Results of the Turkish prospective multi-center study utilizing the 21-gene Oncotype DX assay: Decision impact analysis.
Bildiriler > Özet Bildiri · 2015
Yazarlar: Vahit Ozmen, Ajlan Atasoy, Erhan GÖKMEN, Mustafa Ozdogan, Emine Nilufer Guler, Cihan Uras, Engin Ok, Orhan Demircan, Abdurrahman Isikdogan, Kezban Nur Pilanci, Cetin Ordu, Oben Duman, Ozturk Ates, Fatma Sen, Halil Kara, Bahadir Oz, Pinar Saip
Journal of Clinical Oncology, Amerika Birleşik Devletleri, Uluslararası, Sözlü Sunum, Özet Bildiri, 2015-2015, Wos, cilt 33, ss e11515-e11515
DOI: 10.1200/jco.2015.33.15_suppl.e11515
Özet
e11515 Background: The 21-gene Oncotype DX assay is accepted as an important predictive factor in the adjuvant treatment of node negative, estrogen receptor (ER) positive and HER2 (-) breast cancer. The test is not widely available for Turkish physicians as itÕs currently not reimbursed.We performed a prospective analysis to find the impact of the Recurrence Score result (RS) on treatment decisions. Methods: Ten centers across Turkey participated in this prospective trial. Consecutive breast cancer patients with pT1-3, pN0-N1mic, ER(+) , and HER2 (-) tumors were identified and adjuvant treatment decisions were made at breast tumor boards. The pre assay treatment decision was recorded on a questionnaire form. Cases were discussed at tumor boards again when the RS was available and investigators filled the post-assay questionnaire forms with the final decision. Results: 165 patients were enrolled. Mean age was 49.8 (SD±10.3) years. 108(65.5%) patients had pT1 tumors. Mean RS was 18.8±14.0. RS was low in 56.8%, intermediate in in 35.2% and high in 8.5%. There was an overall treatment decision change in 33% of patients with a reduction of chemotherapy (CT) from 56% to 35% overall and a 48% reduction in patients originally recommended CT. Among the patients with low and intermediate results, the decision changed from CT to Òhormonal therapy (HT) aloneÓ in 36 (85.7%) and 7 (36.8%) patients, respectively. Conclusions: The 21-gene assay has a significant impact on treatment decisions at specialty tumor boards in Turkish hospitals. Our initial findings warrant further consideration for the use of this genomic assay in patients with early stage breast cancer in Turkey. Health economic analysis will be reported separately in the near future. Chemotherapy decision in patients before and after RS by risk groups. Post-RS Decision HT CT+HT N n % n % p value* Pre-RS Decision All patients HT 73 63 86.3 10 13.7 <0.001 CT+HT 92 44 47.8 48 52.2 Total 165 107 64.8 58 35.2 Low RS HT 51 51 100.0 0 0.0 CT+HT 42 36 85.7 6 14.3 Total 93 87 93.5 6 6.5 Intermediate RS HT 19 12 63.2 7 36.8 CT+HT 39 8 20.5 31 79.5 Total 58 20 34.5 38 65.5 High RS HT 3 0 0.0 3 100.0 CT+HT 11 0 0.0 11 100.0 Total 14 0 0.0 14 100.0 *McNemar test