Esselen Katharine M, Cronin Angel M, Bixel Kristin, Bookman Michael A, Burger Robert A, Cohn David E, Cristea Mihaela, Griggs Jennifer J, Levenback Charles F, Mantia-Smaldone Gina, Meyer Larissa A, Matulonis Ursula A, Niland Joyce C, Sun Charlotte, O'Malley David M, Wright Alexi A
Division of Gynecologic Oncology, Department of Obstetrics/Gynecology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.
Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
JAMA Oncol. 2016 Nov 1;2(11):1427-1433. doi: 10.1001/jamaoncol.2016.1842.
A 2009 randomized clinical trial demonstrated that using cancer antigen 125 (CA-125) tests for routine surveillance in ovarian cancer increases the use of chemotherapy and decreases patients' quality of life without improving survival, compared with clinical observation. The Society of Gynecologic Oncology guidelines categorize CA-125 testing as optional and discourage the use of radiographic imaging for routine surveillance. To date, few studies have examined the use of CA-125 tests in clinical practice.
To examine the use of CA-125 tests and computed tomographic (CT) scans in clinical practice before and after the 2009 randomized clinical trial and to estimate the economic effect of surveillance testing.
DESIGN, SETTING, AND PARTICIPANTS: A prospective cohort of 1241 women with ovarian cancer in clinical remission after completion of primary cytoreductive surgery and chemotherapy at 6 National Cancer Institute-designated cancer centers between January 1, 2004, and December 31, 2011, was followed up through December 31, 2012, to study the use of CA-125 tests and CT scans before and after 2009. Data analysis was conducted from April 9, 2014, to March 28, 2016.
The use of CA-125 tests and CT scans before and after 2009. Secondary outcomes included the time from CA-125 markers doubling to retreatment among women who experienced a rise in CA-125 markers before and after 2009, and the costs associated with surveillance testing using 2015 Medicare reimbursement rates.
Among 1241 women (mean [SD] age 59 [12] years; 1112 white [89.6%]), the use of CA-125 testing and CT scans was similar during the study period. During 12 months of surveillance, the cumulative incidence of patients undergoing 3 or more CA-125 tests was 86% in 2004-2009 vs 91% in 2010-2012 (P = .95), and the cumulative incidence of patients undergoing more than 1 CT scan was 81% in 2004-2009 vs 78% in 2010-2012 (P = .50). Among women whose CA-125 markers doubled (n = 511), there was no significant difference in the time to retreatment with chemotherapy before and after 2009 (median, 2.8 vs 3.5 months; P = .40). During a 12-month period, there was a mean of 4.6 CA-125 tests and 1.7 CT scans performed per patient, resulting in a US population surveillance cost estimate of $1 999 029 per year for CA-125 tests alone and $16 194 647 per year with CT scans added.
CA-125 tests and CT scans are still routinely used for surveillance testing in patients with ovarian cancer, although their benefit has not been proven and their use may have significant implications for patients' quality of life as well as costs.
2009年一项随机临床试验表明,与临床观察相比,使用癌抗原125(CA - 125)检测对卵巢癌进行常规监测会增加化疗的使用,降低患者生活质量,且并未提高生存率。妇科肿瘤学会指南将CA - 125检测归类为可选项,并不鼓励将影像学检查用于常规监测。迄今为止,很少有研究探讨CA - 125检测在临床实践中的应用情况。
研究2009年随机临床试验前后CA - 125检测和计算机断层扫描(CT)在临床实践中的应用情况,并评估监测检测的经济影响。
设计、设置和参与者:对2004年1月1日至2011年12月31日期间在6家美国国立癌症研究所指定的癌症中心完成初次肿瘤细胞减灭术和化疗后处于临床缓解期的1241例卵巢癌女性进行前瞻性队列研究,随访至2012年12月31日,以研究2009年前后CA - 125检测和CT扫描的使用情况。数据分析于2014年4月9日至2016年3月28日进行。
2009年前后CA - 125检测和CT扫描的使用情况。次要结局包括2009年前后CA - 125标志物翻倍的女性从CA - 125标志物翻倍到再次接受治疗的时间,以及使用2015年医疗保险报销费率计算的监测检测相关费用。
在1241例女性(平均[标准差]年龄59[12]岁;1112例为白人[89.6%])中,研究期间CA - 125检测和CT扫描的使用情况相似。在12个月的监测期内,2004 - 2009年接受3次或更多次CA - 125检测的患者累积发生率为86%,2010 - 2012年为91%(P = 0.95);接受1次以上CT扫描的患者累积发生率2004 - 2009年为81%,2010 - 2012年为78%(P = 0.50)。在CA - 125标志物翻倍的女性(n = 511)中,2009年前后再次接受化疗的时间无显著差异(中位数,2.8个月对3.5个月;P = 0.40)。在12个月期间,每位患者平均进行4.6次CA - 125检测和1.7次CT扫描,仅CA - 125检测一项美国人群监测成本估计为每年1999029美元,加上CT扫描则为每年16194647美元。
CA - 125检测和CT扫描仍常规用于卵巢癌患者的监测检测,尽管其益处尚未得到证实,且其使用可能对患者生活质量和成本产生重大影响。