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ePoster Display

1087P - The importance of anti-PD-1 dosing in the treatment of patients with inoperable or metastatic melanoma

Date

16 Sep 2021

Session

ePoster Display

Topics

Immunotherapy

Tumour Site

Melanoma

Presenters

Bozena Cybulska-Stopa

Citation

Annals of Oncology (2021) 32 (suppl_5): S867-S905. 10.1016/annonc/annonc706

Authors

B. Cybulska-Stopa1, A.M. Czarnecka2, K. Ostaszewski3, M. Ziętek4, K. Piejko1, R. Dziura5, L. Galus6, B.E. Ziolkowska7, S. Kieszko8, N. Kempa-Kaminska9, J. Calik4, J. Seredyńska1, P. Rogala2, A. Drosik-Kwaśniewska1, G. Kamińska-Winciorek10, T. Kubiatowski8, R. Suwinski11, J. Mackiewicz12, P. Rutkowski13

Author affiliations

  • 1 Department Of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Cracow Branch, 31-115 - Kraków/PL
  • 2 Soft Tissue/bone Sarcoma And Melanoma Department, Maria Sklodowska-Curie National Research Institute of Oncology, 02-781 - Warsaw/PL
  • 3 Klinika Onkologii, Military Medical Institute, 04-141 - Warsaw/PL
  • 4 Department Of Oncology, Department Of Surgical Oncology, Wrocław Medical University, Wrocław Comprehensive Cancer Center, 53-413 - Wrocław/PL
  • 5 Clinical Oncology Department, Holy Cross Cancer Center, 25-734 - Kielce/PL
  • 6 Department Of Medical And Experimental Oncology, University of Medical Sciences, 61-868 - Poznan/PL
  • 7 2nd Dept. Of Radiotherapy And Chemotherapy, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, 44-102 - Gliwice/PL
  • 8 Department Of Clinical Oncology, Saint Jan of Dukla Oncology Centre of the Lublin Region, 20-090 - Lublin/PL
  • 9 Department Of Clinical Oncology, Lower Silesian Oncology Center, Wroclaw, 53-439 - Wroclaw/PL
  • 10 Department Of Bone Marrow Transplantation And Hematology-oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, 44-102 - Gliwice/PL
  • 11 Ii Clinic Of Radiotherapy And Chemotherapy, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, 44-102 - Gliwice/PL
  • 12 Department Of Medical And Experimental Oncology, Department Of Diagnostics And Cancer Immunology, University of Medical Sciences, Greater Poland Cancer Centre, 61-878 - Poznan/PL
  • 13 Department Of Soft Tissue/bone Sarcoma And Melanoma, Maria Sklodowska-Curie National Research Institute of Oncology, 02-781 - Warsaw/PL
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Abstract 1087P

Background

Anti-programmed cell death-1 antibodies (anti-PD-1) has become a standard treatment option for melanoma patients. Unfortunately, there are no clinical data on the efficacy of anti-PD-1 at fixed-doses in routine practice.

Methods

Consecutive patients treated with nivolumab (N) or pembrolizumab (P) for inoperable and metastatic melanoma in comprehensive cancer centers between 2016 and 2020 were enrolled in the study. The initial anti-PD-1 dose in mg/kg was calculated in patients. Baseline factors together with the initial dose anti-PD-1 were evaluated to identify predictors of progression-free (PFS) and overall (OS) survival. PFS and OS were assessed using Kaplan–Meier and Cox models. The Chi Square statistic was used for testing relationships between categorical variables.

Results

Overall, 1053 patients were included in the present analysis (N=590, P=463). In N group there were no differences in OS and PFS between the group 240 mg Q2W vs. 480 mg Q4W and in OS between the group that received the first dose of N ≤ 3 vs. > 3 mg/kg or treatment Q2W vs. Q4W. However, in univariate analysis there were statistically significant differences in PFS between the group that received the first dose of N ≤ 3 vs. > 3 mg/kg (p=0.0002, HR=1.6, Cl 95% 1.2-2.0) or treatment Q2W vs. Q4W (p=0.0023, HR=1.4, Cl 95% 1.1-1.8), this was not confirmed in the multivariate analysis. The first dose of N < 3 vs. ≥ 3mg/kg correlated with response to treatment (RR) and disease control rate (DCR) (p=0.03 and p=0.0132, respectively) but not correlated with the occurrence of immune related adverse events (irAEs). Treatment Q2W vs. Q4W and 240 mg Q2W vs. 480 mg Q4W were not correlated with RR and DCR, however there were correlated with the occurrence of irAE (p=0.0025 and p=0.0047, respectively). In P group there were no significant differences in OS and PFS between the group that received the first dose of P ≤ 2 and >2 mg/kg, treatment Q3W vs. Q6W and 200 mg Q3W vs. 400 mg Q6W. There were also no correlation with RR and DCR however, there was correlation with the occurrence of irAEs.

Conclusions

Anti-PD-1 dosing had no effect on OS and PFS in the study population. However, a correlation of dosing with the occurrence of irAE was demonstrated, but this requires confirmation in further studies.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding

Disclosure

B. Cybulska-Stopa: Financial Interests, Personal, Invited Speaker: BMS, Novartis, Roche, Pierre Fabre, MSD; Financial Interests, , Sponsor/Funding: Pierre Fabre, Astellas, BMS. A.M. Czarnecka: Financial Interests, Personal, Invited Speaker: BMS, Novartis, Roche, Pierre Fabre, MSD; Financial Interests, Personal, Sponsor/Funding: BMS, Novartis, Roche, Pierre Fabre, MSD. K. Ostaszewski: Financial Interests, Personal, Sponsor/Funding: BMS. M. Ziętek: Financial Interests, Personal, Invited Speaker: BMS, Novartis, Roche, Pierre Fabre, MSD. L. Galus: Financial Interests, Personal, Invited Speaker: Roche, Merk, Astellas. J. Calik: Financial Interests, Personal, Invited Speaker: BMS, Novartis, Roche, Pierre Fabre, and MSD. J. Seredyńska: Financial Interests, Personal, Invited Speaker: Pfizer, Roche, Amgen, Sandoz, Lilly, Roche, Novartis, . P. Rogala: Financial Interests, , Invited Speaker: BMS, Novartis, Roche, Pierre Fabre, MSD. G. Kamińska-Winciorek: Financial Interests, Personal, Invited Speaker: Takeda, Novartis, Pierre Fabre , Recordati ; Financial Interests, , Sponsor/Funding: Novartis, Takeda . T. Kubiatowski: Financial Interests, Personal, Invited Speaker: Bristol-Myers Squibb, Novartis, Roche, and Merck. R. Suwinski: Financial Interests, Personal, Invited Speaker: BMS, MSD, Astellas Pharma. J. Mackiewicz: Financial Interests, Personal, Invited Speaker: BMS, Novartis, Roche, Pierre Fabre, MSD; Financial Interests, Personal, Advisory Board: BMS, MSD. P. Rutkowski: Financial Interests, Personal, Invited Speaker: BMS, Novartis, Roche, Pierre Fabre, MSD, Merk, Sanofifi; Financial Interests, Personal, Advisory Board: BMS, Novartis, Roche, Pierre Fabre, MSD, Merk, Sanofi. All other authors have declared no conflicts of interest.

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