Author/Editor     Šmid, Lojze; Šoba, Erika; Budihna, Marjan; Zakotnik, Branko; Lešničar, Hotimir; Strojan, Primož; Žargi, Miha; Fajdiga, Igor
Title     Radiochemotherapy for advanced head and neck carcinoma - Ljubljana experience
Translated title     Kombinirano zdravljenje napredovalega karcinoma glave in vratu - ljubljanska izkušnja
Type     članek
Source     Zdrav Vestn
Vol. and No.     Letnik 71, št. Suppl 3
Publication year     2002
Volume     str. III-81-4
Language     eng
Abstract     In prospectively designed randomized clinical trial the efficacy of simultaneous application of irradiation, Mitomycin C, and Bleomycin was tested. 64 patients with previously untreated, histologically confirmed inoperable squamous cell carcinoma of the head and neck region were randomly assigned to receive either radiation therapy alone (group A) or radiotherapy combined with simultaneous application of Mitomycin C and Bleomycin (group B). In patients with inoperable oropharyngeal carcinoma, the disease free survival was significantly better in combined radiochemotherapy group (48%) then in only irradiated patients (10%) (p=0.001). The same combination was later tested in 114 patients with advanced but still resectable disease in the head and neck region as postoperative treatment. In prospective randomized clinical study, patients were treated postoperatively by irradiation alone (group A), or received postoperatively also concomitant chemotherapy (group B). At four years 1, in patients from radiochemotherapy group, locoregional control (86%) was significantly better than in radiotherapy group (57%) (p=0.037). Also, the overall survival for radiochemotherapy group was significantly better than for radiotherapy group (71% and 43% respectively) (p=0.036). From the subgroup analysis, it seems that the patients who benefited by chemotherapy were those with high risk factors. Proposed combined treatment scheme became in Slovenia the therapy of choice for patients with inoperable oropharyngeal carcinoma as well as for patients operated for advanced but still resectable head and neck carcinoma with one or more high risk factors.
Summary     V prospektivni randomizirani klinični študiji smo ugotavljali učinkovitost sočasnega zdravljenja z obsevanjem, Mitomicinom C in Bleomicinom pri bolnikih z neoperabilnim karcinomom v področju glave in vratu. 64 bolnikov s histološko potrjenim neoperabilnim planocelularnim karcinomom v področju glave in vratu smo z metodo naključnega izbora uvrstili v skupino, kjer so bili zdravljeni samo z obsevanjem (skupina A), ali pa v skupino, kjer so poleg obsevanja sočasno prejemali tudi Mitomicin C in Bleomicin (skupina B). Preživetje brez bolezni je bilo pri bolnikih, zdravljenih s kombinacijo obsevanja in kemoterapije (48%) statistično značilno boljše kot pri tistih, ki so bili zdravljeni samo z obsevanjem (10%) (p=0,001). Enako kombinacijo zdravljenja smo kasneje preizkusili pri 114 bolnikih z napredovalim, a še operabilnim karcinomom v področju glave in vratu kot pooperativno zdravljenje. V randomizirani prospektivni raziskavi so bili bolniki po operaciji zdravljeni samo z obsevanjem (skupina A), ali pa so sočasno z obsevanjem prejemali tudi kemoterapijo (skupina B). Po štirih letih je bilo v skupini B število bolnikov brez lokoregionalnega recidiva (86%) statistično značilno boljše kot pri pooperativno samo obsevanih bolnikih (57%) (p=0,037). Tudi celotno preživetje je bilo pri bolnikih, zdravljenih z radiokemoterapijo (71%,) statistično značilno boljše kot pri pooperativno le obsevanih bolnikih (43%) (p=0,036). Analiza rezultatov je pokazala, da je kombinirano pooperativno zdravljenje indicirano pri bolnikih z neugodnimi napovednimi dejavniki. Na temelju rezultatov obeh raziskav zdravimo v Sloveniji bolnike z neoperabilnim karcinomom ustnega žrela ter bolnike z napredovalim, a še operabilnim karcinomom v področju glave in vratu, pri katerih so bili ugotovljeni napovedno neugodni dejavniki, s pooperativno kombinacijo obsevanja, Mitomicina C in Bleomicina.
Descriptors     HEAD AND NECK NEOPLASMS
DISEASE-FREE SURVIVAL
MITOMYCIN C
BLEOMYCIN
RADICAL NECK DISSECTION