环磷酰胺、阿霉素和依托泊苷与卡铂和紫杉醇治疗广泛期小细胞肺癌患者的III期研究
Phase III study of cyclophosphamide, doxorubicin, and etoposide compared with carboplatin and paclitaxel in patients with extensive disease small-cell lung cancer.
作者信息
de Jong Wouter K, Groen Harry J M, Koolen Mia G J, Biesma Bonne, Willems Luuk N A, Kwa Hian-Bie, van Bochove Aart, van Tinteren Harm, Smit Egbert F
机构信息
Department of Pulmonology, University Medical Center Groningen, University of Groningen, P.O. Box 30.001, 9700 RB Groningen, The Netherlands.
出版信息
Eur J Cancer. 2007 Nov;43(16):2345-50. doi: 10.1016/j.ejca.2007.07.029. Epub 2007 Sep 10.
The progression-free survival (PFS) of cyclophosphamide/doxorubicin/etoposide (CDE) and carboplatin/paclitaxel (CP) was compared in chemonaive patients with extensive disease small-cell lung cancer (ED-SCLC). A total of 203 patients were randomised to three-weekly CDE (n=102) or CP (n=101) for five cycles. Tumour response rates in CDE and CP were 60% and 61%. PFS of CP was 5.2 months, PFS of CDE 4.9 months (p=0.60). The major difference in toxicity between CDE and CP was grade 4 leukocytopaenia in 64% and 9% of the patients (p<0.0001), leading to febrile neutropaenia in 30% and 4% of the patients (p<0.0001), respectively. This was the reason for differences in the total number of hospital admissions (63 for CDE and 40 for CP, p=0.0025). This study failed to demonstrate any benefit in PFS with CP compared with CDE. CP was associated with significantly less haematological toxicity, leading to 37% less hospital admissions for febrile neutropaenia.
在初治的广泛期小细胞肺癌（ED-SCLC）患者中，比较了环磷酰胺/阿霉素/依托泊苷（CDE）和卡铂/紫杉醇（CP）的无进展生存期（PFS）。总共203例患者被随机分为接受每三周一次的CDE方案（n = 102）或CP方案（n = 101），共五个周期。CDE组和CP组的肿瘤缓解率分别为60%和61%。CP组的PFS为5.2个月，CDE组为4.9个月（p = 0.60）。CDE和CP在毒性方面的主要差异在于，4级白细胞减少症在两组患者中的发生率分别为64%和9%（p < 0.0001），导致发热性中性粒细胞减少症的患者比例分别为30%和4%（p < 0.0001）。这就是两组住院总次数存在差异的原因（CDE组63次，CP组40次，p = 0.0025）。该研究未能证明CP方案相较于CDE方案在PFS方面有任何益处。CP方案的血液学毒性显著更低，因发热性中性粒细胞减少症导致的住院次数减少了37%。
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