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First-line gefitinib superior to carboplatin-paclitaxel in advanced pulmonary adenocarcinoma

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Compared with carboplatin-paclitaxel, gefitinib — as initial treatment for pulmonary adenocarcinoma —increased PFS in East Asian patients with non-small cell lung cancer who were non-smokers or former light smokers. According to the researchers, PFS was also prolonged in patients with EGFR-positive disease.

The phase-3, multicenter, randomized, open-label study included previously untreated East Asian patients with non-small cell lung cancer and advanced pulmonary adenocarcinoma who were non-smokers or former light smokers. Six hundred and nine patients were randomly assigned gefitinib (Iressa, Astra Zeneca) 250 mg/day and 608 were assigned to carboplatin plus paclitaxel.

The primary endpoint was PFS; secondary endpoints included OS, objective response rate, quality of life, reduced symptoms, safety and adverse-event profile. Data from this study were also presented at the 2009 ASCO Annual Meeting.

The median PFS was 5.7 months in the gefitinib group vs. 5.8 months in the carboplatin-paclitaxel group. Twelve-month PFS was higher in the gefitinib group (24.9%) compared with the carboplatin-paclitaxel (6.7%) group. The study demonstrated gefitinib’s superiority over carboplatin-paclitaxel (HR for progression or death =0.74; 95% CI, 0.65-0.85).

Six hundred and eighty-three patients provided biomarker analysis samples; 437 had EGFR mutation data. Of those 59.7% were positive for the mutation. Treatment and mutation status correlated in terms of PFS (P<.001). In the mutation-positive subgroup, patients assigned to gefitinib had longer PFS compared with those assigned to carboplatin-paclitaxel (HR=0.48; 95% CI, 0.36-0.64). In the mutation-negative subgroup PFS was shorter among patients assigned to gefitinib compared with carboplatin-paclitaxel (HR=2.85; 95% CI, 2.05-3.98).

Objective response rate was higher in the gefitinib arm (43.0% vs. 32.2%; OR=1.59; 95% CI, 1.25-2.01) and OS was similar between the two groups. Quality of life improved in the gefitinib group compared with carboplatin-paclitaxel (OR=1.34; 95% CI=1.06-1.69). Gefitinib was also associated with fewer grade-3 or -4 adverse events.

Mok TS. N Engl J Med. 2009;361:947-957.

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