Nivolumab in never-smokers with advanced squamous non-small cell lung cancer: Results from the Italian cohort of an expanded access program
Autor: | Marina Chiara Garassino, Annamaria Catino, Luana Calabrò, Francesca Ambrosio, Carmelo Bengala, Alessandro Follador, Fabiana Vitiello, Floriana Morgillo, Lucio Crinò, Paola Bordi, Enrico Mini, Giuseppe Lo Russo, Enrico Vasile, Andrea Ardizzoni, Antonio Santo, Federico Cappuzzo, Alessandro Scoppola, Giuseppe Altavilla, Diana Giannarelli, Enrico Cortesi, Natale Tedde, Fausto Barbieri |
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Přispěvatelé: | Garassino, M. C., Crino, L., Catino, A., Ardizzoni, A., Cortesi, E., Cappuzzo, F., Bordi, P., Calabro, L., Barbieri, F., Santo, A., Altavilla, G., Ambrosio, F., Mini, E., Vasile, E., Morgillo, F., Scoppola, A., Bengala, C., Follador, A., Tedde, N., Giannarelli, D., Lo Russo, G., Vitiello, F., Garassino, Marina Chiara, Crinò, Lucio, Catino, Annamaria, Ardizzoni, Andrea, Cortesi, Enrico, Cappuzzo, Federico, Bordi, Paola, Calabrò, Luana, Barbieri, Fausto, Santo, Antonio, Altavilla, Giuseppe, Ambrosio, Francesca, Mini, Enrico, Vasile, Enrico, Morgillo, Floriana, Scoppola, Alessandro, Bengala, Carmelo, Follador, Alessandro, Tedde, Natale, Giannarelli, Diana, Lo Russo, Giuseppe, Vitiello, Fabiana |
Rok vydání: | 2018 |
Předmět: |
Oncology
Male Cancer Research Lung Neoplasms medicine.medical_treatment never-smokers carcinoma Health Services Accessibility Cohort Studies 0302 clinical medicine Carcinoma Non-Small-Cell Lung 80 and over Medicine 030212 general & internal medicine squamous non-small cell lung cancer RC254-282 Aged 80 and over never-smoker Neoplasms. Tumors. Oncology. Including cancer and carcinogens General Medicine Middle Aged Prognosis expanded access program italian nivolumab Survival Rate Nivolumab 030220 oncology & carcinogenesis Cohort Carcinoma Squamous Cell Disease Progression Female Case-Control Studie Human Cohort study Expanded access program italian never-smokers nivolumab squamous non-small cell lung cancer adult aged aged 80 and over carcinoma non-small-cell lung squamous cell case-control studies cohort studies disease progression female follow-up studies humans lung neoplasms male middle aged nivolumab non-smokers Prognosis survival rate health services accessibility Adult medicine.medical_specialty Italian Prognosi Follow-Up Studie 03 medical and health sciences Internal medicine Humans Survival rate Aged squamous cell Expanded access program business.industry Case-control study Immunotherapy Non-Smokers Lung Neoplasm non-small-cell lung Non-Smoker Expanded access Case-Control Studies Squamous non-small cell lung cancer Cohort Studie business Follow-Up Studies |
Zdroj: | Tumor Biology, Vol 40 (2018) |
ISSN: | 1423-0380 |
Popis: | Objectives: Never-smokers may be a distinct subgroup among patients with advanced non-small cell lung cancer, appearing to benefit less from immunotherapy than smokers. We report results from never-smokers enrolled in the Italian cohort of the nivolumab expanded access program in pre-treated patients with advanced squamous non-small cell lung cancer. Materials and methods: Nivolumab (3 mg/kg every 2 weeks for ≤24 months) was available on physician request. Efficacy data included objective tumor response, date of progression, and survival information. Safety was monitored. Results: Overall, 371 patients received at least one dose of nivolumab, including 31 never-smokers (8%). Objective response rate, disease-control rate, and median overall survival were 23%, 45%, and 12.1 months (95% confidence interval: 3.7–20.4), respectively, in never-smokers, and 18%, 47%, and 7.9 months (95% confidence interval: 6.2–9.6), respectively, in the overall expanded access program population. Any-grade and grade 3–4 treatment-related adverse events were reported in 12 (39%) and 3 (10%) never-smokers, respectively, and in 109 (29%) and 21 (6%) patients, respectively, in the overall expanded access program population. Grade 3–4 treatment-related adverse events in non-smokers were increased transaminases (n = 2; 6%) and diarrhea (n = 1; 3%). Treatment-related adverse events led to treatment discontinuation in 4 non-smokers (17%) and in 26 patients (9%) overall. Conclusion: Pre-treated never-smokers with advanced squamous non-small cell lung cancer in this Italian expanded access program demonstrated efficacy and safety that were consistent with those in the overall expanded access program population and clinical trials. These results suggest that a proportion of never-smoker patients with squamous non-small cell lung cancer may be responsive to immunotherapy. Other factors, such as the tumor mutational load and the status of programmed death-ligand 1, anaplastic lymphoma kinase, and epidermal growth factor receptor, might play a potential key role. |
Databáze: | OpenAIRE |
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