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Article: Cisplatin, irinotecan, and bevacizumab for untreated extensive-stage small-cell lung cancer: CALGB 30306, a phase II study

TitleCisplatin, irinotecan, and bevacizumab for untreated extensive-stage small-cell lung cancer: CALGB 30306, a phase II study
Authors
Issue Date2011
Citation
Journal of Clinical Oncology, 2011, v. 29 n. 33, p. 4436-4441 How to Cite?
AbstractPurpose: The efficacy of cisplatin, irinotecan, and bevacizumab was evaluated in patients with extensive-stage small-cell lung cancer (ES-SCLC). Patients and Methods: Patients with ES-SCLC received cisplatin 30 mg/m 2 and irinotecan 65 mg/m 2 on days 1 and 8 plus bevacizumab 15 mg/kg on day 1 every 21 days for six cycles on this phase II study. The primary end point was to differentiate between 50% and 65% 12-month survival rates. Results: Seventy-two patients were enrolled between March 2005 and April 2006; four patients canceled, and four were ineligible. Grade 3 or 4 toxicities included neutropenia (25%), all electrolyte (23%), diarrhea (16%), thrombocytopenia (10%), fatigue (10%), nausea (10%), hypertension (9%), anemia (9%), infection (7%), vascular access thrombosis (2%), stroke (2%), and bowel perforation (1%). Three deaths (5%) occurred on therapy as a result of pneumonitis (n = 1), stroke (n = 1), and heart failure (n = 1). Complete response, partial response, and stable disease occurred in three (5%), 45 (70%), and 11 patients (17%), respectively. Progressive disease occurred in one patient (2%). Overall response rate was 75%. Median progression-free survival (PFS) was 7.0 months (95% CI, 6.4 to 8.4 months). Median overall survival (OS) was 11.6 months (95% CI, 10.5 to 15.1 months). Hypertension ≥ grade 1 was associated with improved OS after adjusting for performance status (PS) and age (hazard ratio [HR], 0.55; 95% CI, 0.31 to 0.97; P = .04). Lower vascular endothelial growth factor levels correlated with worse PFS after adjusting for age and PS (HR, 0.90; 95% CI, 0.83 to 0.99; P = .03). Conclusion: PFS and OS times were higher compared with US trials in ES-SCLC with the same chemotherapy. However, the primary end point of the trial was not met. Hypertension was associated with improved survival after adjusting for age and PS. © 2011 by American Society of Clinical Oncology.
Persistent Identifierhttp://hdl.handle.net/10722/194336
ISSN
2015 Impact Factor: 20.982
2015 SCImago Journal Rankings: 9.204
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorReady, NE-
dc.contributor.authorDudek, AZ-
dc.contributor.authorPang, HH-
dc.contributor.authorHodgson, LD-
dc.contributor.authorGraziano, SL-
dc.contributor.authorGreen, MR-
dc.contributor.authorVokes, EE-
dc.date.accessioned2014-01-30T03:32:28Z-
dc.date.available2014-01-30T03:32:28Z-
dc.date.issued2011-
dc.identifier.citationJournal of Clinical Oncology, 2011, v. 29 n. 33, p. 4436-4441-
dc.identifier.issn0732-183X-
dc.identifier.urihttp://hdl.handle.net/10722/194336-
dc.description.abstractPurpose: The efficacy of cisplatin, irinotecan, and bevacizumab was evaluated in patients with extensive-stage small-cell lung cancer (ES-SCLC). Patients and Methods: Patients with ES-SCLC received cisplatin 30 mg/m 2 and irinotecan 65 mg/m 2 on days 1 and 8 plus bevacizumab 15 mg/kg on day 1 every 21 days for six cycles on this phase II study. The primary end point was to differentiate between 50% and 65% 12-month survival rates. Results: Seventy-two patients were enrolled between March 2005 and April 2006; four patients canceled, and four were ineligible. Grade 3 or 4 toxicities included neutropenia (25%), all electrolyte (23%), diarrhea (16%), thrombocytopenia (10%), fatigue (10%), nausea (10%), hypertension (9%), anemia (9%), infection (7%), vascular access thrombosis (2%), stroke (2%), and bowel perforation (1%). Three deaths (5%) occurred on therapy as a result of pneumonitis (n = 1), stroke (n = 1), and heart failure (n = 1). Complete response, partial response, and stable disease occurred in three (5%), 45 (70%), and 11 patients (17%), respectively. Progressive disease occurred in one patient (2%). Overall response rate was 75%. Median progression-free survival (PFS) was 7.0 months (95% CI, 6.4 to 8.4 months). Median overall survival (OS) was 11.6 months (95% CI, 10.5 to 15.1 months). Hypertension ≥ grade 1 was associated with improved OS after adjusting for performance status (PS) and age (hazard ratio [HR], 0.55; 95% CI, 0.31 to 0.97; P = .04). Lower vascular endothelial growth factor levels correlated with worse PFS after adjusting for age and PS (HR, 0.90; 95% CI, 0.83 to 0.99; P = .03). Conclusion: PFS and OS times were higher compared with US trials in ES-SCLC with the same chemotherapy. However, the primary end point of the trial was not met. Hypertension was associated with improved survival after adjusting for age and PS. © 2011 by American Society of Clinical Oncology.-
dc.languageeng-
dc.relation.ispartofJournal of Clinical Oncology-
dc.titleCisplatin, irinotecan, and bevacizumab for untreated extensive-stage small-cell lung cancer: CALGB 30306, a phase II study-
dc.typeArticle-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1200/JCO.2011.35.6923-
dc.identifier.pmid21969504-
dc.identifier.scopuseid_2-s2.0-81755172139-
dc.identifier.volume29-
dc.identifier.issue33-
dc.identifier.spage4436-
dc.identifier.epage4441-
dc.identifier.isiWOS:000297257400022-

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