British Columbia Cancer Agency, Department of Medical Oncology, 600 West 10th Avenue, Vancouver, BC, Canada V5Z 4E6.
British Columbia Cancer Agency, Department of Pathology, 600 West 10th Avenue, Vancouver, BC, Canada V5Z 4E6.
Lung Cancer. 2014 Jan;83(1):73-7. doi: 10.1016/j.lungcan.2013.10.007. Epub 2013 Oct 19.
The IPASS trial demonstrated superior progression free survival for Asian, light/never smoking, advanced, pulmonary adenocarcinoma patients treated with first-line gefitinib compared to carboplatin/paclitaxel, of which 59% of those tested were epidermal growth factor receptor (EGFR) mutation positive. In IPASS 39% of gefitinib treated patients went on to receive platin based polychemotherapy. We hypothesized that in a population-based setting fewer patients receive second-line platin based chemotherapy than those enrolled in a clinical trial.
The Iressa Alliance program provided standardized EGFR mutation testing and appropriate access to gefitinib to all patients in British Columbia with advanced, non squamous non small cell lung cancer (NSCLC). We retrospectively analyzed clinical, pathologic data and outcomes for all patients tested in this program between March 2010 and June 2011.
A total of 548 patients were referred for testing and 22% of patients were mutation positive. Baseline characteristics of mutation negative and mutation positive; median age 67/65, male 41%/31%, Asian 15%/51%, never smoker 21%/58%, stage IV 80%/91%. Median overall survival was 12 months in mutation negative patients and not yet reached in mutation positive (p<0.0001). In mutation positive patients 5% of patients had a complete response, 46% partial response, 34% stable disease, 6% progressive disease. Twenty percent of patients continued on gefitinib after radiographic progression and clinical stability. Sixty-one gefitinib treated patients progressed at the time of analysis; 10% of patients received further gefitinib only, 38% platinum based doublet, 8% other chemotherapy and 44% no further treatment. Performance status most strongly predicted for delivery of second line chemotherapy.
This North American population based study shows similar efficacy of gefitinib in mutation positive patients compared to the IPASS trial. Contrary to our hypothesis, delivery of second line chemotherapy was feasible in a significant proportion of gefitinib treated patients.
IPASS 试验表明,与卡铂/紫杉醇相比,一线吉非替尼治疗亚洲、轻度/从不吸烟、晚期肺腺癌患者的无进展生存期有显著改善,其中 59%的患者经检测为表皮生长因子受体(EGFR)突变阳性。在 IPASS 试验中,39%的吉非替尼治疗患者随后接受了基于铂的联合化疗。我们假设,在基于人群的环境中,接受二线基于铂的化疗的患者比例低于临床试验中的入组患者。
Iressa 联盟项目为不列颠哥伦比亚省所有晚期非鳞状非小细胞肺癌(NSCLC)患者提供了标准化的 EGFR 突变检测和吉非替尼的合理使用。我们对该项目中所有在 2010 年 3 月至 2011 年 6 月期间接受检测的患者的临床、病理数据和结局进行了回顾性分析。
共有 548 名患者被推荐进行检测,其中 22%的患者为突变阳性。突变阴性和突变阳性患者的基线特征:中位年龄 67/65 岁,男性 41%/31%,亚洲人 15%/51%,从不吸烟 21%/58%,IV 期 80%/91%。突变阴性患者的中位总生存期为 12 个月,而突变阳性患者尚未达到(p<0.0001)。在突变阳性患者中,5%的患者完全缓解,46%的患者部分缓解,34%的患者病情稳定,6%的患者疾病进展。20%的患者在影像学进展和临床稳定后继续接受吉非替尼治疗。在分析时,61 名接受吉非替尼治疗的患者进展,10%的患者仅接受进一步的吉非替尼治疗,38%的患者接受基于铂的双联化疗,8%的患者接受其他化疗,44%的患者未接受进一步治疗。体能状态是预测二线化疗的最强因素。
这项北美的基于人群的研究表明,吉非替尼在突变阳性患者中的疗效与 IPASS 试验相似。与我们的假设相反,在接受吉非替尼治疗的患者中,有相当一部分患者能够接受二线化疗。