A multicenter study of body mass index in cancer patients treated with anti-PD-1/PD-L1 immune checkpoint inhibitors: When overweight becomes favorable

Alessio Cortellini, Melissa Bersanelli, Sebastiano Buti, Katia Cannita, Daniele Santini, Fabiana Perrone, Raffaele Giusti, Marcello Tiseo, Maria Michiara, Pietro Di Marino, Nicola Tinari, Michele De Tursi, Federica Zoratto, Enzo Veltri, Riccardo Marconcini, Francesco Malorgio, Marco Russano, Cecilia Anesi, Tea Zeppola, Marco FilettiPaolo Marchetti, Andrea Botticelli, Gian Carlo Antonini Cappellini, Federica De Galitiis, Maria Giuseppa Vitale, Francesca Rastelli, Federica Pergolesi, Rossana Berardi, Silvia Rinaldi, Marianna Tudini, Rosa Rita Silva, Annagrazia Pireddu, Francesco Atzori, Rita Chiari, Biagio Ricciuti, Andrea De Giglio, Daniela Iacono, Alain Gelibter, Mario Alberto Occhipinti, Alessandro Parisi, Giampiero Porzio, Maria Concetta Fargnoli, Paolo Antonio Ascierto, Corrado Ficorella, Clara Natoli

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Background: Recent evidence suggested a potential correlation between overweight and the efficacy of immune checkpoint inhibitors (ICIs) in cancer patients. Patients and methods: We conducted a retrospective study of advanced cancer patients consecutively treated with anti-PD-1/PD-L1 inhibitors, in order to compare clinical outcomes according to baseline BMI levels as primary analysis. Based on their BMI, patients were categorized into overweight/obese (≥ 25) and non-overweight (< 25). A gender analysis was also performed, using the same binomial cut-off. Further subgroup analyses were performed categorizing patients into underweight, normal weight, overweight and obese. Results: Between September 2013 and May 2018, 976 patients were evaluated. The median age was 68 years, male/female ratio was 663/313. Primary tumors were: NSCLC (65.1%), melanoma (18.7%), renal cell carcinoma (13.8%) and others (2.4%). ECOG-PS was ≥2 in 145 patients (14.9%). PD-1/PD-L1 inhibitors were administered as first-line treatment in 26.6% of cases. Median BMI was 24.9: 492 patients (50.6%) were non-overweight, 480 patients (50.4%) were overweight/obese. 25.2% of non-overweight patients experienced irAEs of any grade, while 55.6% of overweight/obese patients (p < 0.0001). ORR was significantly higher in overweight/obese patients compared to non-overweight (p < 0.0001). Median follow-up was 17.2 months. Median TTF, PFS and OS were significantly longer for overweight/obese patients in univariate (p < 0.0001, for all the survival intervals) and multivariate models (p = 0.0009, p < 0.0001 and p < 0.0001 respectively). The significance was confirmed in both sex, except for PFS in male patients (p = 0.0668). Conclusions: Overweight could be considered a tumorigenic immune-dysfunction that could be effectively reversed by ICIs. BMI could be a useful predictive tool in clinical practice and a stratification factor in prospective clinical trials with ICIs.

Original languageEnglish
Article number57
JournalJournal for ImmunoTherapy of Cancer
Volume7
Issue number1
DOIs
Publication statusPublished - Feb 27 2019

Fingerprint

Multicenter Studies
Body Mass Index
Neoplasms
Thinness
Renal Cell Carcinoma
Melanoma
Retrospective Studies
Clinical Trials
Weights and Measures

Keywords

  • Anti-PD-1/PD-L1
  • BMI
  • Cancer
  • Immunotherapy
  • Obesity
  • Overweight

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Molecular Medicine
  • Oncology
  • Pharmacology
  • Cancer Research

Cite this

A multicenter study of body mass index in cancer patients treated with anti-PD-1/PD-L1 immune checkpoint inhibitors : When overweight becomes favorable. / Cortellini, Alessio; Bersanelli, Melissa; Buti, Sebastiano; Cannita, Katia; Santini, Daniele; Perrone, Fabiana; Giusti, Raffaele; Tiseo, Marcello; Michiara, Maria; Di Marino, Pietro; Tinari, Nicola; De Tursi, Michele; Zoratto, Federica; Veltri, Enzo; Marconcini, Riccardo; Malorgio, Francesco; Russano, Marco; Anesi, Cecilia; Zeppola, Tea; Filetti, Marco; Marchetti, Paolo; Botticelli, Andrea; Antonini Cappellini, Gian Carlo; De Galitiis, Federica; Vitale, Maria Giuseppa; Rastelli, Francesca; Pergolesi, Federica; Berardi, Rossana; Rinaldi, Silvia; Tudini, Marianna; Silva, Rosa Rita; Pireddu, Annagrazia; Atzori, Francesco; Chiari, Rita; Ricciuti, Biagio; De Giglio, Andrea; Iacono, Daniela; Gelibter, Alain; Occhipinti, Mario Alberto; Parisi, Alessandro; Porzio, Giampiero; Fargnoli, Maria Concetta; Ascierto, Paolo Antonio; Ficorella, Corrado; Natoli, Clara.

In: Journal for ImmunoTherapy of Cancer, Vol. 7, No. 1, 57, 27.02.2019.

Research output: Contribution to journalArticle

Cortellini, A, Bersanelli, M, Buti, S, Cannita, K, Santini, D, Perrone, F, Giusti, R, Tiseo, M, Michiara, M, Di Marino, P, Tinari, N, De Tursi, M, Zoratto, F, Veltri, E, Marconcini, R, Malorgio, F, Russano, M, Anesi, C, Zeppola, T, Filetti, M, Marchetti, P, Botticelli, A, Antonini Cappellini, GC, De Galitiis, F, Vitale, MG, Rastelli, F, Pergolesi, F, Berardi, R, Rinaldi, S, Tudini, M, Silva, RR, Pireddu, A, Atzori, F, Chiari, R, Ricciuti, B, De Giglio, A, Iacono, D, Gelibter, A, Occhipinti, MA, Parisi, A, Porzio, G, Fargnoli, MC, Ascierto, PA, Ficorella, C & Natoli, C 2019, 'A multicenter study of body mass index in cancer patients treated with anti-PD-1/PD-L1 immune checkpoint inhibitors: When overweight becomes favorable', Journal for ImmunoTherapy of Cancer, vol. 7, no. 1, 57. https://doi.org/10.1186/s40425-019-0527-y
Cortellini, Alessio ; Bersanelli, Melissa ; Buti, Sebastiano ; Cannita, Katia ; Santini, Daniele ; Perrone, Fabiana ; Giusti, Raffaele ; Tiseo, Marcello ; Michiara, Maria ; Di Marino, Pietro ; Tinari, Nicola ; De Tursi, Michele ; Zoratto, Federica ; Veltri, Enzo ; Marconcini, Riccardo ; Malorgio, Francesco ; Russano, Marco ; Anesi, Cecilia ; Zeppola, Tea ; Filetti, Marco ; Marchetti, Paolo ; Botticelli, Andrea ; Antonini Cappellini, Gian Carlo ; De Galitiis, Federica ; Vitale, Maria Giuseppa ; Rastelli, Francesca ; Pergolesi, Federica ; Berardi, Rossana ; Rinaldi, Silvia ; Tudini, Marianna ; Silva, Rosa Rita ; Pireddu, Annagrazia ; Atzori, Francesco ; Chiari, Rita ; Ricciuti, Biagio ; De Giglio, Andrea ; Iacono, Daniela ; Gelibter, Alain ; Occhipinti, Mario Alberto ; Parisi, Alessandro ; Porzio, Giampiero ; Fargnoli, Maria Concetta ; Ascierto, Paolo Antonio ; Ficorella, Corrado ; Natoli, Clara. / A multicenter study of body mass index in cancer patients treated with anti-PD-1/PD-L1 immune checkpoint inhibitors : When overweight becomes favorable. In: Journal for ImmunoTherapy of Cancer. 2019 ; Vol. 7, No. 1.
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abstract = "Background: Recent evidence suggested a potential correlation between overweight and the efficacy of immune checkpoint inhibitors (ICIs) in cancer patients. Patients and methods: We conducted a retrospective study of advanced cancer patients consecutively treated with anti-PD-1/PD-L1 inhibitors, in order to compare clinical outcomes according to baseline BMI levels as primary analysis. Based on their BMI, patients were categorized into overweight/obese (≥ 25) and non-overweight (< 25). A gender analysis was also performed, using the same binomial cut-off. Further subgroup analyses were performed categorizing patients into underweight, normal weight, overweight and obese. Results: Between September 2013 and May 2018, 976 patients were evaluated. The median age was 68 years, male/female ratio was 663/313. Primary tumors were: NSCLC (65.1{\%}), melanoma (18.7{\%}), renal cell carcinoma (13.8{\%}) and others (2.4{\%}). ECOG-PS was ≥2 in 145 patients (14.9{\%}). PD-1/PD-L1 inhibitors were administered as first-line treatment in 26.6{\%} of cases. Median BMI was 24.9: 492 patients (50.6{\%}) were non-overweight, 480 patients (50.4{\%}) were overweight/obese. 25.2{\%} of non-overweight patients experienced irAEs of any grade, while 55.6{\%} of overweight/obese patients (p < 0.0001). ORR was significantly higher in overweight/obese patients compared to non-overweight (p < 0.0001). Median follow-up was 17.2 months. Median TTF, PFS and OS were significantly longer for overweight/obese patients in univariate (p < 0.0001, for all the survival intervals) and multivariate models (p = 0.0009, p < 0.0001 and p < 0.0001 respectively). The significance was confirmed in both sex, except for PFS in male patients (p = 0.0668). Conclusions: Overweight could be considered a tumorigenic immune-dysfunction that could be effectively reversed by ICIs. BMI could be a useful predictive tool in clinical practice and a stratification factor in prospective clinical trials with ICIs.",
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TY - JOUR

T1 - A multicenter study of body mass index in cancer patients treated with anti-PD-1/PD-L1 immune checkpoint inhibitors

T2 - When overweight becomes favorable

AU - Cortellini, Alessio

AU - Bersanelli, Melissa

AU - Buti, Sebastiano

AU - Cannita, Katia

AU - Santini, Daniele

AU - Perrone, Fabiana

AU - Giusti, Raffaele

AU - Tiseo, Marcello

AU - Michiara, Maria

AU - Di Marino, Pietro

AU - Tinari, Nicola

AU - De Tursi, Michele

AU - Zoratto, Federica

AU - Veltri, Enzo

AU - Marconcini, Riccardo

AU - Malorgio, Francesco

AU - Russano, Marco

AU - Anesi, Cecilia

AU - Zeppola, Tea

AU - Filetti, Marco

AU - Marchetti, Paolo

AU - Botticelli, Andrea

AU - Antonini Cappellini, Gian Carlo

AU - De Galitiis, Federica

AU - Vitale, Maria Giuseppa

AU - Rastelli, Francesca

AU - Pergolesi, Federica

AU - Berardi, Rossana

AU - Rinaldi, Silvia

AU - Tudini, Marianna

AU - Silva, Rosa Rita

AU - Pireddu, Annagrazia

AU - Atzori, Francesco

AU - Chiari, Rita

AU - Ricciuti, Biagio

AU - De Giglio, Andrea

AU - Iacono, Daniela

AU - Gelibter, Alain

AU - Occhipinti, Mario Alberto

AU - Parisi, Alessandro

AU - Porzio, Giampiero

AU - Fargnoli, Maria Concetta

AU - Ascierto, Paolo Antonio

AU - Ficorella, Corrado

AU - Natoli, Clara

PY - 2019/2/27

Y1 - 2019/2/27

N2 - Background: Recent evidence suggested a potential correlation between overweight and the efficacy of immune checkpoint inhibitors (ICIs) in cancer patients. Patients and methods: We conducted a retrospective study of advanced cancer patients consecutively treated with anti-PD-1/PD-L1 inhibitors, in order to compare clinical outcomes according to baseline BMI levels as primary analysis. Based on their BMI, patients were categorized into overweight/obese (≥ 25) and non-overweight (< 25). A gender analysis was also performed, using the same binomial cut-off. Further subgroup analyses were performed categorizing patients into underweight, normal weight, overweight and obese. Results: Between September 2013 and May 2018, 976 patients were evaluated. The median age was 68 years, male/female ratio was 663/313. Primary tumors were: NSCLC (65.1%), melanoma (18.7%), renal cell carcinoma (13.8%) and others (2.4%). ECOG-PS was ≥2 in 145 patients (14.9%). PD-1/PD-L1 inhibitors were administered as first-line treatment in 26.6% of cases. Median BMI was 24.9: 492 patients (50.6%) were non-overweight, 480 patients (50.4%) were overweight/obese. 25.2% of non-overweight patients experienced irAEs of any grade, while 55.6% of overweight/obese patients (p < 0.0001). ORR was significantly higher in overweight/obese patients compared to non-overweight (p < 0.0001). Median follow-up was 17.2 months. Median TTF, PFS and OS were significantly longer for overweight/obese patients in univariate (p < 0.0001, for all the survival intervals) and multivariate models (p = 0.0009, p < 0.0001 and p < 0.0001 respectively). The significance was confirmed in both sex, except for PFS in male patients (p = 0.0668). Conclusions: Overweight could be considered a tumorigenic immune-dysfunction that could be effectively reversed by ICIs. BMI could be a useful predictive tool in clinical practice and a stratification factor in prospective clinical trials with ICIs.

AB - Background: Recent evidence suggested a potential correlation between overweight and the efficacy of immune checkpoint inhibitors (ICIs) in cancer patients. Patients and methods: We conducted a retrospective study of advanced cancer patients consecutively treated with anti-PD-1/PD-L1 inhibitors, in order to compare clinical outcomes according to baseline BMI levels as primary analysis. Based on their BMI, patients were categorized into overweight/obese (≥ 25) and non-overweight (< 25). A gender analysis was also performed, using the same binomial cut-off. Further subgroup analyses were performed categorizing patients into underweight, normal weight, overweight and obese. Results: Between September 2013 and May 2018, 976 patients were evaluated. The median age was 68 years, male/female ratio was 663/313. Primary tumors were: NSCLC (65.1%), melanoma (18.7%), renal cell carcinoma (13.8%) and others (2.4%). ECOG-PS was ≥2 in 145 patients (14.9%). PD-1/PD-L1 inhibitors were administered as first-line treatment in 26.6% of cases. Median BMI was 24.9: 492 patients (50.6%) were non-overweight, 480 patients (50.4%) were overweight/obese. 25.2% of non-overweight patients experienced irAEs of any grade, while 55.6% of overweight/obese patients (p < 0.0001). ORR was significantly higher in overweight/obese patients compared to non-overweight (p < 0.0001). Median follow-up was 17.2 months. Median TTF, PFS and OS were significantly longer for overweight/obese patients in univariate (p < 0.0001, for all the survival intervals) and multivariate models (p = 0.0009, p < 0.0001 and p < 0.0001 respectively). The significance was confirmed in both sex, except for PFS in male patients (p = 0.0668). Conclusions: Overweight could be considered a tumorigenic immune-dysfunction that could be effectively reversed by ICIs. BMI could be a useful predictive tool in clinical practice and a stratification factor in prospective clinical trials with ICIs.

KW - Anti-PD-1/PD-L1

KW - BMI

KW - Cancer

KW - Immunotherapy

KW - Obesity

KW - Overweight

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U2 - 10.1186/s40425-019-0527-y

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