56PD - Quality of life in TSU-68 study: Combination of docetaxel and TSU-68, an oral antiangiogenic agent, in patients with metastatic breast cancer previ...

Date 20 December 2015
Event ESMO Asia 2015 Congress
Session Breast cancer
Topics Anti-Cancer Agents & Biologic Therapy
Breast Cancer, Metastatic
Presenter Byeong Seok Sohn
Citation Annals of Oncology (2015) 26 (suppl_9): 16-33. 10.1093/annonc/mdv519
Authors B.S. Sohn1, S.B. Kim2, J. Ahn2, K.H. Jung2, K.S. Lee3, J. Ro3, S. Im4, Y. Im5, H. Song6, H. Park7, H.C. Chung8
  • 1Department Of Internal Medicine, Inje University Sanggye Paik Hospital, 139-707 - Seoul/KR
  • 2Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 138-736 - Seoul/KR
  • 3Center For Breast Cancer, National Cancer Center Hospital, 410-769 - Goyang/KR
  • 4Department Of Internal Medicine, Seoul National University Hospital, 110-744 - Seoul/KR
  • 5Division Of Hematology-oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, 135-710 - Seoul/KR
  • 6Department Of Internal Medicine, Keimyung University Dongsan Medical Centre, 700-712 - Daegu/KR
  • 7Department Of Internal Medicine, SoonChunHyang University College of Medicine, Seoul/KR
  • 8Department Of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, 120-752 - Seoul/KR

Abstract

Aim/Background

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).

Methods

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.

Results

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.

Conclusions

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

Disclosure

All authors have declared no conflicts of interest.