Kentepozidis N, Economopoulou P, Christofyllakis Ch, Chelis L, Polyzos A, Vardakis N, Koinis F, Vamvakas L, Katsaounis P, Kalbakis K, Nikolaou Ch, Georgoulias V, Kotsakis A
Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471, Athens, Greece.
Clin Transl Oncol. 2017 Mar;19(3):317-325. doi: 10.1007/s12094-016-1532-y. Epub 2016 Aug 4.
Platinum-based chemotherapy is the standard front-line treatment for patients with advanced non-small cell lung cancer (NSCLC). However, non-platinum combinations of third-generation chemotherapeutic agents are considered an alternative therapeutic option for patients who cannot tolerate the toxic effects of platinum compounds. In this study, the efficacy and toxicity of the combination of irinotecan plus cisplatin (IC) was compared to pemetrexed plus cisplatin (PC) regimen, in platinum-naïve patients with advanced NSCLC, who had been previously treated with the combination of a taxane plus gemcitabine.
A total of 124 patients with locally advanced or metastatic NSCLC were randomly assigned to either irinotecan 110 mg/m on day 1 and 100 mg/m on day 8 plus cisplatin 80 mg/m on day 8 every 3 weeks (IC arm) or pemetrexed 500 mg/m plus cisplatin 80 mg/m on day 1 every 3 weeks (PC arm). The primary endpoint of the study was the overall response rate (ORR).
The ORR and median progression-free survival (PFS) in the IC arm were 18 % and 3.3 months, respectively, while in the PC arm were 19 % and 4.2 months (p = ns). Median overall survival (OS) was significantly higher in patients with PC (6.9 vs. 10.9; p = 0.013). PC regimen had a better toxicity profile compared to IC, with a statistically significant lower incidence of grade 3/4 neutropenia (3 vs. 31 %; p = 0.0001) and diarrhea (1.6 vs. 14.7 %, p = 0.018).
In patients with advanced NSCLC pretreated with docetaxel/gemcitabine, the combination of pemetrexed/cisplatin is associated with increased OS and is better tolerated than the combination of irinotecan/cisplatin and should be considered as a valid therapeutic option for platinum-naive, previously treated patients. CLINICALTRIALS.
NCT00614965.
铂类化疗是晚期非小细胞肺癌（NSCLC）患者的标准一线治疗方案。然而，对于无法耐受铂类化合物毒性作用的患者，第三代化疗药物的非铂联合方案被视为一种替代治疗选择。在本研究中，将伊立替康联合顺铂（IC）方案与培美曲塞联合顺铂（PC）方案在初治的、先前接受过紫杉烷联合吉西他滨治疗的晚期NSCLC患者中的疗效和毒性进行了比较。
总共124例局部晚期或转移性NSCLC患者被随机分为两组，一组为每3周在第1天给予伊立替康110mg/m²、第8天给予100mg/m²，同时在第8天给予顺铂80mg/m²（IC组）；另一组为每3周在第1天给予培美曲塞500mg/m²加顺铂80mg/m²（PC组）。该研究的主要终点是总缓解率（ORR）。
IC组的ORR和中位无进展生存期（PFS）分别为18%和3.3个月，而PC组分别为19%和4.2个月（p =无显著性差异）。PC组患者的中位总生存期（OS）显著更长（6.9对比10.9；p = 0.013）。与IC组相比，PC方案的毒性特征更好，3/4级中性粒细胞减少（3%对比31%；p = 0.0001）和腹泻（1.6%对比14.7%，p = 0.018）的发生率在统计学上显著更低。
在先前接受多西他赛/吉西他滨治疗的晚期NSCLC患者中，培美曲塞/顺铂联合方案与OS延长相关，且耐受性优于伊立替康/顺铂联合方案，对于初治的、先前接受过治疗的患者应被视为一种有效的治疗选择。临床试验。
NCT00614965
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