PubMed Health⌕ Search

Biomedical subjects

B Giantonio

Publications and source records attributed to B Giantonio.

7 recordsLinked to original sources
PubMed1997

Initial report on intravesical administration of N-trifluoroacetyladriamycin-14-valerate (AD 32) to patients with refractory superficial transitional cell carcinoma of the urinary bladder.

OBJECTIVES: This study was designed to assess the pharmacokinetics, safety, and antitumor activity of intravesically administered AD 32, a novel anthracycline, in patients with transitional cell carcinoma (TCC) of the bladder. METHODS: Six weekly doses of AD 32 (200 to 900 mg) were administered to 32 patients with superficial TCC who were candidates for intravesical treatment. Serum drug levels were measured during the 6-hour period after administration of the first, third, and sixth doses. Patients underwent bladder evaluations at 3-month intervals to determine responses to treatment. RESULTS: Very low levels of unmetabolized AD 32 and its two primary metabolites were measured in serum. The lack of systemic exposure was confirmed by the finding of only a few minor systemic adverse events. Local bladder irritation, the main toxicity associated with intravesical administration of AD 32, persisted for several days after each instillation. The maximum tolerated dose was 800 mg. Thirteen patients had complete responses to treatment, including 8 who remained disease free for 12.1 to 38.5 months. CONCLUSIONS: AD 32 is an active drug for the treatment of superficial bladder cancer. Further studies of intravesical administration of AD 32 are warranted.

Administration, Intravesical↗
PubMed1997

Phase II trial of 96-hour paclitaxel plus oral estramustine phosphate in metastatic hormone-refractory prostate cancer.

PURPOSE: To evaluate the antitumor activity of 96-hour paclitaxel and daily oral estramustine phosphate (EMP) in patients with metastatic hormone-refractory prostate cancer (HRPC). PATIENTS AND METHODS: Thirty-four patients with adenocarcinoma of the prostate that progressed after one or more hormonal therapies and a trial of antiandrogen withdrawal were enrolled onto this phase II trial. Patients received paclitaxel 120 mg/m2 by 96-hour intravenous (i.v.) infusion on days 1 through 4 of each 21-day cycle, together with daily oral EMP 600 mg/m2/d, continuously. RESULTS: Four of nine patients with measurable disease had objective responses (one complete response [CR] and three partial responses [PRs]) in liver (two patients) or nodes (two patients) of 2, 6, 8, and 20 months' duration. Of 25 assessable patients with metastases limited to bone, 14 had a > or = 50% decline in pretreatment prostate-specific antigen (PSA) level sustained for at least 6 weeks and seven had a > or = 80% decline. Overall, 17 of 32 patients (53.1%) with elevated pretreatment PSA levels had a > or = 50% decline of PSA and nine (28.1%) had a > or = 80% decrease. The main toxicities (> or = grade 2) were nausea, fluid retention, and fatigue, which occurred in 33%, 33%, and 24.2% of patients. Median time to progression, based on increasing PSA level and other clinical criteria, was 22.5 weeks. The estimated median overall survival time is 69 weeks. CONCLUSION: The combination of EMP and 96-hour paclitaxel is an active regimen for patients with HRPC. These results further support the therapeutic strategy of combining agents that impair microtubule function by complementary mechanisms.

Adenocarcinoma↗
PubMedDate not supplied

Prostate cancer.

Prostate cancer is the most common noncutaneous malignancy diagnosed in American men, and in 1994 it will pass lung cancer as the most common cancer diagnosed in the United States, with an estimated 200,000 new cases. The molecular biology of prostate carcinogenesis is rapidly advancing, and it is clear that, to a degree, prostate cancer is a heritable disease. The use of serum prostate-specific antigen (PSA) as a screening tool has been widely accepted by the medical community, although the evidence to support the efficacy of screening is not yet available. The curative approaches to organ-confined, clinically localized prostate cancer include radiation therapy, radical prostatectomy, and close observation in selected patients. The absence of well-designed clinical trials contributes to the confusion surrounding which curative treatment is the best option in individual patients. The standard approach to patients with evidence of extracapsular spread without distant metastases has been external-beam radiotherapy, although the results with radiation therapy alone in these patients has left considerable room for improvement. Innovative combined-modality approaches are currently being investigated at a number of institutions for these poor-prognosis patients. Three-dimensional conformal radiation therapy is currently being investigated at multiple institutions and offers some hope for improved results. The treatment of metastatic disease remains hormonal manipulation, although the exact nature of optimal androgen deprivation is currently a matter of considerable debate. In patients with hormone-refractory disease newer regimens using novel chemotherapy regimens offer some promise.

Adenocarcinoma↗