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Reviewed By: Dr. Ron Burkes Date posted: December 2008

Gemcitabine + Cisplatin +/- Bevacizumab as 1st-line Treatment of Advanced NSCLC: AVAiL Study Manegold PASCO 25:#7514, 2007/Ann Oncol 19:LBA1, 2008. Reviewed By: Dr. Ron Burkes Date posted: December 2008.

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Reviewed By: Dr. Ron Burkes Date posted: December 2008

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  1. Gemcitabine + Cisplatin +/- Bevacizumab as 1st-line Treatment of Advanced NSCLC: AVAiL StudyManegold PASCO 25:#7514, 2007/Ann Oncol 19:LBA1, 2008 Reviewed By: Dr. Ron Burkes Date posted: December 2008

  2. BO 17704 (AVAIL): A Phase III Randomised Study of First-line Bevacizumab Combined with Cisplatin/Gemcitabine (CG) in Patients (PTS) with Advanced or Recurrent Non-Squamous, Non-small Cell Lung Cancer (NSCLC) Authors: Manegold et al

  3. RANDOMISE Avastin RANDOMISE Avastin 7.5mg/kg + CG 2 PD Previously untreated, stage IIIb, IV or recurrent non-squamous NSCLC* 1 Placebo 7.5 + CG PD 1 Placebo 15 + CG Avastin Avastin 15mg/kg + CG 2 PD • Primary endpoint: progression-free survival • Secondary endpoints: overall survival, time to treatment failure, response rate • Excluded patients with tumours invading or abutting major blood vessels *Stratification factors: disease stage, ECOG PS, region, gender Manegold, et al. ASCO 2007

  4. Highly Selected Patients • PS 0,1 • No uncontrolled hypertension • No squamous pathology • No CNS mets • No previous thromboembolic disease • No NSAIDs • No anticoagulants • No central tumors near or abutting major blood vessels • No hemoptysis > gr 2

  5. Gemcitabine + Cisplatin +/- Bevacizumab as 1st-line Treatment of Advanced NSCLC: AVAiL StudyManegold PASCO 25:#7514, 2007/Ann Oncol 19:LBA1, 2008

  6. AVAIL: Cis/Gem +/- Avastin PROGRESSION FREE SURVIVAL ESMO update: 7.5mg 15mg placebo median survival 13.4m 13.6m 13.1m

  7. Phase III trial of Avastin plus GC in NSCLC (AVAiL): Safety summary Manegold, et al. ASCO 2007

  8. Phase III trial of Avastin plus GC in NSCLC (AVAiL): Severe adverse events of special interest *Includes arterial thromboembolic events Manegold, et al. ASCO 2007

  9. Pulmonary Haemorrhage Events Of note: • 38% of patients in AVAiL had central lesions 4/10 patients with severe pulmonary haemorrhage had central lesions • 9% of patients in AVAiL had therapeutic anticoagulation • but none of them had a severe pulmonary haemorrhage Manegold, et al. ASCO 2007

  10. ECOG 4599 vs AVAiL

  11. Study Commentary • Does this trial confirm ECOG 4599?  there is a very modest improvement in PFS BUT no survival benefit!!! • If one uses Taxol/Carboplatin then Bevacizumab appears to be necessary; however with a Cisplatin-based (GC) doublet the incremental benefit of bevacizumab is modest • Should we be using Bevacizumab as 1st line Rx with chemotherapy for selected pts with advanced NSCLC? • If so with which regimen? • And if so what dose – 7.5 vs 15?

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