Zelkowitz R S, Posner M R, Cummings F, Beitz J, Weitberg A B
Division of Hematology/Oncology, Roger Williams General Hospital, Providence, RI 02908.
Am J Clin Oncol. 1989 Dec;12(6):491-3. doi: 10.1097/00000421-198912000-00006.
Twenty-two patients with metastatic colorectal carcinoma were treated in a Phase I-II study of combination therapy with 5-fluorouracil (5-FU) and etoposide (VP-16). Treatment consisted of weekly intravenous VP-16, 100-120 mg/M2, followed by 5-FU, 400-480 mg/M2, in 28-day cycles. Myelosuppression was the dose-limiting toxicity with a mean nadir leukocyte count of 3,600/mm3 and a mean nadir thrombocyte count of 101,000/mm3. There were no episodes of sepsis or bleeding. The tolerable dose for this regimen is VP-16, 110 mg/M2, and 5-FU, 440 mg/M2, weekly. A total of 63 cycles of chemotherapy were given. Although 10 patients had stabilization of disease, no partial or complete responses were documented. We conclude that there is no clinical support for the in vitro synergy observed with this combination. Further trials of this combination using this schedule in colorectal carcinoma are not indicated.
在一项关于5-氟尿嘧啶（5-FU）与依托泊苷（VP-16）联合治疗的I-II期研究中，对22例转移性结直肠癌患者进行了治疗。治疗方案为每周静脉注射VP-16，剂量为100 - 120mg/M²，随后静脉注射5-FU，剂量为400 - 480mg/M²，每28天为一个周期。骨髓抑制是剂量限制性毒性，平均最低白细胞计数为3600/mm³，平均最低血小板计数为101000/mm³。未发生败血症或出血事件。该方案的可耐受剂量为每周VP-16 110mg/M²和5-FU 440mg/M²。总共进行了63个化疗周期。尽管有10例患者病情稳定，但未记录到部分或完全缓解。我们得出结论，这种联合用药在体外观察到的协同作用没有临床依据。不建议在结直肠癌中按照此方案进一步试验这种联合用药。
