|Canadian Cancer Trials Group MAC.12 (ECOG PACCT-1) - Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial
The first results from the TAILORx Trial -- Canadian Cancer Trials Group MAC.12 -- are part of the larger Canadian Cancer Trials Group MAC.12 (ECOG PACCT-1) trial which is designed to further validate and refine the clinical usefulness of the 21-gene assay (Oncotype DX Recurrence Score, Genomic Health) in women with hormone-receptor-positive, HER2-negative, axillary node-negative invasive breast cancer. In this trial, women were categorized into three groups based on their recurrence score. These initial results report on the outcomes of women who had recurrence scores of 0-10 and who were assigned to receive endocrine therapy alone without chemotherapy.
The investigators found that of the 10,253 eligible women enrolled, 1626 (15.9%) had a recurrence score of 0 to 10 and were assigned to receive only endocrine therapy. At 5 years, the rate of invasive disease-free survival was 93.8%, the rate of freedom from recurrence of breast cancer at a distant site was 99.3%, the rate of freedom from recurrence of breast cancer at a distant or local-regional site was 98.7%, and the rate of overall survival was 98.0% suggesting that women with a recurrence score between 0-10 would not benefit from the addition of adjvuant chemotherapy.
You can read more about these results by using the link to the publication below and by visiting the Canadian Cancer Trials Group website at https://www.ctg.queensu.ca.
Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, Geyer CE, Dees EC, Perez EA, Olson JA, Zujewski J, Lively T, Badve SS, Saphner TJ, Wagner LI, Whelan TJ, Ellis MJ, Paik S, Wood WC, Ravdin P, Keane MM, Gomez Moreno HL, Reddy PS, Goggins TF, Mayer IA, Brufsky AM, Toppmeyer DL, Kaklamani VG, Atkins JN, Berenberg JL, Sledge GW. Prospective Validation of a 21-Gene Expression Assay in Breast Cancer (ONLINE). N Engl J Med 2015.
Canadian Cancer Trials Group SC.20 - A Phase III International Randomized Trial of Single Versus Multiple Fractions for Re-Irradiation of Painful Bone Metastases
The purpose of the study being reported in this publication was to determine the optimal cut points for classification of pain scores as mild, moderate, and severe based on interference with function and quality of life (QOL). The authors' analysis supports the classification of pain scores as follows: 1-4 as mild pain, 5-8 as moderate pain, and 9-10 as severe pain, which may facilitate conduct of future clinical trials.
Chow E, Ding K, Parulekar W, Wong R, van der Linden Y, Roos D, Hartsell W, Hoskin P, Wu J, Nabid A, Ong F, van Tienhoven G, Babington S, Demas W, Wilson C, Brundage M, Zhu L, Meyer R. Revisiting classification of pain from bone metastases as mild, moderate, or severe based on correlation with function and quality of life (ONLINE). Support Care Cancer 1-7, 2015.