Canadian Cancer Trials Group Bulletins

Group Administrators Office


Recent Publications

Canadian Cancer Trials Group MAP.3 - A Phase III Randomized Study of Exemestane versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer

As many may recall, exemestane, a steroidal aromatase inhibitor, reduced invasive breast cancer incidence by 65% among 4,560 postmenopausal women randomly assigned to exemestane (25 mg per day) compared with placebo in the Canadian Cancer Trials Group MAP.3 trial. Results of the trial were published in the New England Journal of Medicine. However, effects on quality of life (QOL) were not fully described.

This article, published in the Journal of Clinical Oncology, describes these effects and concludes that exemestane given for prevention has limited negative impact on menopause-specific and health-related quality of life in healthy postmenopausal women at risk for breast cancer.

Maunsell E, Goss PE, Chlebowski RT, Ingle JN, Mart?nez JE, Sarto GE, Fabian CJ, Pujol P, Ruiz A, Cooke AL, Hendrix S, Thayer DW, Rowland KM, Dub? P, Spadafora S, Pruthi S, Lickley L, Ellard SL, Cheung AM, Wactawski-Wende J, Gelmon KA, Johnston D, Hiltz A, Brundage M, Pater JL, Tu D, Richardson H. Quality of Life in MAP.3 (Mammary Prevention 3): A Randomized, Placebo-Controlled Trial Evaluating Exemestane for Prevention of Breast Cancer (ONLINE). J Clin Oncol 2014.

http://jco.ascopubs.org/content/early/2014/04/16/JCO.2013.51.2483.abstract

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Progressive disease (PD) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 is defined as growth of measurable target lesions, presence of new lesions or unequivocal progression of non-target disease. The purpose of this article was to explore whether a more refined categorisation of tumour response and/or these components of progression, varying over time, can improve prediction of overall survival (OS) in the RECIST database.

The authors concluded that modelling target lesion tumour growth did not show a marked improvement in OS prediction over and above the other components. These analyses enable a better understanding of the role of each component in PD evaluation. Work is ongoing to incorporate this information into an updated version of RECIST with enhanced prediction of subsequent survival.

Litere S, de Vries EGE, Seymour L, Sargent D, Shankar L, Bogaerts J. The components of progression as explanatory variables for overall survival in the Response Evaluation Criteria in Solid Tumours 1.1 database (ONLINE). Eur J Can 2014.

http://www.sciencedirect.com/science/article/pii/S095980491400269X