Purpose Rasburicase is effective in controlling plasma uric acid in pediatric patients with hematologic malignancies. This study in adults evaluated safety of and compared efficacy of rasburicase alone with rasburicase followed by oral allopurinol and with allopurinol alone in controlling plasma uric acid. Patients and Methods Adults with hematologic malignancies at risk for hyperuricemia and tumor lysis syndrome (TLS) were randomly assigned to rasburicase (0.20 mg/kg/d intravenously days 1-5), rasburicase plus allopurinol (rasburicase 0.20 mg/kg/d days 1 to 3 followed by oral allopurinol 300 mg/d days 3 to 5), or allopurinol (300 mg/d orally days 1 to 5). Primary efficacy variable was plasma uric acid response rate defined as percentage of patients achieving or maintaining plasma uric acid ≤ 7.5 mg/dL during days 3 to 7. Results Ninety-two patients received rasburicase, 92 rasburicase plus allopurinol, and 91 allopurinol. Plasma uric acid response rate was 87% with rasburicase, 78% with rasburicase plus allopurinol, and 66% with allopurinol. It was significantly greater for rasburicase than for allopurinol (P = .001) in the overall study population, in patients at high risk for TLS (89% v 68%; P = .012), and in those with baseline hyperuricemia (90% v 53%; P = .015). Time to plasma uric acid control in hyperuricemic patients was 4 hours for rasburicase, 4 hours for rasburicase plus allopurinol, and 27 hours for allopurinol. Conclusion In adults with hyperuricemia or at high risk for TLS, rasburicase provided control of plasma uric acid more rapidly than allopurinol. Rasburicase was well tolerated as a single agent and in sequential combination with allopurinol.

Forty-five patients with advanced squamous cell carcinoma of the head and neck, 23 of whom had received no prior therapy, were given the combination of vinblastine, 4 mg/m2 intravenously (IV) on Day 1; bleomycin, 15 mg/day intramuscularly on Days 1-7; and cis-diamminedichloroplatinum (II), 60 mg/m2 with mannitol diuresis on Day 8. The regimen was repeated at three-week intervals, for a maximum of three cycles. Among the 23 patients without prior surgery or radiation, there were 5 complete responses and 12 partial responses, a 74% response rate; whereas, among the 22 with prior therapy, there were 2 complete responses and 8 partial responses, a response rate of 45%. Nineteen of 23 previously untreated patients were subsequently given radiation, 1 had surgery, and 1 had surgery plus radiation. Twelve of these 19 patients are currently free of disease, with a median duration of ten months from initial response. Four of the 22 previously treated patients received radiation and 2, surgery; 4 of these 6 patients are without evidence of disease. Renal dysfunction with elevation of serum creatinine occurred in 5 patients, a leukocyte count of less than 3,000/mm3 in 3, a platelet count of less than 100,000/mm3 in 2, skin changes in 11, hearing loss in 1, and both peripheral neuropathy and pulmonary changes in 1 patient. This combination of agents has substantial activity in untreated patients and may be useful as initial therapy in advanced head and neck malignancies by diminishing the incidence of local recurrence and distant metastasis.

Forty‐two patients with recurrent or metastatic squamous cell carcinoma of the head and neck were treated with vinblastine, bleomycin, and cisplatin. All patients had received prior surgery, radiation or chemotherapy and all had measurable disease. Forty‐five percent of the patients responded with a median duration of response of eight months and median survival of nine months. Six patients (14%) were complete responders and had a median duration of response of 12 months and median survival of 24+ months. Thirteen patients (31%) were partial responders and had a median duration of response of seven months and survival of 13 months. Toxicity was mild with nausea and vomiting occurring in all patients after cisplatin. There were two cases of bleomycin‐induced pulmonary fibrosis and two cases of mild renal insufficiency (creatinine clearance level, 45 cc/min). This regimen compares favorably with other published regimens for advanced head and neck cancer.

BACKGROUND The current study determined the efficacy and toxicity of weekly paclitaxel in combination with estramustine phosphate (EMP) in patients with androgen‐independent prostate carcinoma (AIPC). METHODS Patients with progressive AIPC received 90 mg/m2 paclitaxel by 1‐hour intravenous infusion weekly for 3 weeks, followed by a 1‐week treatment rest. Patients received 140 mg EMP orally 3 times daily on the day before, the day of, and the day after paclitaxel administration. Patients received 1 mg warfarin daily to prevent thromboembolism. RESULTS Sixty‐six patients with progressive AIPC received treatment at 29 centers. Forty‐two percent of patients had a 50% decline in prostate‐specific antigen (PSA; 95% confidence interval [CI], 30–54%). For 26 patients with bidimensionally measurable disease, the objective response rate was 15% (95% CI, 1–30%). The median time to disease progression was 6.3 months, and the median time to PSA progression was 11.4 months. The median survival period was 15.6 months. Grade 3–4 toxicities were uncommon and included thromboembolism (8%), anemia (3%), neutropenia (3%), and peripheral neuropathy (2%). There was one treatment‐related death. CONCLUSIONS This regimen of EMP plus weekly paclitaxel was an active and well tolerated treatment for patients with AIPC. Cancer 2004;100:746–50. © 2004 American Cancer Society.

Thirty-eight patients with nonseminomatous testicular cancer were treated with cis-platinum, bleomycin, and vinblastine in combination without a prolonged maintenance phase. Twenty-Six patients with Stage III disease were treated. Seventy-six percent of those patients treated achieved complete remission. At a median survival time of 30 months, no patient who achieved a complete remission has relapsed. Twelve Stage II patients given adjuvant therapy remain free of disease at a median time of 23 months. Markedly elevated serum lactate dehydrogenase levels and massive disease were common findings in the patients who did not achieve complete remission. One drug death occurred secondary to sepsis. Symptoms of depression and anxiety were significant dose-limiting factors in this group of patients.