A randomized phase II study to determine the efficacy and tolerability of two doses of eribulin plus lapatinib in trastuzumab-pretreated patients with HER-2-positive metastatic breast cancer (E-VITA)
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A randomized phase II study to determine the efficacy and tolerability of two doses of eribulin plus lapatinib in trastuzumab-pretreated patients with HER-2-positive metastatic breast cancer (E-VITA). / Bischoff, Joachim; Barinoff, Jana; Mundhenke, Christoph; Bauerschlag, Dirk O; Costa, Serban-Dan; Herr, Daniel; Lübbe, Kristina; Marmé, Frederik; Maass, Nicolai; von Minckwitz, Gunter; Grischke, Eva-Maria; Müller, Volkmar; Schmidt, Marcus; Gerber, Bernd; Kümmel, Sherko; Schumacher, Claudia; Krabisch, Petra; Seiler, Sabine; Thill, Marc; Nekljudova, Valentina; Loibl, Sibylle.
In: ANTI-CANCER DRUG, Vol. 30, No. 4, 04.2019, p. 394-401.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - A randomized phase II study to determine the efficacy and tolerability of two doses of eribulin plus lapatinib in trastuzumab-pretreated patients with HER-2-positive metastatic breast cancer (E-VITA)
AU - Bischoff, Joachim
AU - Barinoff, Jana
AU - Mundhenke, Christoph
AU - Bauerschlag, Dirk O
AU - Costa, Serban-Dan
AU - Herr, Daniel
AU - Lübbe, Kristina
AU - Marmé, Frederik
AU - Maass, Nicolai
AU - von Minckwitz, Gunter
AU - Grischke, Eva-Maria
AU - Müller, Volkmar
AU - Schmidt, Marcus
AU - Gerber, Bernd
AU - Kümmel, Sherko
AU - Schumacher, Claudia
AU - Krabisch, Petra
AU - Seiler, Sabine
AU - Thill, Marc
AU - Nekljudova, Valentina
AU - Loibl, Sibylle
PY - 2019/4
Y1 - 2019/4
N2 - The E-VITA study evaluated the efficacy and tolerability of two schedules of eribulin and lapatinib in patients with trastuzumab-pretreated HER-2-positive metastatic breast cancer. This multicenter, open-label phase II trial, randomly assigned patients with trastuzumab-pretreated HER-2-positive metastatic breast cancer to lapatinib 1000 mg daily with eribulin 1.23 mg/m (equivalent to 1.4 mg/m eribulin mesylate) days 1+8 every 21 days (split-dose arm) or eribulin 1.76 mg/m (equivalent to 2.0 mg/m eribulin mesylate) day 1 every 21 days (3-weekly arm). Time to progression and tolerability were defined as primary end points; no sample size calculation for formal comparison of efficacy data has been performed. Secondary end points included objective response rate, clinical benefit rate, and overall survival. Overall, 43 patients of a planned number of 80 patients were recruited. At a median follow-up of 28.7 months, the median time to progression was 8.1 months [95% confidence interval (CI): 4.8-9.4] in the split-dose arm and 6.5 months (95% CI: 4.6-13.4) in the 3-weekly arm. Objective response rate was 52.4% (95% CI: 31.0-73.7) in the split-dose arm and 45.0% (95% CI: 23.2-66.8) in the 3-weekly arm, and clinical benefit rate was 71.4% (95% CI: 52.1-90.8) and 75.0% (95% CI: 56.0-94.0), respectively. Overall survival was also similar in both arms. The most frequent grade 3-4 adverse events were neutropenia (58.5%) and leukopenia (39.0%). The combination of eribulin and lapatinib showed an acceptable safety profile with less toxicity observed in the eribulin 1.23 mg/m day 1+8 group. This might be an alternative regimen when other treatment options are exhausted. Therefore, further clinical studies are warranted.
AB - The E-VITA study evaluated the efficacy and tolerability of two schedules of eribulin and lapatinib in patients with trastuzumab-pretreated HER-2-positive metastatic breast cancer. This multicenter, open-label phase II trial, randomly assigned patients with trastuzumab-pretreated HER-2-positive metastatic breast cancer to lapatinib 1000 mg daily with eribulin 1.23 mg/m (equivalent to 1.4 mg/m eribulin mesylate) days 1+8 every 21 days (split-dose arm) or eribulin 1.76 mg/m (equivalent to 2.0 mg/m eribulin mesylate) day 1 every 21 days (3-weekly arm). Time to progression and tolerability were defined as primary end points; no sample size calculation for formal comparison of efficacy data has been performed. Secondary end points included objective response rate, clinical benefit rate, and overall survival. Overall, 43 patients of a planned number of 80 patients were recruited. At a median follow-up of 28.7 months, the median time to progression was 8.1 months [95% confidence interval (CI): 4.8-9.4] in the split-dose arm and 6.5 months (95% CI: 4.6-13.4) in the 3-weekly arm. Objective response rate was 52.4% (95% CI: 31.0-73.7) in the split-dose arm and 45.0% (95% CI: 23.2-66.8) in the 3-weekly arm, and clinical benefit rate was 71.4% (95% CI: 52.1-90.8) and 75.0% (95% CI: 56.0-94.0), respectively. Overall survival was also similar in both arms. The most frequent grade 3-4 adverse events were neutropenia (58.5%) and leukopenia (39.0%). The combination of eribulin and lapatinib showed an acceptable safety profile with less toxicity observed in the eribulin 1.23 mg/m day 1+8 group. This might be an alternative regimen when other treatment options are exhausted. Therefore, further clinical studies are warranted.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
KW - Biomarkers, Tumor/metabolism
KW - Breast Neoplasms/drug therapy
KW - Female
KW - Follow-Up Studies
KW - Furans/administration & dosage
KW - Humans
KW - Ketones/administration & dosage
KW - Lapatinib/administration & dosage
KW - Middle Aged
KW - Neoplasm Metastasis
KW - Prognosis
KW - Receptor, ErbB-2/metabolism
KW - Salvage Therapy
KW - Survival Rate
KW - Trastuzumab/administration & dosage
U2 - 10.1097/CAD.0000000000000722
DO - 10.1097/CAD.0000000000000722
M3 - SCORING: Journal article
C2 - 30875348
VL - 30
SP - 394
EP - 401
JO - ANTI-CANCER DRUG
JF - ANTI-CANCER DRUG
SN - 0959-4973
IS - 4
ER -
