The EVERPRO study: Final results of a non-interventional study (NIS) evaluating the quality of life (QoL) in second-line treatment of metastatic renal cell carcinoma (mRCC) with everolimus
| Autor: | Anja Rogler, P. J. Goebell, K. Blumenstengel, Norbert Marschner, Christian Doehn, Ulrich Kube, Marc-Oliver Grimm, Lothar Bergmann, Edwin Herrmann, Anja Dietel, Michael Scheffler |
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| Rok vydání: | 2018 |
| Předmět: | |
| Zdroj: | Journal of Clinical Oncology. 36:631-631 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | 631 The EVERPRO study: Final results of a non-interventional study evaluating QoL in second-line treatment of mRCC with everolimus Background: Although the prognosis of mRCC patients remains poor, median overall survival has improved since 2006, probably due to the introduction of TKIs. Everolimus treatment following first-line VEGFR-TKI was demonstrated to be efficacious and safe and is recommended by current guidelines. Assuring an adequate QoL has become a major therapy goal, especially in the 2nd line. Hence, QoL and the implication of time effort of everolimus treatment were the major objectives assessed in this study. Methods: Adult patients scheduled for in-label everolimus treatment after 1st line VEGFR-TKI or bevacizumab were eligible. QoL was assessed by means of the NCCN-FACT FKSI-19 questionnaire. Additionally, time needed for therapy and limitations thereof were evaluated based on a particularly developed questionnaire (including total treatment duration and treatment type). Results: 202 patients were evaluable for analyses. Median treatment duration was 19.1 weeks [95% CI: 16.4 – 23.0] and median time to progression was 26.0 weeks [95% CI: 23.3 – 32.6]. The FKSI-19 median total score remained stable during treatment. The median time effort spent on total therapy was 20 hours per patient. Most of the patients stated to have ‘no’, ‘a little’ or ‘moderate’ limitations in their daily, social and professional life. Two months after treatment start, 65 patients reported none or a little time burden due to therapy. 167 patients experienced 804 adverse events (AEs) in total. The most commonly reported AEs related to everolimus were dyspnoea, fatigue and anaemia (all grade). Conclusions: QoL was maintained during everolimus therapy and limitations as well as time effort were acceptable for most patients. The observed safety profile is consistent with previous data and does not implicate changes on the benefit-risk balance of everolimus. This study supports previously published data demonstrating that everolimus is an effective and safe treatment option following a VEGF(R)-targeted drug. Clinical trial information: 2284. |
| Databáze: | OpenAIRE |
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