Tropé C, Kaern J, Kristensen G, Rosenberg P, Sorbe B
Department of Gynecologic Oncology, Norwegian Radium Hospital, Oslo, Norway.
Ann Oncol. 1997 Aug;8(8):803-6. doi: 10.1023/a:1008230909599.
We wanted to assess the efficacy and toxicity of paclitaxel (Taxol) in previously untreated patients with advanced ovarian cancer. No such study had been performed at the time of initiation of this study.
The study population in this analysis consisted of 35 previously untreated stage III ovarian cancer patients, suboptimally resected at primary surgery. The initial paclitaxel dose was 175 mg/m2 given as a three-hour i.v. infusion every three weeks.
A total of 225 paclitaxel courses were given to 35 patients of whom 34 were evaluable for clinical response. Nine (26%) patients obtained a complete response to paclitaxel, ten (29%) a partial response, seven (21%) stable disease and eight (24%) had progressive disease. Thus, the total response rate to paclitaxel treatment was 55% (19 of 34). The median duration of response for the 19 responding patients was eight months (range 1-44.5+). The median duration for nine patients with clinical complete response was 16 months (range 2-44.5+). A second-look laparotomy was performed in 15 patients after six courses of paclitaxel. Of these, five obtained a histopathologically complete remission, five a partial remission and five stable disease. The five patients with pathologically complete remissions are alive with a median progressive-free survival of 24.5 months (range 15(+)-44.5+). The median progression-free survival for all patients was 6.1 months (range 1-44.5+). Toxicity consisted mainly of neutropenia, easily controlled. Other toxicities were myalgia/arthralgia and peripheral neuropathy. Three patients experienced a severe anaphylactic reaction during the first course.
This study showed that paclitaxel is an effective and safe drug for first-line treatment of ovarian cancer.
我们旨在评估紫杉醇（泰素）对既往未接受过治疗的晚期卵巢癌患者的疗效及毒性。在本研究启动时，尚未开展过此类研究。
本分析中的研究人群包括35例既往未接受过治疗的III期卵巢癌患者，这些患者在初次手术时肿瘤切除不彻底。紫杉醇初始剂量为175mg/m²，每三周静脉输注3小时。
35例患者共接受了225个紫杉醇疗程，其中34例可评估临床反应。9例（26%）患者对紫杉醇完全缓解，10例（29%）部分缓解，7例（21%）病情稳定，8例（24%）病情进展。因此，紫杉醇治疗的总缓解率为55%（34例中的19例）。19例缓解患者的中位缓解持续时间为8个月（范围1 - 44.5 +）。9例临床完全缓解患者的中位缓解持续时间为16个月（范围2 - 44.5 +）。15例患者在接受6个疗程紫杉醇治疗后进行了二次剖腹探查。其中，5例获得组织病理学完全缓解，5例部分缓解，5例病情稳定。5例病理完全缓解的患者存活，中位无进展生存期为24.5个月（范围15(+) - 44.5 +）。所有患者的中位无进展生存期为6.1个月（范围1 - 44.5 +）。毒性主要为中性粒细胞减少，易于控制。其他毒性包括肌痛/关节痛和周围神经病变。3例患者在第一个疗程中发生严重过敏反应。
本研究表明，紫杉醇是一线治疗卵巢癌的有效且安全的药物。
