近日,，一個(gè)國(guó)際研究小組研究發(fā)現(xiàn)，對(duì)于晚期非小細(xì)胞肺癌患者,，白蛋白結(jié)合型紫杉醇（nab-PC）方案的療效要優(yōu)于溶劑型紫杉醇（sb-PC）,。相關(guān)論文發(fā)表在JCO雜志上。
作者指出,，特別是針對(duì)鱗癌患者,，nab-PC的療效非常好，這是非常有意義的，因?yàn)檫@為鱗癌患者提供了一個(gè)改進(jìn)的治療方案,。
此項(xiàng)研究納入了1052例未經(jīng)治療的IIIB~IV期NSCLC患者,。1組使用nab-PC 100 mg/m2聯(lián)合卡鉑，每3周化療1次,；另外1組予以sb-PC200 mg/m2聯(lián)合卡鉑,，每3周化療1次。主要終點(diǎn)是總體客觀應(yīng)答率（ORR）,。
研究發(fā)現(xiàn),，nab-PC組的ORR為33%，顯著高于sb-PC組的25%（P= 0.005）,。對(duì)于鱗癌患者,，nab-PC更為有效，ORR分別為41％和24％(P<0.001),。而在非鱗癌患者中,，nab-PC療效與SB-PC相似（分別為26％和25％，P=0.808）,。
nab-PC能夠提高無進(jìn)展生存期（中位數(shù)分別為6.3月和5.8個(gè)月,；P=0.214）和總生存期（分別為12.1月和11.2個(gè)月；P=0.271）,，但無統(tǒng)計(jì)學(xué)差異,。
在nab-PC組中,，≥3級(jí)的神經(jīng)病變,，白細(xì)胞減少，關(guān)節(jié)痛以及肌痛發(fā)生率顯著減少,，而在sb-PC組,，血小板減少和貧血的發(fā)生率較低。
總而言之,，nab-PC相對(duì)于sb-PC,，一線治療晚期非小細(xì)胞肺癌患者具有良好的療效，且神經(jīng)病變的毒性也較小,。(生物谷Bioon.com)
doi:10.1200/JCO.2011.39.5848
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PMID:
Weekly nab-Paclitaxel in Combination With Carboplatin Versus Solvent-Based Paclitaxel Plus Carboplatin as First-Line Therapy in Patients With Advanced Non–Small-Cell Lung Cancer: Final Results of a Phase III Trial
Mark A. Socinski?, Igor Bondarenko, Nina A. Karaseva, Anatoly M. Makhson, Igor Vynnychenko, Isamu Okamoto, Jeremy K. Hon, Vera Hirsh, Paul Bhar, Hui Zhang, Jose L. Iglesias and Markus F. Renschler Purpose This phase III trial compared the efficacy and safety of albumin-bound paclitaxel (nab-paclitaxel) plus carboplatin with solvent-based paclitaxel (sb-paclitaxel) plus carboplatin in advanced non–small-cell lung cancer (NSCLC).
Patients and Methods In all, 1,052 untreated patients with stage IIIB to IV NSCLC were randomly assigned 1:1 to receive 100 mg/m2 nab-paclitaxel weekly and carboplatin at area under the concentration-time curve (AUC) 6 once every 3 weeks (nab-PC) or 200 mg/m2 sb-paclitaxel plus carboplatin AUC 6 once every 3 weeks (sb-PC). The primary end point was objective overall response rate (ORR).
Results On the basis of independent assessment, nab-PC demonstrated a significantly higher ORR than sb-PC (33% v 25%; response rate ratio, 1.313; 95% CI, 1.082 to 1.593; P = .005) and in patients with squamous histology (41% v 24%; response rate ratio, 1.680; 95% CI, 1.271 to 2.221; P < .001). nab-PC was as effective as sb-PC in patients with nonsquamous histology (ORR, 26% v 25%; P = .808). There was an approximately 10% improvement in progression-free survival (median, 6.3 v 5.8 months; hazard ratio [HR], 0.902; 95% CI, 0.767 to 1.060; P = .214) and overall survival (OS; median, 12.1 v 11.2 months; HR, 0.922; 95% CI, 0.797 to 1.066; P = .271) in the nab-PC arm versus the sb-PC arm, respectively. Patients ≥ 70 years old and those enrolled in North America showed a significantly increased OS with nab-PC versus sb-PC. Significantly less grade ≥ 3 neuropathy, neutropenia, arthralgia, and myalgia occurred in the nab-PC arm, and less thrombocytopenia and anemia occurred in the sb-PC arm.
Conclusion The administration of nab-PC as first-line therapy in patients with advanced NSCLC was efficacious and resulted in a significantly improved ORR versus sb-PC, achieving the primary end point. nab-PC produced less neuropathy than sb-PC.
