A PHASE-II STUDY OF MITOXANTRONE, ETOPOSIDE, AND THIOTEPA WITH AUTOLOGOUS MARROW SUPPORT FOR PATIENTS WITH RELAPSED BREAST-CANCER
A PHASE-II STUDY OF MITOXANTRONE, ETOPOSIDE, AND THIOTEPA WITH AUTOLOGOUS MARROW SUPPORT FOR PATIENTS WITH RELAPSED BREAST-CANCER
复制标题
DOI：
10.1200/jco.1990.8.11.1782
复制
发表时间：
1990-11-01
影响因子：
45.3
通讯作者：
DEISSEROTH, A
中科院分区：
文献类型：
--
作者：
WALLERSTEIN, R;SPITZER, G;DEISSEROTH, A
为了进一步提高高剂量化疗在局部晚期和转移性乳腺癌治疗中的效果，我们寻求开发第二种有效的高剂量无交叉耐药方案，与我们惯常的高剂量环磷酰胺、依托泊苷和顺铂（CVP）联合使用。我们进行了高剂量米托蒽醌30 mg/m2，依托泊苷200 mg/m2每12小时2次的II期试验。6、硫替帕250mg /m2 .次。3天（MVT）， 31例重度预处理转移性乳腺癌患者和1例局部晚期化疗难治性乳腺癌患者。由于先前的治疗量和不良反应状态，这些患者不适合高剂量CVP化疗。在32例患者中，14例对第1周期有反应，没有出现任何4级毒性，并接受了第二周期的MVT。总体而言，31例患者中有7例达到完全缓解（CR; 23%）。14例患者中有4例在第一个治疗周期部分缓解，在第二个治疗周期后达到CR。总缓解率为19 / 31(61%)，总中位无进展期为4 - 5个月，总中位生存期为9个月。毒性主要包括粘膜炎（69%为3级或4级）。结果表明，高剂量MVT产生显著的活性，即使在大量预处理的患者中。给予第二个周期的MVT高剂量治疗增加了CR率，第二个周期的发病率和死亡率不高于第一个周期。由于该方案3级或4级粘膜炎的高发生率，我们目前正在完成一项单独使用大剂量米托蒽醌和硫替帕的随访研究。
To further improve the effect of high-dose chemotherapy in the treatment of locally advanced and metastatic breast cancer, we sought to develop a second active high-dose noncross-resistant regimen to use in tandem with our customary high-dose regimen of cyclophosphamide, etoposide, and cisplatin (CVP). We performed a phase II trial of high-dose mitoxantrone 30 mg/m2, etoposide 200 mg/m2 every 12 hours .times. 6, and thiotepa 250 mg/m2 .times. 3 days (MVT) in 31 patients with heavily pretreated metastatic breast cancer and one with locally advanced chemotherapy-refractory breast cancer. These patients were ineligible for high-dose CVP chemotherapy because of the amount of prior treatment and poor-response status. Of the 32 patients, 14 responded to cycle 1, did not experience any grade 4 toxicity, and received a second cycle of MVT. Overall, seven of 31 patients achieved a complete response (CR; 23%). Four of the 14, who were partial responders to the first cycle, achieved a CR after the second cycle. The overall response rate was 19 of 31 (61%) with an overall median freedom from progression of 4 to 5 months and an overall median survival of 9 months. Toxicity consisted primarily of mucositis (grade 3 or 4 in 69%). The results indicate that high-dose MVT produces significant activity, even in heavily pretreated patients. Administration of a second cycle of high-dose therapy with MVT increased the CR rate, and the morbidity and mortality from the second cycle were not greater than that for the first cycle. Because of the high incidence of grade 3 or 4 mucositis with this regimen, we are currently completing a follow-up study of high-dose mitoxantrone and thiotepa alone.