Bedikian A Y, Valdivieso M, Bodey G P, Freireich E J
Cancer Chemother Pharmacol. 1979;2(4):263-6. doi: 10.1007/BF00257192.
A phase II study of vindesine was carried out in 33 patients with colorectal cancer and nine patients with esophageal cancer. With the exception of six previously untreated patients with esophageal cancer, all others were refractory to 5-FU-containing regimens, w,hich included vincristine in ten patients. The initial dose of vindesine was 4 mg/m2 administered intravenously over 30 min every 2 weeks. Tumor regression less than 50% was set patients (six colorectal and two esophageal) achieved minor responses. Prior treatment with vincristine did not seem to influence response to vindesine. In general, the treatment with vindesine was well tolerated. The hematologic toxicity was acceptable and manifested mainly as moderate and transient neutropenia. The major nonhematologic toxicity was peripheral neuropathy, which became limiting. It occurred in 33% of patients who received two or more courses of vindesine. Because of the apparent antitumor activity and dose-limiting neurotoxicity of vindesine in this sutdy, further investigations of this compound should be conducted in combination chemotherapy programs for patients with metastatic gastrointestinal cancers.
对33例结直肠癌患者和9例食管癌患者进行了长春地辛的II期研究。除6例既往未接受过治疗的食管癌患者外，其他患者均对含5-氟尿嘧啶的方案耐药，其中10例患者的方案中包含长春新碱。长春地辛的初始剂量为4mg/m²，每2周静脉滴注30分钟。设定肿瘤退缩小于50%为无效，8例患者（6例结直肠癌和2例食管癌）取得轻微缓解。既往使用长春新碱治疗似乎不影响对长春地辛的反应。总体而言，长春地辛治疗耐受性良好。血液学毒性可接受，主要表现为中度和短暂性中性粒细胞减少。主要的非血液学毒性是周围神经病变，这成为剂量限制性毒性。在接受两个或更多疗程长春地辛治疗的患者中，33%发生了周围神经病变。鉴于本研究中长春地辛明显的抗肿瘤活性和剂量限制性神经毒性，应在转移性胃肠道癌患者的联合化疗方案中对该化合物进行进一步研究。
