Hollebecque, A. (Antoine)

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    Safety and Efficacy of Nivolumab Monotherapy in Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results From the Phase I/II CheckMate 358 Trial
    (American Society of Clinical Oncology (ASCO), 2019) Naumann, R.W. (R. Wendel); Gu, J. (Junchen); Boni, V. (Valentina); Chen, T. (Tian); Moore, K.N. (Kathleen N.); Zwirtes, R. (Ricardo); Li, B. (Bin); Calvo, E. (Emiliano); Delord, J.P. (Jean-Pierre); Meyer, T. (Tim); Machiels, J.P. (Jean-Pascal); Kerger, J. (Joseph); Lopez-Picazo, J.M. (José M.); Soumaoro, I. (Ibrahima); Topalian, S.L. (Suzanne L.); Hollebecque, A. (Antoine); Devlin, M.J. (Michael-John); Oaknin, A. (Ana); Evans, T.R.J. (Thomas R.J.)
    Purpose: Nivolumab was assessed in patients with virus-associated tumors in the phase I/II CheckMate 358 trial (ClinicalTrials.gov identifier: NCT02488759). We report on patients with recurrent/metastatic cervical, vaginal, or vulvar cancers. Patients and methods: Patients received nivolumab 240 mg every 2 weeks. Although patients with unknown human papillomavirus status were enrolled, patients known to have human papillomavirus-negative tumors were ineligible. The primary end point was objective response rate. Duration of response (DOR), progression-free survival, and overall survival were secondary end points. Safety and patient-reported outcomes were exploratory end points. Results: Twenty-four patients (cervical, n = 19; vaginal/vulvar, n = 5) were enrolled. Most patients had received prior systemic therapy for metastatic disease (cervical, 78.9%; vaginal/vulvar, 80.0%). Objective response rates were 26.3% (95% CI, 9.1 to 51.2) for cervical cancer and 20.0% (95% CI, 0.5 to 71.6) for vaginal/vulvar cancers. At a median follow-up of 19.2 months, median DOR was not reached (range, 23.3 to 29.5+ months; + indicates a censored observation) in the five responding patients in the cervical cohort; the DOR was 5.0 months in the single responding patient in the vaginal/vulvar cohort. Median overall survival was 21.9 months (95% CI, 15.1 months to not reached) among patients with cervical cancer. Any-grade treatment-related adverse events were reported in 12 of 19 patients (63.2%) in the cervical cohort and all five patients in the vaginal/vulvar cohort; there were no treatment-related deaths. In the cervical cohort, nivolumab treatment generally resulted in stabilization of patient-reported outcomes associated with health status and health-related quality of life. Conclusion: The efficacy of nivolumab in patients with recurrent/metastatic cervical and vaginal or vulvar cancers is promising and warrants additional investigation. No new safety signals were identified with nivolumab treatment in this population.
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    Evidence of pseudoprogression in patients treated with PD1/ PDL1 antibodies across tumor types
    (2020) Massard, C. (Christophe); Martin-Romano, P. (Patricia); Vuagnat, P. (Perrine); Postel-Vinay, S. (Sophie); Castañón-Álvarez, E. (Eduardo); Marabelle, A. (Aurelien); Michot, J.M. (Jean Marie); Champiat, S. (Stéphane); Baldini, C. (Capucine); Ferté, C. (Charles); Hollebecque, A. (Antoine); Soria, J.C. (Jean-Charles); Varga, A. (Andrea); Ammari, S. (Samy)
    Background: PD(L)1 antibodies (anti-PD(L)-1) have been a major breakthrough in several types of cancer. Novel patterns of response and progression have been described with anti-PD(L)-1. We aimed at characterizing pseudoprogression (PSPD) among patients with various solid tumor types treated by anti-PD(L)-1. Methods: All consecutive patients (pts) enrolled in phase 1 trials with advanced solid tumors and lymphomas treated in phase I clinical trials evaluating monotherapy by anti-PD(L)-1 at Gustave Roussy were analyzed. We aimed to assess prevalence and outcome of PSPD across tumor types. We also intended to describe potential clinical and pathological factors associated with PSPD. Results: A total of 169 patients treated with anti-PD(L)-1 were included in the study. Most frequent tumor types included melanoma (n = 57) and non-small cell lung cancer (n = 19). At first tumor evaluation 77 patients (46%) presented with immune unconfirmed progressive disease. Six patients (8%) experienced PSPD: 2 patients with partial response; 4 patients with stable disease. Increase in target lesions in the first CT-scan was more frequently associated to PSPD (67% vs 33%; P = .04). Patients with a PSPD had a superior survival when compared to patients progressing (median OS: 10.7 months vs 8.7 months; P = .07). Conclusions: A small subset of PSPD patients may experience response after an initial progression. Assessment of the current strategy for immune-related response evaluations may require further attention.