Our study sought to examine nivolumab efficacy and safety in advanced NSCLC patients treated under the Temporary Authorization for Use (ATU, compassionate use) setting and describe their long-term clinical characteristics, notably the treatments they received after nivolumab discontinuation. The profile of these patients shows greater conformity to that of a non-selected population, yet the clinical data collection does not reflect "real life" conditions and stops when treatment ends, which does not enable us to get an overview of post-immunotherapy treatments.
Although the oncogene addiction concept has led to effective targeted treatments for certain histological non-small cell lung cancer (NSCLC) types, most patients with advanced tumors are still treated with first-line chemotherapy. In 2015, several studiess demonstrated the efficacy of nivolumab, an immunotherapy targeting immune checkpoints. In France, besides the clinical trials, this molecule has been made available in January 2015 under a Temporary Authorization for Use (ATU, compassionate use). Our study sought to examine nivolumab efficacy and safety in advanced NSCLC patients treated under the ATU setting and describe their long-term clinical characteristics, notably the treatments they received after nivolumab discontinuation. The profile of these patients shows greater conformity to that of a non-selected population, yet the clinical data collection does not reflect "real life" conditions and stops when treatment ends, which does not enable us to get an overview of post-immunotherapy treatments.
Study Type
OBSERVATIONAL
Enrollment
907
CH du Pays d'Aix
Aix-en-Provence, France
Clinique du Rambot
Aix-en-Provence, France
CHU d'Amiens-Picardie
Amiens, France
CHU d'Angers
Angers, France
CH Argenteuil
Argenteuil, France
CH d'Avignon
Avignon, France
overall survival
time from start of treatment to death from any cause
Time frame: January 2015 - December 2017
efficacy of nivolumab
progression-free survival, best overall response, exposure time
Time frame: January 2015 - December 2017
maximum toxicities of nivolumab treatment, including delayed toxicities (immune)
Maximum toxicity according to the investigator (Adverse events with NCI-CTC 4.0 Grade ≥2, categorized as: hepatic, pulmonary, endocrine, cutaneous, gastrointestinal, renal, hematologic, other immune toxicities)
Time frame: January 2015 - December 2017
efficacy of the first systemic treatment post-nivolumab
progression-free survival, best response
Time frame: January 2015 - December 2017
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Institut Sainte Catherine
Avignon, France
CH de la Côte Basque
Bayonne, France
CHU de Besançon
Besançon, France
CH de Blois
Blois, France
...and 62 more locations