Author/Editor		Strojan, Primož; Zakotnik, Branko; Šmid, Lojze; Lešničar, Hotimir; Šoba, Erika; Fajdiga, Igor; Žargi, Miha
Title		Konkomitantna radiokemoterapija z mitomycinom C in cisplatinom pri neoperabilnem karcinomu glave in vratu: raziskava faze I-II
Translated title		Concomitant radiochemotherapy with mitomycin C and cisplatin in inoperable carcinoma of the head and neck: phase I-II study
Type		članek
Source		Med Razgl
Vol. and No.		Letnik 43, št. Suppl 3
Publication year		2004
Volume		str. 119-23
Language		slo
Abstract		The Purpose of Phase I-II study was to evaluate concomitant radiochemotherapy with mitomycin C and cisplatin in inoperable carcinoma of the head and neck. The patients were treated with conventional radiotherapy (35 x 2 Gy/day), mitomycin C (15 mg/mz IV, after 10 Gy) and cisplatin applied during the last 10 days of irradiation. The daily dose of cisplatin was esca lated from 10 mg/mz to 12 mg/m2 to 14 mg/mZ IV, in order to determine the maximum tolerated dose and maximum acceptable level of intensity of the regimen. Results: Six patients were treated at each dose level. Fourteen (78%) tumors were classified as T4 and 7 (39%) as N3. Dose-limiting toxicity was not recorded and the daily cisplatin dose of 14 mg/mz was chosen as the maximum tolerated dose. Disease-free survival at 12 months of follow up was 36% and the overall survival rate was 45%. Conclusion: The tested regimen was not associated with unacceptable toxicity and the survival results are encouraging enough to be tested in the continuation of phase II clinical study.
Summary		Namen raziskave faze I-II je bil ovrednotiti konkomitantno radiokemoterapijo z mitomycinom C in cisplatinom pri neoperabilnem karcinomu glave in vratu. Bolniki so bili zdravljeni s konvencionalno radioterapijo (35 x 2 Gy/dan), mitomycinom C (15 mg/mz intravensko, po prejetih 10 Gy) in cisplatinom, ki je bil apliciran v zadnjih 10 dneh obsevanja. Dnevni odmerek cisplatina je bil zviševan od 10 mg/m2 na 12 mg/m2 do 14 mg/mz intravensko, z namenom poiskati maksimalni tolerančni odmerek in določiti za bolnike še sprejemljivo intenzivnost režima. Na vsaki odmerni ravni je bilo zdravljenih po 6 bolnikov. 14 (78%) tumorjev je bilo stadija T4 in 7 (39%) stadija N3. Odmerek omejujoče toksičnosti nismo zabeležili, zato je bil kot maksimalni tolerančni odmerek cisplatina določen dnevni odmerek 14 mg/m2. Po 12 mesecih sledenja sta preživetje brez ponovitve bolezni in celokupno preživetje znašala 36 oziroma 45%. Ker testirani režim ni pokazal nesprejemljive toksičnosti in ker so rezultati preživetja dovolj spodbudni, ga nameravamo testirati v nadaljevanju faze II klinične raziskave.
Descriptors		HEAD AND NECK NEOPLASMS MITOMYCIN C NEOPLASM STAGING TREATMENT OUTCOME