Современная онкология (Feb 2023)
Real-world efficacy of the first line therapy with prolgolimab in patients with metastatic melanoma: interim results of the FORA (FOrteca Real practice Assessment) observational study
- Kristina V. Orlova,
- Mikhail Yu. Fedyanin,
- Konstantin E. Simanenkov,
- Aleksandr S. Dergunov,
- Petr R. Goldshmidt,
- Aleksandra F. Saydullaeva,
- Dary V. Bogacheva,
- Marina A. Yavorskaya,
- Artur Z. Azanov,
- Alexander A. Fedenko,
- Larisa V. Bolotina,
- Tatyana I. Deshkina,
- Kseniya G. Babina,
- Ekaterina A. Kuzevanova,
- Liudmila G. Zhukova,
- Polina S. Feoktistova,
- Natalya I. Polshina,
- Ekaterina V. Peganova,
- Valentina E. Shikina,
- Maksim M. Sobolev,
- Oleg V. Mironov,
- Vera A. Vaschenko,
- Mariya M. Ershova,
- Agniya O. Mezhueva,
- Svetlana A. Orlova,
- Denis A. Tantsyrev,
- Darya K. Taskina,
- Antonina A. Teterich,
- Elena V. Karabina,
- Yuliya V. Kostalanova,
- Marina V. Bogacheva,
- Natalia V. Zhukova,
- Rashida V. Orlova,
- Maksim V. Zinkevich,
- Aleksandr I. Kazmin,
- Mikhail V. Volkonskiy,
- Liya M. Voronkova,
- Anastasiya S. Karpova,
- Mikhail L. Maleyko,
- Mariya N. Gorshenina,
- Elena I. Kryuchkova,
- Fedor V. Moiseenko,
- Yuliya I. Murzina,
- Shamil I. Musin,
- Andrey N. Ogloblin,
- Mariya S. Perminova,
- Regina A. Dumbrava,
- Sergey A. Emelyanov,
- Svetlana A. Protsenko,
- Alexander V. Sultanbaev,
- Anna V. Tarasova,
- Elena B. Shakhnovich,
- Marina V. Demchenkova,
- Yuliya A. Lozovskaya,
- Khedi S. Musaeva,
- Elena M. Pavlova,
- Roman A. Skotnikov,
- Vera V. Chernova,
- Angelina S. Chichkanova,
- Adina M. Akhmatova,
- Marina A. Zafirova,
- Andrey A. Mischenko,
- Elena N. Ovsienko,
- Viktoriya A. Petrukhnenko,
- Oksana A. Syusyukaylova,
- Yana A. Tyugina,
- Elena A. Shumilkina,
- Daniil L. Stroyakovskiy,
- Aleksandr N. Yurchenkov,
- Pavel L. Baldin,
- Anastasiya S. Belova,
- Olga V. Diduk,
- Elena A. Konovalova,
- Lyudmila N. Lebedeva,
- Yaroslav A. Li,
- Viktoriya V. Mashtapa,
- Yana A. Mironenkova,
- Kristina V. Narovenkova,
- Olga A. Pavlikova,
- Elvira L. Parsadanova,
- Irina S. Pimonova,
- Anna A. Ruzhnikova,
- Irina D. Sivunova,
- Ekaterina P. Soloveva,
- Maksim I. Sosnin,
- Toita Kh. Temirsultanova,
- Makhabbat Zh. Tyulegenova,
- Aleksandra V. Khodkevich,
- Nadezhda R. Shakurova,
- Sureya N. Efendieva,
- Karine L. Avagimyan,
- Ekaterina P. Anokhina,
- Mariya I. Antoshkina,
- Stanislav M. Borzyanitsa,
- Samir K. Dzhentemirov,
- Marina V. Dmitrochenko,
- Alla V. Zheleznyak,
- Yuliya V. Komoza,
- Aleksandr S. Kopanev,
- Tatyana I. Kornienko,
- Margarita A. Krasilnikova,
- Darya A. Lukhmanova,
- Natalya S. Mazur,
- Polina M. Markina,
- Zhargal S. Mitapov,
- Svetlana N. Osodoeva,
- Irina A. Prokopenko,
- Irina M. Radyukova,
- Madina S. Ramazanova,
- Alfiya R. Safarova,
- Mariya A. Safronova,
- Khalimat M. Khabrieva,
- Natalya S. Tsygankova,
- Kseniya V. Chermakova,
- Tatyana A. Chirkova,
- Igor V. Samoylenko,
- Valeria V. Nazarova,
- Angelina E. Akhmetyanova,
- Lev V. Demidov
Affiliations
- Kristina V. Orlova
- ORCiD
- Blokhin National Medical Research Center of Oncology
- Mikhail Yu. Fedyanin
- ORCiD
- Blokhin National Medical Research Center of Oncology
- Konstantin E. Simanenkov
- Lipetsk Regional Oncological Dispensary
- Aleksandr S. Dergunov
- Tver Regional Clinical Oncological Dispensary
- Petr R. Goldshmidt
- Oncological Dispensary
- Aleksandra F. Saydullaeva
- Tver Regional Clinical Oncological Dispensary
- Dary V. Bogacheva
- Voronezh Regional Clinical Oncology Dispensary
- Marina A. Yavorskaya
- Oncological Dispensary №2
- Artur Z. Azanov
- Rappoport Kuzbass Clinical Oncological Dispensary
- Alexander A. Fedenko
- ORCiD
- Hertsen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Centre
- Larisa V. Bolotina
- ORCiD
- Hertsen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Centre
- Tatyana I. Deshkina
- Hertsen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Centre
- Kseniya G. Babina
- Volgograd Regional Clinical Oncological Dispensary
- Ekaterina A. Kuzevanova
- Regional Clinical Oncological Dispensary
- Liudmila G. Zhukova
- ORCiD
- Loginov Moscow Clinical Scientific Center
- Polina S. Feoktistova
- ORCiD
- Loginov Moscow Clinical Scientific Center
- Natalya I. Polshina
- ORCiD
- Loginov Moscow Clinical Scientific Center
- Ekaterina V. Peganova
- Clinical Oncology Hospital
- Valentina E. Shikina
- Vladimirsky Moscow Regional Research Clinical Institute
- Maksim M. Sobolev
- City Clinical Oncology Hospital №1
- Oleg V. Mironov
- Tambov Regional Oncological Clinical Dispensary
- Vera A. Vaschenko
- Kostroma Oncological Dispensary
- Mariya M. Ershova
- Sverdlovsk Regional Oncological Dispensary
- Agniya O. Mezhueva
- Moscow Multidisciplinary Clinical Center “Kommunarka“
- Svetlana A. Orlova
- Republican Clinical Oncological Dispensary
- Denis A. Tantsyrev
- Altai Regional Oncological Dispensary
- Darya K. Taskina
- Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
- Antonina A. Teterich
- Belgorod Regional Oncological Dispensary
- Elena V. Karabina
- Tula Regional Clinical Oncological Dispensary
- Yuliya V. Kostalanova
- Samara Regional Clinical Oncology Dispensary
- Marina V. Bogacheva
- Vologda Regional Clinical Hospital №2
- Natalia V. Zhukova
- ORCiD
- Saint Petersburg State University
- Rashida V. Orlova
- ORCiD
- City Clinical Oncology Dispensary
- Maksim V. Zinkevich
- Leningrad Regional Clinical Oncology Dispensary
- Aleksandr I. Kazmin
- Voronezh Regional Clinical Oncology Dispensary
- Mikhail V. Volkonskiy
- ORCiD
- Moscow City Oncological Hospital №62
- Liya M. Voronkova
- Republican Oncological Dispensary
- Anastasiya S. Karpova
- Trans-Baikal Regional Oncological Dispensary
- Mikhail L. Maleyko
- Oncological Dispensary
- Mariya N. Gorshenina
- Republican Oncological Dispensary
- Elena I. Kryuchkova
- Smolensk Regional Oncological Clinical Dispensary
- Fedor V. Moiseenko
- ORCiD
- Saint Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncology)
- Yuliya I. Murzina
- Oncological Dispensary
- Shamil I. Musin
- Republican Clinical Oncology Center
- Andrey N. Ogloblin
- Oryol Oncological Dispensary
- Mariya S. Perminova
- Rappoport Kuzbass Clinical Oncological Dispensary
- Regina A. Dumbrava
- Primorsky Regional Oncological Dispensary
- Sergey A. Emelyanov
- Primushko Republican Clinical Oncological Dispensary
- Svetlana A. Protsenko
- Petrov National Medical Research Center of Oncology
- Alexander V. Sultanbaev
- ORCiD
- Republican Clinical Oncology Center
- Anna V. Tarasova
- Samara Regional Clinical Oncology Dispensary
- Elena B. Shakhnovich
- Korolyov City Hospital
- Marina V. Demchenkova
- Irkutsk Regional Oncological Dispensary
- Yuliya A. Lozovskaya
- Ostroverkhov Kursk Cancer Research and Clinical Center
- Khedi S. Musaeva
- Oncology Center “AiMed”
- Elena M. Pavlova
- Vologda Regional Oncological Dispensary
- Roman A. Skotnikov
- Tula Regional Clinical Oncological Dispensary
- Vera V. Chernova
- Regional Clinical Oncological Dispensary
- Angelina S. Chichkanova
- Nizhny Novgorod Regional Clinical Oncology Center
- Adina M. Akhmatova
- Oncological Dispensary
- Marina A. Zafirova
- Sverdlovsk Regional Oncological Dispensary
- Andrey A. Mischenko
- Primorsky Regional Oncological Dispensary
- Elena N. Ovsienko
- Primushko Republican Clinical Oncological Dispensary
- Viktoriya A. Petrukhnenko
- Oncological Dispensary
- Oksana A. Syusyukaylova
- Ashkhamaf Adygei Republican Clinical Oncology Center
- Yana A. Tyugina
- Ivanovo Regional Oncological Dispensary
- Elena A. Shumilkina
- Republican Clinical Oncological Dispensary
- Daniil L. Stroyakovskiy
- ORCiD
- Moscow City Oncological Hospital №62
- Aleksandr N. Yurchenkov
- Moscow City Oncological Hospital №62
- Pavel L. Baldin
- Naberezhnye Chelny Oncological Dispensary – branch of the Republican Clinical Oncological Dispensary
- Anastasiya S. Belova
- Novgorod Regional Clinical Oncological Dispensary
- Olga V. Diduk
- Kryzhanovsky Krasnoyarsk Regional Clinical Oncology Dispensary
- Elena A. Konovalova
- Murmansk Regional Oncological Dispensary
- Lyudmila N. Lebedeva
- Arkhangelsk Clinical Oncology Dispensary
- Yaroslav A. Li
- Clinic Lyadov
- Viktoriya V. Mashtapa
- Ostroverkhov Kursk Cancer Research and Clinical Center
- Yana A. Mironenkova
- Vologda Regional Oncological Dispensary
- Kristina V. Narovenkova
- Bryansk Regional Oncological Dispensary
- Olga A. Pavlikova
- Republican Oncological Dispensary
- Elvira L. Parsadanova
- Sakhalin Regional Oncological Dispensary
- Irina S. Pimonova
- Tsyb Medical Radiological Research Centre – branch of the National Medical Research Radiological Center
- Anna A. Ruzhnikova
- Arkhangelsk Clinical Oncology Dispensary
- Irina D. Sivunova
- Kamchatka Regional Oncology Center
- Ekaterina P. Soloveva
- Arkhangelsk Clinical Oncology Dispensary
- Maksim I. Sosnin
- Krasnogorsk City Hospital №1
- Toita Kh. Temirsultanova
- Oncology Center “AiMed”
- Makhabbat Zh. Tyulegenova
- Orenburg Regional Clinical Oncology Dispensary
- Aleksandra V. Khodkevich
- Bryansk Regional Oncological Dispensary
- Nadezhda R. Shakurova
- Tomsk Regional Oncological Dispensary
- Sureya N. Efendieva
- Republican Cancer Center
- Karine L. Avagimyan
- Ostroverkhov Kursk Cancer Research and Clinical Center
- Ekaterina P. Anokhina
- Regional Clinical Oncology Dispensary
- Mariya I. Antoshkina
- Republican Oncological Dispensary
- Stanislav M. Borzyanitsa
- Rappoport Kuzbass Clinical Oncological Dispensary
- Samir K. Dzhentemirov
- Stavropol Regional Clinical Oncology Center
- Marina V. Dmitrochenko
- Smolensk Regional Oncological Clinical Dispensary
- Alla V. Zheleznyak
- Nizhny Novgorod Regional Clinical Oncology Center
- Yuliya V. Komoza
- Bryansk Regional Oncological Dispensary
- Aleksandr S. Kopanev
- Center of Oncology and Medical Radiology
- Tatyana I. Kornienko
- Tambov Regional Oncological Clinical Dispensary
- Margarita A. Krasilnikova
- Rappoport Kuzbass Clinical Oncological Dispensary
- Darya A. Lukhmanova
- Regional Clinical Oncology Dispensary
- Natalya S. Mazur
- Sverdlovsk Regional Oncological Dispensary
- Polina M. Markina
- Nizhny Novgorod Regional Clinical Oncology Center
- Zhargal S. Mitapov
- Buryat Republican Clinical Oncological Dispensary
- Svetlana N. Osodoeva
- Buryat Republican Clinical Oncological Dispensary
- Irina A. Prokopenko
- Ostroverkhov Kursk Cancer Research and Clinical Center
- Irina M. Radyukova
- Clinical Oncological Dispensary
- Madina S. Ramazanova
- Center of Oncology and Medical Radiology
- Alfiya R. Safarova
- Almetyevsk branch of the Republican Clinical Oncological Dispensary
- Mariya A. Safronova
- Smolensk Regional Oncological Clinical Dispensary
- Khalimat M. Khabrieva
- Republican Oncological Dispensary of the Republic of Ingushetia
- Natalya S. Tsygankova
- Smolensk Regional Oncological Clinical Dispensary
- Kseniya V. Chermakova
- Ostroverkhov Kursk Cancer Research and Clinical Center
- Tatyana A. Chirkova
- Rappoport Novokuznetsk branch of the Kuzbass Clinical Oncological Dispensary
- Igor V. Samoylenko
- ORCiD
- Blokhin National Medical Research Center of Oncology
- Valeria V. Nazarova
- ORCiD
- Blokhin National Medical Research Center of Oncology
- Angelina E. Akhmetyanova
- Blokhin National Medical Research Center of Oncology
- Lev V. Demidov
- ORCiD
- Blokhin National Medical Research Center of Oncology
- DOI
- https://doi.org/10.26442/18151434.2022.4.202035
- Journal volume & issue
-
Vol. 24,
no. 4
pp. 413 – 425
Abstract
Background. Novel agents immune checkpoint inhibitors fundamentally changed the prognosis for life in patients with metastatic and/or inoperable melanoma. The development, studies, and approval of a new original PD1 inhibitor in Russia in 2020 prompted the professional community to conduct a prospective observational study in the Russian Federation to assess the real-world efficacy and safety of prolgolimab, as real-world patients differ from the refined population in clinical trials. Aim. To evaluate the real-world efficacy and safety of prolgolimab in patients with metastatic and/or inoperable melanoma. Materials and methods. From October 2020 to October 2022, the study enrolled 700 patients with metastatic and/or inoperable melanoma receiving prolgolimab in real clinical settings in oncological institutions of various levels in the Russian Federation. 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 by the patient. Objective response rate (ORR) was considered the main criterion for evaluating the efficacy of therapy, and the safety criterion was the incidence of grade 34 adverse events. Statistical analysis was performed using the SPSS 20.0 software package. Results. The ORR for patients with skin melanoma treated with prolgolimab in the first line therapy (n= 207/337) was 48.3% (n=100), the disease stabilization was reported in 30.4% (n=63), and progression in 21.3% (n=44) of patients. There were no significant differences in response to therapy between patients with/withoutBRAFmutation, although ORR was higher in patients withBRAFmutation: the ORR for patients withBRAFmutation was 57.9% (n=33), and forBRAFnon-mutated patients, 44.4% (n=52;p=0.222). At a median follow-up of 5 months, the median PFS was 10 months (95% confidence interval 7.3512.64). The incidence of grade 34 treatment-related adverse events according to CTCAE 5.0 was 2% (n=12), and 12% (n=82) for grade 12 adverse events. Conclusion. The results confirm the high efficacy and satisfactory tolerability of prolgolimab in patients with metastatic and/or inoperable melanoma in real-world settings. There were no significant differences in ORR between patients with or withoutBRAFmutation.
Keywords