Final data on the efficacy of the FORA study (FOrteca Real practice Assessment): a multicenter prospective observational study on the real-world efficacy of prolgolimab in patients with metastatic melanoma in Russia
Rattachement africain : id, ru, us, gb, by. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
Background. Prior to the introduction of new agents — immune checkpoint inhibitors — for inoperable and/or metastatic melanoma (IMM), chemotherapy outcomes were generally poor. The median (Me) overall survival (OS) in IMM was no more than 6-9 months, and the Me of progression-free survival (PFS) was about 2 months. The introduction of immune checkpoint inhibitors and targeted therapy changed the prognosis for the life of IMM patients dramatically. The development, studies, and approval of a new original PD-1 inhibitor, prolgolimab, in Russia in 2020 prompted the professional community to conduct a prospective observational study in the Russian Federation to assess its real-world efficacy and safety. Aim To evaluate the real-world efficacy and safety of prolgolimab in patients with IMM. Materials and methods. From October 2020 to October 2022, 700 patients with IMM receiving prolgolimab in real clinical settings in oncological institutions of various levels in the Russian Federation were included in the study. The main inclusion criteria were: pathology-confirmed diagnosis of melanoma; metastatic and/or inoperable type; use of prolgolimab outside of clinical trials; and signed informed consent. Objective response rate in the general population and the Intention-to-treat and Per Protocol populations was considered the main criterion for evaluating the efficacy of therapy, and the safety criterion was the incidence of grade 3-4 adverse events (AEs). PFS and OS rates were also assessed. Statistical analysis was performed using the SPSS 25.0 software package. Results. The objective response rate for the Per Protocol population (with radiographic assessment available) was 42% (n=235/559). Disease progression was reported in 26.7% (n=149) of patients, stabilization in 31.3% (n=175), and disease control in 73.3% of patients with IMM, regardless of the line of therapy. At the follow-up Me of 12 months (0-36), PFS for all patients regardless of the line of therapy was 8 months (95% confidence interval [Cl] 6.537-9.463), 6-month PFS was 55%, and 12-month PFS was 41%. OS Me for all included patients was 32 months, 6-month OS was 82%, and 12-month OS was 69%. Depending on the line of therapy, the OS Me was: line 1 - not reached, line 2-30 months (95% Cl 16.007-43.993), line 3 and subsequent- 22 months (95% Cl 14.264-29.736); p=0.736. According to the CTCAE 5.0 general terminology criteria for AEs, a total of 136/693 (19.6%) AEs of varying degrees were reported, in particular: grade 1-2 - 105/693 (15.2%), grade 3-4 - 25/693 (3.6%), unknown grade - 5/693 (0.7%), as well as one fatal case (0.1%) due to thromboembolism in the vascular center with an unclear (according to the investigator's assessment) relation with prolgolimab. Conclusion The results obtained at 12 months of follow-up confirm the high efficacy and satisfactory tolerability of prolgolimab in patients with IMM in real-world practice, regardless of the line of therapy and other characteristics.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Final data on the efficacy of the FORA study (FOrteca Real practice Assessment): a multicenter prospective observational study on the real-world efficacy of prolgolimab in patients with metastatic melanoma in Russia
- Date Crossref
- 05/03/2024
- Éditeur
- Consilium Medicum
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Kementerian Kesehatan Republik Indonesia pays non établi dans la noticeOrganisme public
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National Medical and Surgical Center named after N.I. Pirogov pays non établi dans la noticeStructure de recherche
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State Healthcare Institution "Regional Clinical Oncological Dispensary" pays non établi dans la noticeOrganisme public
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Voronezh Regional Clinical Oncology Center pays non établi dans la noticeÉtablissement de santé
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Oncological Dispensary No. 2 pays non établi dans la noticeÉtablissement de santé
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P.A. Hertzen Moscow Oncology Research Institute pays non établi dans la noticeStructure de recherche
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Volgograd Regional Clinical Oncology Center pays non établi dans la noticeÉtablissement de santé
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Moscow Clinical Scientific Center pays non établi dans la noticeStructure de recherche
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State Clinical Hospital "Clinical Oncology Center No. 1 pays non établi dans la noticeÉtablissement de santé
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Regional Clinical Research pays non établi dans la noticeStructure de recherche
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Moscow City Oncology Hospital №62 pays non établi dans la noticeÉtablissement de santé
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Kostroma Research Institute of Agriculture pays non établi dans la noticeStructure de recherche
Kementerian Kesehatan Republik Indonesia, National Medical and Surgical Center named after N.I. Pirogov et State Healthcare Institution "Regional Clinical Oncological Dispensary", avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.