Italian Cohort of Nivolumab Expanded Access Program in Squamous Non-Small Cell Lung Cancer

Lucio Crinò, Paolo Bidoli, Angelo Delmonte, Francesco Grossi, Filippo De Marinis, Andrea Ardizzoni, Fabiana Vitiello, Giuseppe Lo Russo, Hector Soto Parra, Enrico Cortesi, Federico Cappuzzo, Luana Calabrò, Marcello Tiseo, Daniele Turci, Teresa Gamucci, Paola Antonelli, Alessandro Morabito, Antonio Chella, Diana Giannarelli, Domenico Galetta

Research output: Contribution to journalArticle

Abstract

Background: Nivolumab has shown a survival benefit compared with docetaxel as second-line treatment for patients with previously treated advanced squamous non-small cell lung cancer (NSCLC) in a randomized phase III trial. The experiences of patients and physicians in routine clinical practice are often different from those in a controlled clinical trial setting. We present data from the entire Italian cohort of patients with squamous NSCLC enrolled in a worldwide nivolumab NSCLC expanded access program. Patients and methods: Patients with pretreated advanced squamous NSCLC received nivolumab 3 mg/kg every 2 weeks for up to 24 months. Safety was monitored throughout; efficacy data collected included objective tumor response, date of progression, and survival information. Results: The Italian cohort comprised 371 patients who received at least one dose of nivolumab. In the overall population, the objective response rate (ORR) was 18%, the disease control rate (DCR) was 47%, and median overall survival (OS) was 7.9 months (95% confidence interval 6.2–9.6). In subgroup analyses, ORR, DCR, and median OS were, respectively, 17%, 48%, and 9.1 months in patients previously treated with two or more lines of therapy (n = 209) and 8%, 40%, and 10.0 months in patients treated beyond disease progression (n = 65). In the overall population, the rate of any-grade and grade 3–4 adverse events was 29% and 6%, respectively. Treatment-related adverse events led to treatment discontinuation in 14 patients (5%). There were no treatment-related deaths. Conclusion: To date, this report represents the most extensive clinical experience with nivolumab in advanced squamous NSCLC in current practice outside the controlled clinical trial setting. These data suggest that the efficacy and safety profiles of nivolumab in a broad, real-world setting are consistent with those obtained in clinical trials. Implications for Practice: Nivolumab is approved in the U.S. and Europe for the treatment of advanced non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy. In this cohort of Italian patients with previously treated, advanced squamous NSCLC treated in a real-world setting as part of the nivolumab expanded access program, the efficacy and safety of nivolumab was consistent with that previously reported in nivolumab clinical trials.
Original languageEnglish
JournalOncologist
DOIs
Publication statusPublished - 2019

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Non-Small Cell Lung Carcinoma
Survival
Controlled Clinical Trials
docetaxel
Safety
Therapeutics
nivolumab
Clinical Trials
Platinum
Population
Disease Progression
Confidence Intervals
Physicians
Drug Therapy

Keywords

  • Expanded access program
  • Immunotherapy
  • Nivolumab
  • Real-world
  • Squamous non-small cell lung cancer
  • Treatment beyond disease progression

Cite this

Crinò, L., Bidoli, P., Delmonte, A., Grossi, F., De Marinis, F., Ardizzoni, A., ... Galetta, D. (2019). Italian Cohort of Nivolumab Expanded Access Program in Squamous Non-Small Cell Lung Cancer. Oncologist. https://doi.org/10.1634/theoncologist.2018-0737

Italian Cohort of Nivolumab Expanded Access Program in Squamous Non-Small Cell Lung Cancer. / Crinò, Lucio; Bidoli, Paolo; Delmonte, Angelo; Grossi, Francesco; De Marinis, Filippo; Ardizzoni, Andrea; Vitiello, Fabiana; Lo Russo, Giuseppe; Parra, Hector Soto; Cortesi, Enrico; Cappuzzo, Federico; Calabrò, Luana; Tiseo, Marcello; Turci, Daniele; Gamucci, Teresa; Antonelli, Paola; Morabito, Alessandro; Chella, Antonio; Giannarelli, Diana; Galetta, Domenico.

In: Oncologist, 2019.

Research output: Contribution to journalArticle

Crinò, L, Bidoli, P, Delmonte, A, Grossi, F, De Marinis, F, Ardizzoni, A, Vitiello, F, Lo Russo, G, Parra, HS, Cortesi, E, Cappuzzo, F, Calabrò, L, Tiseo, M, Turci, D, Gamucci, T, Antonelli, P, Morabito, A, Chella, A, Giannarelli, D & Galetta, D 2019, 'Italian Cohort of Nivolumab Expanded Access Program in Squamous Non-Small Cell Lung Cancer', Oncologist. https://doi.org/10.1634/theoncologist.2018-0737
Crinò, Lucio ; Bidoli, Paolo ; Delmonte, Angelo ; Grossi, Francesco ; De Marinis, Filippo ; Ardizzoni, Andrea ; Vitiello, Fabiana ; Lo Russo, Giuseppe ; Parra, Hector Soto ; Cortesi, Enrico ; Cappuzzo, Federico ; Calabrò, Luana ; Tiseo, Marcello ; Turci, Daniele ; Gamucci, Teresa ; Antonelli, Paola ; Morabito, Alessandro ; Chella, Antonio ; Giannarelli, Diana ; Galetta, Domenico. / Italian Cohort of Nivolumab Expanded Access Program in Squamous Non-Small Cell Lung Cancer. In: Oncologist. 2019.
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title = "Italian Cohort of Nivolumab Expanded Access Program in Squamous Non-Small Cell Lung Cancer",
abstract = "Background: Nivolumab has shown a survival benefit compared with docetaxel as second-line treatment for patients with previously treated advanced squamous non-small cell lung cancer (NSCLC) in a randomized phase III trial. The experiences of patients and physicians in routine clinical practice are often different from those in a controlled clinical trial setting. We present data from the entire Italian cohort of patients with squamous NSCLC enrolled in a worldwide nivolumab NSCLC expanded access program. Patients and methods: Patients with pretreated advanced squamous NSCLC received nivolumab 3 mg/kg every 2 weeks for up to 24 months. Safety was monitored throughout; efficacy data collected included objective tumor response, date of progression, and survival information. Results: The Italian cohort comprised 371 patients who received at least one dose of nivolumab. In the overall population, the objective response rate (ORR) was 18{\%}, the disease control rate (DCR) was 47{\%}, and median overall survival (OS) was 7.9 months (95{\%} confidence interval 6.2–9.6). In subgroup analyses, ORR, DCR, and median OS were, respectively, 17{\%}, 48{\%}, and 9.1 months in patients previously treated with two or more lines of therapy (n = 209) and 8{\%}, 40{\%}, and 10.0 months in patients treated beyond disease progression (n = 65). In the overall population, the rate of any-grade and grade 3–4 adverse events was 29{\%} and 6{\%}, respectively. Treatment-related adverse events led to treatment discontinuation in 14 patients (5{\%}). There were no treatment-related deaths. Conclusion: To date, this report represents the most extensive clinical experience with nivolumab in advanced squamous NSCLC in current practice outside the controlled clinical trial setting. These data suggest that the efficacy and safety profiles of nivolumab in a broad, real-world setting are consistent with those obtained in clinical trials. Implications for Practice: Nivolumab is approved in the U.S. and Europe for the treatment of advanced non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy. In this cohort of Italian patients with previously treated, advanced squamous NSCLC treated in a real-world setting as part of the nivolumab expanded access program, the efficacy and safety of nivolumab was consistent with that previously reported in nivolumab clinical trials.",
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author = "Lucio Crin{\`o} and Paolo Bidoli and Angelo Delmonte and Francesco Grossi and {De Marinis}, Filippo and Andrea Ardizzoni and Fabiana Vitiello and {Lo Russo}, Giuseppe and Parra, {Hector Soto} and Enrico Cortesi and Federico Cappuzzo and Luana Calabr{\`o} and Marcello Tiseo and Daniele Turci and Teresa Gamucci and Paola Antonelli and Alessandro Morabito and Antonio Chella and Diana Giannarelli and Domenico Galetta",
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TY - JOUR

T1 - Italian Cohort of Nivolumab Expanded Access Program in Squamous Non-Small Cell Lung Cancer

AU - Crinò, Lucio

AU - Bidoli, Paolo

AU - Delmonte, Angelo

AU - Grossi, Francesco

AU - De Marinis, Filippo

AU - Ardizzoni, Andrea

AU - Vitiello, Fabiana

AU - Lo Russo, Giuseppe

AU - Parra, Hector Soto

AU - Cortesi, Enrico

AU - Cappuzzo, Federico

AU - Calabrò, Luana

AU - Tiseo, Marcello

AU - Turci, Daniele

AU - Gamucci, Teresa

AU - Antonelli, Paola

AU - Morabito, Alessandro

AU - Chella, Antonio

AU - Giannarelli, Diana

AU - Galetta, Domenico

PY - 2019

Y1 - 2019

N2 - Background: Nivolumab has shown a survival benefit compared with docetaxel as second-line treatment for patients with previously treated advanced squamous non-small cell lung cancer (NSCLC) in a randomized phase III trial. The experiences of patients and physicians in routine clinical practice are often different from those in a controlled clinical trial setting. We present data from the entire Italian cohort of patients with squamous NSCLC enrolled in a worldwide nivolumab NSCLC expanded access program. Patients and methods: Patients with pretreated advanced squamous NSCLC received nivolumab 3 mg/kg every 2 weeks for up to 24 months. Safety was monitored throughout; efficacy data collected included objective tumor response, date of progression, and survival information. Results: The Italian cohort comprised 371 patients who received at least one dose of nivolumab. In the overall population, the objective response rate (ORR) was 18%, the disease control rate (DCR) was 47%, and median overall survival (OS) was 7.9 months (95% confidence interval 6.2–9.6). In subgroup analyses, ORR, DCR, and median OS were, respectively, 17%, 48%, and 9.1 months in patients previously treated with two or more lines of therapy (n = 209) and 8%, 40%, and 10.0 months in patients treated beyond disease progression (n = 65). In the overall population, the rate of any-grade and grade 3–4 adverse events was 29% and 6%, respectively. Treatment-related adverse events led to treatment discontinuation in 14 patients (5%). There were no treatment-related deaths. Conclusion: To date, this report represents the most extensive clinical experience with nivolumab in advanced squamous NSCLC in current practice outside the controlled clinical trial setting. These data suggest that the efficacy and safety profiles of nivolumab in a broad, real-world setting are consistent with those obtained in clinical trials. Implications for Practice: Nivolumab is approved in the U.S. and Europe for the treatment of advanced non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy. In this cohort of Italian patients with previously treated, advanced squamous NSCLC treated in a real-world setting as part of the nivolumab expanded access program, the efficacy and safety of nivolumab was consistent with that previously reported in nivolumab clinical trials.

AB - Background: Nivolumab has shown a survival benefit compared with docetaxel as second-line treatment for patients with previously treated advanced squamous non-small cell lung cancer (NSCLC) in a randomized phase III trial. The experiences of patients and physicians in routine clinical practice are often different from those in a controlled clinical trial setting. We present data from the entire Italian cohort of patients with squamous NSCLC enrolled in a worldwide nivolumab NSCLC expanded access program. Patients and methods: Patients with pretreated advanced squamous NSCLC received nivolumab 3 mg/kg every 2 weeks for up to 24 months. Safety was monitored throughout; efficacy data collected included objective tumor response, date of progression, and survival information. Results: The Italian cohort comprised 371 patients who received at least one dose of nivolumab. In the overall population, the objective response rate (ORR) was 18%, the disease control rate (DCR) was 47%, and median overall survival (OS) was 7.9 months (95% confidence interval 6.2–9.6). In subgroup analyses, ORR, DCR, and median OS were, respectively, 17%, 48%, and 9.1 months in patients previously treated with two or more lines of therapy (n = 209) and 8%, 40%, and 10.0 months in patients treated beyond disease progression (n = 65). In the overall population, the rate of any-grade and grade 3–4 adverse events was 29% and 6%, respectively. Treatment-related adverse events led to treatment discontinuation in 14 patients (5%). There were no treatment-related deaths. Conclusion: To date, this report represents the most extensive clinical experience with nivolumab in advanced squamous NSCLC in current practice outside the controlled clinical trial setting. These data suggest that the efficacy and safety profiles of nivolumab in a broad, real-world setting are consistent with those obtained in clinical trials. Implications for Practice: Nivolumab is approved in the U.S. and Europe for the treatment of advanced non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy. In this cohort of Italian patients with previously treated, advanced squamous NSCLC treated in a real-world setting as part of the nivolumab expanded access program, the efficacy and safety of nivolumab was consistent with that previously reported in nivolumab clinical trials.

KW - Expanded access program

KW - Immunotherapy

KW - Nivolumab

KW - Real-world

KW - Squamous non-small cell lung cancer

KW - Treatment beyond disease progression

U2 - 10.1634/theoncologist.2018-0737

DO - 10.1634/theoncologist.2018-0737

M3 - Article

JO - Oncologist

JF - Oncologist

SN - 1083-7159

ER -