Report in English with a Dutch summary (KCE reports 63A)

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84 Breast Cancer KCE reports 63 Study ID Ref Search date Fumoleau P 2003 [186] 621 BC N+ in premenaopausal women Martin M 2003 [187] 985 T1-3, N0-2, M0 BC Taxanes Bria 2006 [85] Early breast cancer: 15.500 patients All trials including N+ patients Population Intervention Outcomes Results Comments Study type Six versus three cycles of epirubicin adj chemo 6 FEC 50 (FU + epirubicin + Cyclophosph) versus 3 FEC 50 or 3 FEC 75 FAC (5FU, doxorub, cyclophos) Versus CMF (5FU, methot, cyclophos) Assess the advantages of adjuvant taxane chemotherapy (placitaxel or docetaxel) over standard chemotherapy DFS disease free survival OS overall survival DFS OS Disease free survival (DFS) Overall survival (OS) After a 131-month median follow-up, the 10year disease-free survival (DFS) was 53.4%, 42.5%, and 43.6% (P = .05) in the three arms, respectively. Pairwise comparisons demonstrate that 6 FEC 50 was superior both to 3 FEC 50 (P = .02) and to 3 FEC 75 (P = .05). The 10-year overall survival (OS) for the 6 FEC 50 arm was 64.3%, for the 3 FEC 50 arm it was 56.6%, and for the 3 FEC 75 arm, it was 59.7% (P = .25), respectively. Pairwise comparisons demonstrate that 6 FEC 50 was more effective than 3 FEC 50 (P =.10). Cox regression analysis demonstrates that OS was significantly better in the 6 FEC 50 than in the 3 FEC 50 arm (P = .046). In the prospectively formed subset of nodenegative patients, disease-free survival and overall survival were statistically superior in the FAC treatment arm (P = 0.041 and 0.034, respectively), but this advantage was not seen in the subset of nodepositive patients. Adjusting data for size of treatment effect and potential interactions (number of positive nodes, tumor size, treatment center), the overall relative risk (RR) of disease recurrence and death were significantly lower with FAC treatment (RR 1.2, P = 0.03, and RR 1.3, P = 0.05, respectively). This result was mainly due to the difference observed in the node-negative patient population. Toxicity was mild: FAC induced more alopecia, emesis, mucositis and cardiotoxicity; this last was of clinical concern, but was infrequent and manageable. CMF induced more conjunctivitis and weight gain. There were no toxic deaths. Significant differences in favour of taxanes in DFS in the overall (RR: 0.86) and lymph node positive population (RR: 0.84) and in OS in the overall (RR 0.87à and lymph node positive population (RR: O.84). Lack of significant heterogeneity in the sensitivity analysis of subpopulations RCT High RCT High Pooled analysis of 9 phase III trials Level of evidence Sartor CI 2005 [188] N=3170 Adjuvant AC Loco regional For patients treated with breast-conserving BCS data concern a RCT Moderate High
KCE reports 63 Breast Cancer 85 Study ID Ref Search date Green MC 2005 [189] 258 women operable breast cancer with primary systemic chemotherapy stage I-IIIA breast cancer Brain GC 2005 [190] 627 women with N0 to N3 Neoadjuvant chemotherapy Mauri D 2005 [86] 2003 Breast cancer patients Population Intervention Outcomes Results Comments Study type N+, M0 breast cancer (doxorubicin/ cyclophosphamide) Or AC followed by paclitaxel (AC + T) Weekly paclitaxel (12 weekly doses) versus every 3 week paclitaxel (4 cyclus over 12 weeks) All groups followed by FAC (fluorouracil/ doxorubicin/ cyclophosphamide), radiotherapy and tamoxifen (if ER- and/or PR+)) Doxorubicin + docetaxel Versus doxorubicin + cyclophosphamide Neoadjuvant vs. adjuvant therapy recurrence (LRR) Pathologic complete response (pCR) Disease free survival Safety Overall survival surgery and RT, the 5-year cumulative incidence of isolated LRR was 9.7% in the AC arm and 3.7% in the AC_T arm (P=0.04) and of LRR as any component of failure was 12.9% versus 6.1%, respectively (P = 0.04). Although LRR rates in patients who did not receive postmastectomy RT were lower in the AC_T arm, the difference was not statistically significant. Clinical response to treatment was similar between groups (P =0.25). Patients receiving weekly paclitaxel had a higher pCR rate (28.2%) than patients treated with onceevery-3-weeks paclitaxel (15.7%; P =0 .02), with improved breastconservation rates (P =0.05). 2 deaths related to drug toxicity and 1 case of perforative peritonitis occurred among patients with febrile neutropenia, all in the doxorubicin-docetaxel group. The incidence of febrile neutropenia was significantly higher with the doxorubicin-docetaxel regimen (40.8%) than with the doxorubicincyclophosphamide regimen (7.1%) (P=.001). No statistically or clinically significant difference between neoadjuvant therapy and adjuvant therapy arms associated with death (RR = 1.00, 95%CI = 0.90 to 1.12), disease progression (RR = 0.99, 95%CI = 0.91 to 1.07), or distant disease recurrence (RR = 0.94, 95% CI = 0.83 to 1.06). However, neoadjuvant therapy was statistically significantly associated with an increased risk of loco-regional disease recurrences (RR = 1.22, 95%CI = 1.04 to 1.43) compared with adjuvant therapy. subanalysis Trial terminated prematurely related to drug toxicity Time too short to analyse the primary endpoint 9 RCTs included Not only concerns neoadjuvant chemotherapy RCT High Level of evidence RCT Moderate SR High
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