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Quality of life in TSU-68 study: Combination of docetaxel and TSU-68, an oral antiangiogenic agent, in patients with metastatic breast cancer previously treated with anthracycline

Date

20 Dec 2015

Session

Breast cancer

Presenters

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

Author affiliations

  • 1 Department Of Internal Medicine, Inje University Sanggye Paik Hospital, 139-707 - Seoul/KR
  • 2 Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 138-736 - Seoul/KR
  • 3 Center For Breast Cancer, National Cancer Center Hospital, 410-769 - Goyang/KR
  • 4 Department Of Internal Medicine, Seoul National University Hospital, 110-744 - Seoul/KR
  • 5 Division Of Hematology-oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, 135-710 - Seoul/KR
  • 6 Department Of Internal Medicine, Keimyung University Dongsan Medical Centre, 700-712 - Daegu/KR
  • 7 Department Of Internal Medicine, SoonChunHyang University College of Medicine, Seoul/KR
  • 8 Department Of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, 120-752 - Seoul/KR
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Abstract 853

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.

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