Martin Tio1, Rajat Rai2, Ogochukwu M Ezeoke3, Jennifer L McQuade4, Lisa Zimmer5, Chloe Khoo6, John J Park7, Lavinia Spain8, Samra Turajlic9, Luke Ardolino10, Desmond Yip11, Simone M Goldinger12, Justine V Cohen13, Michael Millward14, Victoria Atkinson15, Alisa Y Kane16, Paolo A Ascierto17, Claus Garbe18, Ralf Gutzmer19, Douglas B Johnson20, Hira A Rizvi3, Anthony M Joshua21, Matthew D Hellmann3, Georgina V Long22, Alexander M Menzies22. 1. Melanoma Institute Australia, Sydney, Australia. Electronic address: mtio0565@uni.sydney.edu.au. 2. Melanoma Institute Australia, Sydney, Australia. 3. Memorial Sloan Kettering Cancer Center, New York, USA. 4. MD Anderson Cancer Center, Houston, USA. 5. University of Duisburg-Essen Hospital, Heidelberg, Germany. 6. Peter MacCallum Cancer Centre, Melbourne, Australia. 7. Crown Princess Mary Cancer Centre, Sydney, Australia; Westmead Hospital, Sydney, Australia. 8. Skin and Renal Unit, The Royal Marsden NHS Foundation Trust, London, UK. 9. Skin and Renal Unit, The Royal Marsden NHS Foundation Trust, London, UK; Francis Crick Institute, London, UK. 10. St Vincents Hospital, Sydney, Australia. 11. The Canberra Hospital, Canberra, Australia; ANU Medical School, Australian National University, Canberra, Australia. 12. University Hospital Zurich, Zurich, Switzerland. 13. Massachusetts General Hospital, Boston, USA. 14. Sir Charles Gairdner Hospital, Perth, Australia. 15. Princess Alexandra Hospital, Brisbane, Australia. 16. Liverpool Hospital, Sydney, Australia; Garvan Institute, Sydney, Australia. 17. Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy. 18. University of Tubingen, Tubingen, Germany. 19. Hannover Medical School, Hannover, Germany. 20. Vanderbilt Ingram Cancer Center, Nashville, USA. 21. Melanoma Institute Australia, Sydney, Australia; St Vincents Hospital, Sydney, Australia; University of New South Wales, Sydney, Australia. 22. Melanoma Institute Australia, Sydney, Australia; The University of Sydney, Sydney, Australia; Royal North Shore Hospital, Sydney, Australia.
Abstract
BACKGROUND: Anti-programmed cell death protein 1/programmed death ligand 1 (PD-1/PD-L1) immunotherapy is now routinely used to treat several cancers. Clinical trials have excluded several populations, including patients with solid organ transplant, HIV infection and hepatitis B/C infection. We examined the safety outcomes of these populations treated with anti-PD-1/PD-L1 treatment in a multicentre retrospective study. METHODS: Patients from 16 centres with advanced cancer and solid organ transplant, HIV infection or hepatitis B/C infection were included. Demographic, tumour, treatment, toxicity and outcome data were recorded. RESULTS: Forty-six patients were included for analysis, with a median age of 60 years, and the majority of patients diagnosed with melanoma (72%). Among six patients with solid organ transplants, two graft rejections occurred, with one resulting in death, whereas two patients achieved partial responses. There were four responses in 12 patients with HIV infection. In 14 patients with hepatitis B, there were three responses, and similarly, there were three responses in 14 patients with hepatitis C. There was no unexpected toxicity in any viral infection group or an increase in viral load. CONCLUSION: Patients with HIV or hepatitis B/C infections treated with anti-PD-1/PD-L1 immunotherapy may respond to treatment without increased toxicity. Given the risk of graft rejection in solid organ transplant patients and also the potential for response, the role of anti-PD-1/PD-L1 immunotherapy needs to be carefully considered.
BACKGROUND: Anti-programmed cell death protein 1/programmed death ligand 1 (PD-1/PD-L1) immunotherapy is now routinely used to treat several cancers. Clinical trials have excluded several populations, including patients with solid organ transplant, HIV infection and hepatitis B/C infection. We examined the safety outcomes of these populations treated with anti-PD-1/PD-L1 treatment in a multicentre retrospective study. METHODS:Patients from 16 centres with advanced cancer and solid organ transplant, HIV infection or hepatitis B/C infection were included. Demographic, tumour, treatment, toxicity and outcome data were recorded. RESULTS: Forty-six patients were included for analysis, with a median age of 60 years, and the majority of patients diagnosed with melanoma (72%). Among six patients with solid organ transplants, two graft rejections occurred, with one resulting in death, whereas two patients achieved partial responses. There were four responses in 12 patients with HIV infection. In 14 patients with hepatitis B, there were three responses, and similarly, there were three responses in 14 patients with hepatitis C. There was no unexpected toxicity in any viral infection group or an increase in viral load. CONCLUSION:Patients with HIV or hepatitis B/C infections treated with anti-PD-1/PD-L1 immunotherapy may respond to treatment without increased toxicity. Given the risk of graft rejection in solid organ transplant patients and also the potential for response, the role of anti-PD-1/PD-L1 immunotherapy needs to be carefully considered.
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