Schmid Peter, Possinger Kurt
Medizinische Klinik mit Schwerpunkt Onkologie und Hämatologie, Charite Campus Mitte, Humboldt-Universität Berlin, Germany.
Med Klin (Munich). 2002 Nov 15;97(11):677-86. doi: 10.1007/s00063-002-1211-3.
The role of high-dose chemotherapy (HDCT) in primary and metastatic breast cancer remains controversial. Although results of several randomized trials have become available, the data is still inconclusive.
In the adjuvant setting, only one trial has shown an advantage in recurrence-free survival, whereas none of the randomized trials showed a significant improvement in overall survival.
In metastatic breast cancer, four of five randomized trials revealed a significant benefit in progression-free survival for patients treated with HDCT. However, differences in overall survival have not been observed.
Interpretation of the trials is limited due to a lack of statistical power in some of the trials, a relatively short follow-up, a relatively intensive chemotherapy regimen in the control arm, and an inappropriate selection of cytotoxic agents with only moderate activity and/or unacceptable toxicity.
Several questions, especially the approach of early intensification or tandem HDCT, have to be answered yet. The results of ongoing studies are urgently needed.
大剂量化疗（HDCT）在原发性和转移性乳腺癌中的作用仍存在争议。尽管已有多项随机试验的结果，但数据仍无定论。
辅助性HDCT：在辅助治疗中，仅有一项试验显示在无复发生存方面具有优势，而随机试验均未显示总生存期有显著改善。
HDCT用于IV期疾病：在转移性乳腺癌中，五项随机试验中的四项显示，接受HDCT治疗的患者在无进展生存期方面有显著益处。然而，总生存期方面未观察到差异。
由于部分试验缺乏统计学效力、随访时间相对较短、对照组化疗方案相对密集，以及细胞毒性药物选择不当，活性仅为中等和/或毒性不可接受，试验解读受到限制。
若干问题，尤其是早期强化或串联HDCT的方法，仍有待解答。迫切需要正在进行的研究结果。
