Epirubicin–vinorelbine vs FEC100 for node-positive, early breast cancer: French Adjuvant Study Group 09 trial

Kerbrat, Pierre; Roché, Henri; Bonneterre, Jacques; Veyret, Corinne; Lortholary, Alain; Monnier, Alain; Fumoleau, P.; Fargeot, P.; Namer, M.; Chollet, Philippe; Goudier, M.-J.; Audhuy, B.; Simon, H.; Montcuquet, P.; Eymard, J-C.; Walter, Steffen; Clavère, P.; Guastalla, J P

doi:10.1038/sj.bjc.6603773

Cited by 8 publications

(11 citation statements)

References 19 publications

(17 reference statements)

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“…Other single agents were compared with or without vinorelbine in three trials . Nine trials compared vinorelbine‐combined chemotherapy with other regimens .…”

Section: Resultsmentioning

confidence: 99%

A Systematic Review of Vinorelbine for the Treatment of Breast Cancer

Wang

Tang

et al. 2013

Breast J

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The purpose of this study was to investigate the efficacy and safety profile of vinorelbine-based chemotherapy in different settings for the treatment of breast cancer. We performed a computerized search using combinations of the following keywords: "breast cancer", "breast neoplasms", "trial", "vinorelbine" and "navelbine". A total of 20 trials were included in this analysis, with a total of 5,080 patients accrued. Taxane was associated with enhanced overall survival (OS; p = 0.027) and response rate (RR; p = 0.037) as compared with vinorelbine in monotherapy, but did not show significantly favored progression-free survival (PFS; p = 0.136). Vinorelbine alone was equivalent to fluoropyrimidine treatment in RR (p = 0.79) for the treatment of metastatic breast cancer. For vinorelbine-combined regimens, the analysis showed that the vinorelbine group gave similar results as other regimens for OS (p = 0.849) and PFS (p = 0.143). The RR of vinorelbine-combined regimens was slightly better than that of the other regimens (OR, 1.17), but the difference was not statistically significant. In neoadjuvant setting, vinorelbine treatment was as active as AC (doxorubicin, cyclophosphamide) or DAC (doxorubicin, cyclophosphamide, docetaxel) regimens with respect to RR (p = 0.76) and pathologic complete response (pCR; p = 0.77), but showed lower occurrence of grade 3/4 adverse effects. The analysis also demonstrated that vinorelbine-containing therapy is effective as adjuvant, front-line or salvage therapy of metastatic breast cancer, even for patients who were previously treated with anthracyclines or taxanes.

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“…Other single agents were compared with or without vinorelbine in three trials . Nine trials compared vinorelbine‐combined chemotherapy with other regimens .…”

Section: Resultsmentioning

confidence: 99%

A Systematic Review of Vinorelbine for the Treatment of Breast Cancer

Wang

Tang

et al. 2013

Breast J

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“…Of 441 potentially relevant abstracts identified, 98 papers met full inclusion criteria: follow-up modalities were reported in 66 RCTs [ 31 - 95 ] while no information was given in the remaining 32 [ 96 - 127 ]. Two different trials, the ABCSG trial 8 and ARNO 95 trial, are reported in the same paper by Jakesz et al [ 58 ].…”

Section: Resultsmentioning

confidence: 99%

Breast cancer follow-up strategies in randomized phase III adjuvant clinical trials: a systematic review

Sperduti¹,

Vici²,

Tinari

et al. 2013

J Exp Clin Cancer Res

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The effectiveness of different breast cancer follow-up procedures to decrease breast cancer mortality are still an object of debate, even if intensive follow-up by imaging modalities is not recommended by international guidelines since 1997. We conducted a systematic review of surveillance procedures utilized, in the last ten years, in phase III randomized trials (RCTs) of adjuvant treatments in early stage breast cancer with disease free survival as primary endpoint of the study, in order to verify if a similar variance exists in the scientific world. Follow-up modalities were reported in 66 RCTs, and among them, minimal and intensive approaches were equally represented, each being followed by 33 (50%) trials. The minimal surveillance regimen is preferred by international and North American RCTs (P = 0.001) and by trials involving more than one country (P = 0.004), with no relationship with the number of participating centers (P = 0.173), with pharmaceutical industry sponsorship (P = 0.80) and with trials enrolling > 1000 patients (P = 0.14). At multivariate regression analysis, only geographic location of the trial was predictive for a distinct follow-up methodology (P = 0.008): Western European (P = 0.004) and East Asian studies (P = 0.010) use intensive follow-up procedures with a significantly higher frequency than international RCTs, while no differences have been detected between North American and international RCTs. Stratifying the studies according to the date of beginning of patients enrollment, before or after 1998, in more recent RCTs the minimal approach is more frequently followed by international and North American RCTs (P = 0.01), by trials involving more than one country (P = 0.01) and with more than 50 participating centers (P = 0.02). It would be highly desirable that in the near future breast cancer follow-up procedures will be homogeneous in RCTs and everyday clinical settings.

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“…Given that weekly paclitaxel and 3-weekly docetaxel are likely to yield comparable results, it is worth noting that no clinically relevant benefit was obtained by sequencing 4 courses of 3-weekly docetaxel with 4 cycles of 5-fluorouracil, epirubicin and cyclophosphamide (FEC) compared to either 8 cycles of FEC or 4 cycles of epirubicin followed by 4 CMF cycles in a recent UK trial [25]. Only one trial has previously investigated the role of vinorelbine in the adjuvant treatment of breast cancer [26]. This trial compared 6 cycles of epirubicin and vinorelbine versus 6 cycles of FEC-100 and gave comparable results.…”

Section: Discussionmentioning

confidence: 99%

Epirubicin Followed by Cyclophosphamide, Methotrexate and 5-Fluorouracil versus Paclitaxel Followed by Epirubicin and Vinorelbine in Patients with High-Risk Operable Breast Cancer

Boccardo

Amadori²,

Guglielmini³

et al. 2010

Oncology

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Objective: Breast cancer patients with >3 involved nodes (N+) have a poor outcome. Chemotherapy (CT), alone or combined with endocrine therapy (ET) in hormone receptor (HOR)-positive patients, is the standard for these women. However, there are still questions surrounding the optimal adjuvant CT regimen. Methods: 244 patients with >3 N+ were randomized to receive either four 3-weekly courses of epirubicin (E: 100 mg/m², day 1) followed by four 4-weekly cycles of cyclophosphamide, methotrexate and 5-fluorouracil (CMF: 600, 40, 600 mg/m², days 1, 8: n = 122) or four 3-weekly courses of paclitaxel (T: 175 mg/m², day 1) followed by four 3-weekly cycles of epirubicin and vinorelbine (E: 75 mg/m², day 1; V: 25 mg/m², days 1, 8: n = 122). After CT, tamoxifen (plus an LH-RH analog in menstruating women) was given to all HOR-positive patients over a period of 5 years. Overall survival (OS) was the primary end point. Relapse-free survival (RFS) and toxicity were secondary end points. Results: At a median follow-up time of 102 months (range 3–146), OS and RFS did not differ significantly between groups (E-CMF vs. T-EV: OS, HR 0.94, 95% CI 0.59–1.48, p = 0.8; RFS, HR 0.86, 95% CI 0.57–1.29, p = 0.45). The lack of any difference between assigned treatments was confirmed by multivariate analysis (E-CMF vs. T-EV: RFS, HR 0.98, 95% CI 0.64–1.48, p = 0.9). The 2 regimens showed different toxicity profiles. In fact, significantly more women assigned to E-CMF were affected by stomatitis (p = 0.001) while significantly more women in the T-EV group developed peripheral neuropathy (p < 0.0001) and musculoskeletal disorders (p < 0.0001). However, side effects were moderate and manageable and no toxic death occurred in either arm of the study. Conclusions: T-EV was safe and moderately toxic but was not superior to E-CMF.

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Epirubicin–vinorelbine vs FEC100 for node-positive, early breast cancer: French Adjuvant Study Group 09 trial

Cited by 8 publications

References 19 publications

A Systematic Review of Vinorelbine for the Treatment of Breast Cancer

A Systematic Review of Vinorelbine for the Treatment of Breast Cancer

Breast cancer follow-up strategies in randomized phase III adjuvant clinical trials: a systematic review

Epirubicin Followed by Cyclophosphamide, Methotrexate and 5-Fluorouracil versus Paclitaxel Followed by Epirubicin and Vinorelbine in Patients with High-Risk Operable Breast Cancer

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