Detailed Information on Publication Record
2021
Improved osteosarcoma survival with addition of mifamurtide to conventional chemotherapy-Observational prospective single institution analysis
MÚDRY, Peter, Michal KÝR, Ondřej ROHLEDER, Michal MAHDAL, Iva ZAMBO et. al.Basic information
Original name
Improved osteosarcoma survival with addition of mifamurtide to conventional chemotherapy-Observational prospective single institution analysis
Authors
MÚDRY, Peter (203 Czech Republic, guarantor, belonging to the institution), Michal KÝR (203 Czech Republic, belonging to the institution), Ondřej ROHLEDER (203 Czech Republic, belonging to the institution), Michal MAHDAL (203 Czech Republic, belonging to the institution), Iva ZAMBO (203 Czech Republic, belonging to the institution), Marta JEŽOVÁ (203 Czech Republic, belonging to the institution), Tomáš TOMÁŠ (203 Czech Republic, belonging to the institution) and Jaroslav ŠTĚRBA (203 Czech Republic, belonging to the institution)
Edition
JOURNAL OF BONE ONCOLOGY, AMSTERDAM, ELSEVIER, 2021, 2212-1374
Other information
Language
English
Type of outcome
Článek v odborném periodiku
Field of Study
30204 Oncology
Country of publisher
Netherlands
Confidentiality degree
není předmětem státního či obchodního tajemství
References:
Impact factor
Impact factor: 4.491
RIV identification code
RIV/00216224:14110/21:00123645
Organization unit
Faculty of Medicine
UT WoS
000665786400007
Keywords in English
Osteosarcoma; Mifamurtide; Survival; Single institution analysis; Comparative analysis
Tags
International impact, Reviewed
Změněno: 21/2/2022 09:09, Mgr. Tereza Miškechová
Abstract
V originále
Purpose: Conventional osteosarcoma is an orphan disease. Current treatment approaches include combining a three drug chemotherapy schedule and surgery. The 3-and 5-year event-free survival (EFS) in localized disease is roughly 65 and 60%, respectively. The registration study of mifamurtide reported survival benefit, but some methodological controversies have been insufficient for FDA market authorization in contrast to EMA. Methods: prospective single centre survival analysis of a mifamurtide addition to conventional therapy in 23 patients over a 5.5 year enrolment period is reported and compared to a historical control of 26 patient with localized disease. Bias arising from observational methodology was addressed using Landmark analysis and time-dependent Cox models. Blood count dynamics were analysed during the treatment. Results: The adverse event profile was as expected with no dose limiting toxicities. There were no local relapses observed, one patient died in the first complete remission due to doxorubicin cardiotoxicity, one patient had pulmonary metastatic relapse. The observed 3-and 5-year EFS was 87.4% (CI 72.4-100%) and 87.4% (CI 72.4-100%), progression free survival (PFS) was 92.9% (CI 80.3-100%) and 92.9% (CI 80.3-100%), overall survival was 94.1% (CI 83.6-100) and 80.7% (CI 58.3-100), respectively. Comparison to the historical control showed statistically significant better PFS for mifamurtide patients (Landmark analysis; p = 0.044). Risk of progression was 5-times lower for the mifamurtide group (Cox model; HR 0.21, p = 0.136). Only subtle differences in lymphocyte counts were observed across treatment. Conclusion: the PFS benefit of mifamurtide is reported herein. The addition of mifamurtide could be considered as a best treatment option for localized osteosarcoma. (c) 2021 The Authors. Published by Elsevier GmbH. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Links
| MUNI/A/1409/2019, interní kód MU |
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| MUNI/A/1701/2020, interní kód MU |
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| 90128, large research infrastructures |
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