Abstract | BACKGROUND: PATIENTS AND METHODS: The first study, an open-label, dose-escalation and expansion phase I study of L19TNF plus doxorubicin, enrolled 27 patients. Three cohorts (10.4-17 μg/kg L19TNF) of patients received L19TNF intravenously at days 1, 3, and 5 and doxorubicin (75 mg/m2, then 60 mg/m2) on day 1 every 3 weeks. The expansion cohort enrolled patients with STS. The second study tried to re-escalate the doxorubicin dose to 75 mg/m2 with 13 μg/kg L19TNF. Among primary objectives was the establishment of a recommended dose (RD). RESULTS: The combination was safely applicable. Dose-limiting toxicity occurred either at 17 μg/kg L19TNF or at 75 mg/m2 doxorubicin. RD is 13 μg/kg L19TNF plus 60 mg/m2 doxorubicin. In 15 STS patients of the extension cohort evaluable for efficacy, antitumour activity was observed with complete remission in 1, partial remission in 1 and minor tumour shrinkage in 7 patients. The median overall survival for this heavily pretreated cohort was 14.9 months. CONCLUSION:
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Authors | Christoph Schliemann, Teresa Hemmerle, Andrew F Berdel, Linus Angenendt, Andrea Kerkhoff, Jan P Hering, Walter Heindel, Wolfgang Hartmann, Eva Wardelmann, Sant P Chawla, Filippo de Braud, Georg Lenz, Dario Neri, Torsten Kessler, Wolfgang E Berdel |
Journal | European journal of cancer (Oxford, England : 1990)
(Eur J Cancer)
Vol. 150
Pg. 143-154
(06 2021)
ISSN: 1879-0852 [Electronic] England |
PMID | 33901793
(Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2021 Elsevier Ltd. All rights reserved. |
Chemical References |
- Antibiotics, Antineoplastic
- Antineoplastic Agents, Immunological
- Doxorubicin
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Topics |
- Adult
- Aged
- Antibiotics, Antineoplastic
(administration & dosage, adverse effects, pharmacokinetics)
- Antineoplastic Agents, Immunological
(administration & dosage, adverse effects, pharmacokinetics)
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, adverse effects, pharmacokinetics)
- Doxorubicin
(administration & dosage, adverse effects, pharmacokinetics)
- Female
- Humans
- Male
- Middle Aged
- Sarcoma
(drug therapy, immunology, mortality, pathology)
- Soft Tissue Neoplasms
(drug therapy, immunology, mortality, pathology)
- Time Factors
- Treatment Outcome
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