Tucker R D, Ferguson A, Van Wyk C, Sealy R, Hewitson R, Levin W
Cancer. 1978 May;41(5):1710-4. doi: 10.1002/1097-0142(197805)41:5<1710::aid-cncr2820410509>3.0.co;2-m.
A Phase II study of V.P. 16-213 administered to 47 patients suffering from small cell carcinoma of the bronchus. V.P. 16-213 was given as an intravenous infusion over 15 minutes daily for five consecutive days using 60 mg/m2/d at 14-day intervals. Oral V.P. in 100 mg doses was given twice a week between the intravenous courses. Objective response rate for this drug compared favourably with that of other single agents reported. All but two patients showed a degree of response to treatment and 24 of 47 patients showed a true objective response to treatment. The overall median survival of these patients was 225 days and localized disease 278 days. The quality of survival was such that responders lived relatively normal lives up to the latter stages of their disease. The majority of patients had a marked response in performance status, 37 out of 47 showing an improvement. Three patients are alive and well at more than 27 months. In all cases the side effects were minimal. Alopecia was common and reversible haematological complications occurred. Severe toxicity was not encountered and the drug was well tolerated with supportive antiemetic therapy at onset of treatment.
一项针对47例支气管小细胞癌患者使用V.P. 16 - 213的II期研究。V.P. 16 - 213以60mg/m²/d的剂量,在15分钟内静脉输注,每日一次,连续五天,间隔14天重复。在静脉疗程之间,每周两次给予100mg剂量的口服V.P.。该药物的客观缓解率与其他已报道的单一药物相比具有优势。除两名患者外,所有患者均对治疗有一定程度的反应,47例患者中有24例对治疗有真正的客观反应。这些患者的总体中位生存期为225天,局限性疾病患者为278天。生存质量良好,缓解者在疾病后期仍能相对正常地生活。大多数患者的体能状态有明显改善,47例中有37例有所改善。三名患者在27个月以上仍存活且状况良好。在所有病例中,副作用最小。脱发常见,血液学并发症可逆。未出现严重毒性反应,在治疗开始时给予支持性止吐治疗后,该药物耐受性良好。