Key Points
Question
What are the differences in functional and survival outcomes between patients with T1-T2 oropharyngeal squamous cell carcinoma (OPSCC) who undergo primary transoral robotic surgery (TORS) vs treatment with primary radiation and/or chemoradiation therapy (RT/CRT)?
Findings
This national multicenter cohort study of 726 patients with OPSCC found that those who underwent primary TORS had an increased risk of short-term dysphagia compared with those who received primary RT/CRT. Patients in the RT/CRT group had an increased risk of short- and long-term gastrostomy tube dependence and worse 5-year overall survival compared with those in the primary TORS group.
Meaning
These findings indicate that despite increased rates of early dysphagia among patients undergoing primary surgery for OPSCC, patients treated with RT/CRT are more likely to be gastrostomy tube dependent several years posttreatment and demonstrate decreased overall survival.
Abstract
Importance
Due to lack of data from high-powered randomized clinical trials, the differences in functional and survival outcomes for patients with oropharyngeal squamous cell carcinoma (OPSCC) undergoing primary transoral robotic surgery (TORS) vs primary radiation therapy and/or chemoradiation therapy (RT/CRT) are unclear.
Objectives
To compare 5-year functional (dysphagia, tracheostomy dependence, and gastrostomy tube dependence) and survivorship outcomes in patients with T1-T2 OPSCC receiving primary TORS vs RT/CRT.
Design, Setting, and Population
This national multicenter cohort study used data from a global health network (TriNetX) to identify differences in functional and survival outcomes among patients with OPSCC who underwent primary TORS or RT/CRT in 2002 to 2022. After propensity matching, 726 patients with OPSCC met inclusion criteria. In the TORS group, 363 (50%) patients had undergone primary surgery, and in the RT/CRT group, 363 (50%) patients had received primary RT/CRT. Data analyses were performed from December 2022 to January 2023 using the TriNetX platform.
Exposure
Primary surgery with TORS or primary treatment with radiation therapy and/or chemoradiation therapy.
Main Outcomes and Measures
Propensity score matching was used to balance the 2 groups. Functional outcomes were measured at 6 months, 1 year, 3 years, 5 years, and more than 5 years posttreatment and included dysphagia, gastrostomy tube dependence, and tracheostomy dependence according to standard medical codes. Five-year overall survivorship was compared between patients undergoing primary TORS vs RT/CRT.
Results
Propensity score matching allowed a study sample with 2 cohorts comprising statistically similar parameters with 363 (50%) patients in each. Patients in the TORS cohort had a mean (SD) age of 68.5 (9.9) vs 68.8 (9.7) years in RT/CRT cohort; 86% and 88% were White individuals, respectively; 79% of patients were men in both cohorts. Primary TORS was associated with clinically meaningful increased risk of dysphagia at 6 months (OR, 1.37; 95% CI, 1.01-1.84) and 1 year posttreatment (OR, 1.71; 95% CI, 1.22-2.39) compared with primary RT/CRT. Patients receiving surgery were less likely to be gastrostomy tube dependent at 6 months (OR, 0.46; 95% CI, 0.21-1.00) and 5 years posttreatment (risk difference, −0.05; 95% CI, −0.07 to −0.02). Differences in overall rates of tracheostomy dependence (OR, 0.97; 95% CI, 0.51-1.82) between groups were not clinically meaningful. Patients with OPSCC, unmatched for cancer stage or human papillomavirus status, who received RT/CRT had worse 5-year overall survival than those who underwent primary surgery (70.2% vs 58.4%; hazard ratio, 0.56; 95% CI, 0.40-0.79).
Conclusions and Relevance
This national multicenter cohort study of patients undergoing primary TORS vs primary RT/CRT for T1-T2 OPSCC found that primary TORS was associated with a clinically meaningful increased risk of short-term dysphagia. Patients treated with primary RT/CRT had an increased risk of short- and long-term gastrostomy tube dependence and worse 5-year overall survival than those who underwent surgery.
This national multicenter cohort study of patients with T1-T2 oropharyngeal squamous cell carcinoma compares the functional and survival outcomes of primary transoral robotic surgery vs primary radiation therapy and/or chemoradiation.
Introduction
The incidence of oropharyngeal squamous cell carcinoma (OPSCC) continues to rise in the US, and the incidence of human papillomavirus (HPV)-mediated OPSCC is expected to continue rising well beyond 2030.1 Given its distinct tumor biology sensitivity to chemoradiation, HPV-mediated OPSCC has been associated with higher rates of overall and disease-specific survival compared with HPV-negative OPSCC.2 The improved survival seen in this subset of patients, who tend to be younger and have fewer comorbidities, is a driving factor in the focus on functional outcomes in the treatment paradigm of OPSCC. These patients may experience long-term treatment-related toxic effects decades after radiation and/or chemoradiation therapy (RT/CRT).3
The oropharynx presents complex anatomical challenges against surgical resection, necessitating the early establishment of definitive concurrent cisplatin-based CRT to 70 gray as a standard of care for OPSCC.4 Although definitive RT/CRT affords excellent response rates, substantial proportions of patients experience oral cavity, pharyngeal, and laryngeal toxic effects, many developing severe late toxic effects such as gastrostomy tube dependence, infection, fistula, and/or death.5,6 Multiple deintensification strategies for definitive radiation and chemotherapy have been attempted, often without significant improvement in toxic effects.7,8,9,10 Transoral robotic surgery (TORS) is now a widely used minimally invasive surgical alternative to organ-preserving treatment modalities in small-volume low-to-intermediate–risk OPSCC.11,12,13 Available data from randomized clinical trials (RCTs) demonstrate no difference in progression-free or overall survival between TORS and definitive radiation therapy; furthermore, neither modality affords a meaningful improvement in functional outcomes.14 Utilizing TORS as a tool to de-escalate adjuvant therapy has been successful in decreasing toxic effects in patients with low-to-intermediate–risk disease who met acceptable progression-free survival thresholds.15,16,17,18 Controversy remains regarding survival and functional outcomes between primary TORS plus adjuvant therapy and primary CRT in the definitive and de-escalated settings given the paucity of data from high-powered RCTs.
Adverse functional outcomes, such as dysphagia, gastrostomy tube dependence, and tracheostomy dependence, are severe morbidities in head and neck cancer that can greatly affect patient health and quality of life.19,20,21 Data set–derived clinical data offer superior detail and specifics regarding the toxic effects of treatment; however, these data are frequently from single institutions and have limited generalizability.
This study aimed to provide population-level data obtained from a multi-institutional health network with broad outcome data from both academic and nonacademic institutions across the 50 US states. Among the large majority of patients with cancer treated in the community, only 3% enroll in clinical trials, meaning that most patients undergoing de-escalated OPSCC treatment are not captured in the data evaluated in RCTs.22 The objective of this investigation was to report the differences in short- and long-term prevalence of dysphagia, gastrostomy tube dependence, and tracheostomy dependence, as well as survival outcomes between patients with OPSCC who were treated with primary TORS vs primary RT/CRT.
Methods
This study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline. The institutional review board of Thomas Jefferson University exempted the study and waived informed consent because it used only deidentified population-level records. Population-level data were obtained from the TriNetX US Collaborative Network (TriNetX), a real-time multicenter national health network of 66 health care organizations across the 50 US states. The TriNetX platform contains deidentified data of 90 million patients from diverse demographic and socioeconomic backgrounds. Data were collected on December 1, 2022. Participant race and ethnicity information was collected from the database, which primarily obtains this information from institutional electronic health records. The race categories included in the study were Asian, American Indian or Alaska Native, Black or African American, Native Hawaiian or Other Pacific Islander, White, and unknown; Hispanic ethnicity was not available from the database.
Study Population
This epidemiologic investigation used codes from the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10), and the Common Procedural Terminology (CPT) to define cohorts and outcomes. Adult patients (≥18 years) with oropharyngeal carcinoma were identified per the ICD-10 trees for malignant neoplasm of the oropharynx and further refined to T1 or T2 disease (eTables 1 and 2 in Supplement 1). We formed 2 cohorts from the sample population: patients who had undergone TORS as defined by ICD-10 trees for “robotic assisted procedures of the head and neck” and patients who had been treated with RT/CRT as defined by TriNetX’s curated diagnosis trees, which can be used to harmonize related codes (eTables 1 and 2 in Supplement 1). The instance of treatment was required to occur after the instance of OPSCC diagnosis, and treatment type of the opposite cohort was excluded from each group. From the database, we identified 111 918 patients with oropharyngeal carcinoma, of whom 2986 met inclusion criteria for the RT/CRT cohort and 365 patients met inclusion criteria for the TORS cohort (Table 1).
Table 1. Patient Characteristics in Cohorts 1 (TORS) and 2 (RT/CRT) Before and After Propensity Score Matching.
Cohort | ICD-10-CM code | Description | Patients, No. (%) | P value | SD |
---|---|---|---|---|---|
Before matching: cohort 1, n = 365; cohort 2, n = 2986 | |||||
Demographic information | |||||
1 | Age | Mean (SD) age: 68.5 (10.0) y | 365 (100) | .67 | 0.02 |
2 | Mean (SD) age, 68.3 (9.9) y | 2925 (100) | |||
1 | F | Female | 78 (21) | <.001 | 0.17 |
2 | 424 (15) | ||||
1 | M | Male | 287 (79) | .80 | 0.02 |
2 | 2313 (79) | ||||
1 | UN | Unknown gender | 0 | NA | NA |
2 | 188 (6) | ||||
1 | 1002-5 | American Indian/Alaska Native | 10 (2) | .28 | 0.09 |
2 | 10 (<1) | ||||
1 | 2028-9 | Asian | 10 (2) | <.001 | 0.23 |
2 | 15 (1) | ||||
1 | 2054-5 | Black | 22 (6) | .61 | 0.03 |
2 | 236 (8) | ||||
1 | 2076-8 | Native Hawaiian/Other Pacific Islander | 10 (2) | .28 | 0.09 |
2 | 10 (<1) | ||||
1 | 2106-3 | White | 315 (86) | .11 | 0.09 |
2 | 2259 (77) | ||||
1 | 2131-1 | Unknown race | 20 (5) | .06 | 0.13 |
2 | 409 (14) | ||||
Diagnosis | |||||
1 | I00-I99 | Diseases of the circulatory system | 214 (59) | <.001 | 0.58 |
2 | 910 (31) | ||||
1 | Z87.891 | History of nicotine dependence | 115 (32) | <.001 | 0.38 |
2 | 457 (16) | ||||
After matching: cohort 1, n = 363; cohort 2, n = 363 | |||||
Demographic information | |||||
1 | Age | Mean (SD) age, 69.2 (10.5) y | 363 (100) | .73 | 0.03 |
2 | Mean (SD) age, 68.6 (10.0) y | 363 (100) | |||
1 | F | Female | 83 (23) | .77 | 0.03 |
2 | 86 (24) | ||||
1 | M | Male | 280 (77) | .86 | 0.01 |
2 | 279 (77) | ||||
1 | UN | Unknown gender | 0 | NA | NA |
2 | 0 | ||||
1 | 1002-5 | American Indian/Alaska Native | 0 | NA | NA |
2 | 0 | ||||
1 | 2028-9 | Asian | 10 (3) | >.99 | <0.001 |
2 | 10 (3) | ||||
1 | 2054-5 | Black | 22 (6) | .64 | 0.04 |
2 | 21 (6) | ||||
1 | 2076-8 | Native Hawaiian/Other Pacific Islander | 0 | NA | NA |
2 | 0 | ||||
1 | 2106-3 | White | 319 (89) | .31 | 0.08 |
2 | 319 (89) | ||||
1 | 2131-1 | Unknown race | 10 (3) | >.99 | <0.001 |
2 | 10 (3) | ||||
Diagnosis | |||||
1 | I00-I99 | Diseases of the circulatory system | 212 (58) | .82 | 0.02 |
2 | 215 (59) | ||||
1 | Z87.891 | History of nicotine dependence | 113 (31) | .47 | 0.05 |
2 | 104 (29) |
Abbreviations: ICD-10-CM, International Statistical Classification of Diseases, Tenth Revision, Clinical Modification; RT/CRT, radiotherapy/chemoradiotherapy; TORS, transoral robotic surgery.
Outcome Variables
Cohorts were analyzed for functional and survival outcomes. Functional outcomes included dysphagia (code: R13.1), gastrostomy tube placement (multiple codes to capture open and endoscopic placement), and tracheostomy placement (multiple codes to capture open, percutaneous, emergency, and planned placement) (eTable 3 in Supplement 1). Outcomes were compared between cohorts at more than 5 time points: 6 months; 1, 3, and 5 years; beyond 5 years; and at any time after treatment. Specifically, incidence of each outcome was measured within 180 days of each time point (ie, up to 3 months before and after). Lastly, 5-year overall survivorship was compared between groups.
Statistical Analysis
Descriptive statistics were used to characterize the study population and summarize the demographic characteristics. Data were reported as mean (range) or frequency (percentage). Patients between groups were propensity score–matched by age at diagnosis, sex, race and ethnicity, cardiovascular disease, and nicotine dependence. We used χ2 (for categorical variables) and independent t tests (for continuous variables) to identify statistically significant differences in baseline characteristics between cohorts. Propensity score matching (1:1 using the nearest-neighbor greedy matching algorithm) was performed using the TriNetX Analytics platform. Results were reported using measures of effect size and 95% CIs to describe the magnitude of the difference between compared groups and precision of the estimates, respectively. Hazard ratios, odds ratios (ORs), and 95% CIs were calculated through TriNetX Analytics. We used Kaplan-Meier method and hazard ratio (95% CI) to assess the differential effect of treatment modality on overall survival. Data analyses were performed from December 2022 to January 2023 using the TriNetX platform.
Results
Demographic and Population Characteristics
Propensity score matching of 726 patients with OPSCC allowed statistically similar parameters in the 2 study groups. The TORS group had 363 (50%) patients with a mean (SD) age of 69.2 (10.5) years; 280 (77%) men and 83 (23%) women; and 10 (3%) Asian, 22 (6%) Black, 319 (89%) White, and 10 (3%) individuals whose race was not known. The RT/CRT group had 363 (50%) patients with a mean (SD) age of 68.6 (10.0) years; 279 (77%) men and 83 (23%) women; and 10 (3%) Asian, 21 (6%) Black, 319 (89%) White, and 10 (3%) individuals whose race was not known. The TORS group had 212 (58%) patients with cardiovascular disease and 113 (31%) with a history of nicotine dependence; the CT/CRT group had 215 (59%) and 104 (29%), respectively (Table 1).
Functional Outcomes
Primary TORS was associated with an increased risk of dysphagia at all time points, with clinically meaningful differences observed at 6 months posttreatment (OR, 1.37; 95% CI, 1.01-1.84) and 1 year posttreatment (OR, 1.71; 95% CI, 1.22-2.39) compared with primary RT/CRT. The magnitude of the increased risk of dysphagia with TORS was similar at the remaining time intervals (3 years and 5 years) but the imprecision of the estimates, as indicated by the width of the confidence interval, prevented making definitive conclusions. Beyond 5 years, there was essentially no difference in the risk of dysphagia for patients in the 2 cohorts. Overall, at any time point, the risk of dysphagia was higher in the TORS group (OR, 1.25; 95% CI, 0.91-1.71; Table 2).
Table 2. Odds of Dysphagia, Gastrostomy Tube Dependence, and Tracheostomy Dependence Between Patients With OPSCC Who Received Primary TORS vs RT/CRT.
Condition and time point | OR (95% CI) |
---|---|
Dysphagia | |
6 mo | 1.366 (1.013 to 1.841) |
1 y | 1.707 (1.219 to 2.390) |
3 y | 1.305 (0.862 to 1.975) |
5 y | 1.488 (0.874 to 2.535) |
>5 y | 1.047 (0.689 to 1.591) |
Any time | 1.245 (0.908 to 1.707) |
Gastrostomy tube dependence | |
6 mo | 0.455 (0.207 to 0.998) |
1 y | 0.846 (0.346 to 2.079) |
3 y | 1.027 (0.421 to 2.502) |
5 y, RD | −0.045 (−0.072 to −0.018) |
>5 y | 0.822 (0.336 to 2.011) |
Any time | 0.599 (0.414 to 0.868) |
Tracheostomy dependence | |
6 mo | 1.029 (0.422 to 2.506) |
1 y | 1.030 (0.423 to 2.509) |
3 y | 0.836 (0.342 to 2.045) |
5 y | NA |
>5 y | NA |
Any time | 0.968 (0.514 to 1.821) |
Abbreviations: NA, not applicable; OPSCC, oropharyngeal squamous cell carcinoma; OR, odds ratio; RD, risk difference; RT/CRT, radiotherapy or chemoradiotherapy; TORS, transoral robotic surgery.
Patients who underwent primary TORS were less likely to be gastrostomy tube dependent at all time points, with large differences observed at 6 months (OR, 0.46; 95% CI, 0.21-1.00) and at 5 years posttreatment (risk difference [RD], −0.05; 95% CI, −0.07 to −0.02 [RD reported because there were 0 patients with gastrostomy tube placement in the TORS group at 5 years]). The TORS group had a substantial decreased risk of gastrostomy tube dependence at any time after treatment (OR, 0.60; 95% CI, 0.41-0.87). There were inconsistent effects of TORS at the remaining time intervals; however, the imprecision of the estimates prevented making definitive conclusions (1-year OR, 0.85; 95% CI, 0.35-2.08; 3-year OR, 1.03; 95% CI, 0.42-2.50; beyond 5-year OR, 0.82; 95% CI, 0.34-2.01; Table 2).
The difference in the likelihood of tracheostomy dependence between the treatment groups was very small and had inconsistent direction, and estimates were imprecise because of the large width of the confidence intervals (6-month OR, 1.03 [95% CI, 0.42-2.51]; 1-year OR, 1.03 [95% CI, 0.42-2.51]; 3-year OR, 0.84 [95% CI, 0.34-2.05]; 5-year and >5-year ORs had insufficient data for analysis; any time OR, 0.97 [95% CI, 0.51-1.82]; Table 2).
Survival Outcomes
Patients receiving primary RT/CRT had worse 5-year overall survival than those undergoing TORS (70.2% vs 58.4%; hazard ratio, 0.56; 95% CI, 0.40-0.79). Of note, these findings represent incompletely matched cancer stage.
Discussion
This article provides population-level data to compare treatment modalities in patients with localized OPSCC. This study’s results indicate that despite increased rates of dysphagia among patients undergoing surgery, patients treated with primary RT/CRT are more likely to be gastrostomy tube dependent several years posttreatment. There was no clinically meaningful difference observed in tracheostomy dependence between the 2 groups.
Dysphagia has continued to be a highly prevalent morbidity among survivors of OPSCC, even in the setting of the advancements in radiotherapy and minimally invasive surgery in the last decade.1 In addition to increasing mortality, dysphagia is associated with lower quality-of-life measures and decision regret among patients with OPSCC.21,23,24 Multiple retrospective and prospective investigations of objective and subjective swallow function after OPSCC treatment have been published; reported outcomes between primary surgical vs radiation therapy approaches are mixed. The wide variety of assessment tools used adds to the inconsistency of findings and the lack of consensus.
Prospective patient-reported outcomes and objective instrumental swallow evaluations suggest that most patients treated with primary TORS experience dysphagia in the acute and subacute postoperative period.25 Surgical swallowing dysfunction has been shown to resolve or partially recover in 3 to 12 months, especially in patients who do not undergo adjuvant therapy after TORS.15,18,26 Although this investigation did not evaluate dysphagia diagnosis any sooner than 3 months posttreatment, the cited reports support the findings of the current study in which primary TORS was associated with a greater incidence of dysphagia in the subacute posttreatment period compared with primary RT/CRT. Of note, even moderate-to-severe dysphagia does not preclude oral diet intake in the postoperative setting; therefore, further investigation of oral diet status along with dysphagia diagnosis is warranted.25
A meta-analysis of patients with HPV-mediated OPSCC reported that TORS plus adjuvant therapy was associated with worse subjective swallow function in 3 of 4 validated patient-reported swallow and quality-of-life questionnaires at 12 months compared with primary RT/CRT.27 These retrospective findings largely align with the findings of the ORATOR RCT, which indicated that swallowing-related quality of life was in favor of primary CRT.14 Other reports not included in the meta-analysis27 demonstrated better swallow outcomes compared with CRT in TORS alone and TORS plus adjuvant therapy.28,29,30 A more recent meta-analysis focusing on subjective dysphagia among T1-T2, N0-2 OPSCC found similar patient-reported swallow outcomes between primary TORS plus adjuvant therapy and primary CRT.31 Variability in questionnaires, small inclusion, heterogeneous populations, and poor follow-up in many studies make it difficult to interpret validated functional outcome reports.32 The discordancy of reports highlights the need for high-powered RCTs focused on functional outcomes in definitive and de-escalated settings.
Despite the expected increased risk of dysphagia after surgical resection in localized OPSCC redemonstrated by the findings of the present study, primary CRT is associated with greater prevalence of gastrostomy tube placement, most notably well beyond initial therapy. Gastrostomy tube placement is frequently used as a surrogate marker for swallowing dysfunction in patients with OPSCC and can serve as a proxy for moderate-to-severe toxic effects associated with TORS or CRT. Although incidence rates of gastrostomy tube placement vary widely in reports, a systematic review reported 18% to 39% of patients who underwent TORS required gastrostomy placement (excluding prophylactic placement), typically during adjuvant therapy. In contrast, 29% to 60% of patients receiving definitive RT required gastrostomy tube placement.32 In a meta-analysis, gastrostomy tube dependence was similar between TORS plus adjuvant therapy and primary CRT at both 12 months and 24 to 36 months.27
The present investigation found that patients treated with primary CRT were more likely to have gastrostomy tubes placed than were patients who underwent primary TORS, both at 6 months and 5 years posttreatment. Outcomes were indexed to occur after instance of treatment; therefore, gastrostomy tube placement should largely have captured reactive rather than prophylactic tube placement. The increased risk of gastrostomy tube placement at 5 years posttreatment in the RT/CRT cohort is rarely reported given that most reports characterize 2-year posttreatment outcomes as long-term data. An RCT including all head and neck cancers found that no patients were gastrostomy tube dependent at 8 years posttreatment.33 Findings of gastrostomy tube dependence at the 5-year interval highlight the importance of consideration of very late-stage toxic effects, such as radiation fibrosis to crucial swallowing structures related to CRT. Initial severe late dysphagia events can continue to occur beyond 5 years after treatment.34 Importantly, these events, such as fatal aspiration pneumonia, are likely contributing to late noncancer deaths that have been reported in association with other head and neck cancers.34,35
This investigation found no clinically meaningful difference in incidence of posttreatment tracheostomy between the groups receiving primary TORS and RT/CRT. Increased experience in TORS has been associated with a decline in tracheostomy in patients undergoing surgical resection, and as such, has been less frequently reported. A 2015 meta-analysis found that tracheostomy dependency rates had improved among both patients undergoing TORS (0%-3.5%) and those receiving CRT (0.1%-4.5%).36
The shift of focus to functional outcomes has been largely in response to the excellent survival outcomes of OPSCC, especially in HPV-mediated disease.37 Retrospective research comparing CRT and TORS in OPSCC has largely shown equivalent survival outcomes, especially in localized OPSCC.38 Prospective clinical trials of CRT vs TORS are limited and are largely focused on quality-of-life measures.14 Therefore, management of OPSCC is dependent on institution-specific expertise requiring multidisciplinary patient-specific decision-making.39 This study uniquely presents long-term survival outcomes based on data from a large population-based database. Results indicate an improvement in overall survival in patients receiving TORS vs definitive CRT for localized OPSCC. Nevertheless, the current study sample comprised patients with both HPV-mediated and HPV-negative OPSCC, as reflected by the reduced 5-year survival rates. The results favoring TORS for OPSCC management are likely skewed by the nonradiosensitive HPV-negative OPSCC population. More RCTs are required to elucidate survival rates in patients with HPV-mediated vs HPV-negative OPSCC treated with TORS vs RT/CRT.
Limitations
There were several study limitations worth mentioning. Population-level data were obtained via ICD-10 and CPT codes across multiple institutions. Accurately capturing OPSCC diagnosis, treatment, and outcomes was reliant on correct electronic health record documentation along with appropriate inclusion and exclusion codes during TriNetX cohort building and analysis. For example, possible selection bias in which more patients in the TORS cohort had documentation of dysphagia because of disproportionally higher otolaryngologic follow-up may have limited the study conclusions.
Although these data are valuable in their generalizability, TriNetX lacks the refinement capabilities seen in more traditional clinical database studies. Interrogating these data further for multivariable regression analyses was not possible given the nature of the deidentified information. Specifically, this study was unable to match patients for HPV tumor status or N stage because of the limitations of the TriNetX platform. Although only T1 and T2 tumors were included, this study was unable to propensity score-match for T category, which has implications on balancing cohorts for criteria such as tumor size and distribution of patients who were treated with primary RT vs CRT. This is evidenced by the difference in 5-year overall survival between the primary TORS vs primary RT/CRT groups. Several previous investigations have reported similar unmatched comparisons; this investigation used propensity score matching to compare cohorts with statistically similar patient demographic characteristics and comorbidities.
This study was also limited by the inclusion of only diseases of the circulatory system in matching for comorbid ailments. The inclusion of validated comorbidity indices, such as the Charlson comorbidity index or the Elixhauser comorbidity index, to grade overall severity of comorbid ailments was not feasible through the TriNetX platform. This study aimed to elucidate trends in OPSCC management seen at a national level. Although future directions include optimization of cohort design to match for criteria such as tumor profile, performance status, and care distribution, this type of analysis is most feasible in the setting of multi-institutional clinical trials that are currently under way.
Conclusions
The findings of this national multicenter cohort study based on population-level data indicate that patients with T1-T2 OPSCC undergoing primary TORS are more likely to experience a clinically meaningful increase in documented dysphagia in the 6-month to 1-year posttreatment period compared with patients receiving primary RT/CRT. However, patients treated with primary RT/CRT are more likely to be gastrostomy tube dependent at 6 months and at 5 years posttreatment compared with those undergoing surgery. In this population of patients with OPSCC unmatched for cancer stage, patients who underwent TORS had an increased overall survival compared with patients who received primary RT/CRT.
eTable 1. TriNetX TORS Cohort
eTable 2. TriNetX CT/CRT Cohort
eTable 3. TriNetX Functional and Survival Outcomes Query
Data Sharing Statement
References
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
eTable 1. TriNetX TORS Cohort
eTable 2. TriNetX CT/CRT Cohort
eTable 3. TriNetX Functional and Survival Outcomes Query
Data Sharing Statement