Cassier Philippe A, Chabaud Sylvie, Trillet-Lenoir Véronique, Peaud Pierre-Yves, Tigaud Jean-Dominique, Cure Hervé, Orfeuvre Hubert, Salles Bruno, Martin Claude, Jacquin Jean-Philippe, Agostini Cecile, Guastalla Jean-Paul, Pérol David, Bachelot Thomas
Medical Oncology, Hopital Edouard Herriot, Université de Lyon et Hospices Civils de Lyon, Lyon, France.
Breast Cancer Res Treat. 2008 May;109(2):343-50. doi: 10.1007/s10549-007-9651-3. Epub 2007 Jul 5.
In first-line metastatic breast cancer, both paclitaxel (P)-doxorubicin (A) and docetaxel (D)-doxorubicin (A) combinations have shown superiority over treatments without taxane. The aim of this study was to compare the two combinations.
Chemotherapy-naive (except for adjuvant therapy) metastatic breast cancer patients were randomly assigned to intravenous AD (arm D) or AP (arm P) every 3 weeks for a maximum of four cycles, then four cycles of single agent docetaxel (arm D) or paclitaxel (arm P). Primary endpoint was overall quality of life (QoL) measured by EORTC QLQ-C30 after four courses of doxorubicin-taxane combination. Secondary endpoints were toxicity, overall survival (OS), progression-free survival (PFS), and QoL sub-scores.
Between March 2000 and April 2004, 210 patients were randomized: 103 to arm P and 107 to arm D. Patient characteristics were well balanced between arms. After four courses, QoL score differences between groups or compared to baseline scores were not significant. Response rate was 39.6% for AD and 41.8% for AP. After a median follow-up of 50.2 months, median PFS and median OS were 8.7 and 21.4 months in arm D and 8.0 and 27.3 months in arm P (p = 0.977 and 0.081, respectively). Hematological toxicity was significantly more frequent in arm D than in arm P (p < 10(-6)), as well as grades 3-4 asthenia (p = 0.03). Neuropathy occurred more frequently in arm P (p = 0.03).
In this study, paclitaxel or docetaxel combined with doxorubicin were not significantly different in terms of QoL scores and efficacy, but had different toxicity profiles.
在一线转移性乳腺癌中，紫杉醇（P）-阿霉素（A）和多西他赛（D）-阿霉素（A）联合方案均显示出优于不含紫杉烷的治疗方案。本研究的目的是比较这两种联合方案。
未接受过化疗（辅助治疗除外）的转移性乳腺癌患者每3周随机接受静脉注射AD（D组）或AP（P组），最多4个周期，然后接受4个周期的单药多西他赛（D组）或紫杉醇（P组）治疗。主要终点是在接受四个疗程的阿霉素-紫杉烷联合治疗后，通过欧洲癌症研究与治疗组织生活质量问卷核心30项（EORTC QLQ-C30）测量的总体生活质量（QoL）。次要终点是毒性、总生存期（OS）、无进展生存期（PFS）和QoL子评分。
2000年3月至2004年4月期间，210例患者被随机分组：103例分到P组，107例分到D组。两组患者的特征均衡。四个疗程后，两组之间的QoL评分差异或与基线评分相比均无显著性。AD组的缓解率为39.6%，AP组为41.8%。中位随访50.2个月后，D组的中位PFS和中位OS分别为8.7个月和21.4个月，P组为8.0个月和27.3个月（p分别为0.977和0.081）。D组的血液学毒性明显比P组更频繁（p < 10⁻⁶），3-4级乏力也是如此（p = 0.03）。P组的神经病变发生频率更高（p = 0.03）。
在本研究中，紫杉醇或多西他赛联合阿霉素在QoL评分和疗效方面无显著差异，但毒性特征不同。
