Dataset Information

Comparison of Survival After Transoral Robotic Surgery vs Nonrobotic Surgery in Patients With Early-Stage Oropharyngeal Squamous Cell Carcinoma.

ABSTRACT:

Importance

Transoral robotic surgery has been widely adopted since approval by the US Food and Drug Administration in December 2009, despite limited comparative data.

Objective

To compare the long-term outcomes of transoral robotic surgery with those of nonrobotic surgery for patients with early-stage oropharyngeal cancer.

Design, setting, and participants

A 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 measures

Overall survival.

Results

Of 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 relevance

This 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.

SUBMITTER: Nguyen AT

PROVIDER: S-EPMC7441465 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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.

Project description:BackgroundTreatment of human papillomavirus-related oropharyngeal squamous cell carcinoma (HPVOPC) results in unprecedented high survival rates but possibly unnecessary toxicity. We hypothesized that upfront surgery and neck dissection followed by reduced-dose adjuvant therapy for early and intermediate HPVOPC would ultimately result in equivalent progression-free survival (PFS) and overall survival while reducing toxicity.MethodsThis study was a nonrandomized phase II trial for early-stage HPVOPC treated with transoral robotic surgery (TORS) followed by reduced-dose radiotherapy. Patients with previously untreated p16-positive HPVOPC and <20 pack years' smoking history were enrolled. After robotic surgery, patients were assigned to group 1 (no poor risk features; surveillance), group 2 (intermediate pathologic risk factors [perineural invasion, lymphovascular invasion]; 50-Gy radiotherapy), or group 3 (poor prognostic pathologic factors [extranodal extension [ENE], more than three positive lymph nodes and positive margin]; concurrent 56-Gy chemoradiotherapy with weekly cisplatin).ResultsFifty-four patients were evaluable; there were 25 in group 1, 15 in group 2, and 14 in group 3. Median follow-up was 43.9 months (9.6-75.8). Disease-specific survival was 98.1%, and PFS was 90.7%. PFS probability via Kaplan-Meier was 91.3% for group 1, 86.7% for group 2, and 93.3% for group 3. There were five locoregional failures (LRFs), including one distant metastasis and one contralateral second primary. Average time to LRF was 18.9 months (9.6-59.0); four LRFs were successfully salvaged, and the patients remain disease free (11.0-42.7 months); one subject remains alive with disease.ConclusionThe results indicate that upfront surgery with neck dissection with reduced-dose radiation for T1-2, N1 stage (by the eighth edition American Joint Committee on Cancer staging manual) HPVOPC results in favorable survival with excellent function in this population. These results support radiation dose reduction after TORS as a de-escalation strategy in HPVOPC.Implications for practiceTransoral robotic surgery can provide a safe platform for de-escalation in carefully selected patients with early-stage human papillomavirus-related oropharyngeal cancer. In this clinical trial, disease-specific survival was 100%, over 90% of the cohort had a reduction of therapy from standard of care with excellent functional results, and the five patients with observed locoregional failures were successfully salvaged.

Project description:Background/Objective: The incidence of oropharyngeal cancer (OPC) remains significant, with a rising prevalence of HPV-positive (HPV+) cases, underscoring the growing importance of appropriate treatment approaches for this condition. While HPV+ OPC typically exhibits a more favorable prognosis than HPV-negative (HPV-) OPC, certain HPV+ OPC patients still face adverse outcomes. This study aimed to assess the effectiveness of TORS versus traditional surgery in treating OPC patients and investigate the prognostic implications of specific variants in the HPV genome. Methods: The clinical information, including pathological features, treatments, and outcomes (death), of 135 OPC patients treated with traditional surgery from 2008 to 2018 (the non-TORS group) and 130 OPC patients treated with TORS from 2017 to 2021 (the TORS group) were obtained from Sun Yat-sen University Cancer Center (SYSUCC). A comparative analysis of 3-year overall survival (OS) was performed between these two groups. Furthermore, we conducted next-generation sequencing for the HPV16 genome of the 68 HPV+ OPC cases to characterize single-nucleotide variations (SNVs) in the HPV16 genome and evaluate its association with HPV+ OPC patient survival. Results: The comparative analysis of 3-year OS between the two groups (TORS vs. non-TORS) revealed a significant prognostic improvement in the TORS group for OPC patients with a T1-T2 classification (89.3% vs. 72.0%; p = 1.1 × 10-2), stages I-II (92.1% vs. 82.2%; p = 4.6 × 10-2), and stages III-IV (82.8% vs. 62.2%; p = 5.7 × 10-2) and for HPV- patients (85.5% vs. 33.3%; p < 1.0 × 10-6). Furthermore, three SNVs (SNV1339A>G, SNV1950A>C, and SNV4298A>G) in the HPV16 genome were identified as being associated with worse survival. These SNVs could alter protein interactions and weaken the binding affinity for MHC-II, promoting viral amplification and immune evasion. Conclusions: TORS exhibited a superior prognosis to traditional surgery in OPC patients. Additionally, identifying specific SNVs within the HPV16 genome provided potential prognostic markers for HPV+ OPC. These significant findings hold clinical relevance for treatment decision-making and prognostic assessment in patients with OPC.

Project description: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.

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.