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23.11.2017 | PHASE II STUDIES

Phase II study of doxorubicin and thalidomide in patients with refractory aggressive fibromatosis

verfasst von: Xin Liu, Huijie Wang, Xianghua Wu, Xiaonan Hong, Zhiguo Luo

Erschienen in: Investigational New Drugs | Ausgabe 1/2018

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Summary

Background To evaluate the efficacy and safety of doxorubicin (ADM) combined with thalidomide (THA) as a first-line treatment for patients with refractory aggressive fibromatosis (AF). Patients and Methods Eligible patients were treated with ADM 30 mg/m2 on days 1–2 and THA 200 mg nightly on days 1–21 every 3 weeks for a maximum of six cycles. THA was then continued for a total of 1 year. The primary end point was response rate (RR). Results Fifteen patients were enrolled in the study. No patient had a complete response, but five patients had partial responses, resulting in a RR of 33%. Eight patients (53%) had stable disease and two patients (13%) had progressive disease, and the disease control rate was 87%. The median progression free survival (mPFS) was 20.6 months (95% confidence interval, 14.5–26.7 months). Patients with below normal baseline serum albumin levels had significantly inferior mPFS compared with those with normal baseline serum albumin (1.4 months versus 23.7 months, P = 0.045). Grade 3/4 toxicities included leukopenia (33%), neutropenia (60%), febrile neutropenia (7%), nausea (7%), and vomiting (6.6%). Conclusions ADM plus THA was well-tolerated and effective as a first-line treatment for patients with refractory AF. However, patients with hypoalbuminemia at baseline had inferior clinical outcomes, and further studies are needed to investigate this issue.
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Metadaten
Titel
Phase II study of doxorubicin and thalidomide in patients with refractory aggressive fibromatosis
verfasst von
Xin Liu
Huijie Wang
Xianghua Wu
Xiaonan Hong
Zhiguo Luo
Publikationsdatum
23.11.2017
Verlag
Springer US
Erschienen in
Investigational New Drugs / Ausgabe 1/2018
Print ISSN: 0167-6997
Elektronische ISSN: 1573-0646
DOI
https://doi.org/10.1007/s10637-017-0542-0

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