Carboplatin-paclitaxel compared to Carboplatin-Paclitaxel-Bevacizumab in advanced or recurrent endometrial cancer: MITO END-2 - A randomized phase II trial
| Autor: | Giovanni Scambia, Saverio Cinieri, Domenica Lorusso, Gabriella Ferrandina, Nicoletta Colombo, Enrico Breda, Ilaria Sabatucci, Antonella Pietragalla, C. Sonetto, Sandro Pignata, Carmine Conte, Sabrina Chiara Cecere, Antonella Savarese, Davide Lombardi, Pierosandro Tagliaferri, M.T. Lapresa, Roberto Sabbatini, C. Pisano, Giuseppa Maltese |
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| Přispěvatelé: | Lorusso, D, Ferrandina, G, Colombo, N, Pignata, S, Pietragalla, A, Sonetto, C, Pisano, C, Lapresa, M, Savarese, A, Tagliaferri, P, Lombardi, D, Cinieri, S, Breda, E, Sabatucci, I, Sabbatini, R, Conte, C, Cecere, S, Maltese, G, Scambia, G |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Adult
0301 basic medicine Oncology medicine.medical_specialty Paclitaxel Bevacizumab Population Phases of clinical research Carboplatin 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Endometrial cancer Internal medicine Antineoplastic Combined Chemotherapy Protocols Clinical endpoint medicine Humans Chemotherapy Endometrial Neoplasm Prospective Studies Progression-free survival education Aged Aged 80 and over education.field_of_study Antineoplastic Combined Chemotherapy Protocol business.industry Standard treatment Obstetrics and Gynecology Middle Aged medicine.disease Progression-Free Survival Endometrial Neoplasms 030104 developmental biology Settore MED/40 - GINECOLOGIA E OSTETRICIA chemistry 030220 oncology & carcinogenesis Female Neoplasm Recurrence Local business Human medicine.drug |
| Popis: | Objective Increased Vascular Endothelial Growth Factor Receptor (VEGF) expression in endometrial cancer (EC) is associated with a poor prognosis. Preliminary clinical data reported Bevacizumab effectiveness in EC both as single agent and in combination with chemotherapy. Methods In a phase II trial, patients with advanced (FIGO stage III-IV) or recurrent EC were randomized to receive Carboplatin-Paclitaxel standard dose for 6–8 cycles vs Carboplatin-Paclitaxel and Bevacizumab 15 mg/kg in combination with chemotherapy and maintenance until disease progression or unacceptable toxicity. The primary endpoint was progression free survival (PFS). Results 108 patients were randomized; PFS (10.5 vs 13.7 months, HR 0.84 p = 0.43), overall response rate (ORR 53.1% vs 74.4%) and overall survival (OS) (29.7 vs 40.0 months, HR 0.71 p = 0.24) resulted in a non-significant increase in Bevacizumab treated patients. The PFS increase became significant when an exploratory analysis with the Breslow test was used. Moreover, patients treated with Bevacizumab experienced a significant increase in 6-month disease control rate (70.4% vs 90.7%). Cardiovascular events were more frequent in the experimental arm (“de novo” grade ≥2 hypertension 21% vs 0% and grade ≥2 thromboembolic events 11% vs 2% in the Bevacizumab vs standard treatment arm, respectively). Conclusions Bevacizumab combined with chemotherapy in the treatment of advanced/recurrent EC failed to demonstrate a significant increase in PFS in the MITO END-2 trial. Nevertheless, these preliminary data suggests some effectiveness of the antiangiogenic agent which merits further exploration in a larger population with a better molecular characterization. |
| Databáze: | OpenAIRE |
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