Dataset Information

SBRT for early-stage glottic larynx cancer-Initial clinical outcomes from a phase I clinical trial.

ABSTRACT:

Purpose

To confirm safety and feasibility of hypofractionated SBRT for early-stage glottic laryngeal cancer.

Methods

Twenty consecutive patients with cTis-T2N0M0 carcinoma of glottic larynx were enrolled. Patients entered dose-fractionation cohorts of incrementally shorter bio-equivalent schedules starting with 50 Gy in 15 fractions (fx), followed by 45 Gy/10 fx and, finally, 42.5 Gy/5 fx. Maximum combined CTV-PTV expansion was limited to 5 mm. Patients were treated on a Model G5 Cyberknife (Accuray, Sunnyvale, CA).

Results

Median follow-up is 13.4 months (range: 5.6-24.6 months), with 12 patients followed for at least one year. Maximum acute toxicity consisted of grade 2 hoarseness and dysphagia. Maximum chronic toxicity was seen in one patient treated with 45 Gy/10 fx who continued to smoke >1 pack/day and ultimately required protective tracheostomy. At 1-year follow-up, estimated local disease free survival for the full cohort was 82%. Overall survival is 100% at last follow-up.

Conclusions

We were able to reduce equipotent total fractions of SBRT from 15 to 5 without exceeding protocol-defined acute/subacute toxicity limits. With limited follow-up, disease control appears comparable to standard treatment. We continue to enroll to the 42.5 Gy/5 fx cohort and follow patients for late toxicity.

Trial registration

ClinicalTrials.gov NCT01984502.

SUBMITTER: Schwartz DL

PROVIDER: S-EPMC5333979 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Publications

SBRT for early-stage glottic larynx cancer-Initial clinical outcomes from a phase I clinical trial.

Schwartz David L DL Sosa Alan A Chun Stephen G SG Ding Chiuxiong C Xie Xian-Jin XJ Nedzi Lucien A LA Timmerman Robert D RD Sumer Baran D BD

PloS one 20170302 3

<h4>Purpose</h4>To confirm safety and feasibility of hypofractionated SBRT for early-stage glottic laryngeal cancer.<h4>Methods</h4>Twenty consecutive patients with cTis-T2N0M0 carcinoma of glottic larynx were enrolled. Patients entered dose-fractionation cohorts of incrementally shorter bio-equivalent schedules starting with 50 Gy in 15 fractions (fx), followed by 45 Gy/10 fx and, finally, 42.5 Gy/5 fx. Maximum combined CTV-PTV expansion was limited to 5 mm. Patients were treated on a Model G5 ...[more]

PMID: 28253270

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Project description:Importance:Radiotherapy (RT)-based organ preservation approaches for patients with advanced laryngeal cancer have been established stepwise through prospective randomized clinical trials. However, broad adoption of these approaches has stimulated discussion about long-term results challenging their applicability in a heterogeneous patient population, most recently for patients with T3 disease. Objective:To define outcomes in patients with clinical T3N0M0 glottic laryngeal cancer treated with definitive surgical and RT-based approaches. Design, Setting, and Participants:This retrospective cohort study included patients treated from January 1, 2004, through December 31, 2013, with a median follow-up time of 58 months (range, 0-126.6 months) in the National Cancer Database. Of the 4003 patients with T3N0M0 disease, 2622 received definitive therapy defined by the study protocol. Data were obtained from the clinical oncology database sourced from hospital registry data that are collected from more than 1500 Commission on Cancer-accredited facilities. Data were analyzed from September 14, 2016, through April 24, 2017. Interventions:Radiotherapy, chemoradiotherapy, surgery, surgery and RT, or surgery and chemoradiotherapy. Main Outcomes and Measures:Five-year overall survival (OS). Results:A total of 2622 patients (2251 men [85.9%] and 371 women [14.1%]; median age, 64 years [range, 19-90 years]) were included in the analytic cohort. In the overall patient cohort, the adjusted 5-year survival probability was 53%. No statistical differences were observed between the primary surgery (53%; 95% CI, 48%-57%) and primary RT (54%; 95% CI, 52%-57%) cohorts. In multivariate analysis, patient factors associated with decreased OS included age (hazard ratio [HR], 1.04; 95% CI, 1.03-1.04), insurance status (HR, 1.26; 95% CI, 1.06-1.50), and increasing comorbidity (HR, 1.20; 95% CI, 1.02-1.42). Conclusions and Relevance:Current management of T3N0M0 glottic laryngeal cancer relies largely on RT-based organ preservation approaches. The present study substantiates randomized clinical trial data supporting the use of RT-based organ preservation approaches for patients with T3N0M0 glottic laryngeal cancer without compromising OS.

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Project description:BackgroundAbout 20% of all glottic carcinomas involve the anterior commissure (AC), and AC involvement was deemed to be a risk factor of local recurrence and poor prognosis. Transoral robotic surgery (TORS) has been developed for a panoramic view of the AC and en-bloc resection of the tumor by multidirectional dissection with endo-wristed instruments. With satisfactory preliminary results, we would like to update the data with a bigger cohort and present the news on using TORS for salvage treatment of recurrence from irradiation failure.MethodsFrom July 2010 to December 2019, 22 patients with early T1 and 2 stage primary (n = 11) or recurrent (n = 11) glottic cancer with AC involvement received TORS without adjuvant therapy. TORS exposure was found to be better than TLM by conventional laryngoscopy in diagnostic biopsy. Seven of the 22 patients had recurrent cancer from irradiation failure. The perioperative factors that may be associated with survival were retrospectively analyzed, and the 5-year overall survival (OS)/disease-specific survival (DSS)/recurrence-free survival (RFS)/and organ preservation survival (OPS) rate were estimated by the Kaplan-Meier Method. Their voice and swallowing functions were evaluated by questionnaires of Voice Handicap Index-10 (VHI-10) and Functional Outcome Swallowing Scale (FOSS).ResultsAll 22 TORSs were completed smoothly. After a mean follow-up of 49 ± 35.9 months, the Kaplan-Meier method estimated 5-year OS/DSS/RFS/OPS was 93.8%, 93.8%, 74.6%, and 86.3%, respectively. Our 11 patients with fresh cancer had 100% recurrence-free survival. Although the recurrent rate was higher in patients with history of RT, they could be rescued by further open laryngectomy without compromising the OS and DSS. Only one patient expired. The other 21 patients had satisfactory swallowing function with FOSS of 0.33 ± 0.66. Five patients depended on tracheostomy, but the rest 17 patients had serviceable voice with VHI-10 of 18.41 ± 11.29.ConclusionsTORS could be used in the primary or salvage management of glottic cancer with AC involvement while TORS was confirmed to have better exposure to TLM. The RFS was good for patients with primary cancer. In patients having irradiation failure, TORS could also be a minimally invasive transoral approach before trying open surgery to preserve the organ.

Dataset Information

SBRT for early-stage glottic larynx cancer-Initial clinical outcomes from a phase I clinical trial.

Purpose

Methods

Results

Conclusions

Trial registration

Publications

SBRT for early-stage glottic larynx cancer-Initial clinical outcomes from a phase I clinical trial.

Similar Datasets

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