MITOMYCIN-C AS AN ADJUNCT TO POSTOPERATIVE RADIATION-THERAPY IN SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK - RESULTS FROM 2 RANDOMIZED CLINICAL-TRIALS
Bg. Haffty et al., MITOMYCIN-C AS AN ADJUNCT TO POSTOPERATIVE RADIATION-THERAPY IN SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK - RESULTS FROM 2 RANDOMIZED CLINICAL-TRIALS, International journal of radiation oncology, biology, physics, 27(2), 1993, pp. 241-250
Citations number
41
Categorie Soggetti
Oncology,"Radiology,Nuclear Medicine & Medical Imaging
Purpose: This study was undertaken to assess the benefit of mitomycin
C as an adjunct to postoperative radiation therapy in patients with op
erable squamous cell carcinoma of the head and neck. Methods and Mater
ials: Between May 1980 and May 1991, 182 patients have been enrolled i
n two consecutive randomized clinical trials testing mitomycin C as an
adjunct to radiation therapy in squamous cell carcinoma of the head a
nd neck. In both trials, patients were stratified by stage, disease si
te and intent of therapy. This subset analysis includes 113 patients e
ntered into these two randomized trials treated with surgery and posto
perative radiation therapy. In the first trial, patients were randomiz
ed to receive standard postoperative radiation therapy alone compared
with postoperative radiation therapy with concomitant mitomycin C. In
the second trial, patients were randomized to postoperative radiation
therapy or postoperative radiation therapy with concomitant mitomycin
C plus dicoumarol. Results: As of November 1991, the 113 patients trea
ted with surgery and postoperative radiation therapy in both trials ha
d a median follow-up of 93 months. There have been a total of 12 local
recurrences in the radiation therapy alone arm compared to 0 local re
currences in the radiation therapy/mitomycin C arm. There were eight r
egional recurrences in the radiation therapy alone arm compared with f
ive regional recurrences in the mitomycin C arm. Patients in the mitom
ycin C arm experienced a superior 5-year actuarial local regional cont
rol rate (87% vs. 67%, p < .015) and a statistically significant disea
se-free survival benefit (67% vs. 44%, p < .03). Overall survival diff
erence between the two arms (56% vs. 41%) has not reached statistical
significance. Conclusions: We conclude from these prospectively design
ed randomized clinical trials that in patients with operable head and
neck cancer treated with surgery and postoperative radiation therapy,
concomitant administration of mitomycin C with radiation therapy will
result in a statistically significant disease-free survival and local
regional control benefit. We are currently investigating the value of
other bioreductive alkylating agents as adjuncts to radiation therapy
in patients with squamous cell carcinoma of the head and neck.