Quality-Adjusted Survival with Ribociclib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women with HR±HER2-Advanced Breast Cancer in the Monaleesa-3 Trial
JERUSALEM, Guy; Delea, Thomas E.; Martin, Miguleet al.
2022 • In Clinical Breast Cancer, 22 (4), p. 326-335
Quality-Adjusted Survival with Ribociclib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women with HR±HER2-Advanced Breast Cancer in the Monaleesa-3 Trial
Canadian Cancer Society. Breast Cancer Statistics. 2019 Available at: http://www.cancer.ca/en/cancer-information/cancer-type/breast/statistics/?region=on. Accessed: February 10, 2019.
Surveillance, Epidemiology, and End Results Program (SEER). Cancer stat facts: female breast cancer. Natl Cancer Inst 2021. Available at: https://seer.cancer.gov/statfacts/html/breast.html. Accessed: April 16, 2021.
Cardoso, F, Costa, A, Senkus, E, et al. 3rd ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 3). Ann Oncol, 28, 2017, 3111.
Partridge, AH, Rumble, RB, Carey, LA, et al. Chemotherapy and targeted therapy for women with human epidermal growth factor receptor 2-negative (or unknown) advanced breast cancer: American society of clinical oncology clinical practice guideline. J Clin Oncol 32 (2014), 3307–3329.
Cardoso, F, Senkus, E, Costa, A, et al. 4th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 4). Ann Oncol 29 (2018), 1634–1657.
American Cancer Society. Breast Cancer Facts & Figures 2019-2020. 2018, Atlanta: American Cancer Society, Inc Available at: https://www.cancer.org/research/cancer-facts-statistics/breast-cancer-facts-figures.html. Accessed: April 16, 2021.
Slamon, DJ, Neven, P, Chia, S, et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3. J Clin Oncol 36 (2018), 2465–2472.
Slamon, DJ, Neven, P, Chia, S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med 382 (2020), 514–524.
Slamon, DJ, Neven, P, Chia, S, et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3. J Clin Oncol 36 (2018), 2465–2472.
Fasching, PA, Esteva, FJ, Pivot, X, et al. 290O Patient-reported outcomes (PROs) in advanced breast cancer (ABC) treated with ribociclib + fulvestrant: results from MONALEESA-3. Ann Oncol, 2018 29(suppl 8).
Gelber, RD, Goldhirsch, A, Cole, BF, Evaluation of effectiveness: Q-TWiST. the international breast cancer study group. Cancer Treat Rev, 1993, 73–84.
Revicki, DA, Feeny, D, Hunt, TL, et al. Analyzing oncology clinical trial data using the Q-TWiST method: clinical importance and sources for health state preference data. Qual Life Res 15 (2006), 411–423.
Solem, CT, Kwon, Y, Shah, RM, et al. Systematic review and benchmarking of quality-adjusted time without symptoms or toxicity (Q-TWiST) in oncology. Expert Rev Pharmacoecon Outcomes Res 18 (2018), 245–253.
Tate, WR, Skrepnek, GH, Quality-adjusted time without symptoms or toxicity (Q-TWiST): patient-reported outcome or mathematical model? A systematic review in cancer. Psychooncology 24 (2015), 253–261.
Diaby, V, Adunlin, G, Ali, AA, et al. Using quality-adjusted progression-free survival as an outcome measure to assess the benefits of cancer drugs in randomized-controlled trials: case of the BOLERO-2 trial. Breast Cancer Res Treat 146 (2014), 669–673.
Pickard, AS, Law, EH, Jiang, R, et al. United States valuation of EQ-5D-5L health states using an international protocol. Value Health 22 (2019), 931–941.
Lloyd, A, Nafees, B, Narewska, J, et al. Health state utilities for metastatic breast cancer. Br J Cancer 95 (2006), 683–690.
Walker, MS, Wong, W, Ravelo, A, et al. Effectiveness outcomes and health related quality of life impact of disease progression in patients with advanced nonsquamous NSCLC treated in real-world community oncology settings: results from a prospective medical record registry study, 2017, Health Qual Life Outcomes, 160.