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Clinical Trial
. 2017 Mar 2;12(3):e0172055.
doi: 10.1371/journal.pone.0172055. eCollection 2017.

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

David L Schwartz  1 , Alan Sosa  1 , Stephen G Chun  1 , Chiuxiong Ding  1 , Xian-Jin Xie  1 , Lucien A Nedzi  1 , Robert D Timmerman  1 , Baran D Sumer  2
Affiliations
Clinical Trial

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

David L Schwartz et al. PLoS One. .

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.

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Conflict of interest statement

Competing Interests: Robert Timmerman, MD, FACR received research funding unrelated to this manuscript from Accuray, Inc. (Sunnyvale, CA), which manufactures Cyberknife.

Figures

Fig 1
Fig 1. CONSORT diagram.
Fig 2
Fig 2. Estimated local recurrence free survival by fractionation cohort.
Fig 3
Fig 3. Estimated local recurrence free survival for cT1 and cT2 lesions.
See this image and copyright information in PMC

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This work was supported by Cancer Prevention and Research Institute of Texas (CPRIT, http://www.cprit.state.tx.us/), Individual Investigator Research Awards RP150386 and RP150485. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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