Lee W R, Hall M C, McQuellon R P, Case L D, McCullough D L
Comprehensive Cancer Center of Wake Forest University School of Medicine, Winston-Salem, NC 27157-1030, USA.
Int J Radiat Oncol Biol Phys. 2001 Nov 1;51(3):614-23. doi: 10.1016/s0360-3016(01)01707-2.
To prospectively assess the health-related quality of life (HRQOL) and changes in HRQOL during the first year after 3 different treatments for clinically localized prostate cancer.
Ninety men with T1-T2 adenocarcinoma of the prostate were treated with curative intent between May 1998 and June 1999 and completed a quality-of-life Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire before treatment (T0) and 1 month (T1), 3 months (T3), and 12 months (T12) after treatment. Forty-four men were treated with permanent source interstitial brachytherapy (IB), 23 received external beam radiotherapy (EBRT), and 23 men were treated with radical prostatectomy (RP). The mean age of the entire study population was 65.9 years (median 67, range 42-79). The mean pretreatment prostate-specific antigen level of the entire study population was 6.81 ng/mL (median 6.25, range 1.33-19.6). The Gleason score was <or=6 in 65 (72%) of 90. The repeated measures analysis of variance and analysis of covariance were conducted on all quality-of-life and urinary outcome measures.
A comparison of the demographic characteristics of the 3 treatment groups demonstrated significant differences. The men treated with RP were significantly younger than the men in either the IB or EBRT group (median age 61.0 RP, 67.1 IB, 68.8 EBRT; p = 0.0006). The men in the IB group were more likely to have a Gleason score of <or=6 than the EBRT group (Gleason score <or=6, 86% IB and 48% EBRT; p = 0.015). The mean score (standard deviation) at T0, T1, T3, and T12 for the FACT-P questionnaire for each group was as follows: IB 138.4 (17.0), 120.5 (21.7), 130.0 (18.4), and 138.5 (14.2); EBRT 137.1 (12.1), 129.5 (21.0), 134.4 (19.2), and 136.9 (15.6); and RP 138.3 (14.7), 117.7 (18.3), 134.4 (17.8), and 140.4 (14.9), respectively. Statistically significant differences over time were observed for the FACT-P in the IB and RP groups (p <0.0001), but not for the EBRT group (p = 0.08). The examination of the subscales within the FACT-P instrument demonstrated statistically significant changes over time in the IB and RP groups for the following: physical well-being, functional well-being, and prostate cancer symptoms. After adjusting for age, race, T stage, Gleason score, use of hormonal therapy, and baseline FACT-P scores, statistically significant differences in the FACT-P score at T1 according to treatment group were observed. At T12, the FACT-P scores were not significantly different than the baseline FACT-P scores for any group.
The results of this analysis suggest that significant decreases in HRQOL, as measured by the FACT-P instrument, are evident in the first month after IB or RP, but not after EBRT. One year after treatment, however, the FACT-P scores were not statistically different from the baseline measures for any group. For all treatment groups, most of the HRQOL decreases were observed in the physical, functional, and prostate cancer-specific domains. These results suggest that the HRQOL changes are likely to be treatment-specific, further emphasizing the importance of a randomized trial comparing the different treatment options in this population of men.
前瞻性评估临床局限性前列腺癌三种不同治疗方法后第一年的健康相关生活质量(HRQOL)及HRQOL的变化。
1998年5月至1999年6月期间,90例前列腺T1-T2腺癌患者接受了根治性治疗,并在治疗前(T0)、治疗后1个月(T1)、3个月(T3)和12个月(T12)完成了癌症治疗功能评估-前列腺(FACT-P)生活质量问卷。44例患者接受永久性近距离间质内放疗(IB),23例接受外照射放疗(EBRT),23例接受前列腺癌根治术(RP)。整个研究人群的平均年龄为65.9岁(中位数67岁,范围42-79岁)。整个研究人群治疗前前列腺特异性抗原的平均水平为6.81 ng/mL(中位数6.25,范围1.33-19.6)。90例患者中65例(72%)的Gleason评分≤6。对所有生活质量和尿流结果指标进行重复测量方差分析和协方差分析。
三个治疗组的人口统计学特征比较显示出显著差异。接受RP治疗的患者比接受IB或EBRT治疗的患者明显年轻(RP组中位数年龄61.0岁,IB组67.1岁,EBRT组68.8岁;p = 0.0006)。IB组患者Gleason评分≤6的可能性高于EBRT组(Gleason评分≤6,IB组86%,EBRT组48%;p = 0.015)。每组FACT-P问卷在T0、T1、T3和T12时的平均得分(标准差)如下:IB组138.4(17.0)、120.5(21.7)、130.0(18.4)和138.5(14.2);EBRT组137.1(12.1)、129.5(21.0)、134.4(19.2)和136.9(15.6);RP组138.3(14.7)、117.7(18.3)、134.4(17.8)和140.4(14.9)。IB组和RP组的FACT-P得分随时间有统计学显著差异(p <0.0001),但EBRT组无差异(p = 0.08)。对FACT-P量表各子量表的检查显示,IB组和RP组在以下方面随时间有统计学显著变化:身体健康、功能健康和前列腺癌症状。在调整年龄、种族、T分期、Gleason评分、激素治疗的使用和基线FACT-P得分后,观察到治疗组在T1时FACT-P得分有统计学显著差异。在T12时,任何组的FACT-P得分与基线FACT-P得分无显著差异。
该分析结果表明,通过FACT-P量表测量,IB或RP治疗后第一个月HRQOL明显下降,但EBRT后未出现这种情况。然而,治疗一年后,任何组的FACT-P得分与基线测量值无统计学差异。对于所有治疗组,大多数HRQOL下降发生在身体、功能和前列腺癌特异性领域。这些结果表明,HRQOL的变化可能具有治疗特异性,进一步强调了在该男性人群中比较不同治疗方案的随机试验的重要性。