Hayashibara Kenji, Satoh Hiroaki, Shinohara Yoko, Inagaki Masaharu, Kaburagi Takayuki, Hashimoto Toshio, Kurishima Koichi, Ishikawa Hiroichi, Ichimura Hideo, Nawa Takeshi, Funayama Yasunori, Matsumura Takeshi, Kagohashi Katsunori, Endo Takeshi, Furukawa Kinya, Kishi Koji, Sumi Masaaki, Kamiyama Koichi, Ishikawa Shigemi
Ibaraki Higashi Hospital, Ibaraki, Japan.
Med Oncol. 2009;26(2):222-7. doi: 10.1007/s12032-008-9110-y. Epub 2008 Oct 31.
Survival data for non-small cell lung cancer is typically reported from clinical trials that include patients fit enough to meet treatment criteria. The denominator of all patients from which the gefitinib-treated population is derived has rarely been reported and the impact of gefitinib on population-based outcomes is difficult to measure. We have retrospectively reviewed data of 626 patients who received gefitinib in Ibaraki Prefecture (with a population of 3 million) in Japan from July 2002 until September 2007. Overall response rate was found to 30.8%, and the median survival time was 8.0 months (95% confidence interval: 7.0-9.0 months). Female gender, good PS, and adenocarcinoma were significantly associated with prolonged survival. Adverse events were generally mild and were mostly skin reactions and diarrhea. Our population-based study has generated similar results to those previously reported in published clinical trials, which had restrictive criteria for eligible patients.
非小细胞肺癌的生存数据通常来自临床试验报告，这些试验纳入了健康状况足以满足治疗标准的患者。吉非替尼治疗人群所源自的所有患者的分母很少被报告，因此吉非替尼对基于人群的结果的影响难以衡量。我们回顾性分析了2002年7月至2007年9月期间在日本茨城县（人口300万）接受吉非替尼治疗的626例患者的数据。总体缓解率为30.8%，中位生存时间为8.0个月（95%置信区间：7.0 - 9.0个月）。女性、良好的体能状态和腺癌与生存期延长显著相关。不良事件一般较轻，主要是皮肤反应和腹泻。我们基于人群的研究结果与先前发表的临床试验报告相似，那些试验对符合条件的患者有严格标准。
