AIMS AND BACKGROUND: To demonstrate the efficacy of 13-cis-retinoic acid (RA) or Interferon alpha-2a (IFN alpha-2a) with Tamoxifen (TAM) in the treatment of advanced breast cancer. METHODS:Ninety-nine postmenopausal patients with advanced breast cancer, and a positive or unknown estrogen (ER) or progesterone (PgR) receptor status, were randomised to receive TAM 20 mg/m2/day orally (arm A), or TAM plus RA 1 mg/kg/day orally (arm B), or TAM plus IFN alpha-2a 3 MU thrice a week intramuscular (arm C). The three treatment groups were well balanced in terms of the main prognostic factors. RESULTS: Response was evaluable in 32 of the patients in arm A, 32 in arm B, and 30 in arm C. Intention-to-treat analysis showed no significant difference of response rate in the three arms (44% vs 38% vs 42%). After an eight years median follow-up, there was no significant between-group difference in median overall survival: 47.4 vs 38.2 vs 45.1 months. Side effects were negligible in arm A, but cutaneous (39%) and mucosal (62%) toxicities were frequent in arm B, and flu-like syndrome and/or myalgia (46%) in arm C. CONCLUSIONS: The administration of RA or IFN alpha-2a does not add anything to the therapeutic effects of TAM.
RCT Entities:
AIMS AND BACKGROUND: To demonstrate the efficacy of 13-cis-retinoic acid (RA) or Interferon alpha-2a (IFN alpha-2a) with Tamoxifen (TAM) in the treatment of advanced breast cancer. METHODS: Ninety-nine postmenopausal patients with advanced breast cancer, and a positive or unknown estrogen (ER) or progesterone (PgR) receptor status, were randomised to receive TAM 20 mg/m2/day orally (arm A), or TAM plus RA 1 mg/kg/day orally (arm B), or TAM plus IFN alpha-2a 3 MU thrice a week intramuscular (arm C). The three treatment groups were well balanced in terms of the main prognostic factors. RESULTS: Response was evaluable in 32 of the patients in arm A, 32 in arm B, and 30 in arm C. Intention-to-treat analysis showed no significant difference of response rate in the three arms (44% vs 38% vs 42%). After an eight years median follow-up, there was no significant between-group difference in median overall survival: 47.4 vs 38.2 vs 45.1 months. Side effects were negligible in arm A, but cutaneous (39%) and mucosal (62%) toxicities were frequent in arm B, and flu-like syndrome and/or myalgia (46%) in arm C. CONCLUSIONS: The administration of RA or IFN alpha-2a does not add anything to the therapeutic effects of TAM.
Authors: Xingxing Liu; Mélanie Nugoli; Julie Laferrière; Sadiq M Saleh; Ian G Rodrigue-Gervais; Maya Saleh; Morag Park; Michael T Hallett; William J Muller; Vincent Giguère Journal: Proc Natl Acad Sci U S A Date: 2010-12-27 Impact factor: 11.205
Authors: Paola Marcato; Cheryl A Dean; Rong-Zong Liu; Krysta M Coyle; Moamen Bydoun; Melissa Wallace; Derek Clements; Colin Turner; Edward G Mathenge; Shashi A Gujar; Carman A Giacomantonio; John R Mackey; Roseline Godbout; Patrick W K Lee Journal: Mol Oncol Date: 2014-07-24 Impact factor: 6.603