Abstract | PURPOSE: METHODS: Patients with gemcitabine-resistant disease received trabectedin 1.3 mg/m(2) as a 3-h intravenous continuous infusion every 3 weeks until disease progression or unacceptable toxicity or for a maximum of 6 months. The primary endpoint was progression-free survival rate at 6 months (PFS-6). Since trabectedin modulates the production of selected inflammatory mediators, this study also aimed to identify inflammatory biomarkers predictive for response to trabectedin. RESULTS: Between February 2011 and February 2012, 25 patients received trabectedin. PFS-6 was 4%, median PFS 1.9 months (range 0.8-7.4), and median overall survival 5.2 months (range 1.1-24.3). Grade >2 toxicity consisted of neutropenia in 44% of patients, febrile neutropenia and thrombocytopenia both in 12%, anemia in 8%, fatigue in 12%, and AST and ALT increase in 8 and 4%, respectively. Trabectedin was shown to modulate the production of inflammatory mediators, and at disease progression, levels of a subgroup of cytokines/ chemokines were modified. Furthermore, tissue analysis identified 30 genes associated with better prognosis. CONCLUSIONS: Although it has shown some ability to modulate inflammatory process, single-agent trabectedin had no activity as salvage therapy for mPA.
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Authors | Carmen Belli, Lorenzo Piemonti, Maurizio D'Incalci, Massimo Zucchetti, Luca Porcu, Stefano Cappio, Claudio Doglioni, Paola Allavena, Domenica Ceraulo, Paola Maggiora, Erica Dugnani, Maria Giulia Cangi, Greta Garassini, Michele Reni |
Journal | Cancer chemotherapy and pharmacology
(Cancer Chemother Pharmacol)
Vol. 77
Issue 3
Pg. 477-84
(Mar 2016)
ISSN: 1432-0843 [Electronic] Germany |
PMID | 26666646
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents, Alkylating
- Dioxoles
- Tetrahydroisoquinolines
- Deoxycytidine
- Trabectedin
- Gemcitabine
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Topics |
- Adenocarcinoma
(drug therapy, pathology)
- Aged
- Antineoplastic Agents, Alkylating
(administration & dosage, therapeutic use)
- Deoxycytidine
(administration & dosage, analogs & derivatives)
- Dioxoles
(administration & dosage, therapeutic use)
- Disease-Free Survival
- Drug Resistance, Neoplasm
- Female
- Humans
- Male
- Middle Aged
- Neoplasm Metastasis
- Pancreatic Neoplasms
(drug therapy, pathology)
- Prognosis
- Prospective Studies
- Salvage Therapy
(methods)
- Survival Rate
- Tetrahydroisoquinolines
(administration & dosage, therapeutic use)
- Trabectedin
- Treatment Outcome
- Gemcitabine
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