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.