Hassett Michael J, O'Malley A James, Pakes Juliana R, Newhouse Joseph P, Earle Craig C
Center for Outcomes and Policy Research, Dana-Farber Cancer Institute, 44 Binney Street, 454-STE 21, Boston, MA 02115-6084, USA.
J Natl Cancer Inst. 2006 Aug 16;98(16):1108-17. doi: 10.1093/jnci/djj305.
The number, nature, and costs of serious adverse effects experienced by younger women receiving chemotherapy for breast cancer outside of clinical trials are unknown.
From a database of medical claims made by individuals with employer-provided health insurance between January 1998 and December 2002, we identified 12,239 women 63 years of age or younger with newly diagnosed breast cancer, of whom 4075 received chemotherapy during the 12 months after the initial breast cancer diagnosis and 8164 did not. Diagnostic codes for eight chemotherapy-related adverse effects were identified. Total hospitalizations for all causes, hospitalizations or emergency room visits for adverse effects that are typically related to chemotherapy, and health care expenditures were compared between the two groups of women. All statistical tests were two-sided.
Women who received chemotherapy were more likely than those who did not to be hospitalized or to visit the emergency room for all causes (61% versus 42%; mean difference = 19%, 95% confidence interval [CI] = 16.7% to 21.3%, P<.001) and for chemotherapy-related serious adverse effects (16% versus 5%, mean difference = 11%, 95% CI = 9.6% to 12.4%, P<.001). The percentages of chemotherapy recipients who were hospitalized or visited the emergency room during the year after their breast cancer diagnosis were 8.4% for fever or infection; 5.5% for neutropenia or thrombocytopenia; 2.5% for dehydration or electrolyte disorders; 2.4% for nausea, emesis, or diarrhea; 2.2% for anemia; 2% for constitutional symptoms; 1.2% for deep venous thrombosis or pulmonary embolus; and 0.9% for malnutrition. Chemotherapy recipients incurred large incremental expenditures for chemotherapy-related serious adverse effects (1271 dollars per person per year) and ambulatory encounters (17,617 dollars per person per year).
Chemotherapy-related serious adverse effects among younger, commercially insured women with breast cancer may be more common than reported by large clinical trials and lead to more patient suffering and health care expenditures than previously estimated.
在临床试验之外，接受乳腺癌化疗的年轻女性所经历的严重不良反应的数量、性质和费用尚不清楚。
从1998年1月至2002年12月有雇主提供医疗保险的个人医疗理赔数据库中，我们识别出12239名63岁及以下新诊断为乳腺癌的女性，其中4075名在首次乳腺癌诊断后的12个月内接受了化疗，8164名未接受化疗。确定了八种与化疗相关不良反应的诊断编码。比较了两组女性因各种原因的总住院次数、与化疗通常相关不良反应的住院或急诊就诊次数以及医疗保健支出。所有统计检验均为双侧检验。
接受化疗的女性因各种原因住院或急诊就诊的可能性高于未接受化疗的女性（61%对42%；平均差异=19%，95%置信区间[CI]=16.7%至21.3%，P<0.001），因化疗相关严重不良反应住院或急诊就诊的可能性也更高（16%对5%，平均差异=11%，95%CI=9.6%至12.4%，P<0.001）。乳腺癌诊断后一年内，接受化疗的患者因发热或感染住院或急诊就诊的比例为8.4%；因中性粒细胞减少或血小板减少为5.5%；因脱水或电解质紊乱为2.5%；因恶心、呕吐或腹泻为2.4%；因贫血为2.2%；因全身症状为2%；因深静脉血栓形成或肺栓塞为1.2%；因营养不良为0.9%。接受化疗的患者因化疗相关严重不良反应（每人每年1271美元）和门诊就诊（每人每年17617美元）产生了大量额外支出。
在患有乳腺癌的年轻商业保险女性中，与化疗相关的严重不良反应可能比大型临床试验报告的更为常见，并且导致的患者痛苦和医疗保健支出比先前估计的更多。
