The aim of this study is to investigate whether the quality of life (QoL) of patients who treated with TSU-68 plus docetaxel (A) in a randomized phase II study is identical to that of those who treated with docetaxel alone (B) in Korean metastatic breast cancer patients. (Kim SB, Yoo CH, Invest New Drugs. 2014).
Sixty three patients (63 of total 81: A: 33, B: 30) patients had completed the baseline QoL questionnaires and at least one follow-up questionnaires with Korean FACT-B version 4.0; hospital anxiety and depression scale (HAD); the shortened form of the profile of mood states (BPOMS); anticipation and fear for treatment; and ECOG performance status rating scale (PSR). Changes from baseline in the FACT-B total score, FACT-G score, and TOI score at each scheduled visits (6, 12 weeks, 9, 12, 18 months) and at end of study (EOS) were analyzed, and the longitudinal data over time was evaluated.
Between two groups, there were no significant differences in the overall response rates and progression-free survival, and overall survival (p = 0.29, p = 0.95 and p = 0.42, respectively). In subgroup with anthracycline-resistant patients, A was associated with better overall survival than B (p = 0.02). The number at risk at each QoL assessment time was 63, 45, 39, 20, 12, 4 patients from baseline to 18 months. The return rate at EOS was 67.2% (39 patients). At the baseline, two groups were well balanced in age (≤45 vs. 46-55 vs. ≥55), religion (believer vs. no-believer), education (below middle school vs. high school vs. above college), ECOG PSR (0-1 vs. ≥2), and employment status (full/part time vs. homemaker). During study time, FACT-B total score and FACT-G score of A showed higher score than B at 12 months (p = 0.03 and p = 0.02, respectively). Anticipation score and frustration score of A was higher than those of B at 12 weeks and EOT (p = 0.04 and p = 0.02, respectively). However, overall, there were no significant differences in longitudinal data over study period between two groups.
The combination of TSU-68 with docetaxel did not confer any additional adverse effects on patients' QoL throughout the study time compared with docetaxel monotherapy.
Clinical trial identification
All authors have declared no conflicts of interest.