UCBG 2-08: 5-year efficacy results from the UNICANCER-PACS08 randomised phase III trial of adjuvant treatment with FEC100 and then either docetaxel or ixabepilone in patients with early-stage, poor prognosis breast cancer

Mario Campone; Magali Lacroix-Triki; Lise Roca; Marc Spielmann; Hans Wildiers; Paul Cottu; Pierre Kerbrat; Christelle Levy; Isabelle Desmoulins; Thomas Bachelot; Tan Winston; Jean Christophe Eymard; Lionel Uwer; Francois P. Duhoux; Didier Verhoeven; Dominique Jaubert; David Coeffic; Hubert Orfeuvre; Jean Luc Canon; Bernard Asselain; Anne Laure Martin; Jerome Lemonnier; Henri Roché

doi:10.1016/j.ejca.2018.06.025

UCBG 2-08: 5-year efficacy results from the UNICANCER-PACS08 randomised phase III trial of adjuvant treatment with FEC100 and then either docetaxel or ixabepilone in patients with early-stage, poor prognosis breast cancer

Mario Campone, Magali Lacroix-Triki, Lise Roca, Marc Spielmann, Hans Wildiers, Paul Cottu, Pierre Kerbrat, Christelle Levy, Isabelle Desmoulins, Thomas Bachelot, Tan Winston, Jean Christophe Eymard, Lionel Uwer, Francois P. Duhoux, Didier Verhoeven, Dominique Jaubert, David Coeffic, Hubert Orfeuvre, Jean Luc Canon, Bernard AsselainAnne Laure Martin, Jerome Lemonnier, Henri Roché

Hematology / Oncology / Cancer Center / Breast Clinic

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

Abstract

Purpose: UNICANCER-PACS08 compared adjuvant FEC (5-FU; epirubicin; cyclophosphamide) then docetaxel to FEC then ixabepilone in poor prognosis early breast cancer (BC). We evaluated whether replacing docetaxel with ixabepilone would increase 5-year disease-free survival (DFS). Patients and methods: Triple-negative breast cancer (TNBC) or oestrogen receptor (ER)+/progesterone receptor (PR)−/HER2− BC patients were randomised to receive standard FEC (3 cycles) followed by 3 cycles of either docetaxel (100 mg/m²) or ixabepilone (40 mg/m²). Radiotherapy was mandatory after conservative surgery; ER+ patients received endocrine therapy. Results: Seven hundred sixty-two patients were enrolled between October 2007 and September 2010. Baseline characteristics were balanced between arms. Median follow-up was 66.7 months. Median DFS was not reached; 5-year DFS rate was 76% with docetaxel and 79% with ixabepilone (hazard ratio [HR] = 0.80; 95% confidence interval [CI] = 0.58–1.10; p = 0.175). Median overall survival (OS) was not reached; 5-year OS rate was 86% versus 84% (HR = 0.97; 95% CI = 0.66–1.42; p = 0.897). TNBC patients treated with ixabepilone had a 23% lower risk of relapse compared to docetaxel (HR for DFS = 0.77; 95% CI = 0.53–1.11; p = 0.168). DFS was longer with ixabepilone than docetaxel in patients with grade II–III lymphocytic infiltration (HR = 0.55; 95% CI = 0.29–1.05; p = 0.063). All patients experienced ≥1 adverse events (AEs): 75% reported grade III–IV AEs and two (<1%) had grade V AEs (both with neutropenia and infection receiving ixabepilone). Conclusion: After adjuvant FEC, ixabepilone was comparable to docetaxel for treating poor prognosis early BC patients. The benefit of ixabepilone in subgroups (patients with TNBC and grade II–III lymphocytic infiltration) requires further evaluation.

Original language	English (US)
Pages (from-to)	184-194
Number of pages	11
Journal	European Journal of Cancer
Volume	103
DOIs	https://doi.org/10.1016/j.ejca.2018.06.025
State	Published - Nov 2018

Keywords

Adjuvant chemotherapy
Docetaxel
Early breast cancer
Ixabepilone
Poor prognosis breast cancer
Triple-negative breast cancer

ASJC Scopus subject areas

Oncology
Cancer Research

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Campone, M., Lacroix-Triki, M., Roca, L., Spielmann, M., Wildiers, H., Cottu, P., Kerbrat, P., Levy, C., Desmoulins, I., Bachelot, T., Winston, T., Eymard, J. C., Uwer, L., Duhoux, F. P., Verhoeven, D., Jaubert, D., Coeffic, D., Orfeuvre, H., Canon, J. L., ... Roché, H. (2018). UCBG 2-08: 5-year efficacy results from the UNICANCER-PACS08 randomised phase III trial of adjuvant treatment with FEC100 and then either docetaxel or ixabepilone in patients with early-stage, poor prognosis breast cancer. European Journal of Cancer, 103, 184-194. https://doi.org/10.1016/j.ejca.2018.06.025

UCBG 2-08: 5-year efficacy results from the UNICANCER-PACS08 randomised phase III trial of adjuvant treatment with FEC100 and then either docetaxel or ixabepilone in patients with early-stage, poor prognosis breast cancer. / Campone, Mario; Lacroix-Triki, Magali; Roca, Lise et al.
In: European Journal of Cancer, Vol. 103, 11.2018, p. 184-194.

Research output: Contribution to journal › Article › peer-review

Campone, M, Lacroix-Triki, M, Roca, L, Spielmann, M, Wildiers, H, Cottu, P, Kerbrat, P, Levy, C, Desmoulins, I, Bachelot, T, Winston, T, Eymard, JC, Uwer, L, Duhoux, FP, Verhoeven, D, Jaubert, D, Coeffic, D, Orfeuvre, H, Canon, JL, Asselain, B, Martin, AL, Lemonnier, J & Roché, H 2018, 'UCBG 2-08: 5-year efficacy results from the UNICANCER-PACS08 randomised phase III trial of adjuvant treatment with FEC100 and then either docetaxel or ixabepilone in patients with early-stage, poor prognosis breast cancer', European Journal of Cancer, vol. 103, pp. 184-194. https://doi.org/10.1016/j.ejca.2018.06.025

Campone M, Lacroix-Triki M, Roca L, Spielmann M, Wildiers H, Cottu P et al. UCBG 2-08: 5-year efficacy results from the UNICANCER-PACS08 randomised phase III trial of adjuvant treatment with FEC100 and then either docetaxel or ixabepilone in patients with early-stage, poor prognosis breast cancer. European Journal of Cancer. 2018 Nov;103:184-194. doi: 10.1016/j.ejca.2018.06.025

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title = "UCBG 2-08: 5-year efficacy results from the UNICANCER-PACS08 randomised phase III trial of adjuvant treatment with FEC100 and then either docetaxel or ixabepilone in patients with early-stage, poor prognosis breast cancer",

abstract = "Purpose: UNICANCER-PACS08 compared adjuvant FEC (5-FU; epirubicin; cyclophosphamide) then docetaxel to FEC then ixabepilone in poor prognosis early breast cancer (BC). We evaluated whether replacing docetaxel with ixabepilone would increase 5-year disease-free survival (DFS). Patients and methods: Triple-negative breast cancer (TNBC) or oestrogen receptor (ER)+/progesterone receptor (PR)−/HER2− BC patients were randomised to receive standard FEC (3 cycles) followed by 3 cycles of either docetaxel (100 mg/m2) or ixabepilone (40 mg/m2). Radiotherapy was mandatory after conservative surgery; ER+ patients received endocrine therapy. Results: Seven hundred sixty-two patients were enrolled between October 2007 and September 2010. Baseline characteristics were balanced between arms. Median follow-up was 66.7 months. Median DFS was not reached; 5-year DFS rate was 76% with docetaxel and 79% with ixabepilone (hazard ratio [HR] = 0.80; 95% confidence interval [CI] = 0.58–1.10; p = 0.175). Median overall survival (OS) was not reached; 5-year OS rate was 86% versus 84% (HR = 0.97; 95% CI = 0.66–1.42; p = 0.897). TNBC patients treated with ixabepilone had a 23% lower risk of relapse compared to docetaxel (HR for DFS = 0.77; 95% CI = 0.53–1.11; p = 0.168). DFS was longer with ixabepilone than docetaxel in patients with grade II–III lymphocytic infiltration (HR = 0.55; 95% CI = 0.29–1.05; p = 0.063). All patients experienced ≥1 adverse events (AEs): 75% reported grade III–IV AEs and two (<1%) had grade V AEs (both with neutropenia and infection receiving ixabepilone). Conclusion: After adjuvant FEC, ixabepilone was comparable to docetaxel for treating poor prognosis early BC patients. The benefit of ixabepilone in subgroups (patients with TNBC and grade II–III lymphocytic infiltration) requires further evaluation.",

keywords = "Adjuvant chemotherapy, Docetaxel, Early breast cancer, Ixabepilone, Poor prognosis breast cancer, Triple-negative breast cancer",

author = "Mario Campone and Magali Lacroix-Triki and Lise Roca and Marc Spielmann and Hans Wildiers and Paul Cottu and Pierre Kerbrat and Christelle Levy and Isabelle Desmoulins and Thomas Bachelot and Tan Winston and Eymard, {Jean Christophe} and Lionel Uwer and Duhoux, {Francois P.} and Didier Verhoeven and Dominique Jaubert and David Coeffic and Hubert Orfeuvre and Canon, {Jean Luc} and Bernard Asselain and Martin, {Anne Laure} and Jerome Lemonnier and Henri Roch{\'e}",

note = "Publisher Copyright: {\textcopyright} 2018 Elsevier Ltd",

year = "2018",

month = nov,

doi = "10.1016/j.ejca.2018.06.025",

language = "English (US)",

volume = "103",

pages = "184--194",

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TY - JOUR

T1 - UCBG 2-08

T2 - 5-year efficacy results from the UNICANCER-PACS08 randomised phase III trial of adjuvant treatment with FEC100 and then either docetaxel or ixabepilone in patients with early-stage, poor prognosis breast cancer

AU - Campone, Mario

AU - Lacroix-Triki, Magali

AU - Roca, Lise

AU - Spielmann, Marc

AU - Wildiers, Hans

AU - Cottu, Paul

AU - Kerbrat, Pierre

AU - Levy, Christelle

AU - Desmoulins, Isabelle

AU - Bachelot, Thomas

AU - Winston, Tan

AU - Eymard, Jean Christophe

AU - Uwer, Lionel

AU - Duhoux, Francois P.

AU - Verhoeven, Didier

AU - Jaubert, Dominique

AU - Coeffic, David

AU - Orfeuvre, Hubert

AU - Canon, Jean Luc

AU - Asselain, Bernard

AU - Martin, Anne Laure

AU - Lemonnier, Jerome

AU - Roché, Henri

PY - 2018/11

Y1 - 2018/11

N2 - Purpose: UNICANCER-PACS08 compared adjuvant FEC (5-FU; epirubicin; cyclophosphamide) then docetaxel to FEC then ixabepilone in poor prognosis early breast cancer (BC). We evaluated whether replacing docetaxel with ixabepilone would increase 5-year disease-free survival (DFS). Patients and methods: Triple-negative breast cancer (TNBC) or oestrogen receptor (ER)+/progesterone receptor (PR)−/HER2− BC patients were randomised to receive standard FEC (3 cycles) followed by 3 cycles of either docetaxel (100 mg/m2) or ixabepilone (40 mg/m2). Radiotherapy was mandatory after conservative surgery; ER+ patients received endocrine therapy. Results: Seven hundred sixty-two patients were enrolled between October 2007 and September 2010. Baseline characteristics were balanced between arms. Median follow-up was 66.7 months. Median DFS was not reached; 5-year DFS rate was 76% with docetaxel and 79% with ixabepilone (hazard ratio [HR] = 0.80; 95% confidence interval [CI] = 0.58–1.10; p = 0.175). Median overall survival (OS) was not reached; 5-year OS rate was 86% versus 84% (HR = 0.97; 95% CI = 0.66–1.42; p = 0.897). TNBC patients treated with ixabepilone had a 23% lower risk of relapse compared to docetaxel (HR for DFS = 0.77; 95% CI = 0.53–1.11; p = 0.168). DFS was longer with ixabepilone than docetaxel in patients with grade II–III lymphocytic infiltration (HR = 0.55; 95% CI = 0.29–1.05; p = 0.063). All patients experienced ≥1 adverse events (AEs): 75% reported grade III–IV AEs and two (<1%) had grade V AEs (both with neutropenia and infection receiving ixabepilone). Conclusion: After adjuvant FEC, ixabepilone was comparable to docetaxel for treating poor prognosis early BC patients. The benefit of ixabepilone in subgroups (patients with TNBC and grade II–III lymphocytic infiltration) requires further evaluation.

AB - Purpose: UNICANCER-PACS08 compared adjuvant FEC (5-FU; epirubicin; cyclophosphamide) then docetaxel to FEC then ixabepilone in poor prognosis early breast cancer (BC). We evaluated whether replacing docetaxel with ixabepilone would increase 5-year disease-free survival (DFS). Patients and methods: Triple-negative breast cancer (TNBC) or oestrogen receptor (ER)+/progesterone receptor (PR)−/HER2− BC patients were randomised to receive standard FEC (3 cycles) followed by 3 cycles of either docetaxel (100 mg/m2) or ixabepilone (40 mg/m2). Radiotherapy was mandatory after conservative surgery; ER+ patients received endocrine therapy. Results: Seven hundred sixty-two patients were enrolled between October 2007 and September 2010. Baseline characteristics were balanced between arms. Median follow-up was 66.7 months. Median DFS was not reached; 5-year DFS rate was 76% with docetaxel and 79% with ixabepilone (hazard ratio [HR] = 0.80; 95% confidence interval [CI] = 0.58–1.10; p = 0.175). Median overall survival (OS) was not reached; 5-year OS rate was 86% versus 84% (HR = 0.97; 95% CI = 0.66–1.42; p = 0.897). TNBC patients treated with ixabepilone had a 23% lower risk of relapse compared to docetaxel (HR for DFS = 0.77; 95% CI = 0.53–1.11; p = 0.168). DFS was longer with ixabepilone than docetaxel in patients with grade II–III lymphocytic infiltration (HR = 0.55; 95% CI = 0.29–1.05; p = 0.063). All patients experienced ≥1 adverse events (AEs): 75% reported grade III–IV AEs and two (<1%) had grade V AEs (both with neutropenia and infection receiving ixabepilone). Conclusion: After adjuvant FEC, ixabepilone was comparable to docetaxel for treating poor prognosis early BC patients. The benefit of ixabepilone in subgroups (patients with TNBC and grade II–III lymphocytic infiltration) requires further evaluation.

KW - Adjuvant chemotherapy

KW - Docetaxel

KW - Early breast cancer

KW - Ixabepilone

KW - Poor prognosis breast cancer

KW - Triple-negative breast cancer

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UCBG 2-08: 5-year efficacy results from the UNICANCER-PACS08 randomised phase III trial of adjuvant treatment with FEC100 and then either docetaxel or ixabepilone in patients with early-stage, poor prognosis breast cancer

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