Tester W J, Jin P Y, Reardon D H, Cohn J B, Cohen M H
Albert Einstein Cancer Center, Philadelphia, Pennsylvania 19141-3098, USA.
Cancer. 1997 Feb 15;79(4):724-9.
Single-agent chemotherapy produces partial responses in the range of 7-27% in patients with Stage IV nonsmall cell lung carcinoma (NSCLC). Cisplatin-based combination regimens have achieved higher response rates but with significant toxicity. Two prior studies employing 24-hour infusions of paclitaxel showed responses of 21% and 24%. The purpose of this Phase II study was to determine the effects of paclitaxel administered by short duration infusions on response rate, toxicity, and quality of life (QOL) in patients with NSCLC.
Twenty patients with histologically proven Stage IV NSCLC were enrolled in this study. All were treated on an outpatient basis with standard premedication followed by paclitaxel 200 mg/m2 infused intravenously over 3 hours. Treatments were repeated every 21 days for a maximum of 6 cycles.
The objective response rate was 6/19 (32%; 95% confidence interval, 13-57%). The median duration of response was 6.0 months (range, 2-13 months). The median survival of the entire group was 6.0 months (range, 2-24+ months), and the 1-year survival rate was 22%. Toxicity was mild, with only one hospitalization required for treatment of catheter-related thrombosis. Nonresponding patients were found to have worsening Functional Assessment of Cancer Therapy (FACT)-G and FACT-L scores. Because this was a small clinical study, it did not demonstrate consistent improvement in FACT-G or FACT-L in responding patients.
Paclitaxel given as a 3-hour infusion is a well-tolerated, active single agent in the treatment of Stage IV NSCLC, worthy of further study. Baseline QOL scores predicted those more likely to respond to treatment, but changes in QOL status did not correlate well with objective response status.
单药化疗使IV期非小细胞肺癌（NSCLC）患者的部分缓解率在7%至27%之间。基于顺铂的联合方案已取得更高的缓解率，但毒性较大。两项先前采用24小时输注紫杉醇的研究显示缓解率分别为21%和24%。这项II期研究的目的是确定短时间输注紫杉醇对NSCLC患者的缓解率、毒性和生活质量（QOL）的影响。
20例经组织学证实为IV期NSCLC的患者入组本研究。所有患者均在门诊接受标准预处理，随后静脉输注200mg/m²紫杉醇，持续3小时。每21天重复治疗，最多6个周期。
客观缓解率为6/19（32%；95%置信区间，13 - 57%）。中位缓解持续时间为6.0个月（范围，2 - 13个月）。整个组的中位生存期为6.0个月（范围，2 - 24 +个月），1年生存率为22%。毒性较轻，仅1例因导管相关血栓形成住院治疗。未缓解患者的癌症治疗功能评估（FACT）-G和FACT-L评分恶化。由于这是一项小型临床研究，未显示缓解患者的FACT-G或FACT-L有持续改善。
3小时输注的紫杉醇是治疗IV期NSCLC耐受性良好的活性单药，值得进一步研究。基线QOL评分可预测更可能对治疗有反应的患者，但QOL状态的变化与客观缓解状态相关性不佳。
