NEAT: National Epirubicin Adjuvant Trial - toxicity, delivered dose intensity and quality of life

被引:19
作者
Earl, H. M. [1 ]
Hiller, L. [2 ]
Dunn, J. A. [2 ]
Bathers, S. [3 ]
Harvey, P. [4 ]
Stanley, A. [5 ]
Grieve, R. J. [6 ]
Agrawal, R. K. [7 ]
Fernando, I. N. [8 ]
Brunt, A. M. [9 ]
McAdam, K. [10 ]
O'Reilly, S. [11 ]
Rea, D. W. [3 ]
Spooner, D. [8 ]
Poole, C. J. [2 ,3 ]
机构
[1] Univ Cambridge, Addenbrookes Hosp, Dept Oncol, Ctr Oncol, Cambridge CB2 0QQ, England
[2] Univ Warwick, Warwick Med Sch Clin Trials Unit, Coventry CV4 7AL, W Midlands, England
[3] Univ Birmingham, Canc Res UK Clin Trials Unit, Birmingham B15 2TT, W Midlands, England
[4] St James Univ Hosp, Dept Clin & Hlth Psychol, Leeds LS9 7TF, W Yorkshire, England
[5] City Hosp, St Chads Pharm Dept, Birmingham B18 7QH, W Midlands, England
[6] Univ Hosp, Arden Canc Ctr, Coventry CV2 2DX, W Midlands, England
[7] Royal Shrewsbury Hosp, Dept Oncol, Shrewsbury SY3 8XQ, Salop, England
[8] Queen Elizabeth Hosp, Ctr Canc, Birmingham B15 2TH, W Midlands, England
[9] Univ Hosp N Staffordshire, Staffordshire Oncol Ctr, Stoke On Trent ST4 7LN, Staffs, England
[10] Peterborough Dist Gen Hosp, Peterborough PE3 6DA, England
[11] Clatterbridge Oncol Ctr, Bebington CH63 4JY, Merseyside, England
关键词
NEAT; breast cancer; adjuvant chemotherapy toxicity; dose intensity; quality of life;
D O I
10.1038/sj.bjc.6604674
中图分类号
R73 [肿瘤学];
学科分类号
100214 [肿瘤学];
摘要
The NEAT trial reported considerable benefit for ECMF (epirubicin followed by cyclophosphamide, methotrexate and 5-fluorouracil) of 28% for relapse-free survival (RFS) and 30% for overall survival (OS), when compared with classical CMF in early breast cancer. To assess tolerability, toxicity, dose intensity and quality of life (QoL) analyses were undertaken. All 2021 eligible patients had common toxicity criteria (CTC), delivered chemotherapy and supportive treatments details and long-term morbidities recorded. The QoL substudy used multiple validated measures. ECMF produced low CTC scores, although higher than CMF for nausea, vomiting, alopecia, constipation, stomatitis (P = 0.001), infection (P = 0.001) and fatigue (P=0.03). Supportive treatments required, however, were similar across randomised treatments. On-treatment deaths were more common with CMF (13) than ECMF(5). Optimal course-delivered dose intensity (CDDI >= 85%) was received more often by ECMF patients (83 vs 76%: P = 0.0002), and was associated with better RFS (P = 0.0006). QoL over 2 years was equivalent across treatments, despite minimally worse side effects for ECMF during treatment. ECMF benefit spanned all levels of toxicity, CDDI and QoL. There are no reported acute myeloid leukaemias or cardiac dysfunctions. ECMF is tolerable, deliverable, and significantly more effective than CMF, with no serious longterm toxicity or QoL detriment.
引用
收藏
页码:1226 / 1231
页数:6
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