The Phase I/II ACCEPT Trial: Concurrent Cetuximab and Intensity-Modulated Radiotherapy with Carbon Ion Boost for Adenoid Cystic Carcinoma of the Head and Neck: Cetuximab and IMRT/Carbon Ions for ACC.

The Phase I/II ACCEPT Trial: Concurrent Cetuximab and Intensity-Modulated Radiotherapy with Carbon Ion Boost for Adenoid Cystic Carcinoma of the Head and Neck: Cetuximab and IMRT/Carbon Ions for ACC.:

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The Phase I/II ACCEPT Trial: Concurrent Cetuximab and Intensity-Modulated Radiotherapy with Carbon Ion Boost for Adenoid Cystic Carcinoma of the Head and Neck: Cetuximab and IMRT/Carbon Ions for ACC.

Int J Radiat Oncol Biol Phys. 2019 Oct 03;:

Authors: Adeberg S, Akbaba S, Lang K, Held T, Verma V, Nikoghosyan A, Bernhardt D, Münter M, Freier K, Plinkert P, Hauswald H, Herfarth K, Rieken S, Debus J, Jensen AD

Abstract

INTRODUCTION: The adenoid cystic carcinoma (ACC), Erbitux®, and Particle Therapy (xxx) phase I/II trial (NCTxxx) evaluated a combined-modality approach (concurrent cetuximab and intensity-modulated radiotherapy (IMRT) with carbon ion (CIRT) boost) for newly-diagnosed nonmetastatic head and neck ACC.

METHODS: Twenty-three patients with ACC were enrolled between June 2012 and June 2017 following initial diagnosis or postoperatively. All received a 400 mg/m2 cetuximab loading dose a week before radiotherapy, followed by weekly 250 mg/m2 doses starting on the first day of radiotherapy. The CIRT boost was 24 Gy(RBE) in 8 daily fractions, followed by IMRT (54 Gy). The primary endpoint was safety and feasibility (defined based on CTCAE grade ≥3 events). Secondary endpoints included local and distant relapses, disease-free survival (DFS), and overall survival (OS).

RESULTS: Disease was most commonly in the paranasal sinuses (30%), palate (17%), and nasopharynx (17%). Nine (39%) patients underwent surgery (R1: 22%, R2: 78%). Median follow-up was 38.5 months. No patients experienced grade 4-5 events. Rates of grade 3 rash and radiation dermatitis were 17% and 22%, respectively. Grades 2 and 3 mucositis and dysgeusia occurred in 43% & 48% and 9% & 0%, respectively. Grades 2-3 dysphagia and xerostomia were present in 43% & 4% and 26% & 0%, respectively. At last follow-up, 5 (22%) patients experienced in-field relapse and 6 (26%) developed distant metastases. The three-year DFS was 67%, and median OS was 54 months.

CONCLUSIONS: Outcomes of this trial were satisfactory. Although the trial did not meet the pre-defined criteria of feasibility, owing to the comparatively high rates of grade 3 dermatitis, the latter are numerically comparable to existing cetuximab+RT data.

PMID: 31586664 [PubMed - as supplied by publisher]