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Biomedical subjects

B Blumenstein

Publications and source records attributed to B Blumenstein.

At least 19 recordsLinked to original sources
PubMed1997

Treatment of advanced bladder cancer with combined preoperative irradiation and radical cystectomy versus radical cystectomy alone: a phase III intergroup study.

PURPOSE: Our study was designed to compare the effects of preoperative irradiation and cystectomy to surgery alone in patients with transitional cell carcinoma of the bladder. MATERIALS AND METHODS: A total of 140 patients with documented invasive bladder cancer or rapidly recurring superficial high grade tumors was randomized to receive 2,000 rad of pelvic irradiation followed by cystectomy within 1 week or surgery alone. RESULTS: The 5-year survival rate was 53% (95 confidence intervals 41 to 65%) in the surgery only group and 43% (95% confidence intervals 30 to 56%) in the irradiation plus surgery group. The p value for the log rank statistic comparing the survival distributions was 0.23. CONCLUSIONS: Although this trial showed no benefit for preoperative irradiation and cystectomy, the confidence intervals were wide. This finding does not exclude the possibility of a favorable effect of radiation in a subset of patients with high stage tumors. Overall, however, the dominant effect of distant disease as a cause of treatment failure diminishes any potential impact of radiation on results.

Carcinoma, Transitional Cell↗
PubMed1996

Southwest Oncology Group studies in hormone-refractory prostate cancer.

Virtually all patients with hormone-refractory prostate cancer will eventually succumb to their diseases with no demonstrable increase in survival with any second-line therapy, thus making the conventional approach to the treatment of this disease palliative. The Southwest Oncology Group (SWOG) Genitourinary Committee strategy in investigating therapy for hormone-refractory prostate cancer is focused on the application of biologically guided treatments targeting primary patients with limited prior hormonal therapy, taking into account evolving concepts regarding the definitions of "hormone-refractory" disease and response criteria. This report reviews data from selected SWOG studies conducted in the past 10 years, and outlines the rationale and design of current and future studies conducted by the Genitourinary Committee of the SWOG in hormone-refractory prostate cancer.

Clinical Trials as Topic↗
PubMed1995

Regulation of mental states and biofeedback techniques: effects on breathing pattern.

The purpose of the present study was to examine whether breathing pattern may be used as a reliable index for the effectiveness of techniques applied for the regulation of mental states. Heart rate (HR), breathing pattern, galvanic skin response (GSR), and electromyogram (EMG) of the frontalis muscle were measured in 39 male and female subjects aged 18-25 years during 10-minute treatment with relaxation technique (autogenic training and/or music) followed by 10 minutes of imagery training. In the first 7 sessions biofeedback (BFB) was not included, while during the last 6 sessions BFB was introduced and utilized by the subjects. Relaxation (music or autogenic training) led to a decrease in breathing frequency, attributed to lengthening of expiration time, as well as reduced HR, GSR, and frontalis EMG response. In most instances imagery training was related to an increase in these indices. Specifically, significant tachypnea was observed during imagery of sprint running. In most cases BFB substantially augmented the physiological responses. In conclusion, our data suggest that, compared with HR, GSR, and EMG responses, the breathing pattern is at least as sensitive to the mental techniques employed, and may be useful as a psychophysiological index for diagnosis and testing, especially in sport practice.

Adult↗
PubMed1995

Design of the Prostate Cancer Prevention Trial (PCPT).

The PCPT is a chemoprevention trial of finasteride with a primary endpoint of biopsy-proven presence or absence of prostate cancer. A total of 18,000 healthy men, aged 55 years and older, will be randomized. Half will receive finasteride (5 mg/day) and half will receive placebo (one matching tablet per day) for 7 years. The trial is designed to have 92% power to detect a 25% reduction in period prevalence of biopsy-proven disease using a two-sided test with alpha = 0.05. The trial is complicated by the known impact of finasteride on the major screening test for prostate cancer, prostate specific antigen (PSA). This paper describes the PCPT design with reference to alternatives that were considered. The chosen design depends on five critical assumptions that must be monitored closely throughout the 9-year trial.

Aged↗
PubMed1995

The augmenting role of biofeedback: effects of autogenic, imagery and music training on physiological indices and athletic performance.

In this study, three psychoregulative procedures of relaxation and excitation were provided in combination with biofeedback to examine their role on physiological and athletic performance variables. Thirty-nine college students were randomly assigned to three groups of psychoregulatory treatment (autogenic and imagery training, AT+IT; music and imagery training, M+IT; autogenic, music and imagery training, AT+M+IT), one placebo group and the control group. Imagery was related to a 100-m run. The treatment and control conditions lasted 13 sessions of 20 min each. During the first seven sessions, the subjects in the treatment groups underwent 10 min of relaxation followed by 10 min of excitation. During the last six sessions, similar treatment was provided accompanied by frontalis EMG biofeedback. Heart rate, the galvanic skin response, EMG and breathing frequency (fb) were recorded three times during each session. In addition, an athletic task (100-m run) was examined at the outset, after seven sessions (no biofeedback) and after an additional six sessions (with biofeedback). Biofeedback was found to have a significant augmenting effect on physiological components and athletic performance when accompanied by autogenic, imagery and music training. Soft music was found to be as beneficial as other relaxation techniques. The results are compared with similar studies applying mental techniques with biofeedback, and new directions of investigation in the psychophysiological domain are suggested.

Adolescent↗
PubMed1995

Phase II trial of CHIP for the treatment of advanced, hormonally refractory carcinoma of the prostate. A Southwest Oncology Group Study.

CHIP, a second generation analogue of cisplatin, was subjected to a Phase II trial for the treatment of advanced, hormonally refractory carcinoma of the prostate. Forty-six patients were treated with CHIP 300 mg/m2 intravenously every 4 weeks. Evaluations for tumor response were done after three cycles of therapy. Among 40 evaluable patients there were no complete responses, but there were 6 partial responses for an overall response rate of 15% (95% confidence interval of 5.7 to 29.8%). The median time to response was 2.4 months and the median progression-free survival was 4.1 months. Median survival was 8.4 months. The most common toxicities were hematologic and gastrointestinal. While CHIP can be administered on an outpatient basis, its response rate for prostatic carcinoma appears to be similar to that of cisplatin.

Adenocarcinoma↗
PubMed1994

Phase II evaluation of merbarone in renal cell carcinoma.

The Southwest Oncology Group (SWOG) studied the response rate and toxicity of merbarone (1,000 mg/m2 IV continuous infusion days 1-5, q 21 days) in patients with advanced metastatic renal cell carcinoma. Among 36 eligible patients, there was one partial response for a response rate of 3% (95% C.I. 0.1-15%). There were no mixed responses. There were no treatment related deaths or adverse drug reactions. Significant anemia, diarrhea, and hypercalcemia were observed. Mild to moderate degrees of malaise/fatigue/lethargy, dizziness/vertigo, hyperglycemia, creatinine increase, nausea, vomiting, weight loss, pedal edema, dyspnea, and granulocytopenia were noted. Merbarone does not have significant activity as a single agent in advanced renal cell carcinoma.

Antineoplastic Agents↗
PubMed1994

Phase II trial of amonafide for the treatment of advanced, hormonally refractory carcinoma of the prostate. A Southwest Oncology Group study.

Amonafide (benzisoquinolinedione; NSC 308847) was subjected to a Phase II trial for the treatment of advanced hormone-refractory carcinoma of the prostate. In addition to adequate baseline organ functions, patients were required to have a favorable performance status, bidimensionally measurable disease and no prior chemotherapy. Amonafide was given at a dose of 225 mg/m2 intravenously daily for 5 days. Treatment cycles were repeated every 21 days. Dose escalation and reduction schema were used based upon toxicities from preceding cycles. Of 47 patients enrolled, 43 were evaluable. The most common toxicities were hematologic to include leukopenia (72%), granulocytopenia (32.6%), and thrombocytopenia (44.2%). There were no complete responses and only 5 partial responses for an overall response rate of 12% (95% confidence interval: 4-25%). The results indicate that Amonafide, in the dose and schedule tested, lacks sufficient activity against hormone-refractory prostate cancer to warrant further trials.

Adenine↗
PubMed1993

Alternating combination chemotherapy in patients with extragonadal germ cell tumors. A Southwest Oncology Group study.

BACKGROUND: Extragonadal germ cell tumors (EGGCT) are uncommon, occur primarily in the mediastinum and retroperitoneum, and have been noted to have variable response rates to cisplatin-based chemotherapy regimens. METHODS: The Southwest Oncology Group (SWOG) has completed a prospective trial of combination chemotherapy followed by surgical removal of residual disease in patients with this type of germ cell neoplasm. Chemotherapy consisted of alternating cycles of vinblastine, bleomycin, and cisplatin with etoposide, bleomycin, doxorubicin, and cisplatin. Four cycles of therapy were given followed by surgical removal of residual disease where appropriate. RESULTS: Fifty patients were entered into the trial, and 41 were eligible, with 4 patients excluded by pathology review. Of the 41 eligible patients, 24 had mediastinal tumors, 15 had retroperitoneal tumors, and 2 had unknown primary sites. Complete response rates (chemotherapy +/- surgery) for the various sites were as follows: mediastinum, 18 of 24 (75%); retroperitoneum, 10 of 15 (67%); and unknown primary, 2 of 2 (100%). At 2 years, the disease-free survival rate for all patients was 87%. At a median follow-up of 6.8 years, 26 of 41 patients (63%) are alive. The toxicity of the chemotherapy regimen was substantial, with neutropenic fever developing in 17 of 41 patients (41%) during treatment. Additional side effects included nausea and vomiting (76%), mucositis (27%), and pulmonary toxicity (5%). CONCLUSIONS: This prospective trial of chemotherapy in patients with EGGCT demonstrates a significant response in patients with either mediastinal or retroperitoneal tumors and a 4-year survival rate of more than 60% and 70%, respectively.

Adolescent↗
PubMed1993

Doxorubicin, mitomycin C and 5-fluorouracil in the treatment of hormone refractory adenocarcinoma of the prostate: a Southwest Oncology Group study.

In a Southwest Oncology Group phase II clinical trial, 68 patients with hormone refractory carcinoma of the prostate were treated with a combination of doxorubicin, mitomycin C and 5-fluorouracil. Of the patients 11 were classified as good risk and 57 as poor risk. There were 1 complete and 10 partial remissions for a response rate of 16.2% (exact 95% confidence interval 8.4 to 27.1%). Median survival was 9 months (maximum 14) for good risk patients and 10 months (maximum 42) for poor risk patients. Toxicity was significant with leukopenia identified as dose limiting. Because of the low rate of response and significant toxicity, this regimen cannot be recommended as standard therapy for metastatic hormone refractory prostate cancer.

Adenocarcinoma↗
PubMed1992

Combination cisplatin and dichloromethotrexate in patients with advanced bladder cancer. Phase 2. A Southwest Oncology Group study.

The combination of cisplatin and dichloromethotrexate is a pharmacologically rational strategy designed to avoid the nephrotoxicity associated with the systemic chemotherapy of bladder cancer. Of 97 patients with metastatic bladder cancer entered into this study 73 with good renal function received cisplatin and dichloromethotrexate, while 24 with impaired renal function received dichloromethotrexate alone. No responses were noted in the latter group. A 42% response rate (95% exact confidence interval 30.0 to 55.2%), including 9 patients (14%) who achieved a complete response, was observed in the combination group. The toxicity patterns in both groups of patients were consistent with the hypothesis that renal toxicity would be ameliorated with the use of the methotrexate analogue. However, the failure to achieve a higher overall response rate despite near maximum tolerated doses of dichloromethotrexate discourages future studies with this agent. New agents for metastatic bladder cancer should be tested as first line therapy.

Adult↗
PubMed1990

Combined versus sequential chemo-endocrine therapy in advanced prostate cancer: final results of a randomized Southwest Oncology Group study.

Cytotoxic chemotherapy has not provided survival benefit in metastatic prostate cancer, although it has been used most frequently in patients with far-advanced, refractory disease. To evaluate the effects of chemotherapy given earlier in the course of the disease, the Southwest Oncology Group (SWOG) performed a randomized trial between September 1982 and October 1986 comparing endocrine therapy (diethylstilbestrol [DES] or orchiectomy) alone followed by cyclophosphamide-Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH) chemotherapy at progression versus initial combined chemo-endocrine therapy. One hundred forty-three patients were registered, and only six were declared ineligible. Patients on the combined chemo-endocrine therapy arm had a slightly higher response rate (63%) compared with endocrine therapy alone (48%). A log-linear model of tumor response and treatment arm adjusted for the stratification factors favored the combination arm (P = .059). Only three of 27 patients on the endocrine therapy alone arm had an objective partial response when crossed over to chemotherapy, while two others had stable disease. Despite the difference in initial response rate, time to treatment failure and survival were identical in the two treatment arms. Seventy-seven percent of patients on the initial endocrine therapy alone arm have died (median survival, 25.6 months) compared with 78% on the chemo-endocrine therapy arm (median survival, 22.0 months). No significant effect of treatment on survival was observed even after adjustment for the stratification variables in a Cox regression model. Exploratory survival analyses with patients on both arms combined did show a marginally significant time to treatment failure and survival advantage for patients treated with DES rather than orchiectomy as initial endocrine therapy. Eighty-six percent of patients treated by orchiectomy have died compared with only 65% of those treated with DES. These data do not support the addition of cytotoxic chemotherapy to initial endocrine therapy in patients with metastatic prostate cancer.

Adult↗