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

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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

• 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.


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.


R

Treatment A:Carboplatin AUC 6 + Paclitaxel 200 mg/m2

Treatment B:Carboplatin AUC 6 + Paclitaxel 200 mg/m2

+Bevacizumab 15 mg/m2EOCG 4599


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.


RESULTS

Elderly Non-Elderly

p-valuePC PCB PC PCB

PFS (median, mos)

4.9 5.9 4.4 6.2 p<0.001

Median Survival

(mos)12.1 11.3 9.6 12.8 p<0.0027


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%


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%


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.


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.

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

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