[Evaluation of efficacy and safety of ZD1839 as monotherapy in Chinese patients with advanced non-small cell lung cancer].
OBJECTIVE
To report the outcome of gefitinib for Chinese patients with advanced nonsmall cell lung cancer(NSCLC) at Peking Union Medical College Hospital.


METHODS
From Oct. 2002 to Apr. 2006, 204 patients with advanced NSCLC received oral ZD1839 (250 mg/d) treatment. The were 110 (59.9%) men and 94 (40.1%) women aged between 25 and 85 years. Thirty-two patients had squamous cell carcinoma, 125 adenocarcinoma, 30 bronchoalveolar carcinoma or adenocarcinoma with partial bronchoalveolar carcinoma, 6 adenosquamous carcinoma, and 11 unspecified. Twenty-six patients had no history of chemotherapy, 62 had no disease progression after chemotherapy, and 111 failed to prior one or more regimens. Median survival was calculated using the Kaplan-Meier method and a Cox regression analysis was used to detect differences in median survival between strata.


RESULTS
The median survival of all patients and of patients failed to prior chemotherapy were 16.3 months (95% confidential interval CI, 14.5 - 18.2) and 12.5 months (95% CI 9.3 - 15.7). The rate of 1-year survival was 57%. The objective tumor response rate and stable disease rate were 31.4% and 41.7% respectively. The median survival were significantly related with ECOG scores, pathology types, disease progression after chemotherapy, objective efficacy of gefitinib and changes of short-breathing. Among 26 patients with no prior chemotherapy, the median survival was not statistically significant compared with that of other patients. Among the enrolled patients, 111 had disease progression and 62 had stable disease after prior chemotherapy, and their median survivals was statistically different. At the time of this analysis, 142 patients had disease progression, 58 of whom withdrew from taking gefitinib, and 84 continued gefitinib therapy until death. The median survivals for these subgroups were not significantly different. Among 142 patients with disease progression, 40 received other systemic treatment, the median survival was statistically significant compared with that of other patients. Objective response was significantly related with age, smoking status, pathological type, change of short-breathing and rashes induced by gefitinib. Adverse events were generally mild (grade 1 and 2) and reversible. The most frequent adverse events were rash 72.6% (138/190) and diarrhea 33.7% (64/190).


CONCLUSIONS
Our study suggests that treatment with gefitinib maybe well tolerate and beneficial for some Chinese patients after failure of prior chemotherapy.
Wang
Meng-Zhao
MZ
Department of Respiratory Diseases, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China. mengzhaowang@sina.com
Li
Long-Yun
LY
Wang
Shu-Lan
SL
Zhang
Xiao-Tong
XT
Zhong
Wei
W
Zhang
Li
L
Li
Jun-Rong
JR
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002681:China; D005260:Female; D000077156:Gefitinib; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging / Q000706:statistics & numerical data; D016016:Proportional Hazards Models; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D011799:Quinazolines; D000077156:Gefitinib