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)

Diana Stripp, MD

University of Pennsylvania Cancer
Ultima Vez Modificado: 13 de mayo del 2001

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Presenter: Volker Gustav Budach
Affiliation: Charite University Clinics, Berlin, Germany

Background:

    This study attempts to answer whether accelerated chemoradiation is more effective than accelerated radiation therapy alone?

Materials and Methods:

  1. Multicenter study of 384 pts, between March 1995 and May 1999, with locally advanced head and neck cancer from 10 centers.
  2. 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.
  3. The overall treatment time in both study arms was 6 weeks (40 days).
  4. 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.

Results:

  1. 82% of the patients were male with a mean age of 55 years.
  2. 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.
  3. The median follow-up was 30 months for all patients.
  4. 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).
  5. 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.
  6. 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.

Authors' Conclusions

    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.

Clinical/Scientific Implications:

    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.

ASCO Abstract 892

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OncoLink ASCO 2001 coverage is provided by an unrestricted educational grant from Amgen


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