title: Mitoxantrone and cisplatin in recurrent and/or metastatic salivary gland malignancies.
abstract: A phase II study was performed to assess the safety and efficacy of mitoxantrone and cisplatin in locally recurrent and/or metastatic carcinomas of the salivary glands. Between May 1997 and March 2001, a total of 14 patients were entered on this trial. All of them had previously undergone radical resection and 10 were subsequently treated with adjuvant radiation therapy with (n=3) or without (n=7) concomitant chemotherapy. Therapy according to the study protocol consisted of mitoxantrone given as i.v. bolus on day 1 at a dose of 12 mg/m2 and cisplatin given as 90-min infusion at a dose of 30 mg/m2 on days 1-3. We observed two partial responses (14.3%) and stabilization of disease in nine patients (64.3%); progression during therapy was noted in only three cases (21.4%). The median time to progression was 15 months (range 2-36) and the median survival time was 27 months (range 4-54). Myelosuppression was commonly observed. Leukocytopenia occurred in all patients, and was grade 3 or 4 in three (21%) and four (29%) patients. WHO grade 3 thrombocytopenia and anemia was seen in three (21%) and four (29%) patients, respectively. Non-hematologic toxicity was in general mild to moderate except for two cases (14%) of grade 3 nausea and vomiting; overall incidence rates were nausea and vomiting (n=14), stomatitis (n=6), diarrhea (n=3), alopecia (n=11), infection (n=7), increase of serum creatinine (n=3), and peripheral neuropathy (n=3). The combination of mitoxantrone and cisplatin seems to be an active and fairly well-tolerated regimen for the treatment of advanced salivary gland cancers. According to the observed high rate of abrogating progressive disease for a long duration, and the resulting promising progression-free and overall survival time, further investigation seems warranted.
authors.affiliation: Department of Otorhinolaryngology, University of Vienna, 1090 Vienna, Austria.
authors.forename: Claudia
authors.initials: C
authors.lastname: Gedlicka
authors.forename: Birgit
authors.initials: B
authors.lastname: Schüll
authors.forename: Michael
authors.initials: M
authors.lastname: Formanek
authors.forename: Johannes
authors.initials: J
authors.lastname: Kornfehl
authors.forename: Martin
authors.initials: M
authors.lastname: Burian
authors.forename: Birgit
authors.initials: B
authors.lastname: Knerer
authors.forename: Edgar
authors.initials: E
authors.lastname: Selzer
authors.forename: Werner
authors.initials: W
authors.lastname: Scheithauer
authors.forename: Gabriela V
authors.initials: GV
authors.lastname: Kornek
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D009325:Nausea / Q000139:chemically induced; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009503:Neutropenia / Q000139:chemically induced; D010166:Palliative Care; D012468:Salivary Gland Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D008942:Mitoxantrone; D002945:Cisplatin