B. Zakotnik et al., CONCOMITANT RADIOTHERAPY WITH MITOMYCIN-C AND BLEOMYCIN COMPARED WITHRADIOTHERAPY ALONE IN INOPERABLE HEAD AND NECK-CANCER - FINAL REPORT, International journal of radiation oncology, biology, physics, 41(5), 1998, pp. 1121-1127
Citations number
48
Categorie Soggetti
Oncology,"Radiology,Nuclear Medicine & Medical Imaging
Purpose: To compare the efficacy of concomitant irradiation with mitom
ycin C and bleomycin in patients with inoperable head and neck carcino
ma with radiotherapy alone. Methods and materials: Between March 1991
and December 1993, 64 patients with inoperable head and neck carcinoma
(41 with oropharyngeal site) were randomized to radiotherapy alone (g
roup A) or radiotherapy combined with simultaneous application of mito
mycin C and bleomycin (group B), In both groups patients were irradiat
ed five times weekly with 2 Gy to a fetal dose of 66-70 Gy, The planne
d concomitant treatment in group B was: bleomycin 5 units twice a week
IM, total dose 70 units, mitomycin C 15 mg/m(2) IV after delivery of
10 Gy, and 10 mg/m(2) IV on the last day of radiotherapy. To enhance t
he effect of these two drugs, patients received also nicotinamide, chl
orpromazine, and dicoumarol, Because significantly better results were
achieved in arm B for patients with inoperable oropharyngeal carcinom
a, the study was closed and such patients were after December 1993 rou
tinely treated with the combined therapy (as in arm B), Until October
1996, we treated and followed up 48 such consecutive patients.Results:
Median follow-up of our study patients is 42 months, Complete remissi
on (CR) rate in group A was 31% and in group B 59% (p = 0.04); disease
-free survival (DFS) in group A was 8% and in group B 37% (P = 0.01);
and overall survival (OS) was 7% in group A and 26% in group B (p = 0.
08), CR rate for patients with oropharyngeal carcinoma was 29% in grou
p A (N = 21) and 75% in group B (N = 20) (p = 0.007); DFS in group A w
as 10% and in group B 48% (p = 0.001); and the OS was 10% in group A a
nd 38% in group B (p = 0.019), In patients with inoperable oropharynge
al carcinoma treated after December 1993, complete remission was achie
ved in 32/48 (67%, 95% CI: 52%-80%). DFS at the median follow-up of 14
months was 60% (95% CI 43-77%) and OS 58% (95% CI 42-74%). Conclusion
: From the results of our study it seems that the concomitant treatmen
t significantly improves CR rate, DFS, and OS in patients with inopera
ble oropharyngeal carcinoma in comparison with radiotherapy alone. (C)
1998 Elsevier Science Inc.