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Gefitinib or Carboplatin–Paclitaxel in Pulmonary Adenocarcinoma

Authors: Tony S. Mok M.D. et al

Reviewed by: Dr. Charles Butts

Date posted: May 31, 2010

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R

Treatment A: Gefitinib 250 mg po daily until progression

Treatment B: Carboplatin AUC 5 or 6 and Paclitaxel 200 mg/m2 i.v q21 days to max 6 cyclesStage IIIb/IV NSCLC

AdenocaNon-smoker or

Former Light SmokerNo Prior Systemic Rx

Study Design

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RESULTS: ITT Population

Treatment

Gefitinib

Treatment

Chemop-value

Response Rate (%)

43 32 0.001

PFS (median, mos)

5.7 5.8

12 month PFS 24.9% 6.7%

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RESULTS: EGFR Mutation +

Treatment

Gefitinib

Treatment

Chemop-value

Response Rate (%)

71 47 < 0.001

PFS HR 0.48 <0.001

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RESULTS: EGFR Mutation -

Treatment

Gefitinib

Treatment

Chemop-value

Response Rate (%)

1 23.5 0.001

PFS (median, mos)

HR 2.85 <0.001

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PFS Overall Population

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PFS By Mutation Status

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Toxicity

Gefitinib Chemo

Grade 3/4 28.7% 61%

SAE 16% 15.6%

Hospitalization 13.8% 13%

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STUDY COMMENTARY

•This randomized phase III study of first line chemotherapy versus EGFR TKI was done in Asian countries

•Patients selected for factors predicting presence of EGFR mutation

•Overall 36% of patients had tissue evaluated for mutation status and 60% were EGFR mutation positive

•Survival curves for overall population suggested two distinct populations.

•Patients with EGFR mutations had higher likelihood of response and significantly longer PFS with gefitinib.

•Patients lacking EGFR mutations rarely responded to gefitinib (RR1%) and were almost 3 times more likely to progress on gefitinib HR 2.85)

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BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS

•Even in patients with clinical features that would predict for presence of EGFR activating mutations, unless actual mutation status is known, those patients would be best treated with chemotherapy.

•Determination of EGFR mutation status prior to initial treatment of patients with advanced adenocarcinoma of the lung should be a priority.

•For patients lacking adequate tissue for analysis, repeat biopsy if feasible should be considered.

•For patients needing to be treated quickly i.e. before EGFR mutation status can be determined, chemo is a better initial option than EGFR TKI.