Chevallier B, Leyvraz S, Olivier J P, Fargeot P, Facchini T, Vo Van M L
Centre Régional de Lutte contre le Cancer, CRLCC, Rouen, France.
Cancer Invest. 1993;11(2):135-9. doi: 10.3109/07357909309024831.
Thirty patients with previously untreated and measurable or evaluable advanced soft tissue sarcoma entered this phase II study. Median age was 53 years (range: 24-71 years). Starting dose of Epirubicin was 100 mg/m2 IV bolus on day 1 combined with Ifosfamide, 2.5 g/m2, as a 6-hr IV infusion on day 1 and day 2 with uroprotection with Uromitexan, 1.6 g/m2, on day 1 and day 2. This schedule was repeated every 3 weeks. In case of minimal myelosuppression, the dose of Epirubicin was increased by 10 mg/m2 up to 130 mg/m2. Ifosfamide dosage was not increased. Mean cumulative dose of Epirubicin received was 477 +/- 272 mg/m2 (range: 200-1200 mg/m2). Of 27 evaluable patients (WHO criteria), 13 had a partial response (48%), 4 showed no change (15%), and 10 had progressive disease (37%). Median time to progression was 27 weeks. Of 27 patients evaluable for toxicity, hematological toxicity at day 21 was mild. Nonhematological toxicities consisted of nausea and vomiting in 82% of patients (WHO grade 3-4 = 19%), stomatitis in 44.5% (WHO grade 3 = 7.5%), and alopecia in 96% (WHO grade 2-3 = 89%). Appearance of cardiac dysfunction without heart failure during the treatment led to discontinuation of this chemotherapy in 3 patients. The results of this study show that the combination of Epirubicin and Ifosfamide is effective in advanced soft tissue sarcoma with an acceptable toxicity. However, we cannot conclude from this trial whether combination Epirubicin and Ifosfamide is superior to Epirubicin alone.
30例既往未接受过治疗且具有可测量或可评估的晚期软组织肉瘤患者进入了这项II期研究。中位年龄为53岁（范围：24 - 71岁）。表柔比星的起始剂量为100mg/m²，于第1天静脉推注，联合异环磷酰胺2.5g/m²，于第1天和第2天进行6小时静脉输注，第1天和第2天使用美司钠1.6g/m²进行尿路保护。该方案每3周重复一次。若骨髓抑制轻微，表柔比星剂量增加10mg/m²，直至130mg/m²。异环磷酰胺剂量不变。表柔比星的平均累积剂量为477±272mg/m²（范围：200 - 1200mg/m²）。在27例可评估患者（WHO标准）中，13例有部分缓解（48%），4例无变化（15%），10例病情进展（37%）。中位进展时间为27周。在27例可评估毒性的患者中，第21天的血液学毒性较轻。非血液学毒性包括82%的患者出现恶心和呕吐（WHO 3 - 4级 = 19%），44.5%的患者出现口腔炎（WHO 3级 = 7.5%），96%的患者出现脱发（WHO 2 - 3级 = 89%）。3例患者在治疗期间出现无心力衰竭的心脏功能障碍，导致该化疗方案停用。本研究结果表明，表柔比星与异环磷酰胺联合方案对晚期软组织肉瘤有效，毒性可接受。然而，我们无法从该试验得出表柔比星与异环磷酰胺联合方案是否优于单用表柔比星的结论。
