ESTRO 2022

Session Item

Monday

May 09

11:40 - 12:40

Room D1

Highlights of Proffered Papers - Latest Clinical Trials

Chair: , United Kingdom;

Chair: , The Netherlands

Session Type: Proffered Papers

Track: Interdisciplinary

Journey:

12:10 - 12:20

DAHANCA 27, a national prospective non-inferiority study of surgery versus RT for T1a glottic cancer

Nina Munk Lyhne, Denmark

Presentation Number: OC-0832

Abstract

Abstract Title:

DAHANCA 27, a national prospective non-inferiority study of surgery versus RT for T1a glottic cancer

Authors:

Nina Munk Lyhne¹, Thomas Kjærgaard², Christian Godballe³, Jesper Filtenborg Tvedskov⁴, Kirsten Hald⁵, Benedicte Ulhøj⁶, Trine Printz⁷, Jens Overgaard⁸

¹Aalborg University Hospital, Department of Otorhinolaryngology, Head and Neck Surgery, Aalborg, Denmark; ²Aarhus University Hospital, Department of Otorhinolaryngology, Head and Neck Surgery, Århus, Denmark; ³Odense University Hospital, ORL - Head & Neck Surgery and Audiology, Odense, Denmark; ⁴Rigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen, Denmark; ⁵Aalborg University Hospital, Department of Otorhinolaryngology, Head and Neck surgery, Aalborg, Denmark; ⁶Århus University Hospital, Department of Pathology, Aarhus, Denmark; ⁷University of Southern Denmark, Foniatric institute, Odense, Denmark; ⁸Aarhus University Hospital, Department of Experimental Clinical Oncology, Århus, Denmark

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Purpose or Objective

The aim of this study was to evaluate whether treatment with transoral laser microsurgery (TLM) is non-inferior compared to accelerated radiotherapy (RT) in the treatment of T1aN0M0 glottic squamous cell carcinoma (SCC).

Material and Methods

Since 2003 the Danish national standard treatment for T1aN0M0 glottic SCC has been accelerated RT (66Gy, 2 GY/fraction, 6 fractions/week). In 2012 cordectomy type I-III using Trans Oral Laser Microsurgery (TLM) was introduced as an experimental treatment. The DAHANCA 27 trial is a comparative non-inferiority phase II study comparing two timely separated national patient cohorts. Patients treated with radical TLM in the DAHANCA 27-protocol from September 2012 to April 2016 were included in the TLM cohort, and patients treated with accelerated RT from January 2003 to august 2012 were included in the RT cohort. All patients were followed for five years or until death. All Danish patients diagnosed with a head and neck cancer are prospectively registered in the DAHANCA (Danish Head and Neck Cancer) database. Hence, all patients diagnosed with a T1aN0M0 glottic SCC are registered, allowing for the analyses of potential selection biases into the DAHANCA 27 study cohorts.

The primary endpoint was 5-year laryngectomy free survival.

Results

A total of 94 patients were included in the TLM cohort and 553 patients in the RT cohort. With an observation time of 60 month, the proportion of recurrence was 9,6 % (9 patients /94) in the TLM cohort and 7,2 % (40 patients/ 553) in the RT cohort.

The proportion of patients with ultimate failure was 2,1 % (2/94 patients) in the TLM cohort and and 3,1 % (17/553 patients) in the RT cohort. One of the two patients in the TLM cohort with non-cured recurrence initially rejected salvage treatment and became incurable. Laryngectomy was performed in 2 patients in the TLM cohort and 16 patients in the RT cohort.

In total 81 and 100 patients in the TLM and RT cohorts were eligible for voice handicap index evaluation 3 years after the primary treatment, hereof 51 and 39 completed the questionnaire in the two groups respectively. No differences in the overall VHI score or sub-scale sores were observed.

After further data analysis, the 5-year laryngectomy free survival will be reported as will the secondary endpoints local control, locoregional control, disease specific survival, and GRBAS (grade, roughness, breathiness, asthenia, strain) voice scale.

Conclusion

Many smaller studies have shown similar tumor control rates after TLM and RT respectively, but no randomized trial have been published reporting tumor control, laryngectomy rate or survival as the primary endpoint. This study will contribute to the international evidence regarding best practice in the treatment of T1aN0M0 glottic cancer due to the large national cohorts.