Bramwell V H, Mouridsen H T, Mulder J H, Somers R, Van Oosterom A T, Santoro A, Thomas D, Sylvester R, Markham D
Eur J Cancer Clin Oncol. 1983 Aug;19(8):1097-104. doi: 10.1016/0277-5379(83)90034-2.
Eighty-three patients with advanced soft tissue sarcoma who had received no prior chemotherapy entered a randomised phase II study comparing carminomycin (CMM) 20 mg/m2 with adriamycin (ADM) 75 mg/m2, both administered i.v. bolus every 3 weeks. Six patients were ineligible and response could not be evaluated in 6 additional patients. Thirty-eight evaluable patients received ADM and 33 received CMM. There was one complete response to ADM and 10 partial responses, an overall response rate of 29%. CMM showed significantly (P = 0.01) lower antitumour activity--one partial response (3%). Stabilisation of disease was similar in both arms (47 and 45%), but fewer patients progressed on ADM (24 compared to 52%). Durations of response dating from the start of chemotherapy were 5 months for complete remission on ADM, a median of 7 months (range 4-17) for partial response on ADM and 14 months for the one partial remission on CMM. Although the median time to progression for all patients receiving CMM (2 months) was significantly (P = 0.001) shorter than for those receiving ADM (5 months), patients on ADM had only a marginally significant longer duration of survival (P = 0.06) than the patients receiving CMM. A leucocyte nadir less than 2.0 X 10(9)/l occurred in 38% of patients receiving ADM and 43% receiving CMM. Anaemia and thrombocytopoenia were uncommon. Other toxicities such as nausea, vomiting, anorexia and alopecia were more severe in the ADM group. There was one infective death secondary to leucopoenia in the ADM arm, and one patient who had received 109 mg/m2 CMM + 255 mg/m2 ADM developed progressively fatal cardiomyopathy.
83例既往未接受过化疗的晚期软组织肉瘤患者进入一项随机II期研究，比较每3周静脉推注20mg/m²的卡米诺霉素（CMM）与75mg/m²的阿霉素（ADM）。6例患者不符合条件，另有6例患者的反应无法评估。38例可评估患者接受了ADM，33例接受了CMM。ADM有1例完全缓解和10例部分缓解，总缓解率为29%。CMM显示出显著更低的抗肿瘤活性（P = 0.01）——1例部分缓解（3%）。两组疾病稳定情况相似（47%和45%），但接受ADM治疗进展的患者较少（24%，而CMM组为52%）。从化疗开始计算的缓解持续时间，ADM完全缓解为5个月，ADM部分缓解的中位时间为7个月（范围4 - 17个月），CMM的1例部分缓解为14个月。尽管接受CMM的所有患者的中位进展时间（2个月）显著短于接受ADM的患者（5个月），但接受ADM的患者的生存时间仅略长于接受CMM的患者（P = 0.06）。接受ADM的患者中有38%白细胞最低点低于2.0×10⁹/L，接受CMM的患者中有43%。贫血和血小板减少不常见。ADM组恶心、呕吐、厌食和脱发等其他毒性更严重。ADM组有1例因白细胞减少继发感染死亡，1例接受了109mg/m² CMM + 255mg/m² ADM的患者发生进行性致命性心肌病。
