TY - JOUR
T1 - Nanoparticle albumin-bound paclitaxel/liposomal-encapsulated doxorubicin in HER2-negative metastatic breast cancer patients
AU - Fabi, Alessandra
AU - Ferretti, Gianluigi
AU - Malaguti, Paola
AU - Gasparro, Simona
AU - Nisticò, Cecilia
AU - Arpino, Grazia
AU - Papaldo, Paola
AU - Russillo, Michelangelo
AU - Catania, Giovanna
AU - Schettini, Francesco
AU - Giannarelli, Diana
AU - Cognetti, Francesco
N1 - Funding Information:
Editorial assistance was provided by Chiara Degirolamo, Aashni Shah, Barabara Bartolini and Luca Giacomelli (Polistudium srl, Milan, Italy). This assistance was supported by internal funds.
Publisher Copyright:
© 2020
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/8
Y1 - 2020/8
N2 - Aim: To investigate the toxicity of nab-paclitaxel (wNP)/nonpegylated liposome-encapsulated doxorubicin (wNPLD) combination in HER2-negative metastatic breast cancer (MBC) patients as first-line treatment. Materials & methods: Phase I, single-arm study in metastatic breast cancer patients naive to previous chemotherapy for advanced disease. A 3 + 3 dose-escalation design was used to determine the safety. Primary endpoints were the identification of dose-limiting toxicity and maximum tolerated dose. Results: In total, 12 patients (mean age: 52 years; median metastatic sites: 2) were enrolled and 97 cycles were completed. Maximum tolerated dose was wNP + wNPLD 25 mg/m2. The most common adverse events were neutropenia, nausea, diarrhea and mucositis. The objective response rate was 68% (response mean duration: 12.6 months). Conclusion: wNP/wNPLD combination constitutes an active regimen with mild toxicity.
AB - Aim: To investigate the toxicity of nab-paclitaxel (wNP)/nonpegylated liposome-encapsulated doxorubicin (wNPLD) combination in HER2-negative metastatic breast cancer (MBC) patients as first-line treatment. Materials & methods: Phase I, single-arm study in metastatic breast cancer patients naive to previous chemotherapy for advanced disease. A 3 + 3 dose-escalation design was used to determine the safety. Primary endpoints were the identification of dose-limiting toxicity and maximum tolerated dose. Results: In total, 12 patients (mean age: 52 years; median metastatic sites: 2) were enrolled and 97 cycles were completed. Maximum tolerated dose was wNP + wNPLD 25 mg/m2. The most common adverse events were neutropenia, nausea, diarrhea and mucositis. The objective response rate was 68% (response mean duration: 12.6 months). Conclusion: wNP/wNPLD combination constitutes an active regimen with mild toxicity.
KW - advanced breast cancer
KW - dose-limiting toxicity
KW - HER2
KW - nanoparticle
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U2 - 10.2217/fon-2019-0742
DO - 10.2217/fon-2019-0742
M3 - Article
C2 - 32501121
AN - SCOPUS:85089205287
VL - 16
SP - 1629
EP - 1637
JO - Future Oncology
JF - Future Oncology
SN - 1479-6694
IS - 22
ER -