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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
Title | A Phase II study of dasatinib in patients with chemo-sensitive relapsed small cell lung cancer (SCLC): CALGB 30602 |
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Authors | |
Issue Date | 2009 |
Publisher | Lippincott 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? |
Abstract | BACKGROUND: 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 Identifier | http://hdl.handle.net/10722/195797 |
ISSN | 2023 Impact Factor: 21.0 2023 SCImago Journal Rankings: 7.879 |
DC Field | Value | Language |
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dc.contributor.author | Miller, AntoniusA | en_US |
dc.contributor.author | Pang, HMH | en_US |
dc.contributor.author | Hodgson, Lydia | en_US |
dc.contributor.author | Ramnath, Nithya | en_US |
dc.contributor.author | Otterson, GregoryA | en_US |
dc.contributor.author | Vokes, EverettE | en_US |
dc.date.accessioned | 2014-03-10T04:53:31Z | - |
dc.date.available | 2014-03-10T04:53:31Z | - |
dc.date.issued | 2009 | en_US |
dc.identifier.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 | en_US |
dc.identifier.issn | 1556-0864 | en_US |
dc.identifier.uri | http://hdl.handle.net/10722/195797 | - |
dc.description.abstract | BACKGROUND: 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.language | eng | en_US |
dc.publisher | Lippincott Williams & Wilkins | en_US |
dc.relation.ispartof | Journal of Thoracic Oncology | en_US |
dc.title | A Phase II study of dasatinib in patients with chemo-sensitive relapsed small cell lung cancer (SCLC): CALGB 30602 | en_US |
dc.type | Conference_Paper | en_US |
dc.identifier.email | Pang, HMH: herbpang@hku.hk | en_US |
dc.identifier.authority | Pang, HMH=rp01857 | en_US |
dc.identifier.doi | 10.1097/JTO.0b013e3181b9c77e | - |
dc.identifier.volume | 4 | en_US |
dc.identifier.issue | suppl. 1 | - |
dc.identifier.spage | S816, abstract P2.212 | en_US |
dc.identifier.epage | S817 | en_US |
dc.publisher.place | United States | en_US |
dc.identifier.issnl | 1556-0864 | - |