用多导管近距离放疗进行部分乳腺加速放疗可作全乳放疗的替代选择

美国《临床肿瘤学杂志》2018年5月16日在线先发

对一项克里唑替尼一线治疗与一线化疗相比较研究的总生存的最终分析：来自PROFILE 1014试验的结果

BenjaminJ. Solomon, Dong-Wan Kim, Yi-Long Wu,Kazuhiko Nakagawa, Tarek Mekhail,EnriquetaFelip...Show More

目的

PROFILE 1014是一项III期临床试验，在晚期间变性淋巴瘤激酶（ALK）阳性的非鳞非小细胞肺癌患者中对克里唑替尼一线治疗与一线化疗进行了比较。在此，我们对总生存（OS）的最终结果予以报告。

患者与方法

对患者随机分组，一组口服克里唑替尼250mg，每日2次（n=172），另一组静脉给予培美曲塞500mg/m2+顺铂75mg/m2或卡铂（浓度时间曲线下面积5-6mg·mL/min），每3周一个疗程，最多6个疗程（n=171）。肿瘤进展后允许交叉到克里唑替尼组。采用一种分层对数秩检验和一种预置保秩结构失效时间模型解释交叉效应，对总生存进行分析。

结果

对两组总生存的中位随访时间大约为46个月，化疗组，144名（84.2%）患者在后续的治疗中接受了克里唑替尼。总生存的风险比为0.760（95%CI，0.548-1.053；双尾P=0.0978）。克里唑替尼组尚未到中位总生存期（NR），化疗组中位总生存期为47.5个月（95%CI，32.2个月至NR）。克里唑替尼组4年生存概率为56.6%（95%CI，48.3%-64.1%），化疗组49.1%（95%CI，40.5%-57.1%）。对交叉效应校正后，表明克里唑替尼组总生存有改善（风险比，0.346；95%自举CI，0.081-0.718）。在克里唑替尼治疗且随后接受了ALK酪氨酸激酶抑制剂的患者中，观察到了最长的总生存期。没有发现新的安全性事件。

结论

PROFILE 1014研究的最终分析为ALK重排的非小细胞肺癌患者的总生存提供了新的基准，凸显了克里唑替尼对延长这类患者生存期的益处。

《壹篇》南南和北北

Final Overall Survival Analysis Froma Study Comparing First-Line Crizotinib With Chemotherapy: Results From PROFILE1014

Benjamin J.Solomon, Dong-Wan Kim,Yi-Long Wu, KazuhikoNakagawa, Tarek Mekhail,Enriqueta Felip...Show More

Purpose

The phase III PROFILE 1014 trial compared crizotinib withchemotherapy as first-line treatment in patients with anaplastic lymphomakinase (ALK) –positive advanced nonsquamous non–small-cell lung cancer. Here,we report the final overall survival (OS) results.

Patients andMethods

Patients were randomly assigned to receive oralcrizotinib 250 mg twice daily (n = 172) or intravenous pemetrexed 500 mg/m2 plus cisplatin 75mg/m2 or carboplatin(area under the concentration–time curve of 5 to 6 mg·mL/min) every 3 weeks fora maximum of six cycles (n = 171). Crossover to crizotinib was permitted afterdisease progression. OS was analyzed using a stratified log-rank test and aprespecified rank-preserving structural failure time model to account forcrossover.

Results

Median follow-up duration for OS was approximately 46months for both arms. In the chemotherapy arm, 144 patients (84.2%) receivedcrizotinib in subsequent lines. Hazard ratio for OS was 0.760 (95% CI, 0.548 to1.053; two-sided P = .0978). Median OS was not reached (NR) withcrizotinib (95% CI, 45.8 months to NR) and 47.5 months with chemotherapy (95%CI, 32.2 months to NR). Survival probability at 4 years was 56.6% (95% CI,48.3% to 64.1%) with crizotinib and 49.1% (95% CI, 40.5% to 57.1%) with chemotherapy.After crossover adjustment, there was an improvement in OS that favoredcrizotinib (hazard ratio, 0.346; 95% bootstrap CI, 0.081 to 0.718). The longestOS was observed in crizotinib-treated patients who received a subsequent ALKtyrosine kinase inhibitor. No new safety signals were identified.

Conclusion

The final analysis of the PROFILE 1014 study provides anew benchmark for OS in patients with ALK-rearranged non–small-cell lungcancer and highlights the benefit of crizotinib for prolonging survival in thispatient population.

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