Efficacy and Safety of Pola-BR Combination in Relapsed/Refractory Aggressive В-Cell Non-Hodgkin’s Lymphomas: A Russian Multi-Center Study

AUTOIMMUNE THROMBOCYTOPENIA

OG Smykova1, AA Semenova2, YuB Chernykh3, TA Mitina3, AV Kildyushevskii3, SK Kravchenko4, AE Misyurina4, AU Magomedova4, EA Baryakh5, SV Samarina6, NP Volkov1, VV Markelov1, PV Kotselyabina1, LV Fedorova1, KV Lepik1, EV Kondakova1, LV Stelmakh1, VV Baykov1, NB Mikhailova1, IS Moiseev1, GS Tumyan2, EA Osmanov2, AD Kulagin1

1 RM Gorbacheva Scientific Research Institute of Pediatric Oncology, Hematology and Transplantation; IP Pavlov First Saint Petersburg State Medical University, 6/8 L’va Tolstogo ul., Saint Petersburg, Russian Federation, 197022

2 NN Blokhin National Medical Cancer Research Center, 24 Kashirskoye sh., Moscow, Russian Federation, 115478

3 MF Vladimirskii Moscow Regional Research Clinical Institute, 61/2 Shchepkina ul., Moscow, Russian Federation, 129110

4 National Research Center for Hematology, 4 Novyi Zykovskii pr-d, Moscow, Russian Federation, 125167

5 Municipal Clinical Hospital No. 52, 3 Pekhotnaya ul., Moscow, Russian Federation, 123182

6 Kirov Research Institute of Hematology and Transfusiology, 72 Krasnoarmeiskaya ul., Kirov, Russian Federation, 610027

For correspondence: Olesya Gennadevna Smykova, 6/8 L’va Tolstogo ul., Saint Petersburg, Russian Federation, 197022; Tel.: +7(981)144-67-95; e-mail: olesya.gen@gmail.com

For citation: Smykova OG, Semenova AA, Chernykh YuB, et al. Efficacy and Safety of Pola-BR Combination in Relapsed/Refractory Aggressive В-Cell Non-Hodgkin’s Lymphomas: A Russian Multi-Center Study. Clinical oncohematology. 2022;15(3):232–9. (In Russ).

DOI: 10.21320/2500-2139-2022-15-3-232-9

ABSTRACT

Aim. To analyze the first experience of administering polatuzumab vedotin combined with bendamustine and rituximab (Pola-BR) in clinical practice at some specialized institutions in the Russian Federation.

Materials & Methods. The prospective multi-center study enrolled 39 patients with relapsed/refractory aggressive В-cell non-Hodgkin’s lymphomas (B-NHLs): 31 (79 %) patients with diffuse large B-cell lymphoma, 7 (18 %) patients with primary mediastinal (thymic) large B-cell lymphoma, and 1 (3 %) patient with gray zone lymphoma. There were 20 men and 19 women aged 19–69 years (median 43 years). All the patients were treated with Pola-BR protocol: bendamustine 90 mg/m2 on Days 1 and 2, rituximab 375 mg/m2 on Day 1, and polatuzumab vedotin 1.8 mg/kg on Day 1 of each 21-day cycle. Full treatment with 6 cycles was completed by 19 patients. PET-CT was performed prior to therapy and after the 2nd, 4th, and 6th Pola-BR cycles. The tumor response was evaluated according to the Lugano 2014 criteria. The toxicity profile was assessed by means of reporting adverse events according to the NCI CTCAE, version 5.0.

Results. Objective response to the therapy, according to the Lugano 2014 criteria, was identified in 24 (61.5 %) patients: 19 (48.7 %) of them showed the complete response, and 5 (12.8 %) of them showed the partial one. Stable disease as best response to the therapy was reported in 3 (7.7 %) patients, disease progression was observed in 12 (30.8 %) patients. By the time of data analysis, the median follow-up duration was 16.8 months (range 5.3–24.2 months). The 2-year overall survival (OS) was 44 % (95% confidence interval [95% CI] 24–62 %), the median OS was 20.8 months. The 2-year progression-free survival (PFS) was 27 % (95% CI 12–43 %), the median PFS was 7.3 months. Adverse events of grade 3/4 included anemia (n = 4; 10.3 %), neutropenia (n = 15; 38.5 %), thrombocytopenia (n = 3; 7.7 %), and febrile neutropenia (n = 2; 5.1 %). In 2 patients with history of hepatitis B, the virus reactivation was identified on Pola-BR therapy. No cases of peripheral neuropathy were observed.

Conclusion. Results obtained in real-world clinical practice correspond to the previously published data and demonstrate that polatuzumab vedotin therapy (Pola-BR protocol) has a controllable toxicity profile and is, therefore, a promising chemotherapy method of relapsed/refractory aggressive B-NHL treatment.

Keywords: polatuzumab vedotin, aggressive B-NHLs, relapsed/refractory, treatment outcomes.

Received: March 13, 2022

Accepted: June 8, 2022

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