Immunotherapy with anti-PD-1/PD-L1 inhibitors represents a breakthrough in cancer treatment. Because PWHIV are usually excluded from clinical trials, tolerance and efficacy data are limited in this population. The French national network CANCERVIH is dedicated to the management of cancer in PWHIV with the organization of the national multidisciplinary meetings ONCOVIH. The objective of this study was to evaluate tolerance and efficacy of nivolumab, an anti-PD-1 inhibitors, in this specific population.
This study was conducted using the CANCERVIH database. Patients presented in national multidisciplinary meetings since May 2014 were evaluated. Demographic, CD4 lymphocyte count, HIV viral load, tolerance and efficacy data were retrospectively collected from patients treated with nivolumab in daily practice.
Since May 2014, 470 patients have been presented in ONCOVIH national multidisciplinary meetings. Immunotherapy has been proposed for 35 patients and 20 were treated in current practice: 19 (95%) for metastatic non small-cell lung cancer and 1 (5%) for metastatic melanoma. The median CD4 lymphocyte count at diagnosis was 338,5/mm3 (241,3 – 490,5). HIV viral load was undetectable in 17 patients, less than 40 copies/mL in 2 patients and unknown in 1 patient. At the cut-off analysis, with a median follow-up of 10,8 months (1,0 – 27,7), the median number of injections was 6 (3 – 53). No toxic deaths or immune related adverse events have been noted. Only one patient experienced a rising HIV viral load and a decreasing CD4 lymphocyte count but after antiretroviral therapy interruption. On the 17 patients evaluable for response, 4 (24%) had partial response, 2 (12%) had stability and 11 (64%) had disease progression at first evaluation.
Based on these preliminary data, treatment with anti-PD-1 inhibitors seems to be feasible in PWHIV. Antiretroviral therapy should not be interrupted. CD4 lymphocyte count and HIV viral load should be monitored during treatment with immune-checkpoint inhibitors and patients should be included in dedicated clinical trials. Data will be updated at the meeting presentation to better determine tolerance and efficacy of anti-PD-1 inhibitors in this population.