A follow-up study of a management system to maximize medical records standards compliance.
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Efficiency↗
Biomedical subjects
E S Casper
Publications and source records attributed to E S Casper.
Phase I trial of intramuscularly administered tumor necrosis factor in patients with advanced cancer.
A phase I trial of intramuscularly administered recombinant human tumor necrosis factor (rTNF) was conducted in 19 adult patients with advanced solid tumors. The agent was administered daily for up to five consecutive days every other week for two to four courses. Doses of rTNF ranged from 5 to 200 micrograms/m2/d. Dose-limiting toxicities were encountered at doses greater than 100 micrograms/m2/d. Toxicities included tenderness, erythema and induration at the site of injection, fatigue, fever, chills, headache, anorexia, nausea, vomiting, and diarrhea. Moderate to marked reductions in WBC and platelet counts were observed regularly at the highest dose levels, but none were clinically significant. Hepatic enzyme elevation was seen frequently, and two patients developed hyperbilirubinemia. Only one of seven patients treated with doses greater than 100 micrograms/m2/d completed the planned course of therapy. Even at the highest dose levels, serum concentrations of rTNF could only rarely be detected in the serum. No therapeutic responses were observed. The maximal tolerated dose (MTD) of rTNF in this trial was 150 micrograms/m2/d, administered for two courses.
Adult↗
Innovations: medical record standards compliance as a function of selected staff variables.
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Attitude of Health Personnel↗
Clinical trial of iproplatin (cis-dichloro-trans-dihydroxy-bis-isopropylamine platinum IV, CHIP) in patients with advanced breast cancer.
Twenty-five women with advanced breast cancer were treated in a phase II trial of iproplatin 275 mg/m2 administered intravenously every 4 weeks. All patients had measurable or evaluable indicator lesions, and had undergone treatment with no more than one previous chemotherapy regimen, including adjuvant chemotherapy. Two of the twenty-four evaluable patients (8%) experienced major therapeutic responses. One patient had a complete regression of pulmonary nodules lasting 18+ months; another had a partial regression of metastatic disease in the liver (4 months). The inevaluable patient was ineligible for the study because of previous radiation to the indicator lesions on her chest wall; nonetheless, she experienced a 10 month partial regression of those nodules. Myelosuppression was generally dose limiting; thrombocytopenia was more profound, but leukopenia was more prolonged. Nausea, vomiting, diarrhea, and general malaise were prominent toxicities, and led to discontinuation of therapy in 4 patients. Iproplatin has limited activity in previously treated women with advanced breast cancer.
Adult↗
Combined modality treatment of locally advanced breast cancer: adjuvant combination chemotherapy with and without doxorubicin.
Forty-one women with non-metastatic but locally advanced breast cancer were treated by modified radical or radical mastectomy, and were then randomized to receive one of two adjuvant chemotherapy regimens. Regimen A consisted of 6 months of cyclophosphamide, adriamycin, and fluorouracil (CAF) followed by 6 months of cyclophosphamide, methotrexate, fluorouracil, vincristine, and prednisone (CMFVP). Regimen B was 12 months of CMFVP. Patients were stratified for estrogen-receptor status, and all patients with a positive estrogen receptor value received tamoxifen 20 mg bid in addition to the chemotherapy. Eight of 21 patients randomized to Regimen A are alive and free of disease, whereas only 1 of 20 patients on Regimen B is well. A trend toward improved disease-free survival favoring Regimen A was observed (P = .05), although a significant difference in overall survival has not been demonstrated. Our findings support the continued study of adriamycin-containing regimens in the adjuvant setting and in combined modality therapy of locally advanced breast cancer.
Adult↗
A management system to maximize compliance with standards for medical records.
A management system designed to maximize staff's compliance with standards for medical records in the periods between external audits was developed for an outpatient network of a large state hospital. The system was based on analysis of the processes and circumstances that enhance compliance with records standards, such as specifying a clear, concrete goal for each chart and having a time-limited review process, and the major inhibitors, such as too-frequent and random audits and lack of internal or external rewards. Data collected on application of the system to 976 charts in the outpatient network showed the system to be effective; between the initial review and the rereview in the third month, the percent of records achieving more than 80 percent compliance with standards rose from 57 percent to 86 percent.
Community Mental Health Services↗
Clinical pharmacology of recombinant human tumor necrosis factor in patients with advanced cancer.
Twenty-six patients with advanced cancer refractory to standard therapy were treated with recombinant human tumor necrosis factor (rTNF) in a study aimed at determining the toxicity and tolerance of rTNF and at seeking evidence of antitumor activity. The study design involved two treatments per week for 4 weeks with alternating subcutaneous and intravenous (IV) administration, and weekly dose escalation through four levels in each patient. The dose range was 1 to 200 micrograms/m2 for IV bolus injection, and 5 to 250 micrograms/m2 for subcutaneous injection. Thirteen patients completed the full course. Early discontinuation of treatment was related to rTNF toxicity in seven cases. The major side effects were rigors, fever, headache, fatigue, and hypotension. Acute changes in granulocyte, lymphocyte, and monocyte counts, changes in serum zinc levels and plasma cortisol levels consistent with an acute phase response, and inflammation at the site of subcutaneous injection were also seen. At doses of 125 to 250 micrograms/m2, inflammation at the subcutaneous injection site was unacceptably severe. Minor changes were seen in hemostatic parameters. Hypotension was corrected by fluid administration and did not require treatment with vasopressors. Initial serum concentrations of rTNF were measured at five minutes after IV administration and were found to range from 2.5 ng/mL after a dose of 35 micrograms/m2 to 80 ng/mL after a dose of 200 micrograms/m2. The half-life of rTNF in the blood was 20 minutes. A decrease in lymph node size was observed in a patient with B cell lymphoma.
Adult↗
Phase II evaluation of orally administered idarubicin in patients with advanced breast cancer.
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Administration, Oral↗
Phase II trial of carboplatin in advanced malignant melanoma.
Twenty-six evaluable patients with metastatic malignant melanoma who had not received prior chemotherapy were treated in a phase II study with carboplatin (CBDCA), 400 mg/m2 iv every 4 weeks. There were five partial responses of 3, 3+, 5, 7+, and 12+ months' duration. Thrombocytopenia was the dose-limiting toxicity; ten patients had transient platelet count depressions to less than 75,000/mm3. Mild to moderate nausea and/or vomiting occurred in 15 patients. Renal, auditory, and neurologic toxic effects were not encountered. Since the response rate of 19% (95% confidence limits, 8%-38%) is similar to that noted for dacarbazine, carboplatin, singly and in combination with other agents, needs further evaluation in patients with malignant melanoma.
Adult↗
Phase I clinical trial of fludarabine phosphate (F-ara-AMP).
F-Ara-AMP (fludarabine phosphate) is an adenosine analogue that is resistant to deamination; it is a more potent cytotoxic compound than ara-A in experimental tumor systems. F-Ara-AMP was given by continuous IV infusion over 5 days once every 4 weeks to 27 evaluable adult patients with advanced cancer. The median Karnofsky performance status was 70% (range 50%-90%), and the median age was 58 years (range 41-74). In addition to adequate blood counts, a creatinine clearance of at least 60 ml/min was required. The initial dose level was 35 mg/m2/day. Dose-limiting myelosuppression was seen in the first patient. Subsequent patients were treated at lower doses. Myelosuppression was the only major toxicity. Leukopenia was generally more prominent than thrombocytopenia, but 2 patients experienced prolonged thrombocytopenia which prevented further therapy. Nausea was minimal, and neither renal nor neurologic toxicity was encountered. In patients with good renal function a dose of 25 mg/m2/day can be safely administered. However, because of apparent cumulative myelosuppressive effects a lower dose is more appropriate for patients who have had extensive prior chemotherapy or radiotherapy.
Adult↗
Phase II trial of oral 4-demethoxydaunorubicin in patients with non-small cell lung cancer.
4-Demethoxydaunorubicin (4-DMDR) is an orally active analog of daunorubicin that in preclinical testing has demonstrated greater antitumor activity and less cardiotoxicity than its parent compound. Thirty-two patients with metastatic non-small cell lung cancer received 4-DMDR at a dose of 40-50 mg/m2 orally every 21 days. Thirteen patients had received no prior chemotherapy. Among the 30 adequately treated patients, one major response lasting 5.2 months was observed. Leukopenia 10-14 days after treatment was the most commonly observed toxicity. With an overall observed major response rate of 3.3% in 30 patients, the predicted true response rate is less than or equal to 16% (p = 0.05). At the dose and schedule studied in this group of patients with non-small cell lung cancer, 4-DMDR had only marginal activity.
Adult↗
A prospective randomized comparison of epirubicin and doxorubicin in patients with advanced breast cancer.
Fifty-four patients with advanced breast cancer who had failed prior non-anthracycline combination chemotherapy were randomized to treatment with either epirubicin 85 mg/m2 or doxorubicin 60 mg/m2 intravenously every three weeks. Of 52 evaluable patients, 25% (six of 24) treated with epirubicin, and 25% (seven of 28) treated with doxorubicin experienced major therapeutic responses. The median duration of response to epirubicin was 11.9 months compared to 7.1 months with doxorubicin. Cardiotoxicity was monitored by serial multigated radionuclide cineangiocardiography performed at rest and after exercise. Laboratory evidence of cardiotoxicity was defined as a decrease in resting left ventricular ejection fraction of greater than 10% from the baseline value, or a decrease of 5% or greater with exercise compared with the resting study performed on the same day. Fifteen patients treated with epirubicin and 18 patients treated with doxorubicin had at least two determinations of left ventricular ejection fraction and were evaluable for laboratory cardiotoxicity. Using methods of survival analysis, the median doses to the development of laboratory cardiotoxicity were estimated to be 935 mg/m2 of epirubicin and 468 mg/m2 of doxorubicin. Four patients treated with epirubicin and five treated with doxorubicin developed symptomatic congestive heart failure. The median cumulative dose at which congestive heart failure occurred was 1,134 mg/m2 of epirubicin compared with 492 mg/m2 of doxorubicin. Fewer episodes of nausea and vomiting were observed in patients receiving epirubicin. Epirubicin is a new anthracycline with reduced cardiac toxicity, but preserved efficacy in the treatment of patients with advanced breast cancer.
Actuarial Analysis↗
Trial of vindesine plus mitomycin in stage-3 non-small cell lung cancer. An active regimen for outpatient treatment.
Ninety patients with stage-3 non-small cell lung cancer were given vindesine (3 mg/sq m) plus mitomycin (10 mg/sq m). Data on response are available for 84 adequately treated individuals (93 percent). For patients who had received no prior chemotherapy, the rate of major objective response was 36 percent (20/55). For previously treated patients the rate of major response was 17 percent (5/29). The drugs were routinely administered in the outpatient department without difficulty. Moderate or severe myelosuppression, neurotoxic, nephrotoxic, or pulmonary toxic effects, nausea, and vomiting occurred in less than 15 percent of all studied patients. Three-drug extravasation ulcerations occurred in 1,129 administrations of chemotherapy (0.3 percent). There were two treatment-related deaths, one from sepsis and one from the combination of mitomycin-induced pulmonary and renal toxic effects. The combination of vindesine plus mitomycin is an active, well-tolerated outpatient regimen for patients with non-small cell lung cancer who have not previously received chemotherapy. Further trials are warranted to compare this regimen to other active combinations and to use it as a component of a program of treatment using alternating regimens of chemotherapy.
Adenocarcinoma↗
Randomized trial comparing vindesine plus cisplatin with vinblastine plus cisplatin in patients with non-small cell lung cancer, with an analysis of methods of response assessment.
One hundred eight patients with stage III non-small cell lung cancer were randomly assigned to receive cisplatin (120 mg/m2) with either vindesine (3 mg/m2) or vinblastine (6 mg/m2). None had previously received chemotherapy. An additional goal was to determine if the observation of visible evaluable lesions was as accurate a method of response assessment as the observation of bidimensionally measurable lesions in non-small cell lung cancer. When vindesine plus cisplatin was compared to vinblastine plus cisplatin, response rates (33% vs 41%), median response durations (8.6 vs 5.6 months), and median survival times of responding patients (18.4 vs 16.2 months) were similar. Response rates, response durations, and survival times of responding patients determined through the observation of evaluable or measurable indicator lesions did not differ significantly. More patients receiving vinblastine plus cisplatin experienced wbc counts less than 2100/mm3 (P = 0.003). The two regimens demonstrated comparable response and survival data but clinically significant leukopenia was more common in vinblastine-treated patients. There was no difference in response data obtained through the study of patients with measurable and evaluable indicator lesions.
Adenocarcinoma↗
Adenocarcinoma of unknown primary origin: treatment with vindesine and doxorubicin.
Adenocarcinoma of unknown primary origin (ACUP) is a common oncologic problem for which there is no standard therapy. Forty-two patients with metastatic tumor were identified as having ACUP after extensive evaluation failed to reveal a primary site of disease. They were treated with an investigational chemotherapy regimen consisting of vindesine and doxorubicin. Of the 38 evaluable patients, six (16%) had major responses to chemotherapy. The median duration of response was 4 months. The median survival of the responding patients has not been reached, but is greater than 8 months. The median survival of the nonresponding patients was 6 months. Vindesine and doxorubicin were well tolerated. The major toxicity was leukopenia, with a median wbc count nadir of 2600/mm. We conclude that the combination of vindesine and doxorubicin has some activity in ACUP, but does not improve the response rate seen with other regimens.
Adenocarcinoma↗
Phase II trial of gallium nitrate in patients with advanced malignant melanoma.
A phase II trial of gallium nitrate (250-300 mg/m2/day for 7 consecutive days) was conducted in patients with metastatic melanoma. Therapy was well-tolerated, but only one of 31 evaluable patients experienced a partial regression. Further evaluation of gallium nitrate at this dose and schedule is not warranted in patients with malignant melanoma.
Abdominal Neoplasms↗
Phase II trial of 4'-deoxydoxorubicin in patients with advanced breast cancer.
4'Deoxydoxorubicin (25 mg/m2 iv every 3 weeks) was evaluated in 20 patients with advanced breast cancer. The patients had good performance status and had not been heavily pretreated. Although all patients experienced leukopenia, no major therapeutic responses were observed. Nonhematologic toxicity was mild. Further evaluation of 4'-deoxydoxorubicin at this dose and schedule is not warranted in patients with advanced breast cancer.
Adult↗
Phase II trial of 4'-epi-doxorubicin in patients with advanced malignant melanoma.
Thirty-five patients with advanced malignant melanoma were treated with 4'-epi-doxorubicin iv once every 3 weeks. Most patients had not received prior chemotherapy and had good performance status. Three partial remissions and three minor regressions were observed. All patients experienced myelosuppression, but other toxic effects were minimal. 4'-Epi-doxorubicin has limited therapeutic activity in this disease.
Adult↗