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Reviewer: Dr Charles Butts Date posted: June 21, 2007

Outcomes for elderly NSCL cancer patients treated with Bevacizumab (B) and carboplatin/paclitaxel: Analysis of the ECOG 4599 Trial Authors: Ramalingam et al. Reviewer: Dr Charles Butts Date posted: June 21, 2007. Background.

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Reviewer: Dr Charles Butts Date posted: June 21, 2007

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  1. Outcomes for elderly NSCL cancer patients treated with Bevacizumab (B) and carboplatin/paclitaxel: Analysis of the ECOG 4599 TrialAuthors: Ramalingam et al. Reviewer: Dr Charles Butts Date posted: June 21, 2007

  2. Background • ECOG 4599 was first trial to show a benefit from the addition of bevacizumab to standard chemotherapy for advanced NSCL cancer. • Toxicity profile for bevacizumab a particular concern for elderly patients. • Although patients >/= 70 years old constitute almost 50% of all NSCL cancer patients, they are not often included in clinical trials.

  3. Objectives • Compare the outcomes for PC and PCB for elderly patients treated in ECOG 4599. • Too study the differences in safety and efficacy between elderly and younger patients.

  4. Treatment A: Carboplatin AUC 6 + Paclitaxel 200 mg/m2 R Treatment B: Carboplatin AUC 6 + Paclitaxel 200 mg/m2 + Bevacizumab 15 mg/m2 EOCG 4599

  5. Results • 850 patients enrolled • 224 (26%) >/= 70 years old • 1.6% > 80 years old • Well matched for baseline characteristics except more females in the younger age group.

  6. RESULTS

  7. Toxicity PC versus PCB in Elderly • PCB associated with significantly more • Grade 4 neutropenia, febrile neutropenia, and thrombocytopenia • Hypertension, proteinuria and hemorrhage • Higher treatment related deaths (p=NS) • 6.3% versus 1.8%

  8. Toxicity PCB Elderly versus Younger • Elderly experience significantly more • Grade 4 neutropenia • Melena • Proteinuria • Motor neuropathy • Elderly had higher TRD (p=NS) • 6.3% versus 2.8%

  9. STUDY COMMENTARY • This trial examines the potential toxicities as well as the benefits of bevacizumab in an important subgroup of NSCL cancer patients. • ECOG 4599 accrued the highest percentage of “elderly” patients recorded in a randomized trial in advanced NSCL cancer. • Still patients >/= 70 years accounted for only 26% of the patients in the trial, despite making up almost 50% of all those diagnosed with NSCL cancer. • This retrospective , subgroup analysis suggests that patients >/= 70 years with advanced NSCL cancer experience significantly more toxicity than ypunger patients when bevacizumab is added to PC. • Despite the improved response rate seen in elderly patients with PCB, there does not appear to be any improvement in survival.

  10. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • For those convinced of the benefit of the addition of bevacizumab in patients with advanced NSCL cancer, I would suggest proceeding with extreme caution in patients >/= 70 years.

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