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Biomedical subjects

M A Gregurich

Publications and source records attributed to M A Gregurich.

6 recordsLinked to original sources

A phase II multicenter study of combined topotecan and gemcitabine as first line chemotherapy for advanced non-small cell lung cancer.

UNLABELLED: This trial was designed to determine the 1-year survival rate, efficacy, and safety, produced by topotecan and gemcitabine as first line chemotherapy in advanced non-small cell lung cancer (ANSCLC). Fifty-three patients were enrolled; 51 received treatment. Topotecan 1 mg/m(2), days 1-5 and gemcitabine 1 g/m(2) days 1 and 15 were administered IV, each drug over 30 min; cycles consisted of 28 days. Treatment continued until progressive disease or intolerable toxicity. Nineteen patients (36%) had Eastern Cooperative Oncology Group criteria performance status (ECOG PS) = 0, 34 (64%) PS = 1. Median age was 64 years; 37 patients (70%) were male. HISTOLOGY: adenocarcinoma (42%), squamous cell carcinoma (28%), large cell (19%), and unclassified (11%). Among 47 evaluable patients, eight (17%) had partial response, 11 (23%) had stable disease. One-year survival was 39% and median survival was 7.6 months (range, < 1-19.6). Grade 3 and 4 toxicities included neutropenia (53%), anemia (18%), thrombocytopenia (12%), asthenia (8%), and gastrointestinal disorders (8%); three patients (6%) experienced neutropenic fever. There were no treatment-related deaths. The combination topotecan/gemcitabine produced a 1-year survival similar to previous platinum-based regimens, when used as first line chemotherapy for ANSCLC. The toxicity profile was acceptable.

Adenocarcinoma↗

Phase II trial of single-agent weekly docetaxel in hormone-refractory, symptomatic, metastatic carcinoma of the prostate.

The purpose of this study was to assess the efficacy of weekly administration of docetaxel as a single agent in patients with hormone-refractory, symptomatic, metastatic prostate cancer with respect to symptom palliation, tumor response, time to progression, and survival. Sixty men with progressive metastatic prostate cancer that had progressed on at least one hormonal regimen were enrolled in this multicenter phase II study. Twenty-one percent of patients had received prior palliative radiotherapy, and 25% had received prior chemotherapy for hormone-refractory disease. Patients were scheduled to receive three 8-week cycles of docetaxel (36 mg/m(2) on days 1, 8, 15, 22, 29, and 36) with 2-week intervals between cycles. The docetaxel dose could be decreased in the event of toxicity, but no dose escalation was permitted. A > or =50% decrease in serum prostate-specific antigen (PSA) levels from baseline with stabilization or improvement of performance status lasting 2 months or longer occurred in 24 (41%) patients, of whom 16 (27%) had a > or =80% decrease for 2 months or more. The median time to progression for all patients was 5.1 months (range, 0.9 to 18.2 months). The estimated median time to progression for patients who had and those who did not have a > or =50% reduction in serum PSA level with stable or improved performance status was 6.65 and 4.3 months, respectively. The median overall survival was 9.4 months (range, 1.6 to 18.2 months). Treatment toxicity was considered acceptable. Single-agent docetaxel at 36 mg/m(2) weekly was associated with a PSA response rate of 41%, increased time to progression and survival, and minimal myelosuppression in patients with hormone-refractory metastatic prostate cancer.

Adenocarcinoma↗

A multidisciplinary approach to therapy for unresectable malignant thymoma.

BACKGROUND: The therapeutic outcome for unresectable, locally advanced, malignant thymoma has been poor. OBJECTIVE: To improve tumor resectability and patient survival rates by studying a multimodal approach to therapy for unresectable malignant thymoma. DESIGN: Prospective cohort study. SETTING: Tertiary care cancer center. PARTICIPANTS: All eligible patients had newly diagnosed, histologically proven, unresectable malignant thymoma. INTERVENTION: The treatment regimen consisted of induction chemotherapy (three courses of cyclophosphamide, doxorubicin, cisplatin, and prednisone), surgical resection, postoperative radiation therapy, and consolidation chemotherapy (three courses of cyclophosphamide, doxorubicin, cisplatin, and prednisone). Tissue samples were taken at the time of surgical resection for assessment of tumor necrosis and Ki-67 expression. MEASUREMENTS: Tumor response and resectability (both overall and after induction chemotherapy) and disease-free survival rate in patients who received multimodal therapy. RESULTS: 13 patients were consecutively enrolled from February 1990 to December 1996, and 12 evaluable patients were assessed for response. Disease responded to induction chemotherapy completely in 3 patients (25%) and partially in 8 patients (67%); 1 patient had a minor response (8%). Eleven patients had surgical resection; 1 refused surgery. Tumors were removed completely in 9 (82%) and incompletely in 2 (18%) of 11 patients who had been receiving radiation therapy and consolidation chemotherapy. All 12 patients are alive (100% at 7 years), with a median follow-up of 43 months, and 10 patients are disease free (73% disease-free survival at 7 years). A high correlation was seen between tumor necrosis after induction chemotherapy and Ki-67 expression (r=-0.88). CONCLUSIONS: Aggressive multimodal treatment is highly effective and may cure locally advanced, unresectable malignant thymoma.

Adult↗

Prospective, randomized trial of Doppler-assisted subclavian vein catheterization.

OBJECTIVE: To examine the rate of success and complications of Doppler-guided subclavian vein catheter insertion compared with standard insertion in patients considered at high risk for failure. DESIGN: Prospective, randomized, crossover trial. SETTING: University-affiliated tertiary care medical center. PATIENTS: Two hundred forty patients were enrolled in the study. Patients were stratified for 3 known risk factors: (1) prior surgery in the subclavian vein region, (2) prior radiotherapy at the attempted catheterization site, and (3) an abnormal weight-height ratio. INTERVENTIONS: Subclavian vein catheterization was performed either in standard or Doppler-guided fashion using the Smart Needle (Peripheral Systems Group, Mountain View, Calif), which is a Doppler probe at the tip of a cannulating needle. If subclavian vein catheterization was unsuccessful after 2 attempts, patients were crossed over to the other technique. MAIN OUTCOME MEASURE: Successful cannulation of the subclavian vein. RESULTS: The success rate, either as an initial technique or as a salvage technique, and complication rate were not significantly different with use of the Smart Needle. A subgroup of physicians had a significantly lower success rate using the Smart Needle. CONCLUSIONS: Doppler guidance did not increase the success rate or decrease the complication rate of subclavian vein catheterization when compared with the standard technique in high-risk patients. Doppler guidance was not more useful than the standard technique as a salvage technique following a previous failure of catheterization. Furthermore, real-time Doppler guidance of subclavian vein catheterization is a technique that is highly operator dependent.

Adolescent↗

Complications and failures of subclavian-vein catheterization.

BACKGROUND: Although catheterization of the subclavian vein is a common procedure, the risk factors for complications and failures, with the exception of the physician's experience, are poorly understood. Ultrasonography has been recommended to help guide the placement of central venous catheters. METHODS: We conducted a prospective randomized trial of ultrasound-guided location of the subclavian vein as compared with standard insertion procedures. In the group of patients undergoing catheterization with ultrasound guidance, the site of the insertion was marked before the catheterization attempt; real-time ultrasound guidance was not used. The 821 eligible patients (411 in the ultrasound group and 410 in the control group) underwent catheterization in a single procedure suite under controlled nonemergency conditions, in most cases for the administration of chemotherapy. RESULTS: Ultrasound guidance had no effect on the rate of complications or failures of subclavian-vein catheterization (risk ratio for complications, 1.00; 95 percent confidence interval, 0.66 to 1.52; risk ratio for failures, 1.04; 95 percent confidence interval, 0.72 to 1.50). In multivariate analyses, prior major surgery in the region (P = 0.002), a body-mass index (the weight in kilograms divided by the square of the height in meters) higher than 30 or lower than 20 (P = 0.009), and previous catheterization (P = 0.043) were associated with failed attempts. Complications were also associated with failed attempts: 52 of the 721 patients (7.2 percent) in whom catheterization was successful had complications, as compared with 28 of the 100 patients (28 percent) in whom physicians were unable to place catheters. The number of needle passes was strongly associated with the rates of failure and complications. The complication rate rose from 4.3 percent with one pass to 24.0 percent with more than two passes. CONCLUSIONS: Ultrasound guidance of subclavian-vein catheterization, as used in this study, was not beneficial. In patients at highest risk for complications and failures, catheterization should be attempted by the most experienced physicians available.

Body Mass Index↗