Background: Based on the results reported in Emilia trial population, current guidelines consider TDM-1 the standard second-line therapy for HER2 positive metastatic breast cancer (MBC) patients. Despite that, there are no prospective studies supporting the efficacy of TDM-1 following trastuzumab (T) + pertuzumab (P) and taxane first-line treatment. Currently, only real-world data have investigated this sequence with controversial results Methods: We performed a meta-analysis of the available real world data to determine the efficacy of TDM-1 after first-line TP in HER2 positive MBC patients. We used a random-effect model to find differences in the rate of 1-year progression free survival (PFS) between TP pre-treated population and the phase III Emilia trial (T pre-treated population). Results: Seven studies were eligible, in three of them data were from sub-group population analysis. The meta-analysis showed a combined 1-years PFS risk difference for TDM-1 efficacy after TP in second or more lines of -0.122, with lower and upper limits of -0.253 and 0.010, respectively (p=0.07) , with low heterogeneity among studies (I2 < 0.0001, p =0.836). Considering the four studies on TDM-1 in second-line setting, 1-years PFS risk was -0.034 (95% CI -0.207 – 0,139; p=0.701) (I2 < 0.0001, p =0.91). Conclusions: Results from the meta-analysis show that the efficacy of TDM-1 after TP double-block seems to be similar to the previously reported in Emilia trial. In the second line setting, available data are not mature enough to confirm TDM-1 efficacy in TP pre-treated population. Currently, TP pretreated patients should receive TDM-1 as indicated in the guidelines.

TDM-1 efficacy in trastuzumab-pertuzumab pre-treated HER2 positive metastatic breast cancer patients: A meta-analysis / Omarini, Claudia; Piacentini, Federico; Sperduti, Isabella; Cerma, Krisida; Barbolini, Monica; Canino, Fabio; Nasso, Cecilia; Dominici, Massimo; Moscetti, Luca. - In: JOURNAL OF CLINICAL ONCOLOGY. - ISSN 1527-7755. - 39:15(2021), pp. 13010-13010. (Intervento presentato al convegno ASCO 2021 tenutosi a Virtual Meeting nel 2021) [10.1200/JCO.2021.39.15_suppl.e13010].

TDM-1 efficacy in trastuzumab-pertuzumab pre-treated HER2 positive metastatic breast cancer patients: A meta-analysis

Claudia Omarini;Federico Piacentini;Krisida Cerma;Monica Barbolini;Fabio Canino;Cecilia Nasso;Massimo Dominici;
2021

Abstract

Background: Based on the results reported in Emilia trial population, current guidelines consider TDM-1 the standard second-line therapy for HER2 positive metastatic breast cancer (MBC) patients. Despite that, there are no prospective studies supporting the efficacy of TDM-1 following trastuzumab (T) + pertuzumab (P) and taxane first-line treatment. Currently, only real-world data have investigated this sequence with controversial results Methods: We performed a meta-analysis of the available real world data to determine the efficacy of TDM-1 after first-line TP in HER2 positive MBC patients. We used a random-effect model to find differences in the rate of 1-year progression free survival (PFS) between TP pre-treated population and the phase III Emilia trial (T pre-treated population). Results: Seven studies were eligible, in three of them data were from sub-group population analysis. The meta-analysis showed a combined 1-years PFS risk difference for TDM-1 efficacy after TP in second or more lines of -0.122, with lower and upper limits of -0.253 and 0.010, respectively (p=0.07) , with low heterogeneity among studies (I2 < 0.0001, p =0.836). Considering the four studies on TDM-1 in second-line setting, 1-years PFS risk was -0.034 (95% CI -0.207 – 0,139; p=0.701) (I2 < 0.0001, p =0.91). Conclusions: Results from the meta-analysis show that the efficacy of TDM-1 after TP double-block seems to be similar to the previously reported in Emilia trial. In the second line setting, available data are not mature enough to confirm TDM-1 efficacy in TP pre-treated population. Currently, TP pretreated patients should receive TDM-1 as indicated in the guidelines.
2021
ASCO 2021
Virtual Meeting
2021
Omarini, Claudia; Piacentini, Federico; Sperduti, Isabella; Cerma, Krisida; Barbolini, Monica; Canino, Fabio; Nasso, Cecilia; Dominici, Massimo; Moscetti, Luca
TDM-1 efficacy in trastuzumab-pertuzumab pre-treated HER2 positive metastatic breast cancer patients: A meta-analysis / Omarini, Claudia; Piacentini, Federico; Sperduti, Isabella; Cerma, Krisida; Barbolini, Monica; Canino, Fabio; Nasso, Cecilia; Dominici, Massimo; Moscetti, Luca. - In: JOURNAL OF CLINICAL ONCOLOGY. - ISSN 1527-7755. - 39:15(2021), pp. 13010-13010. (Intervento presentato al convegno ASCO 2021 tenutosi a Virtual Meeting nel 2021) [10.1200/JCO.2021.39.15_suppl.e13010].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/1251268
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