Rose P G, Blessing J A, Soper J T, Barter J F
Department of Obstetrics and Gynecology, Case Western Reserve University, Cleveland, Ohio, 44106, USA.
Gynecol Oncol. 1998 Aug;70(2):267-71. doi: 10.1006/gyno.1998.5080.
In a previous study by the Gynecologic Oncology Group only modest activity was seen with bolus etoposide in leiomyosarcoma of the uterus (an 11% response rate). To exploit the schedule dependency of etoposide, which favors longer exposure, a Phase II trial of prolonged oral etoposide was conducted in this tumor.
Eligibility included leiomyosarcoma of the uterus, measurable disease, one prior chemotherapy regimen which did not include etoposide, WBC >/= 3000/microliter, platelet count >/=100, 000/microliter, serum creatinine </=2 mg%, and adequate hepatic function. The starting etoposide dose was 50 mg/m2/day (30-40 mg/m2/day for prior radiotherapy) as a single dose for 21 days, every 28 days. Based on toxicity, a dose escalation to a maximum etoposide dose of 60 mg/m2/day was prescribed.
Thirty-six patients were entered on this study; 34 were evaluable for toxicity and 29 were evaluable for response. A median of 2 courses were given (range 1-14). Grade 4 neutropenia occurred in 20.6% and grade 4 thrombocytopenia occurred in 5.8%. One patient developed acute myeloid leukemia 10 months after completing 7 cycles of therapy. Among the patients evaluable for response, 27 had received prior chemotherapy and 6 had received prior radiation therapy. Two partial responses (6.9%) were observed.
This regimen has minimal activity as second-line chemotherapy in leiomyosarcoma of the uterus. No benefit to the chronic oral schedule is evident.
在妇科肿瘤学组先前的一项研究中，子宫平滑肌肉瘤患者接受大剂量依托泊苷治疗时仅显示出适度疗效（缓解率为11%）。为了利用依托泊苷疗效对给药方案的依赖性（较长的暴露时间更有利），针对该肿瘤开展了一项延长口服依托泊苷的II期试验。
入选标准包括子宫平滑肌肉瘤、可测量病灶、未曾接受过包含依托泊苷的化疗方案、白细胞计数≥3000/微升、血小板计数≥100,000/微升、血清肌酐≤2mg%以及肝功能正常。依托泊苷起始剂量为50mg/m²/天（既往接受过放疗的患者为30 - 40mg/m²/天），单次给药，持续21天，每28天为一个周期。根据毒性反应，将依托泊苷最大剂量增至60mg/m²/天。
36例患者参与了本研究；34例可评估毒性反应，29例可评估疗效。中位给药疗程为2个周期（范围1 - 14个周期）。4级中性粒细胞减少的发生率为20.6%，4级血小板减少的发生率为5.8%。1例患者在完成7个周期治疗后10个月发生急性髓系白血病。在可评估疗效的患者中，27例曾接受过化疗，6例曾接受过放疗。观察到2例部分缓解（缓解率为6.9%）。
该方案作为子宫平滑肌肉瘤的二线化疗方案疗效甚微。未显示出长期口服给药方案有任何益处。
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