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Conference Paper: CALGB 30601: A phase II study of dasatinib (D) in patients (pts) with previously treated malignant mesothelioma (MM)

TitleCALGB 30601: A phase II study of dasatinib (D) in patients (pts) with previously treated malignant mesothelioma (MM)
Authors
Issue Date2010
PublisherAmerican Society of Clinical Oncology. The Journal's web site is located at http://jco.ascopubs.org
Citation
The 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO), Chicago, IL., 4-8 June 2010. In Journal of Clinical Oncology, 2010, v. 28 n. 15 suppl., abstract no. 7037 How to Cite?
AbstractBACKGROUND: SRC is commonly over-expressed in MM. D is a potent inhibitor of SRC family kinases, EphA2 and PDGFRβ. There are no approved therapies for MM pts who progress on pemetrexed. We therefore conducted a phase II trial of D in MM pts who had received 1 prior pemetrexed-based regimen. METHODS: Single arm phase II. Eligible pts had unresectable MM, PS 0-1, measurable disease, and no symptomatic effusions. Primary endpoint: Progression-free survival (PFS) at 24 weeks (wks). D 70 mg BID was given orally. CT scans were obtained every 2 months. Pre- and posttreatment plasma VEGF, PDGFβ, and serum CSF-1 and mesothelin-related protein were collected. Tumor was evaluated for expression of EphA2 and PDGFRβ. RESULTS: 46 pts enrolled at 12 sites 9/07-8/09, 35 are evaluable for PFS, 22 for response, and 46 for toxicity. Pt characteristics: Male 72%; median age 68 (range 35, 81); PS 0 41%; epithelial histology 72%, pleural 76%. Median cycles given 2 (range 1-8). The starting dose was reduced to 50 mg BID after the first 23 pts enrolled because 50% of the first 12 pts enrolled had AE grade 3. Grade 3/4 toxicities (% pts): anemia 2%, fatigue 11%, pleural effusion 9%, pericardial effusion 2%, pneumonitis 2%, hypoxia 2%, nausea 4%, hyponatremia 7%, hypophosphatemia 2%.There were 3 grade 5 toxicities: 1 ARDS, 1 respiratory failure, 1 unknown. Efficacy: 24-week PFS rate 15% (95% CI 6%, 29%), median PFS 8.3 wks (7.7, 10.3), median overall survival 20.7 wks (11.4, 28.3), partial response 0%; stable disease 20%. CONCLUSIONS: Dasatinib is inactive in previously-treated MM; the 70 mg dose is poorly tolerated. Further data on biologic correlates will be presented.
Persistent Identifierhttp://hdl.handle.net/10722/195783
ISSN
2015 Impact Factor: 20.982
2015 SCImago Journal Rankings: 9.204

 

DC FieldValueLanguage
dc.contributor.authorDudek, Aen_US
dc.contributor.authorPang, HMHen_US
dc.contributor.authorKratzke, RAen_US
dc.contributor.authorOtterson, GAen_US
dc.contributor.authorVokes, EEen_US
dc.contributor.authorKindler, HLen_US
dc.date.accessioned2014-03-10T04:53:28Z-
dc.date.available2014-03-10T04:53:28Z-
dc.date.issued2010en_US
dc.identifier.citationThe 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO), Chicago, IL., 4-8 June 2010. In Journal of Clinical Oncology, 2010, v. 28 n. 15 suppl., abstract no. 7037en_US
dc.identifier.issn0732-183X-
dc.identifier.urihttp://hdl.handle.net/10722/195783-
dc.description.abstractBACKGROUND: SRC is commonly over-expressed in MM. D is a potent inhibitor of SRC family kinases, EphA2 and PDGFRβ. There are no approved therapies for MM pts who progress on pemetrexed. We therefore conducted a phase II trial of D in MM pts who had received 1 prior pemetrexed-based regimen. METHODS: Single arm phase II. Eligible pts had unresectable MM, PS 0-1, measurable disease, and no symptomatic effusions. Primary endpoint: Progression-free survival (PFS) at 24 weeks (wks). D 70 mg BID was given orally. CT scans were obtained every 2 months. Pre- and posttreatment plasma VEGF, PDGFβ, and serum CSF-1 and mesothelin-related protein were collected. Tumor was evaluated for expression of EphA2 and PDGFRβ. RESULTS: 46 pts enrolled at 12 sites 9/07-8/09, 35 are evaluable for PFS, 22 for response, and 46 for toxicity. Pt characteristics: Male 72%; median age 68 (range 35, 81); PS 0 41%; epithelial histology 72%, pleural 76%. Median cycles given 2 (range 1-8). The starting dose was reduced to 50 mg BID after the first 23 pts enrolled because 50% of the first 12 pts enrolled had AE grade 3. Grade 3/4 toxicities (% pts): anemia 2%, fatigue 11%, pleural effusion 9%, pericardial effusion 2%, pneumonitis 2%, hypoxia 2%, nausea 4%, hyponatremia 7%, hypophosphatemia 2%.There were 3 grade 5 toxicities: 1 ARDS, 1 respiratory failure, 1 unknown. Efficacy: 24-week PFS rate 15% (95% CI 6%, 29%), median PFS 8.3 wks (7.7, 10.3), median overall survival 20.7 wks (11.4, 28.3), partial response 0%; stable disease 20%. CONCLUSIONS: Dasatinib is inactive in previously-treated MM; the 70 mg dose is poorly tolerated. Further data on biologic correlates will be presented.-
dc.languageengen_US
dc.publisherAmerican Society of Clinical Oncology. The Journal's web site is located at http://jco.ascopubs.org-
dc.relation.ispartofJournal of Clinical Oncologyen_US
dc.titleCALGB 30601: A phase II study of dasatinib (D) in patients (pts) with previously treated malignant mesothelioma (MM)en_US
dc.typeConference_Paperen_US
dc.identifier.emailPang, HMH: herbpang@hku.hken_US
dc.identifier.authorityPang, HMH=rp01857en_US
dc.identifier.volume28en_US
dc.identifier.issue15 suppl.-
dc.publisher.placeUnited States-

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