Teneriello Michael G, Tseng Paul C, Crozier Mark, Encarnacion Carlos, Hancock Kenneth, Messing Mark J, Boehm Kristi A, Williams Alicia, Asmar Lina
US Oncology Research, Houston, TX, USA.
J Clin Oncol. 2009 Mar 20;27(9):1426-31. doi: 10.1200/JCO.2008.18.9548. Epub 2009 Feb 17.
Patients with recurrent ovarian, peritoneal, or fallopian tube cancer have limited therapeutic options. There are no reports of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) in patients with recurrent platinum-sensitive disease. We report efficacy and toxicity with nab-paclitaxel in this group.
Forty-seven patients enrolled (44 assessable patients). Main inclusion criteria were histologically or cytologically confirmed epithelial cancer of the ovary, fallopian tube, or peritoneum (any stage, grade 2 to 3 if stage I) and measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) or elevated CA-125 (> 70 U/mL) in patients without measurable disease. Patients received nab-paclitaxel 260 mg/m(2) administered intravenously for 30 minutes on day 1 of a 21-day cycle for six cycles or until disease progression.
Median age was 65.5 years; 76% of patients had stage IIIC or IV disease, 81% had Eastern Cooperative Oncology Group performance status of 0, and 94% had prior surgery. For assessable patients, the objective response rate (ORR) was 64% (15 complete responses [CR] and 13 partial responses [PR] among 44 assessable patients). In patients evaluated with RECIST only, the ORR was 45% (one CR and four PR of 11 patients). In patients with only elevated CA-125, ORR was 82% (seven CRs and two PRs of 11 patients). In patients meeting both RECIST and CA-125 criteria, the ORR was 64% (seven CRs and seven PRs of 22 patients). Median time to response was 1.3 months (range, 0.5 to 4.8 months). Estimated median progression-free survival was 8.5 months. The most frequent grade 3 to 4 treatment-related toxicities were neutropenia (24%) and neuropathy (9%).
Nab-paclitaxel is active in this group of patients with recurrent ovarian, peritoneal, or fallopian tube cancer. The ORR was 64%. Toxicities were manageable. Further studies of nab-paclitaxel in combination with platinum are warranted.
复发性卵巢癌、腹膜癌或输卵管癌患者的治疗选择有限。目前尚无关于纳米白蛋白结合型紫杉醇（nab-紫杉醇）用于铂敏感复发性疾病患者的报道。我们报告了nab-紫杉醇在该组患者中的疗效和毒性。
47例患者入组（44例可评估患者）。主要纳入标准为组织学或细胞学确诊的卵巢、输卵管或腹膜上皮癌（任何分期，I期患者为2至3级），以及根据实体瘤疗效评价标准（RECIST）可测量的疾病，或无可测量疾病患者的CA-125升高（>70 U/mL）。患者接受nab-紫杉醇260 mg/m²静脉滴注30分钟，每21天为一个周期，第1天给药，共6个周期，或直至疾病进展。
中位年龄为65.5岁；76%的患者为IIIC期或IV期疾病，81%的患者东部肿瘤协作组体能状态为0，94%的患者曾接受过手术。对于可评估患者，客观缓解率（ORR）为64%（44例可评估患者中有15例完全缓解[CR]和13例部分缓解[PR]）。仅根据RECIST评估的患者中，ORR为45%（11例患者中有1例CR和4例PR）。仅CA-125升高的患者中，ORR为82%（11例患者中有7例CR和2例PR）。同时符合RECIST和CA-125标准的患者中，ORR为64%（22例患者中有7例CR和7例PR）。中位缓解时间为1.3个月（范围为0.5至4.8个月）。估计中位无进展生存期为8.5个月。最常见的3至4级治疗相关毒性为中性粒细胞减少（24%）和神经病变（9%）。
nab-紫杉醇对该组复发性卵巢癌、腹膜癌或输卵管癌患者有效。ORR为64%。毒性可控。有必要进一步研究nab-紫杉醇与铂类联合使用的情况。
