Final Results From A Phase II Trial Of Zd1839 ('Iressa') For Patients With Advanced Non-Small-Cell Lung Cancer (IDEAL 1)

Reviewer: Roberto Santiago, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: May 18, 2002

Presenter: Masahiro Fukuoka
Presenter's Affiliation: Kinki University, Osaka, Japan
Type of Session: Poster


  • Iressa is an oral preparation of a selective inhibitor of the epidermal growth factor receptor tyrosine kinase
  • It interferes with signal transduction pathways implicated in proliferation and survival of cancer cells
  • The IDEAL 1 trial is a double-blind study evaluating the tumor response rate (RR) and safety of Iressa in patients with platinum-refractory, advanced NSCLC
  • Disease control rate (DCR; responses + stable disease), progression-free survival (PFS) and overall survival (OS) were also assessed

Materials and Methods

  • Eligible patients had failed 1-2 chemotherapy regimens of which at least one had to be platinum-based (56% had failed one and 44% had failed two regimens)
  • 210 patients with ECOG performance status 0-2 were randomized to 250 or 500 mg/day of Iressa
  • 70% of patients were male, ~80% had metastatic disease (as opposed to locally advanced), and 87% had PS 0-1
  • 208 patients were evaluable for response


  • The RR, DCR, PFS and OS rates were 18.4%, 54.4%, 2.7%, and 7.6%, respectively for the 250mg/day dose
  • The corresponding rates for the 500mg/day dose were 19.0%, 51.4%, 2.8%, and 8.1%, respectively
  • These endpoints were not significantly different between the two doses
  • Similar RRs were noted regardless Iressa was used as 2nd- (17.9%) or 3rd-line treatment (19.8%)
  • Toxic effects were usually mild and most commonly consisted of grade 1-2 rash, diarrhea, pruritus and dry skin
  • A lower rate of CTC grade 3/4 adverse events and withdrawals was observed in patients receiving 250 mg/day compared with those receiving 500 mg/day (8.7% and 1.9% versus 30.2% and 9.4%, respectively)

Author's Conclusions

  • 250 mg/day of Iressa is as efficacious as 500 mg/day and has a lower frequency/severity of toxic effects
  • 250 mg/day of Iressa provides clinically significant antitumor activity in patients with advanced NSCLC who have been previously treated with platinum-based therapy

Clinical/Scientific Implications

    There is growing interest in the use of biologic response modifyers such as Iressa which target EGFR. Early results suggest this to be an active agent in lung cancer patients who have failed standard platinum regimens. This study shows comparable effects with two different dose levels of Iressa and lower side effects in the 250 mg/day arm, making this the recommended dosing schedule.

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