Randomized clinical trial on 7-days-a-week post-operative radiotherapy vs concurrent post-operative radiochemotherapy in locally advanced cancer of the oral cavity/oropharynx: a report on acute normal tissue reactions.

Abstract

OBJECTIVE:

The purpose of the study was to evaluate acute normal tissue reactions and treatment compliance in a randomized clinical trial on 7-days-a-week post-operative radiotherapy (p-CAIR) vs post-operative concurrent radiochemotherapy (p-RTCT) in locally advanced cancer of the oral cavity/oropharynx. The sample analyzed at present represents approximately 30% of the intended future trial size.

METHODS:

The patients were randomly assigned to receive 63 Gy in 1.8-Gy fractions 7 days a week (n = 44) or 63 Gy in 1.8-Gy fractions 5 days a week with concurrent cisplatin 80-100 mg per square metre of body surface area on Days 1, 22 and 43 of the course of radiotherapy (n = 40). Acute mucosal reactions were scored using the modified Dische system.

RESULTS:

15 (17.9%) patients, including 5 patients in p-CAIR and 10 patients in p-RTCT, did not comply with the assigned radiation treatment, mostly because of rapid tumour progression or deteriorating general performance. In p-RTCT, 22 (55%) patients received less than the intended three courses of chemotherapy mostly owing to haematological toxicity. The average maximum mucosal severity score was 14.2 in p-CAIR compared with 13.4 in p-RTCT; the difference was not statistically significant (p = 0.31).

CONCLUSION:

The schedules compared (p-CAIR and p-RTCT) did not differ considerably with respect to acute mucosal reactions. Haematological toxicity in p-RTCT was elevated compared with p-CAIR. Both schedules were considered tolerable with respect to acute toxicity, which justifies further recruitment to the trial.

ADVANCES IN KNOWLEDGE:

The results show that early mucosal reactions are comparable in both trial arms but haematological toxicity is more pronounced during radiochemotherapy.

• Authors: Rafal Suwinski, Grzegorz Wozniak, Maciej Misiolek, Magdalena Jaworska, Maciej Kozaczka, Wieslaw Bal, Elzbieta Nowara, Leszek Miszczyk
• Journal: The British journal of radiology (Br J Radiol) Vol. 89 Issue 1061 Pg. 20150805 ( 2016) ISSN: 1748-880X [Electronic] England
• PMID: 26934504 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Topics

• Adult
• Aged
• Chemoradiotherapy (methods)
• Dose Fractionation, Radiation
• Female
• Head and Neck Neoplasms (therapy)
• Humans
• Male
• Middle Aged
• Mouth (drug effects, radiation effects)
• Oropharynx (drug effects, radiation effects)
• Postoperative Care (methods)
• Radiation Injuries
• Radiotherapy Dosage