Frasci G, Tortoriello A, Facchini G, Conforti S, Persico G, Mastrantonio P, Cardone A, Iaffaioli R V
Cattedra di Oncologia Medica Università di Cagliari, Italy.
Eur J Cancer. 1994;30A(7):946-50. doi: 10.1016/0959-8049(94)90120-1.
21 untreated ovarian cancer patients with stage III and minimal tumour size, were given weekly intraperitoneal (i.p.) carboplatin (150 mg/m2) and alpha-2b interferon (IFN) (30 million U/m2) for a total of 12 courses, from June 1989 to February 1993. To date, a total of 248 courses have been administered. Toxicity was seldom severe, although fever (179 courses), fatigue (141 courses) and other IFN-related side-effects were very frequent. No patient refused to continue treatment, but in 5 patients IFN dose had to be reduced, and in 1 it was discontinued. The IFN mean delivered dose intensity was 19.8 million U/m2 week. Grade 3-4 myelotoxicity occurred in 7 patients (39 courses), but no deaths related to treatment occurred. The actual mean dose intensity of carboplatin was 121.5 mg/m2 week. To date, 20 patients have completed treatment and are evaluable for response. Of 11 patients with tumour size < or = 5 mm, 10 (91%) achieved a pathological complete response (pCR) as did 4/9 (44%) of those with tumour > 5 mm at entry, for a 70% (95% confidence interval 50-90) overall pCR rate. At a median follow-up of 21 months (range 4-46), only one death occurred. The probability of being alive at almost 4 years was 91% in the entire group (100% in those with tumour size less than 5 mm). Only 1 of 14 patients who achieved a pCR relapsed. This i.p. combination seems a feasible approach to previously untreated ovarian cancer patients with minimal tumour burden. IFN dosage should be reduced to improve tolerance. In view of the very high pCR rate achieved in the group of patients with smaller tumours, a randomised trial is warranted to compare this approach to standard treatment in these patients.
1989年6月至1993年2月期间，21例未经治疗的III期且肿瘤体积最小的卵巢癌患者接受了每周一次的腹腔内（i.p.）卡铂（150mg/m²）和α-2b干扰素（IFN）（3000万U/m²）治疗，共12个疗程。迄今为止，共进行了248个疗程的治疗。毒性反应很少严重，尽管发热（179个疗程）、疲劳（141个疗程）及其他与IFN相关的副作用非常常见。没有患者拒绝继续治疗，但有5例患者不得不减少IFN剂量，1例患者停止使用IFN。IFN的平均给药剂量强度为1980万U/m²·周。7例患者（39个疗程）发生3-4级骨髓毒性，但未发生与治疗相关的死亡。卡铂的实际平均剂量强度为121.5mg/m²·周。迄今为止，20例患者已完成治疗并可进行疗效评估。在11例肿瘤大小≤5mm的患者中，10例（91%）达到病理完全缓解（pCR），初始肿瘤>5mm的9例患者中有4例（44%）达到pCR，总体pCR率为70%（95%置信区间50-90）。在中位随访21个月（范围4-46个月）时，仅发生1例死亡。整个组在近4年时的存活概率为91%（肿瘤大小小于5mm的患者为100%）。达到pCR的14例患者中仅1例复发。这种腹腔内联合治疗似乎是治疗先前未经治疗且肿瘤负荷最小的卵巢癌患者的一种可行方法。应减少IFN剂量以提高耐受性。鉴于肿瘤较小的患者组中达到的非常高的pCR率，有必要进行一项随机试验，以比较这种方法与这些患者的标准治疗。
