A Phase III Trial to Compare Standard Versus Accelerated Fractionation in Combination With Concurrent Cisplatin for Head and Neck Carcinomas (RTOG 0129): Report of Compliance and Toxicity
Carolyn Vachani, RN, MSN, AOCN
Abramson Cancer Center of the University of Pennsylvania
Last Modified: October 31, 2007
Scientific Session: A Phase III Trial to Compare Standard Versus Accelerated Fractionation in Combination With Concurrent Cisplatin for Head and Neck Carcinomas (RTOG 0129): Report of Compliance and Toxicity
This study looked at the use of standard radiation therapy, given once daily, five days a week (Mon-Fri), over 7 weeks, compared with hyperfractionated radiation therapy, which consisted of 18 days of daily radiation (180 cGy per day) followed by 12 days of twice a day radiation (AM dose of 180 cGy, PM dose of 150 cGy) in squamous cell head and neck cancer. Both groups got concurrent cisplatin chemotherapy (i.e. given at the same time as the radiation therapy).
The study treated 722 patients, all with stage III or IV disease. Diagnoses included squamous cell cancer of the oropharynx, oral cavity, hypopharynx, and larynx. Patients in the standard radiation arm (SR) received 3 doses of cisplatin, while those in the fractionated arm (FR) received 2 doses.
This study was looking at the toxicity experienced by patients and how well they were able to stick to the treatment plan. The majority of patients were able to tolerate treatment, receiving it as planned or with only minor changes (96% in the SR group versus 92% in the FR group). Toxicity was similar in both groups, except for mucositis, which was higher in the FR group (40% vs. 33%). During treatment, 68% of patients in the SR group and 67% in the FR arm required feeding tubes.
The presenters concluded that patients were able to tolerate the FR treatment as well as standard treatment. The toxicity was similar in both groups. The group will likely present data on how effective the treatment is at a later date, so for now, FR for head and neck cancers is best done in the setting of a clinical trial.
Partially funded by an unrestricted educational grant from Bristol-Myers Squibb.