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Randomized Controlled Trial
. 2020 Dec 1;93(1116):20200288.
doi: 10.1259/bjr.20200288. Epub 2020 Sep 30.

Randomised clinical trial on 7-days-a-week postoperative radiotherapy vs. concurrent postoperative radio-chemotherapy in locally advanced cancer of the oral cavity/oropharynx

Grzegorz Wozniak  1 , Maciej Misiołek  2 , Adam Idasiak  3 , Iwona Dębosz-Suwińska  1 , Magdalena Jaworska  4 , Wieslaw Bal  5 , Boguslaw Maciejewski  1 , Leszek Miszczyk  1 , Krzysztof Składowski  3 , Rafal Suwinski  3
Affiliations
Randomized Controlled Trial

Randomised clinical trial on 7-days-a-week postoperative radiotherapy vs. concurrent postoperative radio-chemotherapy in locally advanced cancer of the oral cavity/oropharynx

Grzegorz Wozniak et al. Br J Radiol. .

Abstract

Objective: To compare the efficacy and tolerance of 7-days-a-week accelerated postoperative radiotherapy (p-CAIR) vs postoperative radio-chemotherapy (p-RTCT).

Methods: Between September 2007 and October 2013, 111 patients were enrolled and randomly assigned to receive 63 Gy in 1.8 Gy fractions 7-days-a-week (n = 57, p-CAIR) or 63 Gy in 1.8 Gy fractions 5-days-a-week with concurrent cisplatin 80-100 mg per square meter of body-surface area on days 1, 22 and 43 of the radiotherapy course (p-RTCT). It represents approximately 40% of the intended trial size, that was closed prematurely due to slowing accrual. Only high-risk patients with squamous cell cancer of the oropharynx/oral cavity, considered fit for concurrent treatment were enrolled.

Results: The rate of locoregional control (LRC) did not differ significantly between treatment arms (p = 0.18, HR = 0.56), 5 year LRC tended, however, to favour p-RTCT (81%) vs p-CAIR (62%). There was no difference in overall survival between treatment arms (p = 0.90, HR = 1.03).The incidence and severity of acute mucosal reactions and late reactions did not differ significantly between treatment arms. Haematological toxicity of p-RTCT was, however, considerably increased compared to p-CAIR.

Conclusion: Concurrent postoperative RTCT tended to improve locoregional control rate as compared to p-CAIR. This, however, did not transferred into improved overall survival. Postoperative RTCT was associated with a substantial increase in haematological toxicity that negatively affected treatment compliance in this arm.

Advances in knowledge: To our knowledge, this is the first trial that compares accelerated radiotherapy and radio-chemotherapy in postoperative treatment for oralcavity/oropharyngeal cancer.

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Figures

Figure 1.
Figure 1.
Consort flow diagram of the trial. Note that some patients lost to follow-up for LRC were available for the analysis of OS. LRC, locoregional tumour control; OS, overall survival.
Figure 2.
Figure 2.
Locoregional tumour control in all patients recruited to the trial (a), and in subset of the patients with cancer of the oral cavity (b) vs oropharynx (c).
Figure 3.
Figure 3.
Graphical display of hazard ratio estimates for comparison of locoregional tumour control (p-RTCT vs p-CAIR) in selected subgroups of patients
Figure 4.
Figure 4.
Overall survival (a), metastases-free survival (b) and second cancer-free survival (c) according to treatment arm (p-CHRT vs p-CAIR).
See this image and copyright information in PMC

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