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Multicenter Study
. 2020 Oct;8(2):e001403.
doi: 10.1136/jitc-2020-001403.

Baseline BMI and BMI variation during first line pembrolizumab in NSCLC patients with a PD-L1 expression ≥ 50%: a multicenter study with external validation

Alessio Cortellini  1   2 , Biagio Ricciuti  3   4 , Marcello Tiseo  5   6 , Emilio Bria  7   8 , Giuseppe L Banna  9 , Joachim Gjv Aerts  10 , Fausto Barbieri  11 , Raffaele Giusti  12 , Diego L Cortinovis  13 , Maria R Migliorino  14 , Annamaria Catino  15 , Francesco Passiglia  16 , Mariangela Torniai  17 , Alessandro Morabito  18 , Carlo Genova  19 , Francesca Mazzoni  20 , Vincenzo Di Noia  21 , Diego Signorelli  22 , Alain Gelibter  23 , Mario Alberto Occhipinti  23 , Francesca Rastelli  24 , Rita Chiari  25 , Danilo Rocco  26 , Alessandro Inno  27 , Michele De Tursi  28 , Pietro Di Marino  29 , Giovanni Mansueto  30 , Federica Zoratto  31 , Francesco Grossi  32 , Marco Filetti  12 , Pamela Pizzutilo  15 , Marco Russano  33 , Fabrizio Citarella  33 , Luca Cantini  10   17 , Giada Targato  34 , Olga Nigro  35 , Miriam G Ferrara  7   8 , Sebastiano Buti  5 , Simona Scodes  36 , Lorenza Landi  36 , Giorgia Guaitoli  11 , Luigi Della Gravara  26 , Fabrizio Tabbò  16 , Serena Ricciardi  14 , Alessandro De Toma  22 , Alex Friedlaender  37 , Fausto Petrelli  38 , Alfredo Addeo  37 , Giampiero Porzio  2 , Corrado Ficorella  39   2
Affiliations
Multicenter Study

Baseline BMI and BMI variation during first line pembrolizumab in NSCLC patients with a PD-L1 expression ≥ 50%: a multicenter study with external validation

Alessio Cortellini et al. J Immunother Cancer. 2020 Oct.

Abstract

Background: The association between obesity and outcomes in patients receiving programmed death-1/programmed death ligand-1 (PD-L1) checkpoint inhibitors has already been confirmed in pre-treated non-small cell lung cancer (NSCLC) patients, regardless of PD-L1 tumor expression.

Methods: We present the outcomes analysis according to baseline body mass index (BMI) and BMI variation in a large cohort of metastatic NSCLC patients with a PD-L1 expression ≥50%, receiving first line pembrolizumab. We also evaluated a control cohort of metastatic NSCLC patients treated with first line platinum-based chemotherapy. Normal weight was set as control group.

Results: 962 patients and 426 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. Obese patients had a significantly higher objective response rate (ORR) (OR=1.61 (95% CI: 1.04-2.50)) in the pembrolizumab cohort, while overweight patients had a significantly lower ORR (OR=0.59 (95% CI: 0.37-0.92)) within the chemotherapy cohort. Obese patients had a significantly longer progression-free survival (PFS) (HR=0.61 (95% CI: 0.45-0.82)) in the pembrolizumab cohort. Conversely, they had a significantly shorter PFS in the chemotherapy cohort (HR=1.27 (95% CI: 1.01-1.60)). Obese patients had a significantly longer overall survival (OS) within the pembrolizumab cohort (HR=0.70 (95% CI: 0.49-0.99)), while no significant differences according to baseline BMI were found in the chemotherapy cohort. BMI variation significantly affected ORR, PFS and OS in both the pembrolizumab and the chemotherapy cohorts.

Conclusions: Baseline obesity is associated to significantly improved ORR, PFS and OS in metastatic NSCLC patients with a PD-L1 expression of ≥50%, receiving first line pembrolizumab, but not among patients treated with chemotherapy. BMI variation is also significantly related to clinical outcomes.

Keywords: immunotherapy.

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Conflict of interest statement

Competing interests: AC received speaker fees and grant consultancies by Astrazeneca, MSD, BMS, Roche, Novartis and Astellas. JA reports receiving commercial research grants from Amphera and Roche, holds ownership interest (including patents) in Amphera BV, and is a consultant/advisory board member for Amphera, Boehringer Ingelheim, Bristol-Myers Squibb, Eli-Lilly, MSD and Roche. EB received speakers’ and travels’ fee from MSD, Astra-Zeneca, Celgene, Pfizer, Helsinn, Eli-Lilly, BMS, Novartis and Roche. EB received consultant’s fee from Roche, Pfizer. EB received institutional research grants from Astra-Zeneca, Roche. MT received speaker fees and grant consultancies by Astrazeneca, Pfizer, Eli-Lilly, BMS, Novartis, Roche, MSD, Boehringer Ingelheim, Otsuka, Takeda and Pierre Fabre. AM received speaker fees by Astra, Roche, BMS, MSD, Boehringer, Pfizer, Takeda. FM received grant consultancies by MSD and Takeda. RG received speaker fees and grant consultancies by Astrazeneca and Roche. FP received grant consultancies by MSD and Astrazeneca. AF received grant consultancies by Roche, Pfizer, Astellas and BMS. AA received grant consultancies by Takeda, MSD, BMJ, Astrazeneca, Roche and Pfizer. RC received speaker fees by BMS, MSD, Takeda, Pfizer, Roche and Astrazeneca. CG received speaker fees/grant consultancies by Astrazeneca, BMS, Boehringer-Ingelheim, Roche and MSD. MR received honoraria for scientific events by Roche, Astrazeneca, Bristol-Myers Squibb, Merck Sharp & Dohme and Boehringer Ingelheim.

Figures

Figure 1
Figure 1
Forest plot graph for objective response rate (ORR). aOR, adjusted OR; BMI, body mass index.
Figure 2
Figure 2
Forest plot graph for progression-free survival (PFS). aHR, adjusted HR; BMI, body mass index.
Figure 3
Figure 3
Forest plot graph for overall survival (OS). aHR, adjusted HR; BMI, body mass index.
See this image and copyright information in PMC

References

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