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Reviewer: Dr. Ron Burkes Date posted: June 21, 2007

Phase III study of Gefitinib vs Docetaxel in Japanese Patients with NSCLC who Failed 1 or 2 Chemotherapy Regimens Author: Niho PASCO 25:#7509, 2007. Reviewer: Dr. Ron Burkes Date posted: June 21, 2007. Treatment A: Gefitinib 250 mg/day  Post study treatment. R.

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Reviewer: Dr. Ron Burkes Date posted: June 21, 2007

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  1. Phase III study of Gefitinib vs Docetaxel in Japanese Patients with NSCLC who Failed 1 or 2 Chemotherapy RegimensAuthor: Niho PASCO 25:#7509, 2007 Reviewer: Dr. Ron Burkes Date posted: June 21, 2007

  2. Treatment A: Gefitinib 250 mg/day  Post study treatment R Treatment B: Docetaxel 60mg/m2 every 3 weeks  Post study treatment Metastatic NSCLC who failed 1 or 2 Chemotherapy regimens *Post study treatment following randomization varied depending on patients requests

  3. Primary Objective • Compare overall survival between gefitinib and docetaxel in patients having prior treatment for advanced NSCL cancer with one or two prior regimens, with at least one platinum containing regimen, with the aim of demonstrating non-inferiority. • Upper limit of CI </= 1.25

  4. Post study Treatment BSC alone 65 (27%) Continue gefitinib 34 (13%) *Docetaxel (36%) Other chemotherapy (24%) Gefitinib BSC alone 56 (23%) Continue docetaxal 5 (3%) *Gefitinib (36%) Other chemotherapy (20%) Docetaxel

  5. RESULTS

  6. STUDY COMMENTARY • Randomized comparison of second/third line therapy in “unselected” (Japanese) patients of gefitinib versus standard docetaxel. • No statistically significant difference in survival or PFS NUT confidence interval for survival exceeded the upper limit for non-inferiority margin. Therefore, could not claim non-inferiority. • RR and quality of life (some measures) were better for gefitinib. • Major effect on survival appears to be in subsequent therapies received after progression. More patients in docetaxel arm received “active” therapy.

  7. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • Although this was an “unselected” population of patients, the trial was done in Japan where there is a higher prevalence of mutations which predict for response to EGFR-TKI’s. • In addition 80% of patients had adenocarcinoma and 30% were never smokers, suggesting that selection was taking place. • The results of the INTEREST trial, which was done in patients more closely resembling Canadian NSCL cancer patients, more relevant to our setting. • Since erlotinib is approved for second or third line therapy after a platinum regimen, most oncologists are likely already selecting patients for second line TKI versus docetaxel.

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