Chauvergne J, Chinet-Charrot P, Stöckle E, Thomas L, Toulouse C
Institut Bergonié, Bordeaux, France.
Bull Cancer. 1996 Apr;83(4):315-23.
The objective of this phase II study was to determine the efficacy and toxicity of a combination of carboplatin and etoposide as salvage treatment, in previously treated patients with persistent or recurrent ovarian cancer following first-line cisplatin-based chemotherapy.
From July 1990 to August 1994, 58 patients were treated with 3-week cycles of chemotherapy consisting of carboplatin (200 mg/m2, D1) and etoposide (120 mg/m2, D1, D2). Criteria for evaluating previous response to cisplatin were strictly defined.
The overall response rate was 36%, with five complete responses (CR, 9%), 16 partial responses (PR, 27%) and the median duration of response was 10 months (range: 4 to 38). In the group of patients who progressed during the first year following the diagnosis, the response was 1 CR and 2 PR (12%) and in the group of patients who progressed from the second year after diagnosis, 4 CR and 14 PR (56%), with a median survival of 8.5 and 21 months respectively (p = 0.0013). The response rate was 59% in the potentially platinum sensitive group versus 8.7% in the primary resistant group (0.02 < p < 0.05). Myelotoxicity was the main side-effect but did not appear to be cumulative. Grade 3 and grade 4 anemia were observed in 26% and 3% of the patients respectively, neutropenia in 14% and 2% and thrombocytopenia in 14% and 8.5%. One patient died of sepsis associated with neutropenia.
Treatment was easily manageable and well tolerated. The advantage of carboplatin and etoposide combination in potentially responsive patients is represented by the reduced nephrotoxicity, neurotoxicity and ototoxicity as compared with cisplatin containing regimen, with durable feasibility in outpatients. This second-line chemotherapy for ovarian cancer is effective as salvage treatment in potentially responsive patients with late recurrent tumors, while paclitaxel is the drug of choice for patients who have developped primary or secondary resistance to platin therapy.
本II期研究的目的是确定卡铂和依托泊苷联合方案作为挽救治疗对先前接受以顺铂为基础的一线化疗后仍持续或复发的卵巢癌患者的疗效和毒性。
1990年7月至1994年8月，58例患者接受为期3周的化疗周期，化疗方案为卡铂（200mg/m²，第1天）和依托泊苷（120mg/m²，第1、2天）。严格定义了评估先前对顺铂反应的标准。
总缓解率为36%，5例完全缓解（CR，9%），16例部分缓解（PR，27%），中位缓解持续时间为10个月（范围：4至38个月）。在诊断后第一年内病情进展的患者组中，缓解情况为1例CR和2例PR（12%）；在诊断后第二年病情进展的患者组中，4例CR和14例PR（56%），中位生存期分别为8.5个月和21个月（p = 0.0013）。潜在铂敏感组的缓解率为59%，而原发耐药组为8.7%（0.02 < p < 0.05）。骨髓毒性是主要副作用，但似乎无累积性。分别有26%和3%的患者出现3级和4级贫血，14%和2%的患者出现中性粒细胞减少，14%和8.5%的患者出现血小板减少。1例患者死于与中性粒细胞减少相关的败血症。
治疗易于管理且耐受性良好。与含顺铂方案相比，卡铂和依托泊苷联合方案在潜在反应性患者中的优势在于肾毒性、神经毒性和耳毒性降低，且在门诊患者中具有持久的可行性。这种卵巢癌二线化疗作为挽救治疗对晚期复发肿瘤的潜在反应性患者有效，而紫杉醇是对铂类治疗产生原发或继发耐药的患者的首选药物。
