Accelerated chemoradiation to 70.6 gy is more effective than accelerated radiation to 77.6 gy alone — two year's results of a German multicenter randomized trial (ARO 95-6)
University of Pennsylvania Cancer
Last Modified: May 13, 2001
Presenter: Volker Gustav Budach
Affiliation: Charite University Clinics, Berlin, Germany
- This study attempts to answer whether accelerated chemoradiation is more effective than accelerated radiation therapy alone?
- Multicenter study of 384 pts, between March 1995 and May 1999, with locally advanced head and neck cancer from 10 centers.
- Three target volumes (TV) were defined as follows: a. Macroscopic tumor and lymph nodes. b. High risk regions for lymphatic spread. c. Low-risk areas of lymphatic spread.
- The overall treatment time in both study arms was 6 weeks (40 days).
- Arm A:14 Gy/2 Gy q.d., then 1.4 Gy b.i.d. to a total dose of 77.6 Gy. Arm B: 30 Gy/2 Gy and then 1.4 Gy b.i.d. to a total of 70.6 Gy. Mitomycin C 10mg/m2 on day 5 and 36, and 5-FU 350 mg/m2 as bolus plus 600 mg/m2 as 120-hr continuous infusion.
- 82% of the patients were male with a mean age of 55 years.
- The oropharynx (60.4%) and hypopharynx (32.3%) were the predominant tumor sites. Oral cavity accounted for only 7.3%. All patients with stage III (5.5%) and IV (94.5)disease lacking evidence of distant metastases qualified for the treatment.
- The median follow-up was 30 months for all patients.
- The absolute values of locoregional failures were arm A 49.7% vs. arm B 37.6% (p=0.03). The total number of metastases did not differ between the groups. Actuarial locoregional control(LRC) values were 46.4% (arm A) vs. 57.0% (arm B) @ 2 years (p=0.03). The overall survival (OS) rates were 39.1% (arm a) vs. 49.4% (arm B) @ 2 years (p=0.05).
- None of seven parameters tested for late grade 3 and 4 morbidity were statistically different between the 2 arms. Of 12 parameters tested for late grade 3- and 4 morbidity, only dysphagia (p=0.01) turned out to be pronounced in arm A.
- Pts with pre-tx Hgb level of 14gm/dl had better LRC and OS. This difference was statistically significant in arm A but no in arm B.
- Accelerated radiotherapy of 70.6 Gy plus MMC/5-FU is superior to 77.6 Gy of accelerated fractionation alone in LRC (p=0.03) and OS (p=0.05) with similar toxicity profile.
- MMC/5-Fu is not the standard regimen used in concurrent chemoradiation in head and neck cancer. Future studies may test other chemotherapy regimens along with accelerated radiation therapy.
OncoLink ASCO 2001 coverage is provided by an unrestricted educational grant from Amgen