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Bending the Curve Trial by Trial
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IPASS

Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma (IPASS)

Phase 3NCT00322452

Population
Previously untreated East Asian patients with advanced pulmonary adenocarcinoma who were nonsmokers or former light smokers (EGFR mutation not required for entry)
Design
Open-label phase 3 trial of previously untreated East Asian patients with advanced pulmonary adenocarcinoma who were nonsmokers or former light smokers; primary endpoint progression-free survival (non-inferiority, then superiority); EGFR mutation status analysed as a subgroup
Primary endpoint
PFS
Arms
  • Gefitinib (experimental, n = 609): Gefitinib 250 mg per day
  • Carboplatin-paclitaxel (control, n = 608): Carboplatin (AUC 5 or 6) plus paclitaxel 200 mg per square metre
People
Mok TS
PFSHR 0.74 (95% CI 0.65–0.85)Δ 12-month PFS+18.2 pointsPFSHR 0.48 (95% CI 0.36–0.64)PFSHR 2.85 (95% CI 2.05–3.98)
Show the numbers
Results reported for IPASS
EndpointAnalysisGefitinibCarboplatin-paclitaxelEffect
PFSprimaryMok 200924.9% at 12 mo6.7% at 12 moHR 0.74 (95% CI 0.65–0.85)P<0.001Median PFS is not given in the abstract and is not recorded here.
PFSEGFR mutation-positive subgroup (n=261)primaryMok 2009——HR 0.48 (95% CI 0.36–0.64)P<0.001Subgroup analysis; hazard ratio for progression or death with gefitinib versus carboplatin-paclitaxel.
PFSEGFR mutation-negative subgroup (n=176)primaryMok 2009——HR 2.85 (95% CI 2.05–3.98)P<0.001Subgroup analysis; hazard ratio above 1 means shorter PFS with gefitinib than with carboplatin-paclitaxel.
Results reported for IPASS
EndpointAnalysisGefitinibCarboplatin-paclitaxelEffect
PFSprimaryMok 200924.9% at 12 mo6.7% at 12 moHR 0.74 (95% CI 0.65–0.85)P<0.001Median PFS is not given in the abstract and is not recorded here.
PFSEGFR mutation-positive subgroup (n=261)primaryMok 2009——HR 0.48 (95% CI 0.36–0.64)P<0.001Subgroup analysis; hazard ratio for progression or death with gefitinib versus carboplatin-paclitaxel.
PFSEGFR mutation-negative subgroup (n=176)primaryMok 2009——HR 2.85 (95% CI 2.05–3.98)P<0.001Subgroup analysis; hazard ratio above 1 means shorter PFS with gefitinib than with carboplatin-paclitaxel.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSPFSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.740.65–0.85
PFS0.480.36–0.64
PFS2.852.05–3.98
Primary publication: Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009;361(10):947-57. PubMedDOI

Appears in

Sources

  1. Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009;361(10):947-57.

    PubMedDOI