Payne Miranda, Ellis Paul, Dunlop David, Ranson Malcolm, Danson Sarah, Schacter Lee, Talbot Denis
Cancer Research UK Oxford Cancer Centre, Oxford, UK.
J Thorac Oncol. 2006 Nov;1(9):984-90.
This prospective, open-label, non-randomized, multi-institutional phase II study was undertaken to assess the antitumor activity and safety of docosahexaenoic acid-paclitaxel (Taxoprexin) as first-line treatment of patients with advanced non-small cell lung cancer.
Chemotherapy-naive patients were eligible if they had measurable stage IIIB or IV non-small cell lung cancer. Forty-four patients received docosahexaenoic acid-paclitaxel by intravenous infusion every 21 days. Two doses were evaluated: 1100 mg/m and 900 mg/m. Patients were monitored for toxicity and tumor response.
Patients received between one and seven (median, two) cycles of treatment. Twenty-eight courses were administered in the cohort starting at 1100 mg/m and 109 courses at 900 mg/m. The starting dose was reduced to 900 mg/m because of toxicity in the first 13 patients. Subsequently, the most severe toxicity was neutropenia (grade III/IV in 68% of patients treated with 900 mg/m). Forty patients were eligible for assessment of tumor response. Two partial responses (4.5%) were documented, and a further 16 patients (36.4%) had stable disease based on an intent-to-treat analysis. The median duration of survival for all patients was 243 days (range, 154-359) and the 1-year survival rate was 35%.
As a single-agent, docosahexaenoic acid-paclitaxel has little activity in patients with advanced non-small cell lung cancer, with 18 patients (40.1%) achieving either stable disease or a partial response after treatment. Despite the low objective response rate, treatment was associated with survival comparable to that seen with standard platinum-based combination chemotherapy. The dose-limiting toxicity was myelosuppression.
本前瞻性、开放标签、非随机、多机构的II期研究旨在评估二十二碳六烯酸紫杉醇（Taxoprexin）作为晚期非小细胞肺癌患者一线治疗的抗肿瘤活性和安全性。
未接受过化疗的患者若患有可测量的IIIB期或IV期非小细胞肺癌则符合入组条件。44例患者每21天接受一次二十二碳六烯酸紫杉醇静脉输注。评估了两个剂量：1100mg/m²和900mg/m²。对患者进行毒性和肿瘤反应监测。
患者接受了1至7个（中位数为2个）周期的治疗。起始剂量为1100mg/m²的队列中给予了28个疗程，起始剂量为900mg/m²的队列中给予了109个疗程。由于前13例患者出现毒性反应，起始剂量降至900mg/m²。随后，最严重的毒性反应是中性粒细胞减少（在接受900mg/m²治疗的患者中，68%为III/IV级）。40例患者符合肿瘤反应评估条件。根据意向性分析，记录到2例部分缓解（4.5%），另有16例患者（36.4%）病情稳定。所有患者的中位生存期为243天（范围为154 - 359天），1年生存率为35%。
作为单一药物，二十二碳六烯酸紫杉醇在晚期非小细胞肺癌患者中的活性较低，治疗后有18例患者（40.1%）病情稳定或部分缓解。尽管客观缓解率较低，但该治疗与标准铂类联合化疗的生存率相当。剂量限制性毒性为骨髓抑制。
