Wang Yun, Herrstedt Jørn, Havsteen Hanne, DePoint Christensen Rene, Mirza Mansoor Raza, Lund Bente, Maenpaa Johanna, Kristensen Gunnar
Department of Gynecologic Oncology, Norwegian Radium Hospital, Oslo University Hospital, PB 4953 Nydalen 0424, Oslo, Norway.
BMC Cancer. 2014 Dec 11;14:937. doi: 10.1186/1471-2407-14-937.
In patients with ovarian cancer relapsing at least 6 months after end of primary treatment, the addition of paclitaxel to platinum treatment has been shown to improve survival but at the cost of significant neuropathy. In the first line setting, the carboplatin-docetaxel combination was as effective as the combination of carboplatin and paclitaxel but with less neurotoxicity. This study was initiated to evaluate the feasibility of carboplatin with docetaxel as second line treatment in patients with ovarian, peritoneal or fallopian tube cancer.
Patients with stage IC-IV epithelial ovarian, peritoneal or fallopian tube cancer were enrolled at the first relapse after at least 6 months since completion of the first line treatment. Docetaxel 75 mg/m2 was given as an one hour IV infusion followed immediately by carboplatin (AUC=5) given as a 30-60 min. IV infusion on day 1 and repeated every 3 weeks for 6-9 courses. Primary endpoint was toxicity; secondary endpoints were response rate and the time to progression.
A total of 74 patients were included. Of these, 50 patients received 6 or more cycles, 13 received 3-5 courses and 11 received less than 3 courses. A total of 398 cycles were given. Grade 3/4 neutropenia was seen in 80% (59 of 74) patients with an incidence of febrile neutropenia of 16%. Grade 2/3 sensory peripheral neuropathy occurred in 7% of patients, but no grade 4 sensory peripheral neuropathy was observed. Sixty patients were evaluable for response. The overall response rate was 70% with 28% complete responses in the response evaluable patient population. Median progression-free survival was 12.4 months (95% CI 10.4-14.4).
The three-weekly regimen of docetaxel in combination with carboplatin was feasible and active as second-line treatment of platinum-sensitive ovarian, peritoneal and Fallopian tube cancer. The major toxicity was neutropenia, while the frequency of peripheral neuropathy was low.
在初次治疗结束后至少6个月复发的卵巢癌患者中，铂类治疗联合紫杉醇已显示可提高生存率，但代价是严重的神经病变。在一线治疗中，卡铂-多西他赛联合方案与卡铂和紫杉醇联合方案效果相当，但神经毒性较小。本研究旨在评估卡铂联合多西他赛作为卵巢癌、腹膜癌或输卵管癌患者二线治疗的可行性。
IC-IV期上皮性卵巢癌、腹膜癌或输卵管癌患者在一线治疗完成后至少6个月首次复发时入组。多西他赛75mg/m²静脉输注1小时，随后立即静脉输注卡铂（AUC = 5）30 - 60分钟，于第1天给药，每3周重复一次，共6 - 9个疗程。主要终点是毒性；次要终点是缓解率和疾病进展时间。
共纳入74例患者。其中，50例患者接受了6个或更多周期的治疗，13例接受了3 - 5个疗程，11例接受的疗程少于3个。总共进行了398个周期的治疗。80%（74例中的59例）患者出现3/4级中性粒细胞减少，发热性中性粒细胞减少的发生率为16%。7%的患者出现2/3级感觉性周围神经病变，但未观察到4级感觉性周围神经病变。60例患者可评估缓解情况。在可评估缓解的患者群体中，总体缓解率为70%，完全缓解率为28%。无进展生存期的中位数为12.4个月（95%CI 10.4 - 14.4）。
多西他赛联合卡铂每三周一次的方案作为铂敏感型卵巢癌、腹膜癌和输卵管癌的二线治疗是可行且有效的。主要毒性是中性粒细胞减少，而周围神经病变的发生率较低。
