Real world data of nivolumab as second-line treatment in advanced non-small cell lung cancer in Greece: effectiveness analysis and cost estimation of the treatment
Ανάλυση αποτελεσματικότητας και εκτίμηση κόστους του nivolumab ως δεύτερης γραμμής θεραπεία για τον προχωρημένο μη-μικροκυτταρικό καρκίνο του πνεύμονα βασισμένη σε πραγματικά δεδομένα ασθενών
Λέξεις κλειδιάNivolumab ; Real-world data ; Clinical practice ; Effectiveness ; Overall survival ; Progression free survival ; Safety profile ; Healthcare costs
Background: For the last two years, nivolumab has become the new standard of care for second line treatment in advanced non-small cell lung cancer. This is a retrospective multicenter study using real world data of pretreated patients with advanced NSCL that received nivolumab as second line treatment. Methods: In 14 health care centers in Greece patients with stage III-IV of NSCLC, with all histological types, who had disease progression after at least on platinum based chemotherapy, were treated with nivolumab as second-line treatment. The aim of this study was to evaluate the effectiveness and the safety profile of nivolumab in this patients, to perform a subgroup analysis and finally to estimate the total cost related to nivolumab treatment. Results: A total of 141 patients were included in the study. The median age of the patients was 67.2 years, 104 were male and 107 were current or former smokers, 54.8% had adenocarcinoma, 38.7% squamous carcinoma, 64.8% were diagnosed with stage IV, 13.9% with IIIB and 65% with stage IIIA. Of the 141 patients, 19 patients (13.48%) were not evaluated. From the 122 evaluable patients 29% had CR/PR, 34% had PD and 37% had SD. The median OS was 19.7 months (95% CI, 12.7-NE) while the median PFS was 7.4 months (95% CI, 5.9-11.6). In the subgroup analysis there were no statistical significant differences regarding age and gender. Grade 3-4 toxicities were evaluated but non of these toxicities had an incidence ≥5. Only direct costs of the treatment were included in the analysis expressed in insurance prices. The total cost of nivolumab treatment per month was estimated at 5.616,08€ per patient and the total annual cost at 67.392,96€ per patient. Conclusions: Nivolumab proved its meaningful survival benefit in clinical practice since the effectiveness appears to be higher in this unselected non-clinical trial population as compared to the results of the clinical trials. The safety profile reported in our study confirmed those reported in the clinical trials. The total cost of nivolumab treatment as second-line therapy in advanced NSCLC results high but its increased effectiveness and the low incidence of adverse events, respect to previous treatments, favor its introduction as second-line treatment.