The EPAZ study (NCT01861951) showed that pazopanib was non-inferior to doxorubicin in advanced, inoperable STS in elderly pts. We report an analysis on HR-QoL of EPAZ.
STS patients ³60 years were randomly assigned to receive either DOX 75 mg/m2 q3wks for a total of 6 cycles or PAZ 800 mg OD continuously in a 1:2 fashion. EORTC QLQ C30 and elderly minimal comprehensive geriatric assessment (consisting of G8 screening tool, Charlson Comorbidity Index (CCI), instrumental activities of daily living (IADL) and social situation) were utilized for HR-QoL evaluation. All tools were applied at baseline and end of treatment. Subsequent measures were as follows: QLQ C30 weeks 3, 6, 9, 12, 15, 19, and 26; geriatric assessment weeks 12, 26 and then every 12 weeks thereafter.
A total of 39 pts were randomly assigned to DOX and 81 to PAZ and PFS was 5.3 vs. 4.4 mo (HR 1.00; 95%CI 0.65-1.53; P=.993), respectively. The median age was 71 years (range: 60-88). Frequent AEs for DOX were fatigue (64.9%), alopecia (56.8%), nausea (48.6%) and constipation (13.5%), and for PAZ fatigue (58.0%), nausea (43.2%) and diarrhea (43.2%). QLQ C30 global scale and geriatric assessment were not significantly different at baseline nor at time points during the study. For DOX and PAZ 9 (25.0%) and 25 (32.5%) pts. were dependent (P=.4200) and 36 (100%) and 71 (97.3%) pts. remained at home (P=.6018), respectively. Overall the CCI was low for DOX 0 (IQR 0-1) and PAZ 0 (IQR 0-1) (P=.7244). However, differences were detected in QLQ C30 symptom scales at week 9, indicating more symptoms from diarrhea for PAZ (P = 0.0274) and more symptoms from constipation for DOX (P = 0.0409). The remaining functional and symptom scales remained without significant difference between treatment groups.
EPAZ recruited mainly independent and fit elderly patients with STS. While achieving non-inferior PFS, no apparent difference in HR-QoL measures was seen between treatment groups, except for symptom scales addressing specific adverse events of DOX (constipation) and PAZ (diarrhea).
Clinical trial identification
NCT01861951. EudraCT: 2011-004168-30
Legal entity responsible for the study
Medical School Hannover.
V. Grünwald: Consulting: BMS, MSD, Merck Kga, AstraZeneca, Novartis, Pfizer, Ipsen, Cerulean, EUSA-Pharma, Roche; Shares: BMS, MSD, AstraZeneca; Honoraria: BMS, MSD, Merck Kga, AstraZeneca, Novartis, Pfizer, Ipsen, Eisai, Roche; Research funding: AstraZeneca, BMS, MSD, Pfizer; Travel: MSD, BMS, Roche. M. Schuler: Research funding: Novartis. P. Schöffski: Honoraria: Daiichi, Eisai, Lilly, Medscape, Novartis, Swedish Orphan Biovitrium; Consulting: 6th Element capital, Adaptimmune, Amcure, AstraZeneca, Bayer, Blueprint, BMS, Boehringer Ingelheim, Cristal Therapeutics, Daiichi, Lilly, Epizyme, Genzyme, Ipsen, Loxo Oncology, Medscape, Nektar, Novartis, Philogen, Piquir Ther., Plexxikon; Speaker's bureau: Bayer, Eisai, Lilly, GSK, Novartis, PharmaMar, Swedich Orphan Biovitum; Research: Bayer, Blueprint, Cobiores. H-G. Kopp: Consulting: MSD, BMS, Sanofi; Expert testimony: Novartis, Pfizer, IcoPharma; Travel: Sanofi, Lilly, Amgen, Novartis, MSD. B. Kasper: Honoraria: Bayer, Lilly, Novartis, PharmaMar; Consulting: Bayer, Lilly, Eisai; Rsearch funding: PharmaMar. L.H. Lindner: Reasearch funding: Sennewald Medizintechnik; Travel: PharmaMar; Consulting: Novartis, Lilly, Eisai, EZ Medconsult; Speaker Bureau: PharmaMar. J.M. Chemnitz: Honoraria: Ablynx; Consulting: Amgen, Ablynx; Travel: Amgen, PharmaMar. G. Egerer: Consulting: MSD; Speaker Bureau: MSD, PharmaMar; Travel: MSD, Astellas. All other authors have declared no conflicts of interest.