Garewal H S, Robertone A, Salmon S E, Jones S E, Alberts D S, Brooks R
J Clin Oncol. 1984 Sep;2(9):1034-9. doi: 10.1200/JCO.1984.2.9.1034.
A phase I study of 4'deoxydoxorubicin (esorubicin) was performed on an every-21-day bolus intravenous (IV) schedule in 36 patients with advanced cancer. Thirty-four patients were evaluable for toxicity analysis. Toxicity included mild nausea, occasional local skin reactions, and mild to moderate alopecia. Myelo-suppression was dose limiting. Clinically evident congestive heart failure was not observed. However, two patients developed premature ventricular contractions. Overall, esorubicin was better tolerated than doxorubicin at equally potent doses. Although response analysis was not the primary objective of this phase I study, minor responses were observed in melanoma, breast cancer, lymphoma, and gastric cancer. On the basis of this study, a starting dose of 30 mg/m2 IV every 21 days is recommended for good-risk patients with escalation to 32.5 mg/m2 depending on bone marrow tolerance. For patients with poor bone marrow reserve, a starting dose of 25 mg/m2 every 21 days is recommended. Phase II trials with esorubicin in this dosage schedule are clearly warranted in a wide variety of metastatic neoplasms including a substantial population of patients who have not received prior chemotherapy.
对36例晚期癌症患者进行了一项关于4'-脱氧阿霉素（表柔比星）的I期研究，采用每21天一次的大剂量静脉注射（IV）方案。34例患者可进行毒性分析。毒性包括轻度恶心、偶尔的局部皮肤反应以及轻度至中度脱发。骨髓抑制是剂量限制性毒性。未观察到临床明显的充血性心力衰竭。然而，有2例患者出现室性早搏。总体而言，在同等有效剂量下，表柔比星的耐受性优于阿霉素。虽然反应分析不是这项I期研究的主要目的，但在黑色素瘤、乳腺癌、淋巴瘤和胃癌中观察到了轻微反应。基于这项研究，对于风险较低的患者，建议起始剂量为每21天静脉注射30mg/m²，根据骨髓耐受性可增至32.5mg/m²。对于骨髓储备较差的患者，建议起始剂量为每21天25mg/m²。显然有必要在包括大量未接受过先前化疗的患者在内的各种转移性肿瘤中，按照此剂量方案进行表柔比星的II期试验。
