Phase III study on efficacy of taxanes plus bevacizumab with or without capecitabine as first-line chemotherapy in metastatic breast cancer

被引：17

作者：

Lueck, Hans-Joachim

Luebbe, Kristina ^{[1
]}

Reinisch, Mattea ^{[2
]}

Maass, Nicolai ^{[3
]}

Feisel-Schwickardi, Gabriele ^{[4
]}

Tome, Oliver ^{[5
]}

Janni, Wolfgang ^{[6
]}

Aydogdu, Mustafa ^{[7
]}

Neunhoeffer, Tanja ^{[8
]}

Ober, Angelika ^{[9
]}

Aktas, Bahriye ^{[10
]}

Park-Simon, Tjoung-Won ^{[11
]}

Schumacher, Claudia ^{[12
]}

Hoeffkes, Heinz-Gert ^{[13
]}

Illmer, Thomas

Wagner, Harald ^{[14
]}

Mehta, Keyur ^{[2
]}

von Minckwitz, Gunter ^{[2
]}

Nekljudova, Valentina ^{[2
]}

Loibl, Sibylle ^{[2
]}

机构：

[1] Henriettenstiftung Hannover, Breast Ctr, Hannover, Germany

[2] German Breast Grp, Neu Isenburg, Germany

[3] Univ Womens Clin, Dept Obstet & Gynecol, Aachen, Germany

[4] Klinikum Kassel, Dept Obstet & Gynecol, Kassel, Germany

[5] St Vincentius Clin Karlsruhe, Breast Ctr, Karlsruhe, Germany

[6] Univ Hosp Ulm, Dept Obstet & Gynecol, Ulm, Germany

[7] Klinikum Bremen Mitte, Breast Ctr, Bremen, Germany

[8] Dr Horst Schmidt Kliniken, Breast Ctr, Wiesbaden, Germany

[9] St Vincenz Hosp Limburg, Breast Ctr, Limburg, Germany

[10] Univ Hosp Essen, Dept Obstet & Gynecol, Essen, Germany

[11] Hannover Med Sch, Dept Obstet & Gynecol, Hannover, Germany

[12] St Elisabeth Hosp Koln Hohenlind, Breast Ctr, Cologne, Germany

[13] Klinikum Fulda, Breast Ctr, Fulda, Germany

[14] Oncol Clin Drs Med Wilke Wagner, Furth, Germany

来源：

BREAST CANCER RESEARCH AND TREATMENT | 2015年 / 149卷 / 01期

关键词：

Metastatic breast cancer; Capecitabine; Bevacizumab; Taxane; Response; Progression-free survival; COMBINATION THERAPY; PACLITAXEL; TRIAL; SURVIVAL; DOCETAXEL; SAFETY;

D O I：

10.1007/s10549-014-3217-y

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Taxanes (T) plus bevacizumab (B) and taxanes plus capecitabine (X) showed better progression-free survival (PFS) compared to taxanes alone. Since life-threatening or highly symptomatic situations require polychemotherapy in metastatic breast cancer (MBC), combination of taxanes, capecitabine plus bevacizumab appears reasonable. TABEA (NCT01200212), a prospectively randomized, open-label, phase III trial compares taxanes (paclitaxel 80 mg/m(2) i.v. d1,8,15 q22 or docetaxel 75 mg/m(2) i.v. d1 q22) plus bevacizumab (15 mg/kg i.v. d1 q22) with (TBX) or without capecitabine (TB, 1800 mg/m(2) daily d1-14 q22) as first-line therapy in MBC. Histologically confirmed HER2-negative, locally advanced or MBC patients with a chemotherapy indication and measurable or non-measurable target lesions (RECIST criteria) were included. Primary objective was PFS. Secondary objectives were response rate and duration, clinical benefit rate (complete response, partial response, stable disease a parts per thousand yen24 weeks), 3-year overall survival, PFS in patients a parts per thousand yen65 years, toxicity, and compliance. We assumed 10 and 13.3 months PFS for TB and TBX, respectively (HR = 0.75), requiring 432 patients and 386 events. Preplanned interim futility and safety analyses after 100 events in 202 patients showed no efficacy benefit and higher toxicity for TBX. Recruitment and therapy were stopped following advice from the IDMC. Final analysis revealed a HR 1.13 [95 %CI 0.806-1.59], P = 0.474, for PFS. Overall grade 3-4 adverse event (77.3 vs. 62.1 %, P = 0.014) and serious adverse event (40.0 vs. 30.2 %, P = 0.127) rates were higher for TBX after 26.1 months median follow-up, with six deaths for TBX versus 1 for TB. Adding capecitabine to TB cannot be recommended as first-line therapy in MBC.

引用

页码：141 / 149

页数：9

共 15 条

[1] Gemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment [J].