Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 24, No 18S (June 20 Supplement), 2006: 4534
© 2006 American Society of Clinical Oncology

This Article Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Dhanda, R. Articles by Escudier, B. Search for Related Content PubMed Articles by Dhanda, R. Articles by Escudier, B.

Abstract

A comparison of quality of life and symptoms in kidney cancer patients receiving sorafenib versus placebo

Bayer Pharmaceuticals, West Haven, CT; Northwestern University, Evanston, IL; Cleveland Clinic Cancer Center, Cleveland, OH; Institut Gustave Roussy, Villejuif, France

4534

Background: Results from the Phase III TARGETs study showed that sorafenib significantly prolonged progression-free survival compared with placebo in patients with advanced renal cell carcinoma. Overall survival was longer with sorafenib than placebo with a hazard ratio of 0.72. The impact of sorafenib treatment on health-related quality of life (HRQL) and symptoms was also evaluated. Methods: HRQL was measured by the Functional Assessment of Cancer Therapy-General (FACT-G). Symptoms were measured by the FACT-Kidney Cancer Symptom Index (FKSI), in which patients used a Likert scale (0–4) to respond to each of 15 items. FACT-G and FKSI were administered at baseline, at Day 1 of each cycle, and at end-of-treatment visit. Statistical analyses used a random coefficient model over five cycles, using MSKCC risk and treatment as factors and baseline score and relative days as covariates, adjusted for multiple comparisons with Bonferroni correction. Results: A total of 903 patients were randomized. The FACT-G completion rates at baseline, and Cycles 2, 3, 4, and 5 were; 96%, 91%, 95%, 99%, and 100%, respectively. The FKSI completion rates were; 94%, 89%, 94%, 97%, and 100%, respectively. The completion rate within each patient reported outcome (PRO) measure, across all visits, was 93%. At baseline, there was no between-treatment difference in score for either FACT-G or FKSI. There was no treatment difference after adjusting for multiple comparisons in mean FACT-G total score (p = 0.96) or its domains (physical well-being [p = 0.92]; emotional well-being [p = 0.46]); social well-being [p = 0.75]; functional well-being [p = 0.94]), and no difference in total score of FKSI over time. FKSI single-item analysis showed that sorafenib-treated patients had significantly less symptoms vs placebo (e.g. cough [p < 0.0001], fevers [p = 0.0015], ‘worry that condition will worsen’ [p = 0.0004], shortness of breath [p 0.0312], and ‘ability to enjoy life’ [p = 0.0119]). Only ‘concern about treatment side-effects’ favored placebo patients (p < 0.0001). Conclusions: Sorafenib demonstrates clinical benefit without adversely impacting overall HRQL, and has a positive impact on individual symptoms.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bayer Abbott, Antigenics, Bayer, GlaxoSmithKline, Inate Pharma, Pfizer, Roche Antigenics, Bayer, Genentech, GlaxoSmithKline, Inate Pharma, Pfizer, Roche, Wyeth Bayer, Celgene, Genentech, GlaxoSmithKline, PDL, Pfizer, Wyeth

Abstract presentation from the 2006 ASCO Annual Meeting