Predictive and prognostic clinical and pathological factors of nivolumab efficacy in non-small-cell lung cancer patients
- 563 Downloads
Immunotherapy increases overall response rate (ORR) and overall survival (OS) in patients with non-small-cell lung cancer (NSCLC). Prognostic and predictive factors are a high need.
Patients and methods
Retrospective review of NSCLC patients treated with nivolumab was performed. Analyzed variables included age, sex, stage, performance status (PS), location of metastases, presence of tumour-related symptoms and comorbidities, number of metastasis locations, previous chemotherapy, anti-angiogenic and radiotherapy treatments, and analytical data from the standard blood count and biochemistry.
A total of 175 patients were included. Median age was 61.5 years, 73.1% were men, 77.7% were ECOG-PS 0–1, and 86.7% were included with stage IV disease. Histology was non-squamous in 77.1%. Sixty-five received nivolumab in second line (37.1%). Thirty-eight patients had brain metastasis (22%), and 39 (22.3%) liver metastasis and 126 (72%) had more than one metastatic location. The ORR was 15.7% with median Progression free survival (PFS) 2.8 months and median OS 5.81 months. Stage III vs IV and time since the beginning of the previous line of treatment ≥ 6 vs < 6 months were associated with better response. PS 2, time since the previous line of treatment < 6 vs ≥ 6 months, and more than one metastatic location were independently associated with shorter OS in multivariable analysis (7.8 vs 2.7 months, 11.2 vs 4.6 months, and 9.4 vs 5.1 month). Finally, time since the previous treatment < 6 vs ≥ 6 months and more than one metastatic location were independently associated with shorter PFS in multivariable analysis (4.3 vs 2.3 months and 4.7 vs 2.3 months).
Poor PS, short period of time since the previous treatment, and more than one metastatic location were associated with poorer prognostic.
KeywordsImmunotherapy Nivolumab Non-small-cell lung cancer GIDO
No funding was provided for this research work.
Compliance with ethical standards
Conflict of interest
The authors have no relevant affiliations with any organization or entity with a financial interest in with the subject matter or materials discussed in the manuscript.
This study was approved by the Local Research Ethics Committees and was executed in accordance with the Declaration of Helsinki, Good Clinical Practice, and local ethical and legal requirements.
All enrolled patients signed informed consent.
- 1.International Agency for Research on Cancer (IARC). Latest world. Cancer Statistics. IARC, Lyon, France; 2013.Google Scholar
- 6.Kader Y, Le Chevalier T, El-Nahas T, Sakr A. Comparative study analyzing survival and safety of bevacizumab/carboplatin/paclitaxel and cisplatin/pemetrexed in chemotherapy-naïve patients with advanced non-squamous bronchogenic carcinoma not harboring EGFR mutation. Oncol Targets Ther. 2013;6:803–9.Google Scholar
- 8.Sanofi-Aventis U.S. TAXOTERE, prescribing information, (docetaxel) Injection concentrate, intravenous infusión (IV), NJ, USA. 2013; 6 Eli Lilly and Company Limited. Alimta (pemetrexed) summary of product characteristics; 2012.Google Scholar
- 9.Scagliotti GV, Parikh P, von Pawel J, Biesma B, Vansteenkiste J, Manegold C, et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol. 2008;26:3543–51.CrossRefPubMedGoogle Scholar
- 10.Roche Products Limited. Tarceva (erlotinib) summary of product characteristics; 2014.Google Scholar
- 11.Garon EB, Ciuleanu TE, Arrieta O, Prabhash K, Syrigos KN, Goksel T, et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicenter, double-blind, randomised phase 3 trial. Lancet. 2014;384:665–73.CrossRefPubMedGoogle Scholar
- 12.Reck M, Kaiser R, Mellemgaard A, Douillard JY, Orlov S, Krzakowsky M, et al. Docetaxel plus nintedanib versus docetaxel plus placebo in patients with previously treated non-small-cell lung cancer (LUME-LUNG 1): a phase 3, double-blind, randomised controlled trial. Lancet Oncol. 2014;15:143–55.CrossRefPubMedGoogle Scholar
- 15.Commmitee for Medicinal Products for Human Use (CHMP). European Medicines Agency Assessment report of Opdivo. EMA/246304/2016; 2016.Google Scholar