Cole Bernard F, Glantz Michael J, Jaeckle Kurt A, Chamberlain Marc C, Mackowiak John I
Department of Community and Family Medicine, Dartmouth Medical School, Lebanon, New Hampshire, USA.
Cancer. 2003 Jun 15;97(12):3053-60. doi: 10.1002/cncr.11449.
The authors compared the quality of life of patients with solid tumor neoplastic meningitis treated in a controlled trial that compared conventional intrathecal methotrexate with a depot cytosine arabinoside liposomal injection (DepoCyt). The authors evaluated the trade-off between toxicity and improved clinical outcome.
Quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis was used to evaluate data collected prospectively from a randomized clinical trial that compared DepoCyt with methotrexate. Sixty-one patients with confirmed solid tumor neoplastic meningitis were randomized to receive either methotrexate or DepoCyt.
Within the 12-month follow-up, the average patient in the DepoCyt arm (compared with the methotrexate arm) achieved 71 more days of neurologic progression-free survival and 52 more days of overall survival, but experienced slightly more days with toxicity. The DepoCyt regimen provided greater quality-adjusted survival regardless of the quality-of-life valuations placed on time with toxicity and time following disease progression (range, 44-79 days). This gain was significant (P < 0.05) for all patients except for those who placed a high relative value on time following disease progression.
The clinical benefits of DepoCyt offset a trend toward additional toxicity among patients with sold tumor neoplastic meningitis. The magnitude of the benefit depends on how the patient values time spent in toxicity and disease progression. The results of this analysis can be used at the bedside to make evidence-based individual treatment decisions.
作者在一项对照试验中比较了实体瘤性脑膜炎患者的生活质量,该试验对比了传统鞘内注射甲氨蝶呤与阿糖胞苷脂质体长效注射剂(DepoCyt)。作者评估了毒性与改善临床结局之间的权衡。
采用质量调整无症状或毒性时间(Q-TWiST)分析来评估从一项将DepoCyt与甲氨蝶呤进行比较的随机临床试验中前瞻性收集的数据。61例确诊为实体瘤性脑膜炎的患者被随机分配接受甲氨蝶呤或DepoCyt治疗。
在12个月的随访期内,DepoCyt组的平均患者(与甲氨蝶呤组相比)无神经功能进展生存期多了71天,总生存期多了52天,但毒性反应的天数略多。无论对毒性期和疾病进展后的时间给予何种生活质量评估(范围为44 - 79天),DepoCyt方案均能提供更高的质量调整生存期。除了那些对疾病进展后的时间给予较高相对价值的患者外,所有患者的这一获益均具有统计学意义(P < 0.05)。
DepoCyt的临床益处抵消了实体瘤性脑膜炎患者额外毒性增加的趋势。获益程度取决于患者对毒性期和疾病进展期时间的重视程度。该分析结果可用于床边决策,以做出基于证据的个体化治疗决策。