Frasci G, Tortoriello A, Facchini G, Conforti S, Cardone A, Persico G, Mastrantonio P, Iaffaioli R V
Cattedra di Oncologia Medica Università di Cagliari, Italy.
Gynecol Oncol. 1993 Jul;50(1):60-7. doi: 10.1006/gyno.1993.1165.
Forty-one ovarian cancer patients with less than 2 cm residual disease after systemic cisplatin-based chemotherapy received 4 courses of an ip regimen including cisplatin (75 mg/m2), mitoxantrone (20 mg/m2), and interferon-alpha 2b (30 mil IU/m2). The most important side effects were abdominal pain and fatigue. Overall 15/41 patients (37%) required narcotic analgesia for severe abdominal pain. In 1 case laparotomy was necessary due to bowel obstruction. Grade 3-4 myelotoxicity was observed in 18/41 patients (28 courses). No treatment-related death occurred. Pathological complete response (pCR) was achieved in 23/37 (62%) evaluable patients. Four-year disease-free survival was 50%, and no relapse occurred after 32 months. The estimated 4-year progression-free survival (PFS) and overall survival were 35 and 60%, respectively. Patients who achieved pCR showed significantly better survival than the others (P < 0.000). At multivariate Cox's analysis pCR achievement was the most important predictor of PFS (P < 0.005) and survival (P < 0.02). Age (< or = 60 vs > 60) and CA-125 serum levels at entry (normal vs increased) also showed independent predictive value. On the basis of multivariate analysis results we created a risk model for survival and PFS based on age and CA-125 at entry. We identified three subgroups of patients with significantly different outcomes. With this new ip combination long-term disease-free survival is achieved in a significant part of ovarian cancer patients with small tumor burden. A longer follow-up is needed to see whether it can cure some of these patients, and further comparisons with other ip or systemic regimens are needed to draw definitive conclusions about its role in these patients.
41例在接受以顺铂为基础的全身化疗后残留病灶小于2厘米的卵巢癌患者接受了4个疗程的腹腔内（ip）化疗方案，该方案包括顺铂（75毫克/平方米）、米托蒽醌（20毫克/平方米）和α-2b干扰素（3000万国际单位/平方米）。最重要的副作用是腹痛和疲劳。总体而言，41例患者中有15例（37%）因严重腹痛需要使用麻醉性镇痛药。有1例患者因肠梗阻需要进行剖腹手术。41例患者中有18例（28个疗程）观察到3-4级骨髓毒性。未发生与治疗相关的死亡。37例可评估患者中有23例（62%）实现了病理完全缓解（pCR）。4年无病生存率为50%，32个月后无复发。估计4年无进展生存率（PFS）和总生存率分别为35%和60%。实现pCR的患者生存率明显优于其他患者（P<0.000）。在多变量Cox分析中，实现pCR是PFS（P<0.005）和生存率（P<0.02）的最重要预测因素。年龄（≤60岁与>60岁）和入组时的CA-125血清水平（正常与升高）也显示出独立的预测价值。基于多变量分析结果，我们根据年龄和入组时的CA-125创建了一个生存和PFS风险模型。我们确定了三个预后明显不同的患者亚组。通过这种新的ip联合方案，相当一部分肿瘤负荷较小的卵巢癌患者实现了长期无病生存。需要更长时间的随访来观察它是否能治愈其中一些患者，并且需要与其他ip或全身化疗方案进行进一步比较，以得出关于其在这些患者中作用的明确结论。
