Sequential cycles of high-dose chemotherapy with dose escalation of carboplatin with or without paclitaxel supported by G-CSF mobilized peripheral blood progenitor cells: a phase I/II study in advanced ovarian cancer

Sequential cycles of high-dose chemotherapy with dose escalation of carboplatin with or without paclitaxel supported by G-CSF mobilized peripheral blood progenitor cells: a phase I/II study in advanced ovarian cancer
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由 G-CSF 动员的外周血祖细胞支持的高剂量化疗的连续周期,卡铂剂量递增,联合或不联合紫杉醇:晚期卵巢癌的 I/II 期研究

DOI:
10.1038/sj.bmt.1701659
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发表时间:
1999
影响因子:
4.8
通讯作者:
W. Gallmeier
W. Gallmeier
中科院分区:
医学3区
文献类型:
--
作者:
H. Wandt;J. Birkmann;T. Denzel;K. Schäfer;G. Schwab;D. Pilz;H. Egger;A. Both;W. Gallmeier

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在一项I/II期研究中,为了评估高剂量卡铂化疗联合或不联合紫杉醇与非格司亭动员的外周血祖细胞(PBPC)支持,共有21例患者接受了4个周期的高剂量化疗,这些患者大多患有化疗无效疾病。第1个周期(环磷酰胺,6 g/m2)之后是两个周期的卡铂(1600 mg/m2或1800 mg/m2)。第4周期包括卡铂(1600 mg/m2)、依托泊苷(1600 mg/m2)和美法仑(140 mg/m2)。通过在所有周期中添加紫杉醇(175 mg/m2)和固定卡铂剂量(1600 mg/m2)实现进一步化疗强化。耳毒性是卡铂序贯周期递增的剂量限制性因素。卡铂1800 mg/m2时观察到2级和3级耳毒性、不需要助听器的听力损失或可使用助听器纠正的听力损失。因此,在本研究中确定序贯卡铂的最大耐受剂量(MTD)为1600 mg/m2。第1、2、3和4周期后,白细胞减少症(<1.0 × 109/l)的中位持续时间为7、4、4和6天。严重的3级和4级感染仅见于7%的周期。在21例可评价疾病缓解的患者中,57%完全缓解,43%部分缓解,总体缓解率为100%。中位无进展生存期为25(15-36)个月,中位总生存期为36.5(15-38)个月。大多数患者在化疗开始时减容效果不佳或有巨大的残留病变。最大剂量达1600 mg/m2卡铂的序贯大剂量化疗是有效可行的。一项随机、前瞻性试验比较序贯大剂量化疗与最佳标准化疗,现在是必要的。
To assess high-dose carboplatin chemotherapy with or without paclitaxel with filgrastim mobilized peripheral blood progenitor cell (PBPC) support in a phase I/II study, a total of 21 patients with mostly chemonaive disease received four cycles of high-dose chemotherapy. Cycle 1 (cyclophosphamide, 6 g/m2) was followed by two cycles of carboplatin (1600 mg/m2 or 1800 mg/m2). Cycle 4 consisted of carboplatin (1600 mg/m2), etoposide (1600 mg/m2), and melphalan (140 mg/m2). Further chemotherapy intensification was achieved by adding paclitaxel (175 mg/m2) to all cycles with a fixed carboplatin dose (1600 mg/m2). Ototoxicity was dose-limiting for escalation of sequential cycles of carboplatin. Grade 2 and grade 3 ototoxicity, hearing loss not requiring a hearing aid, or hearing loss correctable with a hearing aid, was observed with carboplatin at 1800 mg/m2. The maximum tolerated dose (MTD) of sequential carboplatin, therefore, was identified in this study as 1600 mg/m2. After cycles 1, 2, 3 and 4 the median duration of leukopenia (<1.0 × 109/l) was 7, 4, 4 and 6 days. Severe grade 3 and 4 infections were seen in only 7% of cycles. Of the 21 patients evaluable for disease response, 57% had complete remissions and 43% experienced partial remissions resulting in an overall response rate of 100%. The median progression-free survival is 25 (15–36) months, the median overall survial 36.5 (15–38) months. Most patients were suboptimally debulked or had bulky residual disease at the start of chemotherapy. Sequential high-dose chemotherapy to a maximum dose of 1600 mg/m2 carboplatin is effective and feasible. A randomized, prospective trial comparing sequential high-dose chemotherapy with optimal standard chemotherapy is now warranted.
使用外周血祖细胞支持对晚期卵巢癌患者进行紫杉醇和高剂量卡铂的剂量递增。
DOI: --
发表时间: 1997
期刊: Seminars in oncology.
影响因子: --
作者:
Fennelly,DW;Aghajanian,C;Shapiro,F;O'Flaherty,C;O'Connor,K;Curtin,JP;Crown,JP;Hoskins,WJ;Spriggs,DR
通讯作者: Spriggs,DR
乳腺癌和卵巢癌患者使用紫杉醇、环磷酰胺和重组人粒细胞集落刺激因子后的外周血干细胞采集。
DOI: 10.1200/jco.1995.13.7.1714
发表时间: 1995
期刊: Journal of clinical oncology : official journal of the American Society of Clinical Oncology
影响因子: --
作者:
Demirer,T;Rowley,S;Buckner,CD;Appelbaum,FR;Lilleby,K;Storb,R;Schiffman,K;Bensinger,WI
通讯作者: Bensinger,WI