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Biomedical subjects

B A Blumenstein

Publications and source records attributed to B A Blumenstein.

At least 37 records · Page 2Linked to original sources
PubMed1996

Local toxicity patterns associated with intravesical bacillus Calmette-Guérin: a Southwest Oncology Group Study.

BACKGROUND: While the efficacy of bacillus Calmette-Guérin (BCG) immunotherapy has been demonstrated, the relative benefit, given a seemingly high incidence and severity of toxicities, remains an issue. Adequate understanding and management of toxicities can maximize the safety of the treatment and enable the administration of required doses of BCG intravesical therapy. METHODS: All week-to-week symptoms recorded for the 143 immunotherapy-naive participants assigned to the BCG arm of SWOG-8216, BCG vs. Doxorubicin in Superficial Bladder Cancer were analyzed in order to document the pattern of toxicities in the first six week induction course of intravesical BCG treatments. The statistical analysis consisted of fitting logistic regression models to these data for the probability of irritative bladder symptoms (IBS). RESULTS: In the optimal model, the probability of IBS depends only on whether there was IBS associated with the previous treatment, and not on which treatment. The estimated probability of having IBS when there were no IBS associated with the previous instillation is 0.136, whereas the estimated probability of having IBS when there was IBS associated with the previous instillation is 0.689. CONCLUSIONS: Irritative bladder symptoms are unlikely in the week after the first intravesical BCG treatment. Once a patient experiences IBS, he or she is more likely to have IBS with the next and subsequent treatments. Clinicians can use the findings of this analysis when informing their patients about the treatment course and when making decisions about continuing treatments.

Administration, Intravesical↗
PubMed1995

Serum basic fibroblast growth factor in men with and without prostate carcinoma.

BACKGROUND: Angiogenesis is essential for the growth of neoplasms. Increased vascularity has been associated with human prostatic carcinoma stage and has been shown to offer prognostic information. Basic fibroblast growth factor (bFGF) is a potent angiogenic inducer expressed in malignant prostate tissue. In this investigation, serum bFGF levels were measured in men with and without prostate cancer. METHODS: Serum bFGF was measured using a commercial enzyme-linked immunosorbent assay in archival serum from men with various clinical stages of prostate carcinoma. Sera from men with negative systematic sector biopsies and serum prostate specific antigen (PSA) less than 2.0 ng/ml served as controls. Prostate volume was measured with transrectal ultrasound. RESULTS: Serum bFGF level was significantly higher in men with prostate carcinoma compared with those without (P < 0.0007). Among 44 men (11 with carcinoma) with a serum PSA less than 4.0 ng/ml, only bFGF level was associated with carcinoma (P = 0.008). Using a cutoff of 1.0 pg/ml, bFGF afforded a sensitivity of 83% and specificity of 44% in this group. There was no association between bFGF levels and clinical stage, Gleason score, or prostate volume. CONCLUSIONS: These data demonstrate that serum levels of bFGF are elevated in most men with prostatic carcinoma. Although association with stage was not observed, the finding of significant elevation in most men with carcinoma who have "normal" serum PSA levels may indicate diagnostic utility for this analyte.

Aged↗
PubMed1995

Results of a multicenter trial using the BTA test to monitor for and diagnose recurrent bladder cancer.

OBJECTIVES: We compare the Bard BTA (bladder tumor antigen) test to voided cytology studies in patients undergoing surveillance cystoscopy for recurrent bladder cancer. MATERIALS AND METHODS: A prospective, blinded, multicenter trial was performed. RESULTS: A total of 499 patients underwent 1,014 cystoscopic examinations and tumor was identified in 151. The bladder tumor antigen test was more sensitive than cytology studies in detecting recurrent cancer (p < 0.001), being positive in 61 cases versus 25 for cytology. The trial in healthy volunteers and nonurological patients estimates bladder tumor antigen test specificity to be 95.9%. CONCLUSIONS: The bladder tumor antigen test is a simple, rapid and inexpensive adjunct to cystoscopy, and the results are equivalent or superior to those of voided cytology as performed in this trial.

Adult↗
PubMed1994

Phase II trial of menogaril in metastatic adenocarcinoma of the prostate. A Southwest Oncology Group study.

Menogaril, a semisynthetic anthracycline antibiotic, was administered to patients with metastatic adenocarcinoma of the prostate. Forty-five patients with measurable disease and 45 patients with evaluable disease received 150-200 mg/m2 over 1 hour every 28 days. There were three partial responses (PR) among 87 patients evaluable for response. Myelosuppression was dose limiting. There were two deaths related to leukepenia. Other toxicities included phlebitis, alopecia, nausea and vomiting. One patient developed acute nonlymphocytic leukemia. Menogaril at these doses and schedule is toxic and has no significant antitumor activity in metastatic adenocarcinoma of the prostate.

Adenocarcinoma↗
PubMed1993

Some statistical considerations for the interpretation of trials of combined androgen therapy.

Since 1989, there have been strongly conflicting opinions regarding the validity of the proposition that an antiandrogen added to standard hormonal therapy could improve the outcome in patients with newly diagnosed metastatic prostate cancer. To some degree, these conflicting opinions arose from misinterpretations of a number of "negative" clinical trials. The misinterpretations happened because these "negative" trials had insufficient statistical power to refute the reported "positive trial", and information illustrating their statistical power was absent from their reports. Thus, readers were not given the necessary information to distinguish between negative and inconclusive results. In addition, many of the negative reports were early analyses of ongoing clinical trials, a practice that always should be avoided. This article reviews and illustrates the statistical principles that are applicable to the interpretation of low-powered negative clinical trials and discusses the design and conduct of clinical trials.

Androgen Antagonists↗
PubMed1993

The use of flutamide in hormone-refractory metastatic prostate cancer.

In a recent intergroup study under the auspices of the National Cancer Institute, 603 eligible patients with newly diagnosed disseminated adenocarcinoma of the prostate were prospectively randomized in a double-blinded clinical trial to receive either a gonadotropin-releasing hormone analogue (leuprolide) and a nonsteroidal antiandrogen (flutamide) or leuprolide and placebo. Of the 603 eligible patients, 300 were in the leuprolide and placebo arm and 303 were in the leuprolide and flutamide arm. At the time of disease progression, the code was broken: Those patients in the placebo arm were given the opportunity to receive flutamide, and the patients in the flutamide arm were treated at their physician's discretion. There was no survival time distribution difference, based on survival measured from the progression data, between the patients who were received flutamide after progression and those who were treated at their physician's discretion after progression. Furthermore, the addition of flutamide to leuprolide at the time of disease progression resulted in a survival-time distribution that is similar to other treatments of hormone-refractory prostate cancer.

Adenocarcinoma↗
PubMed1993

Verifying keyed medical research data.

Although diminished use of double keying for the verification of keyed medical research data has occurred, there are no published data that demonstrate the existence of equivalent or better replacement. The simple replacement of double keying with visual comparison is not recommended because visual comparison is too susceptible to the transient energy levels of the individual who makes the comparison. Some system design innovations applicable in specific situations allow elimination of verification by providing nearly equivalent or possibly even superior data quality assurance opportunities. These alternatives include designs where one replaces the transcription to data forms by direct keying from original source documents coupled with extensive quality reviews, and designs with direct data base input of data subjected to intense automated consistency checking and immediate analytic use. In both cases, the absence of keyed data verification places a greater burden for data quality assurance on other subsystems, such as quality review, and ultimately the analytic process. Data entry systems based on new technologies, such as tablet computers, electronic image processing, and voice input, will require similar considerations for assuring data quality.

Clinical Trials as Topic↗
PubMed1993

Cyclophosphamide, methotrexate, and 5-fluorouracil in the treatment of metastatic prostate cancer. A Southwest Oncology Group study.

BACKGROUND: Hormone-refractory metastatic prostate cancer remains a therapeutic challenge. Cyclophosphamide, methotrexate, and 5-fluorouracil (CMF), a drug combination that is active in solid tumors, was evaluated using specific response criteria. METHODS: Fifty-two eligible patients with measurable (19), evaluable (29), or bone scan only (4) metastatic prostate cancer were treated with cyclophosphamide, 100 mg/m2 every day by mouth, methotrexate, 15 mg/m2 intravenously weekly, and 5-fluorouracil, 300 mg/m2 intravenously weekly. Treatment was given continuously unless interrupted by toxicity or disease progression. RESULTS: There were two partial responses (7%) among the evaluable patients. Six (32%) measurable patients and four (14%) evaluable patients had stable disease. Median time to progression was 3.2 months for measurable and 2.8 months for evaluable disease patients. Median survivals were 10.9 and 10.2 months, respectively. There was no difference between the two groups with regard to response rate or survival. Toxicity was acceptable and consisted primarily of myelosuppression. CONCLUSIONS: CMF is minimally active in hormone-refractory metastatic prostate cancer.

Acid Phosphatase↗
PubMed1992

Controversies in the treatment of metastatic prostate cancer.

BACKGROUND: Prostate cancer is the most common cancer in American men today. Unfortunately, at the time of diagnosis, most men will have either regional or distant metastatic disease. METHODS: Six hundred three patients with advanced prostate cancer who could be examined were randomized in a double-blind, placebo-controlled trial to receive the luteinizing hormone-releasing hormone (LHRH) agonist leuprolide with either flutamide or placebo. RESULTS: Patients receiving the combined therapy arm of leuprolide and flutamide had an increased progression-free survival time of 16.9 versus 13.8 months and a survival advantage of 35.1 versus 20.3 months. A more striking difference was found in the subset of patients receiving combination therapy who had good performance and minimal disease. CONCLUSIONS: There appears to be a definite advantage of combination therapy over leuprolide alone, especially in patients with minimal disease and good performance. Another larger intergroup study using orchiectomy and flutamide versus orchiectomy and placebo is currently underway.

Double-Blind Method↗
PubMed1992

Phase II study of platinum and mitoxantrone in metastatic prostate cancer: a Southwest Oncology Group Study.

44 eligible patients with measurable or evaluable metastatic prostate cancer were treated with monthly cycles of cisplatin and mitoxantrone. Good-risk patients received cisplatin 60 mg/m2 intravenously and mitoxantrone 10 mg/m2 intravenously every 4 weeks. The dose in poor-risk patients (elderly or white blood cell count less than 4000/microliters, 4 x 10(9)/l, or extensive prior radiation) was reduced to 8 mg/m2. Toxicity was manageable and consisted primarily of myelosuppression. There were no complete responses and the partial response rate was only 12%. Median progression-free survival was 2.7 months for measurable and 4.1 months for evaluable disease patients. Median survivals were 4.9 and 8.7 months, respectively. This combination has minimal activity in hormone refractory metastatic prostate cancer.

Adenocarcinoma↗
PubMed1991

A randomized trial of intravesical doxorubicin and immunotherapy with bacille Calmette-Guérin for transitional-cell carcinoma of the bladder.

BACKGROUND: In carcinoma of the bladder, both intravesical chemotherapy and immunotherapy can induce tumor regression and reduce the rate of recurrence, but the relative merits of these two therapies are unclear. We conducted a multi-institutional study to address this question. METHODS: Patients with rapidly recurrent (stage Ta and T1) or in situ transitional-cell carcinoma of the bladder were randomly assigned to receive either doxorubicin administered intravesically or bacille Calmette-Guérin (BCG) administered both intravesically and percutaneously. The 262 eligible patients were followed for a median of 65 months. Complete responses to treatment of carcinoma in situ were confirmed by biopsy and cytologic analysis of the urine. RESULTS: For patients with Ta and T1 tumors without carcinoma in situ, the estimated probability of being disease free at five years was 17 percent after doxorubicin, as compared with 37 percent after immunotherapy with BCG (P = 0.015). The median times to treatment failure (termination of treatment, due to persistence, recurrence, or progression of disease) were 10.4 and 22.5 months, respectively. For patients with carcinoma in situ the complete-response probability estimates (i.e., the estimated probability of documented disappearance of disease) were 34 percent for doxorubicin (23 of 67 patients) and 70 percent for BCG (45 of 64 patients) (P less than 0.001); the median times to treatment failure were 5.1 and 39 months, respectively. The probability of being disease-free at five years survival among the patients with carcinoma in situ was 18 percent after treatment with doxorubicin and 45 percent after BCG therapy. Patients treated with BCG had a higher incidence of toxic systemic effects and a larger number of local irritative symptoms than patients treated with doxorubicin, but few of these adverse reactions were severe. CONCLUSIONS: As compared with intravesical doxorubicin, immunotherapy with BCG provides improved protection against the recurrence of superficial bladder cancer.

Administration, Cutaneous↗
PubMed1991

A randomized trial of cisplatin, vinblastine, and bleomycin versus vinblastine, cisplatin, and etoposide in the treatment of advanced germ cell tumors of the testis: a Southwest Oncology Group study.

This is a Southwest Oncology Group (SWOG) prospective randomized trial of cisplatin, vinblastine, and bleomycin (PVB) versus vinblastine, cisplatin, and etoposide (VP-16) (VPV) in the treatment of advanced germ cell tumors of the testis. The study objective was to determine what effect the replacement of bleomycin with VP-16 has on complete response (CR), survival, and drug toxicity. One hundred sixty-nine patients were registered and randomized. Of these patients, 160 were assessable for response. All had histologically confirmed disseminated germ cell neoplasms of testicular origin. Forty-six had minimal metastatic disease, and 114 had maximal disease. Seventy-seven were randomized to PVB and 83 to VPV chemotherapy. There was no significant difference in pretreatment characteristics between the two arms with regard to tumor burden, histologic type, and overall performance status. Patients received four courses of induction chemotherapy, either PVB (cisplatin 120 mg/m2 day 3, vinblastine 12 mg/m2 day 1, bleomycin 15 U/m2 twice per week) or VPV (vinblastine 8 mg/m2 day 1, cisplatin 120 mg/m2 day 3, VP-16 50 mg/m2 days 2 to 5). Chemotherapy was given every 3 weeks. Cytoreductive surgery was done postinduction if a chemotherapy CR was not achieved. There was no difference in the percentage of patients achieving a disease-free status between PVB (77%) and VPV (73%). The mean leukocyte nadir was similar for both treatments, but the mean platelet nadir was significantly lower (P = .003) in the VPV arm. All bleomycin-related toxicities (pulmonary, mucositis, skin) were avoided in the VPV arm. We conclude that bleomycin can be replaced in first-line therapy for advanced germ cell tumors without sacrificing efficacy and with the advantage of avoiding unnecessary drug toxicity.

Adolescent↗
PubMed1990

Leuprolide with and without flutamide in advanced prostate cancer.

In a randomized, double-blind trial for metastatic prostate cancer (Stage D2), 603 men received leuprolide, a gonadotropin-releasing hormone analog that inhibits the release of gonadotropins, coupled with either placebo or flutamide, a nonsteroidal antiandrogen that inhibits the binding of androgens to the cell nucleus. The 303 men receiving androgen blockade with leuprolide and flutamide demonstrated a longer progression-free survival (16.9 vs. 13.9 months, P = 0.039) and an increased median length of survival (35.0 vs. 27.9 months, P = 0.035). In the subgroup of men with minimal disease and good performance status, the advantages of maximal androgen blockade were more pronounced. It is concluded that combined androgen blockade with leuprolide and flutamide was more effective than leuprolide alone for patients with metastatic cancer of the prostate. The therapeutic benefits, although greatest in patients with minimum disease, need to be evaluated in a prospective, randomized fashion in trials specifically designed for men with minimal disease and good performance status. Exploratory analyses using the black race as an explanatory variable were also performed. Black race is associated with shorter survival times and is also associated with other prognostic factors, including recent weight loss, anemia, elevated phosphatase levels, and pain. These findings suggest the need for future studies of the relationship of black race and response to prostate cancer therapy.

Adult↗
PubMed1990

Long-term methotrexate treatment in corticosteroid-dependent asthma.

STUDY OBJECTIVE: To study the long-term efficacy and toxicity of low-dose methotrexate as corticosteroid-sparing adjunctive therapy in patients with corticosteroid-dependent bronchial asthma. DESIGN: A prospectively evaluated case series. PATIENTS: We studied 31 cushingoid asthmatics who needed daily prednisone and were found to be unable to reduce their prednisone dosage. These patients had used maximal daily doses of bronchodilator and inhaled corticosteroid and, on average, had used prednisone, 26.8 mg/d, for 4.7 years (range, 1 to 11 years). Of these 31 patients, 25 completed 18 to 28 months of methotrexate therapy. INTERVENTION: Patients were treated for at least 18 months with low-dose methotrexate (range, 15 to 50 mg/wk). RESULTS: The mean prednisone dose was reduced from 26.9 mg/d to 6.3 mg/d (P = 0.0001) in the 25 patients treated with long-term methotrexate: Fifteen patients discontinued the regular use of prednisone, 9 patients reduced prednisone use by more than 50%, and 1 patient failed to respond. The forced expiratory volume in 1 second (FEV1) improved from 1.7 L/s to 1.9 L/s (P = 0.0513), and subjective symptom scores for breathing ability, cough, wheeze, and frequency of nocturnal awakenings all improved. Adverse drug reactions were noted in 15 patients. These reactions were mild and did not lead to discontinuation of drug therapy. CONCLUSION: Methotrexate is effective and safe when used as a long-term, corticosteroid sparing agent in patients with severe bronchial asthma.

Adult↗