Moinpour Carol M, Hayden Katherine A, Unger Joseph M, Thompson Ian M, Redman Mary W, Canby-Hagino Edith D, Higgins Betsy A, Sullivan Jerry W, Lemmon Dianne, Breslin Sheila, Crawford E David
Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA 98109-1024, USA.
J Clin Oncol. 2008 Jan 1;26(1):112-20. doi: 10.1200/JCO.2006.10.4505.
To compare short- and long-term effects of adjuvant treatment versus observation after surgery on health-related quality of life (HRQL) of prostate cancer patients.
The Southwest Oncology Group (SWOG) intergroup trial compared radical prostatectomy (RP) plus observation versus RP plus adjuvant radiation therapy (RT). Two-hundred seventeen of 425 therapeutic trial patients were eligible and registered to the HRQL study. Patients completed the SWOG Quality of Life Questionnaire (emotional, physical, social, and role function; general symptom status; treatment/disease-specific symptoms; and global HRQL [GHRQL]) at baseline, 6 weeks, 6 months, and annually for 5 years. Prespecified outcomes were three genitourinary symptoms (bowel function tenderness, frequent urination, and erectile dysfunction [ED]) and measures of physical and emotional function. Adjustments were made for the baseline score.
Patients receiving adjuvant RT reported worse bowel function (through approximately 2 years) and worse urinary function. There were no statistically significant differences for ED. GHRQL was initially worse for the RP+RT arm but improved over time and was better at the end of the period than the GHRQL reported for RP alone (treatment arm x time interaction, P = .0004). Symptom distress was significantly worse for the RP+RT arm compared with the RP alone arm, but the treatment arms did not differ with respect to other general measures of HRQL.
The addition of RT to surgery resulted in more frequent urination, as well as early report of more bowel dysfunction, although bowel function differences disappeared over the 5-year period. The addition of RT did not negatively impact ED.
比较辅助治疗与术后观察对前列腺癌患者健康相关生活质量(HRQL)的短期和长期影响。
西南肿瘤协作组(SWOG)的组间试验比较了根治性前列腺切除术(RP)加观察与RP加辅助放射治疗(RT)的效果。425例治疗试验患者中有217例符合条件并登记参加HRQL研究。患者在基线、6周、6个月时以及之后每年共5年的时间里,完成SWOG生活质量问卷(包括情绪、身体、社会和角色功能;一般症状状态;治疗/疾病特异性症状;以及总体HRQL [GHRQL])。预先设定的结果是三种泌尿生殖系统症状(肠道功能压痛、尿频和勃起功能障碍[ED])以及身体和情绪功能的测量指标。对基线分数进行了调整。
接受辅助RT的患者报告肠道功能较差(持续约2年)且泌尿功能较差。ED方面无统计学显著差异。RP + RT组的GHRQL最初较差,但随时间改善,在研究期末比单独接受RP治疗组报告的GHRQL更好(治疗组×时间交互作用,P = .0004)。与单独接受RP治疗组相比,RP + RT组的症状困扰明显更严重,但在HRQL的其他一般测量指标方面,治疗组之间没有差异。
手术加RT导致尿频更频繁,且早期报告的肠道功能障碍更多,不过肠道功能差异在5年期间消失。添加RT对ED没有负面影响。