Dataset Information

Commercial Claims-Based Comparison of Survival and Toxic Effects of Definitive Radiotherapy vs Primary Surgery in Patients With Oropharyngeal Squamous Cell Carcinoma.

ABSTRACT: Importance:Definitive radiotherapy (RT) and primary surgery (PS) are considered to be equally viable local therapy modalities for oropharyngeal squamous cell carcinoma (OPSCC). The comparative effectiveness of these therapies is often debated, and treatment decisions are based on a paucity of comparative data. Objective:To examine the differences in overall survival and key toxic effects in patients with OPSCC treated with RT and PS. Design, Setting, and Participants:This retrospective cohort analysis used the HealthCore Integrated Research Database to identify 884 patients diagnosed with OPSCC from January 1, 2007, to December 31, 2014. Patients were categorized as receiving definitive RT (with or without chemotherapy) or PS (with or without adjuvant RT or chemoradiotherapy). Administrative claims data were linked with state cancer registries from California, Connecticut, Georgia, Kentucky, New York, and Ohio. Data analysis was performed from February 29, 2016, to February 6, 2018. Exposures:Definitive RT or PS. Main Outcomes and Measures:Overall survival was analyzed using Cox proportional hazards regression. Risks of gastrostomy dependence, esophageal stricture, and osteoradionecrosis were determined through claims and analyzed using logistic regression. Results:A total of 884 patients (608 [68.8%] in the RT group and 276 [31.2%] in the PS group; mean [SD] age, 61.5 [10.7] years; 727 [82.2%] male; 842 [95.3%] white) were included in this study. The 3-year overall survival was 76% among patients treated with RT and 81% among patients treated with PS (hazard ratio, 0.76; 95% CI, 0.54-1.01). On multivariable analysis, increasing age, female sex, and low income were associated with inferior survival; treatment type was not. Patients treated with RT were more likely to have gastrostomy dependence within the first year (391 [64.3%] vs 127 [46.0%]; adjusted OR, 0.57; 95% CI, 0.42-0.77). After treating chemotherapy as an effect modifier, there was no difference between modalities. Treatment type was not associated with esophageal stricture or osteoradionecrosis risk. Mean costs were approximately $100 000 for payers and $5000 for patients, with no adjusted differences between RT and PS. Conclusions and Relevance:This study suggests that RT and PS are equally viable treatment options for OPSCC; therefore, local therapy decisions may be individualized to each patient. However, the frequent addition of chemotherapy was associated with increased gastrostomy dependence among patients undergoing RT, which may be relevant in clinical decision making.

SUBMITTER: Sher DJ

PROVIDER: S-EPMC6233826 | biostudies-other | 2018 Oct

REPOSITORIES: biostudies-other

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Commercial Claims-Based Comparison of Survival and Toxic Effects of Definitive Radiotherapy vs Primary Surgery in Patients With Oropharyngeal Squamous Cell Carcinoma.

Sher David J DJ Agiro Abiy A Zhou Siting S Day Andrew T AT DeVries Andrea A

JAMA otolaryngology-- head & neck surgery 20181001 10

<h4>Importance</h4>Definitive radiotherapy (RT) and primary surgery (PS) are considered to be equally viable local therapy modalities for oropharyngeal squamous cell carcinoma (OPSCC). The comparative effectiveness of these therapies is often debated, and treatment decisions are based on a paucity of comparative data.<h4>Objective</h4>To examine the differences in overall survival and key toxic effects in patients with OPSCC treated with RT and PS.<h4>Design, setting, and participants</h4>This r ...[more]

PMID: 30326060

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Project description:ImportanceThe optimal approach for treatment deescalation in human papillomavirus (HPV)-related oropharyngeal squamous cell carcinomas (OPSCCs) is unknown.ObjectiveTo assess a primary radiotherapy (RT) approach vs a primary transoral surgical (TOS) approach in treatment deescalation for HPV-related OPSCC.Design, setting, and participantsThis international, multicenter, open-label parallel-group phase 2 randomized clinical trial was conducted at 9 tertiary academic cancer centers in Canada and Australia and enrolled patients with T1-T2N0-2 p16-positive OPSCC between February 13, 2018, and November 17, 2020. Patients had up to 3 years of follow-up.InterventionsPrimary RT (consisting of 60 Gy of RT with concurrent weekly cisplatin in node-positive patients) vs TOS and neck dissection (ND) (with adjuvant reduced-dose RT depending on pathologic findings).Main outcomes and measuresThe primary end point was overall survival (OS) compared with a historical control. Secondary end points included progression-free survival (PFS), quality of life, and toxic effects.ResultsOverall, 61 patients were randomized (30 [49.2%] in the RT arm and 31 [50.8%] in the TOS and ND arm; median [IQR] age, 61.9 [57.2-67.9] years; 8 women [13.6%] and 51 men [86.4%]; 31 [50.8%] never smoked). The trial began in February 2018, and accrual was halted in November 2020 because of excessive toxic effects in the TOS and ND arm. Median follow-up was 17 months (IQR, 15-20 months). For the OS end point, there were 3 death events, all in the TOS and ND arm, including the 2 treatment-related deaths (0.7 and 4.3 months after randomization, respectively) and 1 of myocardial infarction at 8.5 months. There were 4 events for the PFS end point, also all in the TOS and ND arm, which included the 3 mortality events and 1 local recurrence. Thus, the OS and PFS data remained immature. Grade 2 to 5 toxic effects occurred in 20 patients (67%) in the RT arm and 22 (71%) in the TOS and ND arm. Mean (SD) MD Anderson Dysphagia Inventory scores at 1 year were similar between arms (85.7 [15.6] and 84.7 [14.5], respectively).Conclusions and relevanceIn this randomized clinical trial, TOS was associated with an unacceptable risk of grade 5 toxic effects, but patients in both trial arms achieved good swallowing outcomes at 1 year. Long-term follow-up is required to assess OS and PFS outcomes.Trial registrationClinicaltrials.gov Identifier: NCT03210103.

Project description:ImportanceTransoral robotic surgery has been widely adopted since approval by the US Food and Drug Administration in December 2009, despite limited comparative data.ObjectiveTo compare the long-term outcomes of transoral robotic surgery with those of nonrobotic surgery for patients with early-stage oropharyngeal cancer.Design, setting, and participantsA retrospective cohort comparative effectiveness analysis was performed of patients in the National Cancer Database with clinical T1 and T2 oropharyngeal squamous cell carcinoma diagnosed between January 1, 2010, and December 31, 2015, who underwent definitive robotic and nonrobotic surgery. Multivariable Cox proportional hazards regression analysis and propensity score matching were performed in patients with known human papillomavirus status to adjust for patient- and disease-related covariates. Survival after robotic and nonrobotic surgery was also compared in 3 unrelated cancers: prostate, endometrial, and cervical cancer. Statistical analysis was performed from April 10, 2019, to May 21, 2020.Main outcomes and measuresOverall survival.ResultsOf 9745 patients (7652 men [78.5%]; mean [SD] age, 58.8 [9.6] years) who met inclusion criteria, 2694 (27.6%) underwent transoral robotic surgery. There was a significant increase in the use of robotic surgery from 18.3% (240 of 1309) to 35.5% (654 of 1841) of all surgical procedures for T1 and T2 oropharyngeal cancers from 2010 to 2015 (P = .003). Robotic surgery was associated with lower rates of positive surgical margins (12.5% [218 of 1746] vs 20.3% [471 of 2325]; P < .001) and lower use of adjuvant chemoradiotherapy (28.6% [500 of 1746] vs 35.7% [831 of 2325]; P < .001). Among 4071 patients with known human papillomavirus status, robotic surgery was associated with improved overall survival compared with nonrobotic surgery in multivariable Cox proportional hazards regression (hazard ratio [HR], 0.74; 95 CI, 0.61-0.90; P = .002). Similar results were seen when analyzing only the subset of facilities offering both robotic and nonrobotic surgery. The 5-year overall survival was 84.8% vs 80.3% among patients undergoing robotic vs nonrobotic surgery in propensity score-matched cohorts (P = .001). By contrast, there was no evidence that robotic surgery was associated with improved survival in other cancers, such as prostate cancer (HR, 0.92; 95% CI, 0.79-1.07; P = .26), endometrial cancer (HR, 0.97; 95% CI, 0.90-1.04; P = .36), and cervical cancer (HR, 1.27; 95% CI, 0.96-1.69; P = .10).Conclusions and relevanceThis study suggests that transoral robotic surgery was associated with improved surgical outcomes and survival compared with nonrobotic surgery in patients with early-stage oropharyngeal cancer. Evaluation in comparative randomized trials is warranted.

Project description:ImportanceHuman papillomavirus (HPV)-negative oropharyngeal squamous cell carcinoma (OPSCC) has shown resistance to conventional concurrent chemoradiation (CRT) therapy and carries a relatively poor prognosis in comparison with HPV-positive disease, with decreased locoregional control and overall survival (OS). In the present analysis, we examine whether upfront surgical resection improves overall survival in a large national sample.ObjectiveTo compare survival outcomes among patients with newly diagnosed cT1-2 N1-2b HPV-negative OPSCC when treated with primary surgical resection vs CRT.Design, setting, and participantsThis was an observational study of factors associated with primary treatment modality were identified using multivariable logistic regression. Overall survival was compared using Kaplan-Meier analysis with log-rank tests, multivariable Cox regression, and propensity score matching. Statistical tests were 2-sided. Patients newly diagnosed as having cT1-2 N1-2b pathologically confirmed HPV-negative OPSCC in 2010 to 2012 were identified using the National Cancer Data Base, which includes more than 70% of patients newly diagnosed as having cancer in the United States.ExposuresPrimary surgical resection vs definitive CRT.Main outcomes and measuresOverall survival.ResultsWe identified 1044 patients, among whom 460 (44.1%) received upfront surgery and 584 (55.9%) received CRT. Median age was 59 years (range, 25-90 years); 812 patients were male (77.8%), 232 were female (22.2%). Median follow-up was 30 months. Approximately 59% of surgical patients received adjuvant CRT. On multivariable Cox regression, upfront surgery was not associated with increased OS when compared with CRT (adjusted hazard ratio [HR], 1.01; 95% CI, 0.74-1.39; P = .93). Propensity score-matching identified a cohort of 822 patients and redemonstrated equivalent OS (HR, 1.14; 95% CI, 0.81-1.62; P = .46). Lack of OS benefit with upfront surgery persisted in a subset analysis of patients with margin-negative resection (HR, 0.97; 95% CI, 0.66-1.45; P = .88).Conclusions and relevanceIn this observational study, OS was similar for patients with HPV-negative OPSCC when treated with primary surgery vs CRT. Most surgical patients received trimodal therapy with adjuvant CRT. Our data may have implications for future research focusing on optimal patient selection for surgery.

Project description:IMPORTANCE:Treatment of oropharyngeal squamous cell carcinoma (OPSCC) presents unique challenges and can be associated with significant morbidity. Transoral robotic surgery (TORS) has emerged as a treatment modality for OPSCC, but data comparing outcomes between patients treated with TORS-based therapy and nonsurgical therapy are limited. OBJECTIVE:To compare survival and gastrostomy prevalence between patients with OPSCC treated with TORS-based therapy and those treated with nonsurgical therapy. DESIGN, SETTING, AND PARTICIPANTS:This retrospective matched-cohort study identified patients with OPSCC treated at the University of Washington and University of Minnesota tertiary care medical centers from January 1, 2005, to December 31, 2013. Each patient treated with TORS-based therapy was matched by stage with as many as 3 patients treated with nonsurgical therapy. Final follow-up was completed on April 1, 2015. MAIN OUTCOMES AND MEASURES:Disease-free survival, overall survival, and gastrostomy tube prevalence. RESULTS:One hundred twenty-seven patients met the study criteria (113 men [89.0%]; 14 women [11.0%]; median [interquartile range] age, 57 [52-63] years); 39 patients who underwent TORS were matched to 88 patients who underwent nonsurgical therapy. Compared with the nonsurgical group, more patients had p16-positive tumors in the TORS group (30 of 31 [96.8%] vs 30 of 37 [81.1%] among patients with known p16 status). No statistically significant difference in survival between treatment groups was found in multivariable analysis (disease-free survival hazard ratio, 0.22; 95% CI, 0.04-1.36; P?=?.10). Patients who received TORS-based therapy had lower gastrostomy tube prevalence after treatment (13 of 39 [33.3%] vs 74 of 88 [84.1%]) for a univariable relative risk of 0.43 (95% CI, 0.27-0.67; P?<?.001) and a multivariable relative risk of 0.43 (95% CI, 0.27-0.68; P?<?.001). Gastrostomy prevalence decreased by time after treatment for both groups (TORS group: 3 of 34 [9%] at 3 months to 1 of 33 [3%] at 12 months; nonsurgical group: 37 of 82 [45%] at 3 months to 7 of 66 [11%] at 12 months). CONCLUSIONS AND RELEVANCE:Patients undergoing TORS for OPSCC have statistically indistinguishable survival but lower gastrostomy prevalence compared with patients undergoing nonsurgical therapy for stage-matched OPSCC. TORS offers promise for improved swallowing function in patients with OPSCC.

Dataset Information

Commercial Claims-Based Comparison of Survival and Toxic Effects of Definitive Radiotherapy vs Primary Surgery in Patients With Oropharyngeal Squamous Cell Carcinoma.

Publications

Commercial Claims-Based Comparison of Survival and Toxic Effects of Definitive Radiotherapy vs Primary Surgery in Patients With Oropharyngeal Squamous Cell Carcinoma.

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