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
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