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Thématique :
- Cancers autres (hors CCR et CHC)
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Originalité :
Intermédiaire
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| Doit faire évoluer notre pratique : |
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Pas encore
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Nom du veilleur :
Professeur David TOUGERON
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Annals of oncology
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2017/05
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2017 May; 28(5): 1036–1041.
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doi: 10.1093/annonc/mdx029
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Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal
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P. A. Ott, S. A. Piha-Paul, P. Munster, M. J. Pishvaian, E. M. J. van Brummelen, R. B. Cohen, C. Gomez-Roca, S. Ejadi, M. Stein, E. Chan, M. Simonelli, A. Morosky, S. Saraf, K. Emancipator, M. Koshiji, and J. Bennouna
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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5406758/
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Abstract
Background
Safety and efficacy of pembrolizumab, a humanized programmed death 1 monoclonal antibody, was assessed in KEYNOTE-028, a multicohort, phase Ib trial for patients with programmed death ligand 1 (PD-L1)-positive advanced solid tumors. We report results for the cohort of patients with advanced anal carcinoma.
Patients and methods
Patients with PD-L1-positive tumors (≥1%) received intravenous pembrolizumab 10 mg/kg once every 2 weeks for up to 2 years or until confirmed progression or unacceptable toxicity. Response was assessed every 8 weeks for the first 6 months and every 12 weeks thereafter per Response Evaluation Criteria In Solid Tumors, version 1.1. Primary endpoints were safety and overall response rate per investigator review. Secondary endpoints included progression-free survival, overall survival, and response duration. Data cutoff date was 1 July 2015.
Results
Of the 43 patients with advanced anal carcinoma evaluable for PD-L1 expression, 32 (74%) had PD-L1-positive tumors as assessed with the 22C3 prototype assay, of whom 25 were enrolled between April and September 2014. Sixteen patients (64%) experienced treatment-related adverse events; the most common ones were diarrhea and fatigue in four patients (16%) each and nausea in three patients (12%). There were no treatment-related deaths or discontinuations as of the data cutoff date. Among the 24 patients with squamous cell carcinoma histology, four had confirmed partial response, for an overall response rate of 17% [95% confidence interval (CI), 5%–37%) and 10 (42%) had confirmed stable disease, for a disease control rate of 58%. One additional patient with non-squamous histology had confirmed stable disease.
Conclusion
In this population of patients with PD-L1-positive advanced squamous cell anal carcinoma, pembrolizumab demonstrated a manageable safety profile and encouraging antitumor activity. These data support further study of pembrolizumab for this patient population.
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Les inhibiteurs des immunes chekpoints (PD-1 et anti-PD-L1) ont montré une efficacité majeure dans différentes tumeurs, notamment les mélanomes et les cancers pulmonaires. Cet article rapporte les résultats du pembrolizumab (anti-PD-1) dans les carcinomes épidermoïdes de l’anus en échappement thérapeutiques, traités dans l’essai KEYNOTE-028.
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Le pembrolizumab permet un taux de contrôle de la maladie de 58% avec une tolérance acceptable.
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Ces résultats sont encourageants dans une pathologie où les possibilités thérapeutiques sont minces. Ces résultats doivent être confirmés dans un essai randomisé II/III avant une utilisation en pratique courante.
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