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Treatment, Survival, and Costs of Laryngeal Cancer Care in the Elderly

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The Laryngoscope VC 2014 The American Laryngological, Rhinological and Otological Society, Inc. Treatment, Survival, and Costs of Laryngeal Cancer Care in the Elderly Christine G. Gourin, MD, MPH; Sydney
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The Laryngoscope VC 2014 The American Laryngological, Rhinological and Otological Society, Inc. Treatment, Survival, and Costs of Laryngeal Cancer Care in the Elderly Christine G. Gourin, MD, MPH; Sydney M. Dy, MD, MSc; Robert J. Herbert, BS; Amanda L. Blackford, ScM; Harry Quon, MD; Arlene A. Forastiere, MD; David W. Eisele, MD; Kevin D. Frick, PhD Objectives/Hypothesis: To examine associations between treatment and volume with survival and costs in elderly patients with laryngeal squamous cell cancer (SCCA). Study Design: Retrospective cross-sectional analysis of Surveillance, Epidemiology, and End Results Medicare data. Methods: We evaluated 2,370 patients diagnosed with laryngeal SCCA from 2004 to 2007 using cross-tabulations, multivariate logistic and generalized linear regression modeling, and survival analysis. Results: Chemoradiation was significantly associated with supraglottic tumors (relative risk ratio: 2.6, 95% confidence interval [CI]: ), additional cancer-directed treatment (odds ratio [OR]: 1.8, 95% CI: ), and a reduced likelihood of surgical salvage (OR: 0.3, 95% CI: ). Surgery with postoperative radiation was associated with significantly improved survival (hazard ratio [HR]: 0.7, 95% CI: ), after controlling for patient and tumor variables including salvage. Highvolume care was not associated with survival for nonoperative treatment but was associated with improved survival (HR: 0.7, 95% CI: ) among surgical patients. Initial treatment and 5-year overall costs for chemoradiation were higher than for all other treatment categories. High-volume care was associated with significantly lower costs of care for surgical patients but was not associated with differences in costs of care for nonoperative treatment. Conclusions: Chemoradiation in elderly patients with laryngeal cancer was associated with increased costs, additional cancer-directed treatment, and a reduced likelihood of surgical salvage. Surgery with postoperative radiation was associated with improved survival in this cohort, and high-volume hospital surgical care was associated with improved survival and lower costs. These findings have implications for improving the quality of laryngeal cancer treatment at a time of both rapid growth in the elderly population and diminishing healthcare resources. Key Words: Laryngeal neoplasms, squamous cell cancer, treatment, surgery, radiation, chemotherapy, survival, costs, Surveillance, Epidemiology, and End Results Medicare, elderly. Level of Evidence: 2c Laryngoscope, 124: , 2014 INTRODUCTION The use of chemoradiation in the treatment of larynx cancer was established by the Veterans Affairs Laryngeal Cancer Study Group in 1991, followed by the Radiation Therapy Oncology Group (RTOG) Trial Additional Supporting Information may be found in the online version of this article. From the Department of Otolaryngology Head and Neck Surgery (C.G.G., D.W.E.), Johns Hopkins Medicine, Baltimore, Maryland, Maryland; Department of Oncology (S.M.D., A.L.B., A.A.F.), Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine, Baltimore, Maryland; Department of Health Policy and Management (S.M.D., R.J.H., K.D.F.), Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Department of Radiation Oncology and Molecular Radiation Sciences (H.Q.), Johns Hopkins Medicine, Baltimore, Maryland; and the Johns Hopkins Carey Business School (K.D.F.), Baltimore, Maryland, U.S.A. Editor s Note: This Manuscript was accepted for publication December 24, This work was supported by an American Academy of Otolaryngology Head and Neck Surgery Percy Memorial Research Award. The authors have no other funding, financial relationships, or conflicts of interest to disclose. Send correspondence to Christine G. Gourin, MD, Johns Hopkins Outpatient Center, Department of Otolaryngology Head and Neck Surgery, 601 N. Caroline Street, Suite 6260, Baltimore, MD DOI: /lary in These randomized, controlled clinical trials showed that larynx preservation was possible in patients with advanced laryngeal cancer using chemoradiation, and have changed practice patterns in both academic and community centers, with an increase in the use of chemoradiation for laryngeal cancer and a decrease in the use of primary surgery. 4 7 Elderly patients with larynx cancer have generally been under-represented in larynx preservation clinical trials, 1,2,8,9 have poorer survival, 10 may benefit less from the addition of chemotherapy to radiation, 11 and may have greater treatment-related toxicity, 12 leading the Larynx Preservation Consensus Panel to suggest that future phase III clinical trials of larynx preservation in advanced laryngeal cancer exclude patients over 70 years of age. 13 However, age does not factor into treatment guidelines for larynx cancer care endorsed by the American Society of Clinical Oncology, which recommends organ preservation as appropriate, standard treatment for the majority of patients with laryngeal cancer. 14 The United States Census Bureau projects that the population aged 65 years and older will increase by 36% in the next 10 years and double by The passage of the Affordable Care Act reduces the rate of growth of Medicare 1827 spending to 5% per year; however, by 2020 Medicare spending is projected to grow to 7% per year, exceeding the average annual growth rate of the gross domestic product. 16 Assuming a compounded 5% increase in costs per year, the costs of treating head and neck cancer in the elderly will increase by 80% by Given the growth in the aging population and changes in practice patterns, there is a need for contemporary estimates of survival and costs of larynx cancer care in the elderly to inform healthcare reform efforts. The objective of this study was to examine the association between treatment and hospital volume with survival and costs in elderly patients undergoing definitive treatment for laryngeal cancer. MATERIALS AND METHODS Data Source A cross-sectional analysis of patients diagnosed with larynx cancer in 2004 to 2007 was performed using discharge data from the Surveillance, Epidemiology, and End Results (SEER) Medicare linked database. The SEER data are a combination of population-based registries and are linked with Medicare data and data from the American Medical Association Masterfile through a collaborative effort that involves the National Cancer Institute (NCI), the SEER registries, and the Centers for Medicare and Medicaid Services. Study Population Patients with larynx (SEER site code 38) squamous cell cancer without a previous diagnosis of head and neck cancer (01-10, 37, 38, and 41) or lymphoma (68-69, 71-72) comprised the study population. Patients with in situ disease, distant metastatic disease, diagnosis by autopsy or death certificate, and less than 1 year of continuous claims were excluded from analysis, as were patients enrolled in Medicare health maintenance organizations, because health maintenance organizations do not generate claims for their care. Analyses were restricted to Medicare Part A and B enrollees in the SEER Medicare data aged 66 years and older to include patients who were enrolled continuously in Medicare s fee-for-service program from 365 days prior to the time of diagnosis, to allow identification of prevalent comorbid conditions prior to diagnosis. Patients were followed through December 2009 until the end of data (ineligibility or end of claims) or death. Variables Primary site, American Joint Committee on Cancer stage, subsite, age, sex, ethnicity, US Census tract median income, marital status, geographic region, urban/rural location, and hospital characteristics were obtained from the SEER Patient Entitlement and Diagnosis Summary File. Age, marital status, location, and income were examined as categorical variables, with Census tract median income divided into quintiles. Preexisting chronic conditions identified in claims from 365 days prior to diagnosis were used to calculate a comorbidity index using the Charlson score 18 as implemented by Deyo et al. 19 and modified by Klabunde et al. 20 Treatment Treatment was ascertained using Medicare claims files including physician (National Claims History), hospital (Medicare Provider Analysis and Review), outpatient and hospice claims files using International Classification of Disease, 9th revision codes, Current Procedural Terminology codes, and Healthcare Common Procedure Coding System codes for treatment. Initial treatment was categorized as surgery only, surgery with postoperative radiation (including postoperative chemoradiation), radiation only, or chemoradiation based on treatment claims provided within the first 180 days following diagnosis. Patients undergoing chemotherapy only or no treatment were excluded from analysis. Currently, the NCI does not permit the use of SEER Medicare data for analyses of disease recurrence or progression because of limitations to the use of SEER Medicare data in accurate identification of recurrent disease, as information on recurrence is not collected. We limited our analysis of recurrence to patients who received subsequent additional cancer-directed treatment using codes for treatment usually given for treatment of recurrence occurring more than 30 days after the end of initial treatment, including entry into hospice services. Volume Hospital volume associated with initial treatment was categorized into tertiles using the number of patients with laryngeal squamous cell cancer treated by each hospital. We examined the distribution of the number of cases per hospital, and categorized hospitals into low- (6 cases), intermediate- (7 11 cases), or high- (12 cases) volume hospitals. Costs Costs were evaluated using all Medicare paid amounts from all standard analytic files, including inpatient, outpatient, physician/supplier, hospice, home health, and durable medical equipment. Costs were categorized as inpatient, outpatient, and other, and combined into overall costs. The costs associated with initial treatment were calculated from date of diagnosis to 30 days after the end of initial treatment, and costs associated with subsequent additional cancer-directed treatment were calculated from the start date of subsequent cancer-directed treatment to 30 days after the completion of treatment. Costs were adjusted for inflation, with results converted to 2012 US$ and adjusted for differences in Medicare reimbursements by geographic region as previously described. 21 Statistical Analysis Data were analyzed using Stata 12 (StataCorp, College Station, TX). Associations between variables were analyzed using cross-tabulations and multivariate regression modeling. Non-zero counts with fewer than 11 observations were masked in accordance with the SEER Medicare data use agreement. Initial treatment and subsequent additional cancer-directed treatment were examined as dependent variables using multinomial and multiple logistic regression analysis. Independent variables included age, sex, race, comorbidity, marital status, median income quintile, primary site, stage, urban/rural location, SEER region, hospital volume, and initial treatment. Overall survival, defined as time from diagnosis to either last claim date or death, was analyzed using the Kaplan-Meier method and multivariate Cox proportional hazard analysis. Generalized linear regression modeling with a log link was used to analyze incremental differences in costs by treatment, as costs were not normally distributed. This protocol was reviewed and approved by the Johns Hopkins Medicine institutional review board. RESULTS There were 2,370 cases that met study criteria, with demographic data shown in Table I. The mean age was 74.5 years (range, years). No patient was 1828 TABLE I. Demographic Characteristics of Patients With Laryngeal Squamous Cell Cancer Diagnosed in by Initial Treatment. All, N 5 2,370 Surgery Only, N Radiation Only, N Surgery 1 Radiation, N 5 1,017 Chemoradiation, N P Value Primary site .001 Glottic 1,558 (65.8%) 185 (68.3%) 503 (64.9%) 774 (76.1%) 96 (31.3%) Supraglottic 624 (26.3%) 64 (23.6%) 216 (27.9%) 175 (17.2%) 169 (55.0%) Other larynx 188 (7.9%) 22 (8.1%) 56 (7.2%) 68 (6.7%) 42 (13.7%) Age, yr ,333 (56.5%) 148 (54.6%) 428 (55.2%) 556 (54.5%) 206 (67.1%) (21.4%) 53 (19.6%) 176 (22.7%) 223 (21.9%) 56 (18.2%) (22.1%) 70 (25.8%) 171 (22.1%) 238 (23.4%) 45 (14.7%) Race.287 White 2,057 (86.9%) 238 (88.2%) 672 (86.8%) 889 (87.5%) 258 (84.0%) Black 202 (8.5%) 20 (7.4%) 63 (8.1%) 81 (8.0%) 38 (12.4%) Hispanic * * * * * Other 70 (3.0%) * 28 (3.6%) 28 (2.8%) * Missing * * * * 0 Sex.006 Male 1,902 (80.3%) 206 (76.0%) 631 (81.4%) 836 (82.2%) 229 (74.6%) Female 468 (19.7%) 65 (24.0%) 144 (18.6%) 181 (17.8%) 78 (25.4%) Comorbidity score ,030 (43.5%) 116 (42.8%) 303 (39.1%) 474 (46.6%) 137 (44.6%) (32.0%) 96 (35.4%) 255 (32.9%) 302 (29.7%) 106 (34.5%) (14.0%) 38 (14.0%) 113 (14.6%) 139 (13.7%) 42 (13.7%) (10.5%) 21 (7.8%) 104 (13.4%) 102 (10.0%) 22 (7.2%) Marital status.466 Married 1,370 (57.8%) 146 (53.9%) 448 (57.8%) 604 (59.4%) 172 (56.0%) Single 204 (8.6%) 27 (10.0%) 61 (7.9%) 90 (8.9%) 26 (8.5%) Divorced/separated 211 (8.9%) 21 (7.8%) 77 (9.9%) 81 (8.0%) 32 (10.4%) Widowed 492 (20.8%) 59 (21.8%) 161 (20.8%) 207 (20.4%) 65 (21.2%) Missing 93 (3.9%) 18 (6.6%) 28 (3.6%) 35 (3.4%) 12 (3.9%) TNM stage .001 I 1,225 (51.7%) * 409 (52.8%) 603 (59.3%) * II 452 (19.1%) 36 (13.3%) 178 (23.0%) 177 (17.4%) 61 (19.9%) III 337 (14.2%) 40 (14.8%) 99 (12.8%) 88 (8.7%) 110 (35.8%) IV 177 (7.5%) * * * 70 (22.8%) Unknown 179 (7.5%) * * * * T stage .001 T1 1,252 (52.8%) 165 (60.9%) 411 (53.0%) 613 (60.3%) 63 (20.5%) T2 563 (23.8%) 42 (15.5%) 207 (26.7%) 207 (20.4%) 107 (34.9%) T3 305 (12.9%) 36 (13.3%) 85 (11.0%) 87 (8.6%) 97 (31.6%) T4 49 (2.1%) * * * * Missing 201 (8.5%) * * * * N stage .001 N0/N1 1,958 (82.6%) 232 (85.6%) 670 (86.5%) 838 (82.4%) 218 (71.0%) N2/N3 142 (6.0%) * * 54 (5.3%) 55 (17.9%) Missing 270 (11.4%) * * 125 (12.3%) 34 (11.1%) Census median income quintile.082 Very low 469 (19.8%) 51 (18.8%) 151 (19.5%) 201 (19.8%) 66 (21.5%) Low 464 (19.6%) 50 (18.5%) 161 (20.8%) 193 (19.0%) 60 (19.5%) Intermediate 464 (19.6%) 44 (16.2%) 154 (20.0%) 193 (19.0%) 73 (23.8%) High 480 (20.2%) 69 (25.5%) 165 (21.3%) 191 (18.8%) 55 (17.9%) Very high 493 (20.8%) 57 (21.0%) 144 (18.6%) 239 (23.5%) 53 (17.3%) 1829 TABLE I. (Continued) All, N 5 2,370 Surgery Only, N Radiation Only, N Surgery 1 Radiation, N 5 1,017 Chemoradiation, N P Value SEER region .001 Connecticut 171 (7.2%) 22 (8.1%) 49 (6.3%) 77 (7.6%) 23 (7.5%) Detroit 184 (7.8%) 19 (7.0%) 55 (7.1%) 81 (8.0%) 29 (9.5%) Hawaii 18 (0.8%) * * * 0 Iowa 167 (7.1%) 32 (12.2%) 61 (7.8%) 52 (5.1%) 21 (6.8%) New Mexico 60 (2.5%) * * * * Seattle 132 (5.6%) * * * * Utah 30 (1.3%) 11 (4.1%) * * * Georgia 78 (3.3%) * * * * Kentucky 271 (11.4%) 28 (10.3%) 109 (14.1%) 99 (9.7%) 35 (11.4%) Louisiana 209 (8.8%) 15 (5.5%) 83 (10.7%) 88 (8.7%) 23 (7.5%) New Jersey 409 (17.3%) 57 (21.0%) 93 (12.0%) 215 (21.1%) 44 (14.3%) California 631 (26.6%) 58 (21.4%) 206 (26.6%) 281 (27.6%) 86 (28.0%) Hospital location .001 Urban 2,097 (88.5%) 234 (86.4%) 660 (85.2%) 934 (91.8%) 269 (87.6%) Rural 273 (11.5%) 37 (13.6%) 115 (14.8%) 83 (8.2%) 38 (12.4%) Hospital volume .001 Low 765 (32.3%) 59 (21.7%) 236 (30.5%) 364 (35.8%) 106 (34.5%) Intermediate 651 (27.4%) 50 (18.5%) 204 (26.3%) 302 (29.7%) 95 (30.9%) High 305 (12.9%) 17 (6.3%) 112 (14.4%) 143 (14.0%) 33 (10.8%) Missing 649 (27.4%) 145 (53.5%) 223 (28.8%) 208 (20.5%) 73 (23.8%) Subsequent additional cancer-directed treatment .001 No 1,168 (49.3%) 156 (57.6%) 490 (52.0%) 493 (48.5%) 116 (37.8%) Yes 1,202 (50.7%) 115 (42.4%) 372 (48.0%) 524 (51.6%) 191 (62.2%) .001 Salvage surgery 375 (31.2%) 60 (52.2%) 123 (33.1%) 150 (28.6%) 42 (22.0%) .001 Salvage radiation 768 (63.9%) 43 (37.4%) 258 (69.4%) 350 (66.8%) 117 (61.3%) .001 Salvage chemotherapy 386 (32.1%) 42 (36.5%) 82 (22.0%) 154 (29.4%) 108 (56.5%) .001 Salvage neck dissection 42 (3.5%) * * 16 (3.1%) 13 (6.8%).051 Hospice 132 (11.0%) 19 (16.5%) 44 (11.8%) 52 (9.9%) 17 (8.9%).149 Died during follow-up .001 No 1,459 (61.6%) 158 (58.3%) 457 (59.0%) 689 (67.8%) 155 (50.5%) Yes 911 (38.4%) 113 (41.7%) 318 (41.0%) 328 (32.2%) 152 (49.5%) *The exact number of patients was suppressed because of the presence of cells with 11 observations to comply with the SEER Medicare data use agreement. Restricted to population undergoing additional cancer-directed treatment following definitive initial treatment. Patients may have received more than one cancer-directed treatment. SEER 5 Surveillance, Epidemiology, and End Results staged as T4b. Only 13% of patients received care at high-volume hospitals, and the incidence of high-volume care did not differ by stage or site. Less than 1% of patients participated in a clinical trial. Overall, there were 1,583 cases of early stage disease (66.8%), of which 1,221 cases were glottic primary site (77.1%), and 608 cases of advanced stage disease (25.7%), of which 216 were glottic (35.5%). In patients with supraglottic primary tumors and advanced stage disease, initial treatment was most commonly chemoradiation (37.8%), followed by radiation alone (28.3%) and surgery with postoperative radiation (25.7%), whereas patients with glottic primary tumors and advanced stage disease more often received surgery with postoperative radiation (37.0%), followed by radiation alone (26.9%) and chemoradiation (23.6%). Chemotherapy was compliant with National Comprehensive Cancer Network (NCCN) guidelines in 70.0% of patients with advanced stage disease, in 73.9% of patients with advanced supraglottic disease, and 68.6% with advanced glottic disease. 22 Platinum-based chemotherapy was used in 74.3% of patients, 5-fluorouracil was used in 10.1% of patients, a taxane was used in 18.6% of patients, and cetuximab was used in 17.9% of patients and was the only chemotherapy drug in 14.3% of patients. Multinomial logistic regression analysis of variables significantly associated with initial treatment selection revealed that patients with supraglottic tumors (relative risk ratio [RRR]: 2.59, 95% confidence interval [CI]: , P .001) and stage III or IV disease (RRR: 4.20, 95% CI: , P .001) were more likely to receive chemoradiation, after controlling for all other demographic and tumor variables (Supplemental Table 1). Advanced comorbidity was significantly associated with use of radiation alone (RRR: 1.79, 95% CI: , P 5.036). Patients in rural locations were less likely to receive surgery with postoperative radiation (RRR: 0.51, 95% CI: , P 5.016). Chemoradiation was significantly associated with T3 (RRR: 3.79, 95% CI: , P .001) and T4 (RRR: 4.28, 95% CI: , P .001) tumors, after controlling for all other variables including nodal status. High-volume hospital care was not significantly associated with initial treatment. Multivariate logistic regression analysis of variables associated with subsequent additional cancer-directed treatment after the initial treatment period demonstrated an increased odds of subsequent additional cancerdirected treatment for supraglottic tumors (odds radio [OR]: 1.65, 95% CI: , P .001), advanced comorbidity (OR: 1.58, 95% CI: , P 5.007), age 80 years (OR: 1.40, 95% CI: , P 5.007), and initial treatment with chemoradiation (OR: 1.75, 95% CI: , P 5.009) (Supplemental Table 2). Salvage surgery was less likely to be performed in patients with supraglottic tumors (OR: 0.54, 95% CI: , P .001), age 75 to 79 years (OR: 0.61, 95% CI: , P 5.002) or 80 years (OR: 0.50, 95% CI: , P .001), advanced comorbidity (OR: 0.37, 95% CI: , P .001), and initial treatment with surgery and postoperative radiation (OR: 0.50, 95% CI: , P .001) or chemoradiation (OR: 0.33, 95% CI: , P .001). High-volume hospital care was not associated with subsequent additional cancer-directed treatment; however, among patients undergoing subsequent additional cancerdirected treatment, high-volume hospi
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