Introduction: For patients with recurrent SCLC, topotecan remains the only approved second-line treatment, and the outcomes are poor. CheckMate 032 is a phase 1/2, multicenter, open-label study of nivolumab or nivolumab plus ipilimumab in SCLC or other advanced/metastatic solid tumors previously treated with one or more platinum-based chemotherapies. We report results of third- or later-line nivolumab monotherapy treatment in SCLC. Methods: In this analysis, patients with limited-stage or extensive-stage SCLC and disease progression after two or more chemotherapy regimens received nivolumab monotherapy, 3 mg/kg every 2 weeks, until disease progression or unacceptable toxicity. The primary end point was objective response rate. Secondary end points included duration of response, progression-free survival, overall survival, and safety. Results: Between December 4, 2013, and November 30, 2016, 109 patients began receiving third- or later-line nivolumab monotherapy. At a median follow-up of 28.3 months (from first dose to database lock), the objective response rate was 11.9% (95% confidence interval: 6.5–19.5) with a median duration of response of 17.9 months (range 3.0–42.1). At 6 months, 17.2% of patients were progression-free. The 12-month and 18-month overall survival rates were 28.3% and 20.0%, respectively. Grade 3 to 4 treatment-related adverse events occurred in 11.9% of patients. Three patients (2.8%) discontinued because of treatment-related adverse events. Conclusions: Nivolumab monotherapy provided durable responses and was well tolerated as a third- or later-line treatment for recurrent SCLC. These results suggest that nivolumab monotherapy is an effective third- or later-line treatment for this patient population.

Third-Line Nivolumab Monotherapy in Recurrent Small Cell Lung Cancer : CheckMate 032 / N. Ready, A. Farago, F. de Braud, A. Atmaca, M. Hellmann, J. Schneider, D. Spigel, V. Moreno, I. Chau, C. Hann, J. Eder, N. Steele, A. Pieters, J. Fairchild, S. Antonia. - In: JOURNAL OF THORACIC ONCOLOGY. - ISSN 1556-0864. - (2018 Oct 10). [Epub ahead of print] [10.1016/j.jtho.2018.10.003]

Third-Line Nivolumab Monotherapy in Recurrent Small Cell Lung Cancer : CheckMate 032

F. de Braud;
2018

Abstract

Introduction: For patients with recurrent SCLC, topotecan remains the only approved second-line treatment, and the outcomes are poor. CheckMate 032 is a phase 1/2, multicenter, open-label study of nivolumab or nivolumab plus ipilimumab in SCLC or other advanced/metastatic solid tumors previously treated with one or more platinum-based chemotherapies. We report results of third- or later-line nivolumab monotherapy treatment in SCLC. Methods: In this analysis, patients with limited-stage or extensive-stage SCLC and disease progression after two or more chemotherapy regimens received nivolumab monotherapy, 3 mg/kg every 2 weeks, until disease progression or unacceptable toxicity. The primary end point was objective response rate. Secondary end points included duration of response, progression-free survival, overall survival, and safety. Results: Between December 4, 2013, and November 30, 2016, 109 patients began receiving third- or later-line nivolumab monotherapy. At a median follow-up of 28.3 months (from first dose to database lock), the objective response rate was 11.9% (95% confidence interval: 6.5–19.5) with a median duration of response of 17.9 months (range 3.0–42.1). At 6 months, 17.2% of patients were progression-free. The 12-month and 18-month overall survival rates were 28.3% and 20.0%, respectively. Grade 3 to 4 treatment-related adverse events occurred in 11.9% of patients. Three patients (2.8%) discontinued because of treatment-related adverse events. Conclusions: Nivolumab monotherapy provided durable responses and was well tolerated as a third- or later-line treatment for recurrent SCLC. These results suggest that nivolumab monotherapy is an effective third- or later-line treatment for this patient population.
Immunotherapy; Nivolumab; PD-1 inhibitor; Small cell lung cancer; Third-line
Settore MED/06 - Oncologia Medica
10-ott-2018
Article (author)
File in questo prodotto:
File Dimensione Formato  
JTHO 1158.pdf

accesso aperto

Tipologia: Post-print, accepted manuscript ecc. (versione accettata dall'editore)
Dimensione 309.77 kB
Formato Adobe PDF
309.77 kB Adobe PDF Visualizza/Apri
1-s2.0-S1556086418331812-main.pdf

accesso aperto

Tipologia: Publisher's version/PDF
Dimensione 303.17 kB
Formato Adobe PDF
303.17 kB Adobe PDF Visualizza/Apri
Pubblicazioni consigliate

Caricamento pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/597155
Citazioni
  • ???jsp.display-item.citation.pmc??? 99
  • Scopus 193
  • ???jsp.display-item.citation.isi??? 172
social impact