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Abstract
Background: Checkpoint inhibitors have proven effectiveness in clinical trials for non-small cell lung cancer (NSCLC) patients, but if this is congruent with routine patient care is discussed. We present real-world experience with the PD1-inhibitor nivolumab in NSCLC.
Patients and methods: Patients with NSCLC were considered eligible for nivolumab treatment after one or more lines of chemotherapy, and when in reasonable performance status (PS) [Eastern Cooperative Oncology Group (ECOG) < 3]. Treatment was given according to guidelines in the two phase III studies, CA209017 and CA209057. Response evaluation was done according to Recist 1.1, and treatment given until unequivocal progression or intolerable toxicity.
Results: Fifty-eight patients (30 females) commenced therapy in the period June–August 2015. Median age was 64.6 years (range 32.3–88.2). Twenty-four patients had squamous cell carcinoma and 32 adenocarcinoma, 38 had received two or more prior lines of therapy. Fourteen cases (24%) were in ECOG PS 2. After a medium observation time of 14.3 months, 13 (22%) are still in treatment. Median time to treatment failure (TTF) was 4.0 months, 34% were off treatment during the first two months. Median overall survival (OS) is 11.7 months. There was no difference in TTF or OS among patients with squamous versus non-squamous histology or between 1 versus >1 prior line of therapy. Four patients (7%) were off treatment due to toxicity, none were grade 4 or 5.
Conclusion: Nivolumab treatment outside clinical trials seems to perform as expected.
Acknowledgements
The collaboration with physicians at referring hospitals is highly appreciated. We thank Ingrid Lydersen for expert nursing assistance, and Ali Areffard, PhD, Scientific Advisor, Immuno-Oncology Bristol Myers-Squibb (BMS) Norway, for valuable support. Free drug for the first 475 cycles was provided by BMS, but no funding was provided for the execution of the treatment, or for writing or other aspects of this work.
Disclosure statement
The authors have declared no conflicts of interest.
Funding
The writing phase of this manuscript was partially funded by the Norwegian Cancer Society and the South-Eastern Norway Regional Health Authority.
