|An Intergroup Phase III Comparison of Standard Radiation Therapy and Two Schedules of Concurrent Chemoradiotherapy in Patients With Unresectable Squamous Cell Head and Neck Cancer|
|Reviewer: John Wilson, MD|
|The Abramson Cancer Center of the University of Pennsylvania|
Authors: Adelstein D, Li Y, Adams G, et al.
Radiotherapy (RT) is the standard of care for unresectable squamous cell carcinomas of the Head and Neck, but the overall survival has been relatively poor, usually less than 25%. Efforts have been made to improve these results, including altered RT fractionation and using chemotherapy with RT, especially concurrently. There have been several studies looking at using cisplatin based chemotherapy concurrent with standard and altered fractionation RT, and they have shown promising results, with 4yr overall survival of 34-49%. Based on these studies, the authors started a study using a control arm of standard RT compared to two arms: standard RT with weekly high dose cisplatin, and split course RT with concurrent 5FU and cisplatin.
This study reports on a randomized trial investigating the use of chemotherapy in addition to radiation for unresectable squamous cell carcinomas of the head and neck. There was a significant survival benefit between the high dose cisplatin and control arm, but the study was underpowered and because of this used a one-sided p-value instead of the standard two-sided for their analysis. Therefore, this puts the survival benefit seen into some question.
The group C pts (split course with cisplatin/5FU) did not do as well as expected. One reason might be that during the break, not that many patients went to surgery, which was the main purpose of the break. It is known that doing split course radiotherapy is suboptimal in general, so this might have cancelled out any benefit that could be gained from surgery.
Before this study, high dose cisplatin was thought to be too toxic for oncologists to administer in a community setting, but this study shows the toxicity is manageable. This study and others support the belief that adding cisplatin to radiation is better than radiation alone. However, carboplatin is more widely used today (because of the decreased toxicity), without much supportive scientific evidence.