A Randomized, Double-blind, Placebo-controlled, Phase IIIb Trial (ATLAS) Comparing Bevacizumab...
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Transcript of A Randomized, Double-blind, Placebo-controlled, Phase IIIb Trial (ATLAS) Comparing Bevacizumab...
![Page 1: A Randomized, Double-blind, Placebo-controlled, Phase IIIb Trial (ATLAS) Comparing Bevacizumab Therapy with or without Erlotinib, after Completion of Chemotherapy.](https://reader035.fdocuments.in/reader035/viewer/2022062516/56649e445503460f94b37e47/html5/thumbnails/1.jpg)
A Randomized, Double-blind, Placebo-controlled, Phase IIIb Trial (ATLAS) Comparing Bevacizumab Therapy with or without Erlotinib, after Completion
of Chemotherapy with Bevacizumab for 1st-line Treatment of Locally-advanced, Recurrent, or
Metastatic Non-small Cell Lung Cancer (NSCLC)
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Background & Rationale
Adapted from: 1Sandler A, et al., N Engl J Med 2006; 2Shepherd FA, et al., N Engl J Med 2005; 3Ciuleanu T, et al., ASCO 2008; 4Herbst RS, et al., J Clin Oncol 2007; 5Hainsworth J, et al., IASLC 2008.
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ATLAS Study Design
Carboplatin/paclitaxel; cisplatin/vinorelbine; carboplatin or cisplatin/gemcitabine; carboplatin or cisplatin/docetaxel.
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ATLAS Objective
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ATLAS: Randomized Patients by Region
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ATLAS Statistical Considerations
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ATLAS: Analysis Populations
<2% of patients were lost to follow-up or withdrew consent.
As of data cutoff date: 18 July 2008.
*The randomized safety population consists of all randomized patients who received at least one dose of bevacizumab, erlotinib or placebo during the post-chemotherapy phase.
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ATLAS: Baseline Characteristics (ITT population)
*Patients randomized as of July 18, 2008.
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ATLAS: Baseline Characteristics (cont.)
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ATLAS Efficacy Results
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ATLAS: Progression-free Survival(ITT population, investigator assessment)
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ATLAS: Additional PFS Outcome Measures(ITT population)
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ATLAS: Progression-free Survival in Subgroups
*Includes <1% patients with ECOG PS 2.
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ATLAS: Progression-free Survival in Subgroups(ITT population)
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ATLAS: Preliminary Analysis of Subsequent Therapies Received (ITT population)
*Pemetrexed was most commonly used.
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ATLAS Safety Results
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ATLAS: Summary for Post Chemotherapy Treatment Phase (Safety population)
Formal statistical comparison testing between treatment arms was not done.
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ATLAS: Causes of Death (Safety population)
*Other causes of death reported by investigators: carcinomatous meningitis, breast cancer, respiratory failure, unexplained pneumonia.
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ATLAS: Adverse Events of Special Interest during the Post-chemotherapy Phase (Safety population)
Grade 5 events: Bevacizumab + Placebo: 1 (0.3%) CHF; Bevacizumab + Erlotinib: 2 (0.5%) Cardiovascular other than HTN, 1 (0.3%) ATE; 1 (0.3%) VTE.
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ATLAS: Adverse Events of Special Interest (Cont.)
Grade 5 events: Bevacizumab + Placebo: 1 (0.3%) infection.
*Renal failure and hepatic events were reversible.
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ATLAS Conclusions & Next Steps