title: Gefitinib in the adjuvant setting: safety results from a phase III study in patients with completely resected non-small cell lung cancer.
abstract: Standard therapy for stage I-IIIA non-small cell lung cancer (NSCLC) is surgery, although adjuvant therapies are required to prevent disease recurrence and improve patient survival. This is the first study that planned to administer adjuvant gefitinib (Iressa) 250 mg/day or placebo to randomized patients with completely resected NSCLC (stage IB-IIIA) 4-6 weeks following surgery, for 2 years, until recurrence/withdrawal. However, recruitment was stopped after the randomization of 38 patients, because interstitial lung disease (ILD)-type events were being increasingly reported in Japan in the advanced disease setting. Finally, the trial was halted. Safety data for 38 recruited patients (18 gefitinib and 20 placebo) showed no unexpected adverse drug reactions (ADRs), with the most common being grade 1/2 gastrointestinal and skin disorders in 12 and 16 patients receiving gefitinib and in five and six patients receiving placebo, respectively. Grade 3/4 ADRs occurred in four patients receiving gefitinib and one patient receiving placebo. ILD-type events were reported in one patient receiving gefitinib (concomitantly with other ILD-inducing drugs) who died and two patients receiving placebo. Eight patients receiving gefitinib withdrew due to ADRs compared with three patients receiving placebo. Adverse events associated with surgical complications were reported for six patients receiving gefitinib and four patients receiving placebo. In the adjuvant setting there were no unexpected adverse events observed. Gefitinib had no impact on surgery-related complications when given within 4-6 weeks post-operatively.
authors.affiliation: Tokyo Medical University Hospital, Tokyo, Japan. mtsuboi@za2.so-net.ne.jp
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tsuboi
authors.forename: Harubumi
authors.initials: H
authors.lastname: Kato
authors.forename: Kanji
authors.initials: K
authors.lastname: Nagai
authors.forename: Ryosuke
authors.initials: R
authors.lastname: Tsuchiya
authors.forename: Hiromi
authors.initials: H
authors.lastname: Wada
authors.forename: Hirohito
authors.initials: H
authors.lastname: Tada
authors.forename: Yukito
authors.initials: Y
authors.lastname: Ichinose
authors.forename: Masahiro
authors.initials: M
authors.lastname: Fukuoka
authors.forename: Haiyi
authors.initials: H
authors.lastname: Jiang
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D005260:Female; D000077156:Gefitinib; D006801:Humans; D017563:Lung Diseases, Interstitial / Q000139:chemically induced*; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000139:chemically induced; D011184:Postoperative Period; D011799:Quinazolines / Q000009:adverse effects* / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000077156:Gefitinib