Group Administrators Office
|Canadian Cancer Trials Group MAC.4 (IBCSG 24-02) - A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer (SOFT)
Canadian Cancer Trials Group MAC.5 - (IBCSG 25-02) - A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer (TEXT)
In these two phase III trials, premenopausal women with hormone-receptor-positive early breast cancer were randomly assigned to the aromatase inhibitor exemestane plus ovarian suppression or tamoxifen plus ovarian suppression for a period of 5 years. The purpose of these studies was to determine whether adjuvant therapy with an aromatase inhibitor improves outcomes, as compared with tamoxifen. The primary analysis combined data from 4690 patients in the two trials.
The researchers concluded that, in premenopausal women with hormone-receptor-positive early breast cancer, adjuvant treatment with exemestane plus ovarian suppression, as compared with tamoxifen plus ovarian suppression, significantly reduced recurrence.
Pagani O, Regan MM, Walley BA, Fleming GF, Colleoni M, L?ng I, Gomez HL, Tondini C, Burstein HJ, Perez EA, Ciruelos E, Stearns V, Bonnefoi H, Martino S, Geyer CE, Pinotti G, Puglisi F, Crivellari D, Ruhstaller T, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Bernhard J, Luo W, Ribi K, Viale G, Coates AS, Gelber RD, Goldhirsch A, Francis PA. Adjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer (ONLINE). N Engl J Med 2014
Canadian Cancer Trials Group SR.5 ((EORTC 62012) - Randomized Trial of Single Agent Doxorubicin vs Doxorubicin/Ifosfamide/Neulasta in First Line Treatment of Advanced or Metastatic Soft Tissue Sarcoma
The purpose of this study was to assess whether dose intensification of doxorubicin with ifosfamide improves survival of patients with advanced soft-tissue sarcoma compared with doxorubicin alone. Between April 30, 2003, and May 25, 2010 455 patients were randomly assigned to receive either doxorubicin alone or doxorubicin and ifosfamide.
The researchers found there was no significant difference in overall survival between groups and concluded their results do not support the use of intensified doxorubicin and ifosfamide for palliation of advanced soft-tissue sarcoma unless the specific goal is tumour shrinkage.
Judson I, Verweij J, Gelderblom H, Hartmann JT, Sch?ffski P, Blay JY, Kerst JM, Sufliarsky J, Whelan J, Hohenberger P, Krarup-Hansen A, Alcindor T, Marreaud S, Liti?re S, Hermans C, Fisher C, Hogendoorn PCW, dei Tos AP, van der Graaf WTA. Doxorubicin alone versus intensified doxorubicin plus ifosfamide for first-line treatment of advanced or metastatic soft-tissue sarcoma: a randomised controlled phase 3 trial. The Lancet Oncology 15: 415-23, 2014.
Paoletti X, Le Tourneau C, Verweij J, Siu LL, Seymour L, Postel-Vinay S, Collette L, Rizzo E, Ivy P, Olmos D, Massard C, Lacombe D, Kaye SB, Soria JC. Defining dose-limiting toxicity for phase 1 trials of molecularly targeted agents: Results of a DLT-TARGETT international survey. Eur J Can 50: 2050-6, 2014.