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Conference Paper: A Phase II study of dasatinib in patients with chemo-sensitive relapsed small cell lung cancer (SCLC): CALGB 30602

TitleA Phase II study of dasatinib in patients with chemo-sensitive relapsed small cell lung cancer (SCLC): CALGB 30602
Authors
Issue Date2009
PublisherLippincott Williams & Wilkins
Citation
The 13th World Conference on Lung Cancer, San Francisco, CA., 31 July-4 August 2009. In Journal of Thoracic Oncology, 2009, v. 4 suppl. 1, p. S816-S817, abstract P2.212 How to Cite?
AbstractBACKGROUND: SRC is an oncogene with an essential role in the invasiveness and metastasis of solid tumors including SCLC. Dasatinib is a potent inhibitor of SRC as well as other tyrosine kinases. The primary objective of this study was to determine the efficacy of secondline dasatinib in patients with chemo-sensitive (relapse or progression ≥90 days after completing first-line therapy) SCLC. METHODS: Patients with measurable disease, performance status (PS) 0-1, no more than 1 prior platinum-based chemotherapy regimen, and adequate hematologic, hepatic, and renal function were eligible. Dasatinib was administered orally at 70 mg twice daily continuously (1 cycle = 21 days) until disease progression or unacceptable toxicity. Response was determined after every 2 cycles. Patients were followed until disease progression or death. The study was prospectively designed to simultaneously discriminate between complete plus partial response rates of 5% versus 20% and progression-free survival (PFS) rates at 6 weeks of 50% versus 70.7% in 53 evaluable patients with at least 92% power. The study was to be terminated early and declared negative if 1 or less objective response and 14 or fewer instances of PFS ≥ 6 weeks were observed among the initial 27 patients; however, patient accrual continued while the initial 27 patients were evaluated. RESULTS: Between 4/2007 and 12/2008, 45 patients were enrolled: male/female, 17/28; white/black/other, 42/2/1; median age, 69 (range, 36-88) years; and PS 0/1, 12/33. No objective response was recorded among all 45 patients. Among the initial 27 patients, only 13 instances of PFS ≥ 6 weeks were observed. With a median follow up time of 1.6 months, the median estimated overall survival and PFS times for all 45 patients were 22 and 6 weeks, respectively. Common reasons for removal of patients from protocol treatment were progressive disease (51%) and adverse events (27%). Toxicity was generally mild to moderate: grade 3 events of approximately 10% frequency included fatigue, pleural and pericardial effusions, and dyspnea, but higher grade toxicity was infrequent. CONCLUSIONS: Dasatinib did not reach our specified efficacy criteria in this clinical setting, and the study was terminated.
Persistent Identifierhttp://hdl.handle.net/10722/195797
ISSN
2015 Impact Factor: 5.04
2015 SCImago Journal Rankings: 2.597

 

DC FieldValueLanguage
dc.contributor.authorMiller, AntoniusAen_US
dc.contributor.authorPang, HMHen_US
dc.contributor.authorHodgson, Lydiaen_US
dc.contributor.authorRamnath, Nithyaen_US
dc.contributor.authorOtterson, GregoryAen_US
dc.contributor.authorVokes, EverettEen_US
dc.date.accessioned2014-03-10T04:53:31Z-
dc.date.available2014-03-10T04:53:31Z-
dc.date.issued2009en_US
dc.identifier.citationThe 13th World Conference on Lung Cancer, San Francisco, CA., 31 July-4 August 2009. In Journal of Thoracic Oncology, 2009, v. 4 suppl. 1, p. S816-S817, abstract P2.212en_US
dc.identifier.issn1556-0864en_US
dc.identifier.urihttp://hdl.handle.net/10722/195797-
dc.description.abstractBACKGROUND: SRC is an oncogene with an essential role in the invasiveness and metastasis of solid tumors including SCLC. Dasatinib is a potent inhibitor of SRC as well as other tyrosine kinases. The primary objective of this study was to determine the efficacy of secondline dasatinib in patients with chemo-sensitive (relapse or progression ≥90 days after completing first-line therapy) SCLC. METHODS: Patients with measurable disease, performance status (PS) 0-1, no more than 1 prior platinum-based chemotherapy regimen, and adequate hematologic, hepatic, and renal function were eligible. Dasatinib was administered orally at 70 mg twice daily continuously (1 cycle = 21 days) until disease progression or unacceptable toxicity. Response was determined after every 2 cycles. Patients were followed until disease progression or death. The study was prospectively designed to simultaneously discriminate between complete plus partial response rates of 5% versus 20% and progression-free survival (PFS) rates at 6 weeks of 50% versus 70.7% in 53 evaluable patients with at least 92% power. The study was to be terminated early and declared negative if 1 or less objective response and 14 or fewer instances of PFS ≥ 6 weeks were observed among the initial 27 patients; however, patient accrual continued while the initial 27 patients were evaluated. RESULTS: Between 4/2007 and 12/2008, 45 patients were enrolled: male/female, 17/28; white/black/other, 42/2/1; median age, 69 (range, 36-88) years; and PS 0/1, 12/33. No objective response was recorded among all 45 patients. Among the initial 27 patients, only 13 instances of PFS ≥ 6 weeks were observed. With a median follow up time of 1.6 months, the median estimated overall survival and PFS times for all 45 patients were 22 and 6 weeks, respectively. Common reasons for removal of patients from protocol treatment were progressive disease (51%) and adverse events (27%). Toxicity was generally mild to moderate: grade 3 events of approximately 10% frequency included fatigue, pleural and pericardial effusions, and dyspnea, but higher grade toxicity was infrequent. CONCLUSIONS: Dasatinib did not reach our specified efficacy criteria in this clinical setting, and the study was terminated.-
dc.languageengen_US
dc.publisherLippincott Williams & Wilkinsen_US
dc.relation.ispartofJournal of Thoracic Oncologyen_US
dc.titleA Phase II study of dasatinib in patients with chemo-sensitive relapsed small cell lung cancer (SCLC): CALGB 30602en_US
dc.typeConference_Paperen_US
dc.identifier.emailPang, HMH: herbpang@hku.hken_US
dc.identifier.authorityPang, HMH=rp01857en_US
dc.identifier.doi10.1097/JTO.0b013e3181b9c77e-
dc.identifier.volume4en_US
dc.identifier.issuesuppl. 1-
dc.identifier.spageS816, abstract P2.212en_US
dc.identifier.epageS817en_US
dc.publisher.placeUnited Statesen_US

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