Stanford University School of Medicine, Stanford, California.
Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California.
JAMA Otolaryngol Head Neck Surg. 2019 Dec 1;145(12):1160-1167. doi: 10.1001/jamaoto.2019.2381.
Clinicians frequently use radiotherapy with cetuximab over radiotherapy only or radiotherapy with cisplatin because of a perceived survival and tolerability advantage, but scant data are available to support this perception.
To measure the 3 aspects of value (quality, outcomes, and cost) in older patients receiving radiotherapy only, radiotherapy with cisplatin, or radiotherapy with cetuximab for locoregionally advanced head and neck cancer.
DESIGN, SETTING, AND PARTICIPANTS: For this cohort study, patient records were obtained from the Surveillance, Epidemiology, and End Results Program (SEER)-Medicare outcomes and claims database from January 1, 2004, to December 31, 2014. Participants were 65 years or older; received a diagnosis between 2006 and 2013 of stages III to IVB head and neck cancer; had only 1 cancer on record; and did not undergo surgical intervention. Data analysis was conducted from February 5, 2018, to March 27, 2019.
Patients were divided into exposure arms on the basis of their first-line therapy or identified chemoradiotherapy and radiotherapy regimen.
Overall survival was analyzed by propensity score matching Cox proportional hazards regression models, quality by measuring 90-day emergency department (ED) visit and inpatient admission rates, and costs by assessing 90-day total Medicare spending.
The overall cohort included 1091 patients, of whom 815 (74.7%) were male; the mean (SD) age was 73.9 (6.6) years. Patients receiving radiotherapy with cisplatin had higher overall survival compared with those receiving radiotherapy only (adjusted hazard ratio [HR], 0.64; 95% CI, 0.47-0.87). This finding was not seen in patients receiving radiotherapy with cetuximab (adjusted HR, 0.95; 95% CI, 0.75-1.20), compared with the radiotherapy only group, and it persisted after stratifying patients by age. The ED visit (adjusted incidence rate ratio [IRR], 1.72; 95% CI, 1.30-2.30) and inpatient admission (adjusted IRR, 1.48; 95% CI, 1.12-1.98) rates in the 90 days after treatment start were higher in patients receiving radiotherapy with cisplatin compared with those treated with radiotherapy only. Patients receiving radiotherapy with cetuximab had a higher rate of ED visits (adjusted IRR, 1.38; 95% CI, 1.05-1.82) compared with those in the radiotherapy only group. The 90-day after-treatment spending for patients receiving radiotherapy with cetuximab was $48 620 (95% CI, $46 466-$50 775) compared with $33 009 (95% CI, $31 499-$34 519) for radiotherapy with cisplatin and $27 622 (95% CI, $25 118-$30 126) for radiotherapy only.
In this cohort study, no survival difference, a higher rate of ED visits but not of inpatient admissions, and higher spending were observed in patients receiving radiotherapy with cetuximab compared with patients receiving radiotherapy only. The findings suggest that radiotherapy alone should be maintained as a treatment arm in evaluation of novel therapeutics for locoregionally advanced head and neck cancer in older and sicker patients.
临床医生经常使用西妥昔单抗联合放疗、顺铂联合放疗或单纯放疗治疗局部晚期头颈部癌,因为他们认为这样可以提高生存率和耐受性,但很少有数据支持这种观点。
测量在接受单纯放疗、顺铂联合放疗或西妥昔单抗联合放疗的局部晚期头颈部癌老年患者中,3 个方面的价值(质量、结果和成本)。
设计、地点和参与者:这项队列研究从 2004 年 1 月 1 日至 2014 年 12 月 31 日,从监测、流行病学和最终结果计划(SEER)-医疗保险结果和索赔数据库中获取患者记录。参与者为 65 岁或以上;在 2006 年至 2013 年间诊断为 III 期至 IVB 期头颈部癌;仅有 1 个记录的癌症;没有接受手术干预。数据分析于 2018 年 2 月 5 日至 2019 年 3 月 27 日进行。
根据患者的一线治疗或识别的放化疗方案,将患者分为暴露臂。
采用倾向评分匹配 Cox 比例风险回归模型分析总生存率,通过测量 90 天急诊(ED)就诊和住院入院率来衡量质量,通过评估 90 天总医疗保险支出来衡量成本。
整个队列包括 1091 名患者,其中 815 名(74.7%)为男性;平均(SD)年龄为 73.9(6.6)岁。与单纯放疗相比,接受顺铂联合放疗的患者总体生存率更高(调整后的危险比[HR],0.64;95%置信区间[CI],0.47-0.87)。在接受西妥昔单抗联合放疗的患者中没有发现这种情况(调整后的 HR,0.95;95%CI,0.75-1.20),与单纯放疗组相比,这种情况在按年龄分层的患者中仍然存在。与单纯放疗相比,治疗开始后 90 天内接受顺铂联合放疗的患者 ED 就诊(调整后的发病率比[IRR],1.72;95%CI,1.30-2.30)和住院入院(调整后的 IRR,1.48;95%CI,1.12-1.98)率更高。与单纯放疗组相比,接受西妥昔单抗联合放疗的患者 ED 就诊率更高(调整后的 IRR,1.38;95%CI,1.05-1.82)。接受西妥昔单抗联合放疗的患者在治疗后 90 天的花费为 48620 美元(95%CI,46466-50775),而接受顺铂联合放疗的患者为 33009 美元(95%CI,31499-34519),单纯放疗的患者为 27622 美元(95%CI,25118-30126)。
在这项队列研究中,与单纯放疗相比,接受西妥昔单抗联合放疗的患者没有生存差异,但 ED 就诊率较高,而住院入院率较低,且支出较高。这些发现表明,在评估局部晚期头颈部癌的新型治疗方法时,单纯放疗应作为治疗臂保留在老年和病情较重的患者中。