumab in Advanced Melanoma by Age and Sex: A National Population-Based Study

Saginala K, Barsouk A, Aluru JS, Rawla P, Barsouk A. Epidemiology of melanoma. Med Sci. 2021;9:63.

CAS  Google Scholar 

Huang J, Chan SC, Ko S, Lok V, Zhang L, Lin X, et al. Global incidence, mortality, risk factors and trends of melanoma: a systematic analysis of registries. Am J Clin Dermatol. 2023;24:965–75.

Article  PubMed  Google Scholar 

American Cancer Society. Survival rates for melanoma skin cancer. 2025. Available from: https://www.cancer.org/cancer/types/melanoma-skin-cancer/detection-diagnosis-staging/survival-rates-for-melanoma-skin-cancer-by-stage.html. Accessed 01 Mar 2025.

Carlino MS, Larkin J, Long GV. Immune checkpoint inhibitors in melanoma. Lancet. 2021;398:1002–14.

Article  CAS  PubMed  Google Scholar 

Li Y, Liang X, Li H, Chen X. Comparative efficacy and safety of immune checkpoint inhibitors for unresectable advanced melanoma: a systematic review and network meta-analysis. Int Immunopharmacol. 2023;115: 109657.

Article  CAS  PubMed  Google Scholar 

Seth R, Messersmith H, Kaur V, Kirkwood JM, Kudchadkar R, McQuade JL, et al. Systemic therapy for melanoma: ASCO guideline. J Clin Oncol. 2020;38:3947–70.

Article  CAS  PubMed  Google Scholar 

Seth R, Agarwala SS, Messersmith H, Alluri KC, Ascierto PA, Atkins MB, et al. Systemic therapy for melanoma: ASCO guideline update. J Clin Oncol. 2023;41:4794–820.

Article  CAS  PubMed  Google Scholar 

Cancer Council Australia. Clinical practice guidelines for the diagnosis and management of melanoma. 2021. Available from: https://www.cancer.org.au/clinical-guidelines/skin-cancer/melanoma. Accessed 01 Mar 2025.

Michielin O, Van Akkooi ACJ, Ascierto PA, Dummer R, Keilholz U, Committee EG. Cutaneous melanoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019;30:1884–901.

Article  CAS  PubMed  Google Scholar 

Garbe C, Amaral T, Peris K, Hauschild A, Arenberger P, Basset-Seguin N, et al. European consensus-based interdisciplinary guideline for melanoma. Part 2: treatment-update 2022. Eur J Cancer. 2022;170:256–84.

Article  PubMed  Google Scholar 

Therapeutic Goods Administration. Australian public assessment report for Keytruda. Canberra: Australian Government Department of Health and Aged Care; 2023.

Pharmaceutical Benefits Scheme. Public summary document: March 2015 PBAC Meeting. Canberra: Australian Government Department of Health and Aged Care; 2015.

Pharmaceutical Benefits Scheme. PBS expenditure and prescriptions. Available from: https://m.pbs.gov.au/info/statistics/expenditure-prescriptions/pbs-expenditure-and-prescriptions.html. Accessed 01 Mar 2025.

Tuffaha HW, Scuffham PA. The Australian managed entry scheme: are we getting it right? Pharmacoeconomics. 2018;36:555–65.

Article  PubMed  Google Scholar 

Robert C, Schachter J, Long GV, Arance A, Grob JJ, Mortier L, et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med. 2015;372:2521–32.

Article  CAS  PubMed  Google Scholar 

Donia M, Kimper-Karl ML, Høyer KL, Bastholt L, Schmidt H, Svane IM. The majority of patients with metastatic melanoma are not represented in pivotal phase III immunotherapy trials. Eur J Cancer. 2017;74:89–95.

Article  PubMed  Google Scholar 

Machado MADÁ, de Moura CS, Chan K, Curtis JR, Hudson M, Abrahamowicz M, et al. Real-world analyses of therapy discontinuation of checkpoint inhibitors in metastatic melanoma patients. Sci Rep. 2020;10:14607.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Jang SR, Nikita N, Banks J, Keith SW, Johnson JM, Wilson M, et al. Association between sex and immune checkpoint inhibitor outcomes for patients with melanoma. JAMA Netw Open. 2021;4: e2136823.

Article  PubMed  PubMed Central  Google Scholar 

Cowey CL, Scherrer E, Boyd M, Aguilar KM, Beeks A, Krepler C. Pembrolizumab utilization and clinical outcomes among patients with advanced melanoma in the US community oncology setting: an updated analysis. J Immunother. 2021;44:224–33.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Casarotto E, Chandwani S, Mortier L, Dereure O, Dutriaux C, Dalac S, et al. Real-world effectiveness of pembrolizumab in advanced melanoma: analysis of a French national clinicobiological database. Immunotherapy. 2021;13:905–16.

Article  CAS  PubMed  Google Scholar 

Mohr P, Scherrer E, Assaf C, Bender M, Berking C, Chandwani S, et al. Real-world therapy with pembrolizumab: outcomes and surrogate endpoints for predicting survival in advanced melanoma patients in Germany. Cancers. 2022;14:1804.

Article  PubMed  PubMed Central  Google Scholar 

Hribernik N, Boc M, Ocvirk J, Knez-Arbeiter J, Mesti T, Ignjatovic M, et al. Retrospective analysis of treatment-naive Slovenian patients with metastatic melanoma treated with pembrolizumab: real-world experience. Radiol Oncol. 2020;54:119–27.

Article  PubMed  PubMed Central  Google Scholar 

Ab Rahman AS, Strother RM, Paddison J. New Zealand national retrospective cohort study of survival outcomes of patients with metastatic melanoma receiving immune-checkpoint inhibitors. Asia Pac J Clin Oncol. 2023;19:179–86.

Article  PubMed  Google Scholar 

Angeles MR, Crosland P, Hensher M. Challenges for Medicare and universal health care in Australia since 2000. Med J Aust. 2023;218:322–9.

Article  PubMed  Google Scholar 

Mellish L, Karanges EA, Litchfield MJ, Schaffer AL, Blanch B, Daniels BJ, et al. The Australian Pharmaceutical Benefits Scheme data collection: a practical guide for researchers. BMC Res Notes. 2015;8:634.

Article  PubMed  PubMed Central  Google Scholar 

Australian Bureau of Statistics. Microdata: Person Level Integrated Data Asset (PLIDA) [DataLab].

Von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007;370:1453–7.

Article  Google Scholar 

Kim H, Comey S, Hausler K, Cook G. A real world example of coverage with evidence development in Australia: ipilimumab for the treatment of metastatic melanoma. J Pharm Policy Pract. 2018;11:4.

Article  PubMed  PubMed Central  Google Scholar 

Australian Bureau of Statistics. Socio-economic indexes for areas. Available from: https://www.abs.gov.au/websitedbs/censushome.nsf/home/seifa. Accessed 01 Mar 2025.

Australian Bureau of Statistics. Remoteness areas. Available from: https://www.abs.gov.au/statistics/standards/australian-statistical-geography-standard-asgs-edition-3/jul2021-jun2026/remoteness-structure/remoteness-areas. Accessed 01 Mar 2025.

Pratt NL, Kerr M, Barratt JD, Kemp-Casey A, Ellett LMK, Ramsay E, et al. The validity of the Rx-Risk comorbidity index using medicines mapped to the Anatomical Therapeutic Chemical (ATC) classification system. BMJ Open. 2018;8: e021122.

Article  PubMed  PubMed Central  Google Scholar 

Cancer Institute NSW. List of notifiable ICD–10 12th ed. topography codes. Available from: https://www.cancer.nsw.gov.au/research-and-data/cancer-data-and-statistics/information-for-patients-clinicians-and-notifiers/submit-cancer-cases-to-the-nsw-cancer-registry/list-of-notifiable-icd-10-am-12th-edition-topograp. Accessed 01 Mar 2025.

Strohbehn GW, Holleman R, Burns J, Klamerus ML, Kelley MJ, Kerr EA, et al. Adoption of extended-interval dosing of single-agent pembrolizumab and comparative effectiveness vs standard dosing in time-to-treatment discontinuation. JAMA Oncol. 2022;8:1663–7.

Article  PubMed  PubMed Central  Google Scholar 

Cancer Institute NSW. eVIQ: management of immune-related adverse events (irAEs). Available from: https://www.eviq.org.au/clinical-resources/side-effect-and-toxicity-management/immunological/1993-management-of-immune-related-adverse-events. Accessed 01 Mar 2025.

Iyer PC, Cabanillas ME, Waguespack SG, Hu MI, Thosani S, Lavis VR, et al. Immune-related thyroiditis with immune checkpoint inhibitors. Thyroid. 2018;28:1243–51.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Jin K-T, Wang S-B, Ying X-J, Lan H-R, Lv J-Q, Zhang L-H, et al. Immune-mediated adverse effects of immune-checkpoint inhibitors and their management in cancer. Immunol Lett. 2020;221:61–71.

Article  CAS  PubMed  Google Scholar 

Goyal G, Goyal LD, Singla H, Arora K, Kaur H. Subclinical hypothyroidism and associated cardiovascular risk factor in perimenopausal females. J Midlife Health. 2020;11:6–11.

PubMed  PubMed Central  Google Scholar 

Robert C, Ribas A, Schachter J, Arance A, Grob J-J, Mortier L, et al. Pembrolizumab versus ipilimumab in advanced melanoma (KEYNOTE-006): post-hoc 5-year results from an open-label, multicentre, randomised, controlled, phase 3 study. Lancet Oncol. 2019;20:1239–51.

Article  CAS  PubMed  Google Scholar 

Long GV, Carlino MS, McNeil C, Ribas A, Gaudy-Marqueste C, Schachter J, et al. Pembrolizumab versus ipilimumab for advanced melanoma: 10-year follow-up of the phase III KEYNOTE-006 study. Ann Oncol. 2024;35:1191–9.

Comments (0)

No login
gif