четверг, 17 апреля 2008 г.

Intensified neoadjuvant chemotherapy in early-responding breast cancer: phase iii randomized gepartrio study

JOURNAL OF THE NATIONAL CANCER INSTITUTE ADVANCE ACCESS ORIGINALLY PUBLISHED ONLINE ON APRIL 8, 2008 JNCI Journal of the National Cancer Institute 2008 100(8):552-562; doi:10.This Article All Versions of this Article: 100/8/552 _most recent_ Services Google Scholar PubMed Related Collections Social Bookmarking ARTICLES INTENSIFIED NEOADJUVANT CHEMOTHERAPY IN EARLY-RESPONDING BREAST CANCER: PHASE III RANDOMIZED GEPARTRIO STUDY Gunter von Minckwitz, Sherko Kmmel, Petra Vogel, Claus Hanusch, Holger Eidtmann, Jrn Hilfrich, Bernd Gerber, Jens Huober, Serban Dan Costa, Christian Jackisch, Sibylle Loibl, Keyur Mehta, Manfred Kaufmann; for the German Breast Group AFFILIATIONS OF AUTHORS: German Breast Group, Frankfurt, Germany (GvM, SL, KM); Universitts-Frauenklinik, Essen, Germany (SK); Frauenklinik, Horst Schmidt Kliniken, Wiesbaden, Germany (PV); Frauenklinik vom Roten Kreuz, Munich, Germany (CH); Universitts-Frauenklinik, Kiel, Germany (HE); Frauenklinik Henriettenstiftung, Hannover, Germany (J.Rostock, Germany (BG); Universitts-Frauenklinik, Tbingen, Germany (J.Magdeburg, Germany (SDC); Stdtisches Klinikum Offenbach, Offenbach, Germany (CJ); Universitts-Frauenklinik, Frankfurt, Germany (GvM, SL, MK) CORRESPONDENCE TO: Gunter von Minckwitz, MD, Universitts-Frauenklinik Frankfurt difference = 2.Interval = -1.6.= .More clinical (48.52.4.= -0.9.= .Sonographic (22.27.= 5%; 95% CI = 0.9..At surgery were observed with eight TAC cycles than with six TAC cycles.Rate of breast-conserving surgery was similar in both arms (67.68._P_ = .Grade 3 or 4 leukopenia and edema and various grade 1 or 2 adverse events were more frequent in patients receiving eight TAC cycles than in those receiving six cycles.Conclusion: Patients receiving eight TAC cycles had statistically significantly higher sonographic response rates but not pathologicalplete response rates than those receiving six TAC cycles.Also had more toxic effects.Far, eight cycles of TAC cannot be rmended for the whole group of patients responding to two initial cycles of TAC.CONTEXT AND CAVEATS PRIOR KNOWLEDGE Patients with an early response to neoadjuvant chemotherapy have chemosensitive tumors and a high probability for a pathologicalplete response at surgery.DESIGN Phase III randomized trial among previously untreated breast cancer patients who responded to two cycles of docetaxel, doxorubicin, and cyclophosphamide (TAC) that evaluated four or six more cycles of TAC, for a total of six or eight TAC cycles.Response rates and rates of breast-conserving surgery and adverse effects were also assessed.Patients who received eight TAC cycles had statistically significantly higher sonographic response rates and more toxic effects but not pathologicalplete response rates than those who received six TAC cycles.Eight cycles of TAC cannot be rmended for the whole group of patients who respond to two initial cycles of TAC.The power of the study to detect a statistically significant difference between arms was reduced because of the small sample size.In the eight-cycle arm than in the six-cycle arm discontinued treatment.Interobserver variability in the assessment of sonographic and clinical responses exists.October 24, 2007; revised February 11, 2008; accepted February 28, 2008.IN JNCI IN THIS ISSUE J Natl Cancer Inst 2008 100: 519.THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES: G.S.P.C.H.J.Gerber, J.S.Costa, C._et al.VERSUS DOCETAXEL-DOXORUBICIN-CYCLOPHOSPHAMIDE IN EARLY NONRESPONSIVE BREAST CANCER: PHASE III RANDOMIZED GEPARTRIO TRIAL J Natl Cancer Inst, April 16, 2008; 100(8): 542 - 551.J.And G.Hortobagyi CAN EARLY RESPONSE ASSESSMENT GUIDE NEOADJUVANT CHEMOTHERAPY IN EARLY-STAGE BREAST CANCER?Natl Cancer Inst, April 16, 2008; 100(8): 521 - 523.
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