title: Phase II trial of gefitinib in pretreated Chinese women with advanced non-small-cell lung cancer.
abstract: A phase II clinical trial was performed to evaluate the efficacy and safety of gefitinib on pretreated Chinese female non-small-cell lung cancer (NSCLC) patients. Chinese female patients with locally advanced or metastatic NSCLC who failed at least one platinum-based chemotherapy received gefitinib monotherapy (250 mg/day) between April 2002 and January 2010. The primary endpoint was overall response rate (ORR), and secondary endpoints were overall survival (OS) and progression-free survival (PFS). Of the 40 evaluable female patients, the ORR was 62.5%. All patients have responded with one (2.5%) complete response, 24 (60%) partial response, 12 (30%) stable disease, and 3 (7.5%) progressive disease. The OS and PFS were 20 months (95% CI: 11.9-28 months) and 13 months (95% CI: 8.0-17.9 months), respectively. Survival (OS and PFS) were longer in patients with good performance status and in patients older than 65 years (P < 0.05). The most frequently observed toxicities were rash/dry skin (80%), diarrhea (42.5%), and vomiting/anorexia (32.5%). Four patients developed grade 3 toxicities (rash and diarrhea) but did not require either dose reduction or discontinuation. Gefitinib is a highly effective and well-tolerated agent for Chinese women with pretreated advanced NSCLC.
authors.affiliation: Department of Medical Oncology, The First Hospital Affiliated to Medical School of Zhejiang University, 79 Qingchun Road, 310003 Hangzhou, Zhejiang, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Deng
authors.forename: Wei Jia
authors.initials: WJ
authors.lastname: Fang
authors.forename: Xiao Chen
authors.initials: XC
authors.lastname: Zhang
authors.forename: Dong Ping
authors.initials: DP
authors.lastname: Wu
authors.forename: Hong Ming
authors.initials: HM
authors.lastname: Fang
authors.forename: Jing
authors.initials: J
authors.lastname: Chen
authors.forename: Jiong
authors.initials: J
authors.lastname: Qian
authors.forename: Hai Bo
authors.initials: HB
authors.lastname: Mou
authors.forename: Bin Bin
authors.initials: BB
authors.lastname: Chu
authors.forename: Nong
authors.initials: N
authors.lastname: Xu
authors.forename: Li Song
authors.initials: LS
authors.lastname: Teng
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D002282:Adenocarcinoma, Bronchiolo-Alveolar / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D044466:Asian People; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D066246:ErbB Receptors / Q000037:antagonists & inhibitors; D005260:Female; D005500:Follow-Up Studies; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D011799:Quinazolines / Q000627:therapeutic use*; D016879:Salvage Therapy; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; C512478:EGFR protein, human; D066246:ErbB Receptors; D000077156:Gefitinib