PRS-02: Gefitinib (IRESSA) versus docetaxel in patients with locally advanced or metastatic non-small-cell lung cancer pre-treated with platinum-based chemotherapy: a randomized, open-label Phase III study (INTEREST)

Abstract

Background: In 1950, the association between cigarette smoking and lung cancer was firmly established. However, adenocarcinoma of the lung comprised only about 5% of lung cancers at the time and appeared unrelated to smoking. In the 1960s and 1970s, incidence of adenocarcinoma increased sharply, and became strongly related to smoking. Methods: SEER data on 307,797 lung cancer patients diagnosed in the US between 1975 and 2003 were analyzed. The objective was to assess changes in age-standardized incidence rates (per 100,000 population) at diagnosis of the four major lung cancer histologies: adenocarcinoma, squamous cell carcinoma, small cell carcinoma and large cell carcinoma. Incidence of each histologic subtype was measured during six time periods

Tobacco Smoking and Lung Cancer : Perception Changing Facts = تدخين التبغ و سرطان الرئة : إدراك تغير الحقائق

“…57 The odds of an EGFR mutation are 6.5 times higher in neversmokers (P <0.0001), 4.4 times higher in those with adenocarcinoma (P <0.0001), 1.7 times higher for females (P 0.039), and 4-6 times higher in East Asians. [58][59][60][61][62][63] Advanced age and acinar predominant subtypes were also independent predictors of EGFR mutations. mutations were associated with ever-smoking status, male gender, and poor differentiation; however, Western studies have not been able to validate these findings.…”

Considerations for Second-Line Therapy of Non-Small Cell Lung Cancer

“…While gefitinib was not a treatment option for the vast majority of the patients in the U.S. it was approved in other countries, and trials investigating the activity of gefitinib continued. A recent phase III trial compared the efficacy of docetaxel (75 mg/ m 2 every 3 weeks) with that of gefitinib (250 mg daily) in patients who had progressed after chemotherapy (n = 1,466) [49]. The primary endpoint was the noninferiority of gefitinib in comparison with docetaxel in terms of overall survival, and the coprimary endpoint was the superiority of gefitinib in patients with high EGFR gene copy number.…”

First- and second-line therapy for advanced nonsmall cell lung cancer

“…In both studies docetaxel significantly improved some parameters of quality of life. Since these two pivotal studies, new potential second-line drugs were compared with the docetaxel standard of care [117][118][119][120][121][122][123]. With regards to the therapeutic results of the docetaxel arm of these studies, it must be emphasised that response rates and survival data were highly and significantly reproducible (table 11).…”