Edmonson J H, Suman V J, Dalton R J, Bro W C, Gallenberg M M, Long H J, Levitt R, Hatfield A K, Krook J E, Mailliard J A, Gerstner J B
Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA.
Cancer Invest. 2001;19(6):597-602. doi: 10.1081/cnv-100104287.
Between March 1992 and November 1994, 91 patients with stage III and IV ovarian carcinoma were enrolled in a randomized comparative study of cyclophosphamide 600 mg/m2 plus carboplatin 300 mg/m2 vs. cyclophosphamide 600 mg/m2 plus carboplatin 600 mg/m2, each regimen given monthly for six cycles. Patients on the intensive regimen also received 10 micrograms/kg of granulocyte macrophage colony stimulating factor (GM-CSF) (molgramostim) daily for 14 days following each chemotherapy treatment. The study was closed prematurely because of very poor case accrual following the preliminary announcement (in May 1993) that paclitaxel appeared superior to cyclophosphamide in the platinum-based treatment of ovarian cancer. More than 4 years after our last case entry, we analyzed the survival results for the 44 eligible patients who received the conventional dose of carboplatin and the 43 eligible patients receiving our intensified dose of carboplatin. More than 90% of the treated patients receiving the conventional dose regimen received at least 75% of the planned doses at each of the six treatment intervals, whereas the percentage of treated patients able to receive at least 75% of the assigned intensive dose regimen had declined from 95% in cycle 2 to 53% by cycle 6. Furthermore, although 32 patients received all six planned cycles of treatment in the conventional regimen group, only 15 received all six cycles of the intensified regimen. Patients receiving the intensive regimen had more fever, dermatitis, lethargy, musculoskeletal pain, and pulmonary complications than did the conventional dose patients. Median survival times for the two treatment groups were very similar (38.5 and 38.1 months, respectively, for the conventional and intensive regimens), and we saw no evidence that the distribution of survival times differed between the treatment regimens (p = 0.95).
1992年3月至1994年11月期间，91例III期和IV期卵巢癌患者参加了一项随机对照研究，比较环磷酰胺600 mg/m²加卡铂300 mg/m²与环磷酰胺600 mg/m²加卡铂600 mg/m²的疗效，每种方案每月给药一次，共六个周期。强化方案组的患者在每次化疗后还接受14天的每日10微克/千克粒细胞巨噬细胞集落刺激因子（GM-CSF）（莫拉司亭）治疗。由于在初步宣布（1993年5月）紫杉醇在铂类治疗卵巢癌方面似乎优于环磷酰胺后病例积累非常少，该研究提前结束。在我们纳入最后一例病例4年多后，我们分析了44例接受常规剂量卡铂的合格患者和43例接受强化剂量卡铂的合格患者的生存结果。接受常规剂量方案治疗的患者中，超过90%在六个治疗间隔中的每个间隔至少接受了计划剂量的75%，而能够接受至少75%指定强化剂量方案的治疗患者百分比从第2周期的95%下降到第6周期的53%。此外，虽然常规方案组有32例患者接受了所有六个计划周期的治疗，但强化方案组只有15例患者接受了所有六个周期的治疗。接受强化方案的患者比接受常规剂量的患者有更多的发热、皮炎、嗜睡、肌肉骨骼疼痛和肺部并发症。两个治疗组的中位生存时间非常相似（常规方案组和强化方案组分别为38.5个月和38.1个月），并且我们没有发现证据表明治疗方案之间的生存时间分布存在差异（p = 0.95）。
