ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Design of adjuvant trials using trastuzumab

Design of adjuvant trials using trastuzumab
Trial
(number of patients)		 Treatment arms Definition of severe cardiotoxicity Monitoring frequency

NSABP B-31[1]

(n = 2030)

AC for four cycles, paclitaxel for four cycles, then observation

AC for four cycles, followed by paclitaxel for four cycles, with concurrent trastuzumab, continued for one year		 Grade III/IV HF or cardiac death; or LVEF decrease >15 percentage points* MUGA three weeks, six months, and nine months after end of initial AC, and three months after last trastuzumab dose

HERA[2]

(n = 5090)

Any chemotherapy regimen, then observation

Any chemotherapy regimen, then trastuzumab for one year

Any chemotherapy regimen, then trastuzumab for two years		 Severe HF; symptomatic HF; or LVEF decrease >10 percentage points* LVEF (echo or MUGA) at baseline, 3, 6, 12, 18, 24, 30, 36, and 60 months

BCIRG-006[3]

(n = 3222)

AC for four cycles, docetaxel for four cycles, then observation

AC for four cycles, followed by docetaxel for four cycles, with concurrent trastuzumab, continued for one year

Docetaxel and carboplatin for six cycles, with concurrent trastuzumab, continued for one year		 Grade III/IV HF; cardiac death; grade 3 to 4 arrhythmias; grade 3 to 4 ischemia/infarction; or LVEF decrease >10 percentage points* After AC, after second dose of docetaxel, at end of chemotherapy, and 3, 12, and 36 months after randomization

FinHer[4]

(n = 232)

Docetaxel (every three weeks) and vinorelbine (weekly) for three cycles, then CEF for three cycles

Docetaxel (every three weeks) and vinorelbine (weekly) for three cycles, plus trastuzumab for nine weeks, then CEF for three cycles		 Myocardial infarction; HF; or LVEF decrease >15 percentage points Echo or MUGA before chemotherapy, after CEF, and 12 and 36 months after chemotherapy

NCCTG N9831[5]

(n = 3505)

AC for four cycles, weekly paclitaxel for 12 weeks, then observation

AC for four cycles, weekly paclitaxel for 12 weeks, with concurrent trastuzumab, continued for one year

AC for four cycles, weekly placlitaxel for 12 weeks, followed by trastuzumab for one year		 Grade III/IV HF or cardiac death; or LVEF decrease >15 percentage points* MUGA or echo at entry, after AC, and 6, 9, 18, and 21 months after entry
AC: doxorubicin and cyclophosphamide; HF: heart failure; LVEF: left ventricular heart failure; MUGA: multi-gated acquisition scan; CEF: cyclophosphamide, epirubicin, and fluorouracil.
* Measured from baseline.
¶ Only patients with HER2-positive disease.
References:
  1. Romond EH, et al. N Engl J Med 2005; 353:1673.
  2. Piccart-Gebhart MJ, et al. N Engl J Med 2005; 353:1659.
  3. Slamon D, et al. N Engl J Med 2011; 365:1273.
  4. Joensuu H, et al. N Engl J Med 2006; 354:809.
  5. Perez A, et al. J Clin Oncol 2011; 29:4491.
Modified from: Bria E, et al. Cardiotoxicity and incidence of brain metastases after adjuvant trastuzumab for early breast cancer: the dark side of the moon? A meta-analysis of the randomized trials. Breast Cancer Res Treat 2008; 109:231 and Telli ML, et al. Trastuzumab-related cardiotoxicity: Calling into question the concept of reversibility. J Clin Oncol 2007; 25:3525.
Graphic 70022 Version 9.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟