Clinical Experience of Immunotherapy Treatment: Efficacy and Toxicity Analysis of the Compassionate Use Program of Nivolumab in Patients with Advanced Squamous Cell Non-Small Cell Lung Cancer.
Aged
Aged, 80 and over
Antineoplastic Agents, Immunological
/ adverse effects
Carcinoma, Non-Small-Cell Lung
/ drug therapy
Clinical Trials as Topic
Compassionate Use Trials
Female
Humans
Immunotherapy
Lung Neoplasms
/ drug therapy
Male
Middle Aged
Nivolumab
/ adverse effects
Progression-Free Survival
Efficacy
Immunotherapy
Nivolumab
Non-small cell lung cancer
Safety
Squamous cell carcinoma
Journal
Oncology research and treatment
ISSN: 2296-5262
Titre abrégé: Oncol Res Treat
Pays: Switzerland
ID NLM: 101627692
Informations de publication
Date de publication:
2019
2019
Historique:
received:
23
11
2018
accepted:
27
02
2019
pubmed:
18
4
2019
medline:
12
9
2019
entrez:
18
4
2019
Statut:
ppublish
Résumé
Anti-PD1 monoclonal antibody nivolumab is an approved therapy option for the treatment of advanced squamous cell non-small cell lung cancer (SQ-NSCLC) patients. Data outside clinical trials about therapy efficacy and safety in later therapy line treatments have rarely been described until now. We performed a retrospective data analysis of patients who were enrolled into the nivolu-mab Compassionate Use Program (CUP) in Germany. Sufficient clinical data of 40 patients were available for efficacy and safety analysis. Overall, 47.5% of all treated patients were not affected by any adverse events (AEs); 17.5% of patients suffered from severe AEs. The 1-year survival rate was 61.3%. Estimated median progression-free survival (PFS) was 5.3 months. Patients who received nivolumab as third or later therapy line treatment (77.5%) achieved similar median PFS and 12-month overall survival rate of 52%. Our findings of immunotherapy treatment outside clinical trials support the results of studies in the past and confirm the efficacy and favorable toxicity profile of nivolumab treatment in advanced SQ-NSCLC patients. In addition, we can present some rarely described information about nivolumab treatment of heavily pretreated patients, which provides some evidence that immunotherapy could also be useful in later therapy lines.
Sections du résumé
BACKGROUND
BACKGROUND
Anti-PD1 monoclonal antibody nivolumab is an approved therapy option for the treatment of advanced squamous cell non-small cell lung cancer (SQ-NSCLC) patients. Data outside clinical trials about therapy efficacy and safety in later therapy line treatments have rarely been described until now.
METHODS
METHODS
We performed a retrospective data analysis of patients who were enrolled into the nivolu-mab Compassionate Use Program (CUP) in Germany. Sufficient clinical data of 40 patients were available for efficacy and safety analysis.
RESULTS
RESULTS
Overall, 47.5% of all treated patients were not affected by any adverse events (AEs); 17.5% of patients suffered from severe AEs. The 1-year survival rate was 61.3%. Estimated median progression-free survival (PFS) was 5.3 months. Patients who received nivolumab as third or later therapy line treatment (77.5%) achieved similar median PFS and 12-month overall survival rate of 52%.
CONCLUSION
CONCLUSIONS
Our findings of immunotherapy treatment outside clinical trials support the results of studies in the past and confirm the efficacy and favorable toxicity profile of nivolumab treatment in advanced SQ-NSCLC patients. In addition, we can present some rarely described information about nivolumab treatment of heavily pretreated patients, which provides some evidence that immunotherapy could also be useful in later therapy lines.
Identifiants
pubmed: 30995666
pii: 000499321
doi: 10.1159/000499321
doi:
Substances chimiques
Antineoplastic Agents, Immunological
0
Nivolumab
31YO63LBSN
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
243-255Informations de copyright
© 2019 S. Karger AG, Basel.