The goal of chemotherapy for metastatic breast cancer (MBC) is to prolong survival and maintain health-related quality of life. This study aimed to evaluate long-term health status of patients with MBC who participated in the phase III randomized SELECT BC trial.
In the SELECT BC trial, patients were randomly allocated to the S-1 or taxane (paclitaxel or docetaxel) arm. Health status was assessed by EQ-5D at pre-treatment, 3 and 6 months after randomization, and every 6 months thereafter to the extent possible. Least square mean scores were assessed to compare EQ-5D index values between groups. Time to deterioration analysis was also performed by defining the minimally important difference of EQ-5D as 0.05 or 0.1.
The number of patients for EQ-5D analysis was 175 and 208 in the taxane and S-1 arms, respectively. Least square mean EQ-5D index values up to 60 months were 0.741 (95 % CI [0.713–0.769]) in the taxane arm and 0.748 [0.722–0.775] in the S-1 arm. The EQ-5D index value during PFS up to 12 months in the S-1 was superior to the corresponding index value in the taxane (0.812 [0.789–0.834] vs. 0.772 [0.751–0.792], P = 0.009). Time to deterioration analysis also revealed that S-1 significantly delayed the deterioration of EQ-5D index value during the period before progression (P = 0.002 and 0.003).
Our findings suggest that the EQ-5D index value was higher in patients treated with S-1 during first-line chemotherapy. Considering non-inferiority of S-1 in terms of OS, obtained quality-adjusted life years may be greater in the S-1 arm.
GBD 2013 Mortality and Causes of Death Collaborators (2015). Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990–2013: A systematic analysis for the Global Burden of Disease Study 2013. Lancet, 385(9963), 117–171.
Shimozuma, K., Ohashi, Y., Takeuchi, A., Aranishi, T., Morita, S., Kuroi, K., et al. (2012). Taxane-induced peripheral neuropathy and health-related quality of life in postoperative breast cancer patients undergoing adjuvant chemotherapy: N-SAS BC 02, a randomized clinical trial. Supportive Care in Cancer,20(12), 3355–3364. CrossRefPubMed
Shiroiwa, T., Fukuda, T., Shimozuma, K., Kuranami, M., Suemasu, K., Ohashi, Y., et al. (2011). Comparison of EQ-5D scores among anthracycline-containing regimens followed by taxane and taxane-only regimens for node-positive breast cancer patients after surgery: The N-SAS BC 02 trial. Value Health,14(5), 746–751. CrossRefPubMed
Piedbois, P., Rougier, P., Buyse, M., Pignon, J., Ryan, L., Hansen, R., et al. (1998). Efficacy of intravenous continuous infusion of fluorouracil compared with bolus administration in advanced colorectal cancer. Journal of Clinical Oncology,16(1), 301–308. PubMed
Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., et al. (1993). The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute,85(5), 365–376. CrossRefPubMed
Hakamies-Blomqvist, L., Luoma, M., Sjostrom, J., Pluzanska, A., Sjodin, M., Mouridsen, H., et al. (2000). Quality of life in patients with metastatic breast cancer receiving either docetaxel or sequential methotrexate and 5-fluorouracil. A multicentre randomised phase III trial by the Scandinavian breast group. European Journal of Cancer,36(11), 1411–1417. CrossRefPubMed
Miller, K. D., Chap, L. I., Holmes, F. A., Cobleigh, M. A., Marcom, P. K., Fehrenbacher, L., et al. (2005). Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. Journal of Clinical Oncology,23(4), 792–799. CrossRefPubMed
Cassier, P. A., Chabaud, S., Trillet-Lenoir, V., Peaud, P. Y., Tigaud, J. D., Cure, H., et al. (2008). A phase-III trial of doxorubicin and docetaxel versus doxorubicin and paclitaxel in metastatic breast cancer: Results of the ERASME 3 study. Breast Cancer Research and Treatment,109(2), 343–350. CrossRefPubMed
Nuzzo, F., Morabito, A., Gravina, A., Di Rella, F., Landi, G., Pacilio, C., et al. (2011). Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: Results of a single-centre randomized phase 3 trial. BMC Cancer,11, 75. CrossRefPubMedPubMedCentral
Wu, Y., Amonkar, M. M., Sherrill, B. H., O’Shaughnessy, J., Ellis, C., Baselga, J., et al. (2011). Impact of lapatinib plus trastuzumab versus single-agent lapatinib on quality of life of patients with trastuzumab-refractory HER2+ metastatic breast cancer. Annals of Oncology,22(12), 2582–2590. CrossRefPubMed
Burris, H. A., 3rd, Lebrun, F., Rugo, H. S., Beck, J. T., Piccart, M., Neven, P., et al. (2013). Health-related quality of life of patients with advanced breast cancer treated with everolimus plus exemestane versus placebo plus exemestane in the phase 3, randomized, controlled, BOLERO-2 trial. Cancer,119(10), 1908–1915. CrossRefPubMed
Welslau, M., Dieras, V., Sohn, J. H., Hurvitz, S. A., Lalla, D., Fang, L., et al. (2014). Patient-reported outcomes from EMILIA, a randomized phase 3 study of trastuzumab emtansine (T-DM1) versus capecitabine and lapatinib in human epidermal growth factor receptor 2-positive locally advanced or metastatic breast cancer. Cancer,120(5), 642–651. CrossRefPubMed
Park, Y. H., Jung, K. H., Im, S. A., Sohn, J. H., Ro, J., Ahn, J. H., et al. (2015). Quality of life (QoL) in metastatic breast cancer patients with maintenance paclitaxel plus gemcitabine (PG) chemotherapy: Results from phase III, multicenter, randomized trial of maintenance chemotherapy versus observation (KCSG-BR07-02). Breast Cancer Research and Treatment,152(1), 77–85. CrossRefPubMed
Rasanen, P., Roine, E., Sintonen, H., Semberg-Konttinen, V., Ryynanen, O. P., & Roine, R. (2006). Use of quality-adjusted life years for the estimation of effectiveness of health care: A systematic literature review. International Journal of Technology Assessment in Health Care,22(2), 235–241. CrossRefPubMed
Le, Q. A., Doctor, J. N., Zoellner, L. A., & Feeny, N. C. (2013). Minimal clinically important differences for the EQ-5D and QWB-SA in Post-traumatic Stress Disorder (PTSD): Results from a Doubly Randomized Preference Trial (DRPT). Health and Quality of Life Outcomes,11, 59. CrossRefPubMedPubMedCentral
Gray, R. (1998). A class of K-sample tests for comparing the cumulative incidence of a competing risk. The Annals of Statistics,16, 1141–1154. CrossRef
Fine, J., & Gray, R. (1999). A proportional hazards model for the subdistribution of a competing risk. Journal of the American Statistical Association,94, 496–509. CrossRef
Harano, K., Terauchi, F., Katsumata, N., Takahashi, F., Yasuda, M., Takakura, S., et al. (2014). Quality-of-life outcomes from a randomized phase III trial of dose-dense weekly paclitaxel and carboplatin compared with conventional paclitaxel and carboplatin as a first-line treatment for stage II-IV ovarian cancer: Japanese Gynecologic Oncology Group Trial (JGOG3016). Annals of Oncology,25(1), 251–257. CrossRefPubMed
Anota, A., Hamidou, Z., Paget-Bailly, S., Chibaudel, B., Bascoul-Mollevi, C., Auquier, P., et al. (2015). Time to health-related quality of life score deterioration as a modality of longitudinal analysis for health-related quality of life studies in oncology: Do we need RECIST for quality of life to achieve standardization? Quality of Life Research,24(1), 5–18. CrossRefPubMed
- Long-term health status as measured by EQ-5D among patients with metastatic breast cancer: comparison of first-line oral S-1 and taxane therapies in the randomized phase III SELECT BC trial
- Springer International Publishing