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2009 ASCO年会上发表了新辅助剂量-密集双周表柔比星、环磷酰胺序贯多西紫杉和曲妥珠单抗治疗HER2阳性可手术乳腺癌的结果
发布时间:2009-07-01   作者:淳于

2009 ASCO年会上发表了新辅助剂量-密集双周表柔比星、环磷酰胺序贯多西紫杉和曲妥珠单抗治疗HER2阳性可手术乳腺癌的结果(Neoadjuvant dose-dense sequential biweekly epirubicin and cyclophosphamide followed by docetaxel and trastuzumab for HER2+ operable breast cancer.  )
Citation:J Clin Oncol 27:15s, 2009 (suppl; abstr 595)
Author(s):L. Blakely, B. Somer, M. Keaton, R. Hermann, F. Schnell, P. Cobb, A. Johns, M. Walker, L. Schwartzberg; The West Clinic, Memphis, TN; Accelerated Community Oncology Research Network, Memphis, TN
使用剂量密集序贯双周表柔比星100 mg/m2+环磷酰胺600 mg/m2 4周期再加用双周多西紫杉75 mg/m2和曲妥珠单抗6 mg/kg loading dose, then 4 mg/kg 4周期新辅助化疗方案治疗HER2+可手术乳腺癌能够达到较高病理完全缓解率,其毒性反应可耐受,未出现新的安全问题。

Abstract:Background: Neoadjuvant (Neo) chemotherapy (CT) with trastuzumab (H) improves pathologic complete response (pCR) rate for HER2+ breast cancer. Dose-dense regimens improve outcome in the adjuvant setting but have not been fully evaluated as preoperative therapy. We designed this regimen to utilize full doses of active agents including docetaxel (T) and H in a novel biweekly schedule to explore efficacy and safety. Methods: Patients (pts) with biopsy proven, clinical stage IIA-IIIC, noninflammatory breast cancer were eligible. HER2+ by FISH was determined locally. CT consisted of epirubicin (E) 100 mg/m2 and cyclophosphamide (C) 600 mg/m2 Q 14 days x 4 followed by T 75 mg/m2 and H 6 mg/kg loading dose, then 4 mg/kg Q 14 days x 4, all with pegfilgrastim support. Surgery was scheduled 20-24 weeks from start after a fifth cycle of H 4mg/kg. EF was measured prior to CT, after EC, after TH and at 6, 12 and 24 months after surgery. Additional adjuvant H to complete 1 year of therapy by conventional schedule was recommended after surgery. The primary endpoint was pCR for invasive cancer in breast and lymph nodes. Results: 30 pts were enrolled at 5 centers: median age was 50.1 (range, 31-72); ethnicity African-American 14, Caucasian 14, other 2; clinical stage IIA, 14, IIB, 4, IIIA, 7, IIIB/C, 5; ER+ 18, PR+ 14; grade 3, 21 and grade 2, 8. Twenty eight pts were evaluable for pathologic response- 2 withdrew before completing treatment, 1 for toxicity. Dose delivery on schedule was >95% for all drugs. Clinical response prior to surgery was cCR 20; cPR 5; and stable 2 pts. Pathologic response: pCR 16 (57%) including 4 with residual DCIS only; 9 pPR, and 2 stable. Mean EF was 63.1 (range, 51-81) before treatment, 62.4 (49-75) after EC and 58.3 (35-74) after TH. Two pts had EF <50% during Neo, one with clinical CHF and 1 additional pt developed CHF during adjuvant single agent H. Both pts had symptomatic improvement with cessation of H. Adverse events were generally mild with 14 grade 3 AEs including 3 episodes of dyspnea and no grade 3 skin toxicity or any grade 4 toxicity noted. Conclusions: Sequential Neo dose-dense Q 14 day EC followed by Q 14 day TH yields a high pCR rate in HER2+ breast cancer with acceptable toxicity profile and no new safety signals noted.

 

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