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Biomedical subjects

E A Gehan

Publications and source records attributed to E A Gehan.

At least 91 records · Page 5Linked to original sources
PubMed1981

Radiation therapy in the multimodal management of Ewing's sarcoma of bone: report of the Intergroup Ewing's Sarcoma Study.

This paper is a progress report on the role of radiation therapy (RT) in local tumor control and the decreased incidence of pulmonary metastasis in 251 patients entered in the Intergroup Ewing's Sarcoma Study. All were followed for more that 1 year, and their RT records were reviewed. Doses to the primary tumor in the range of 4,500--6,500 rad were administered over approximately 5 to 6 weeks in combination with 4 drugs, i.e., vincristine (VCR), dactinomycin (DAC), cyclophosphamide (CY), and adriamycin, or only the first 3. One group of patients received the 3 drugs and bilateral pulmonary irradiation (approximately 1,500 rad in 2 wk). Preliminary analysis showed a local primary tumor control of approximately 90%. Patients with lesions in the pelvis and humerus had local failure rates of 13% (7 of 54) and 21.4% (6 of 28), respectively. The treatment groups differed significantly in the incidence of pulmonary metastasis. Patients treated with the 4 drugs (regimen 1) had a 14% incidence, whereas 42% of those treated with only 3 drugs (regimen 2) developed pulmonary metastases. Of all patients treated with 3 drugs and pulmonary irradiation (regimen 3), 18% showed lung metastases. The study indicated that intensive chemotherapy and RT significantly improved the local control and survival of patients with localized Ewing's sarcoma. However, the high incidence of metastasis indicated the need for more effective systemic chemotherapy for further improvement of treatment results. More studies are needed so we can define the volume to be treated and the optimal dose of irradiation to determine a therapeutic strategy that will yield optimal survival and tumor control with the fewest sequelae.

Adolescent↗
PubMed1981

Prognostic factors in children with Ewing's sarcoma.

Patient characteristics of 272 patients entered in a clinical trial conducted by the Pediatric Intergroup Ewing's Sarcoma Committee between June 1972 and November 1978 were examined for their relationship to prognosis. Prognosis was defined as disease-free survival time (time to local recurrence and/or metastatic disease) and overall survival time; all times were measured from the start of treatment. In a multivariate regression model, primary site of disease was the major variable that influenced prognosis, and patients with pelvic sites had the least favorable prognoses, followed by those with proximal and rib sites. The most favorable sites were distal and other. The median disease-free and survival times in weeks by primary site were, respectively: pelvis (69, 112), proximal (102, 141), rib (105, 109+), distal (226+, 240), and other (96+, 199+). Females had better prognoses than males; the median survival times were 197 and 147 weeks, respectively. An abnormal liver function as indicated by an abnormal serum glutamic-oxaloacetic transaminase value (greater than 45 IU) was a bad prognostic sign, although only 8 patients had this finding; their median survival time was 94 weeks. Patients who had resections had a slight advantage in survival compared with those having biopsies, though the difference favoring resection patients was not consistent for both sexes in any primary site. Individual characteristics of the patients that were of prognostic significance were: blood lymphocyte counts (high counts favorable), polymorphonuclear leukocyte counts (high counts unfavorable), and time from symptoms to diagnosis (times less than 1 mol favorable). Patients who received treatment 2 had significantly poorer prognoses than those given treatments 1 or 3. The median disease-free and survival times by treatment were (in wk): 1 (134, 198+), 2 (81, 120), and 3 (123, 182).

Adolescent↗
PubMed1981

Multimodal therapy in metastatic Ewing's sarcoma: an Intergroup Study.

Multimodal therapy consisting of radiation therapy to all areas of gross disease and intensive combination chemotherapy was administered to 44 patients with Ewing's sarcoma. Seven of these patients had regional disease and the others had clinical evidence of distant metastases. The median duration of time on study for all patients was 75 weeks. A complete response occurred in 31 of the patients and 17 are currently free of disease. Four deaths resulted from complications of therapy; 2 were due to infection and 2 due to adriamycin-related cardiomyopathy.

Bone Neoplasms↗
PubMed1981

Radiation therapy combined with systemic chemotherapy of rhabdomyosarcoma in children: local control in patients enrolled in the Intergroup Rhabdomyosarcoma Study.

The 524 children enrolled in the Intergroup Rhabdodomyosarcoma Study were the basis for our reviewing the effect on local tumor control by radiation therapy (RT) when combined with systemic chemotherapy. Of those who received RT, 291 were evaluated for dose and 317 for volume. No statistical differences of local control were observed at doses ranging between 3,500 and 6,000 rad, by extent of local disease, nor by adequacy of RT volume as long as the tumor mass and a 5-cm margin were in the RT portal.

Adolescent↗
PubMed1981

Prognostic factors in children with rhabdomyosarcoma.

The characteristics of 554 evaluated patients entered into a clinical trial conducted by the Pediatric Intergroup Rhabdomyosarcoma Committee between November 1972 and September 1978 were examined for their relationship to prognosis. Prognosis was defined as disease-free time and overall survival time in clinical groups I and II and time on study and survival time in clinical groups III and IV; all times were measured from the start of treatment. The percentage of patients surviving 2 years differed significantly among the clinical groups: I, 92; II, 78; III, 64; and IV, 35. The percentage of patients free of disease at 2 years was significantly higher in group I than in group II (83 vs. 72%, respectively); P = 0.02. The patient characteristics of group I most related to disease-free and overall survival were histologic cell type (alveolar, unfavorable), lymphocyte count (low count, unfavorable), and primary site (disease in extremities, unfavorable). In group II, sex (male, favorable) and lymphocyte count (low count, unfavorable) were significantly related to disease-free and overall survival times. Patients in the clinical subgroup with both microscopic residual disease and lymph node metastasis had poorer survival than patients in other subgroups. Primary site of disease was the only characteristic of group III related to length of time on study and to survival. Orbit and the genitourinary system were favorable primary sites, whereas the retroperitoneal area and extremities were unfavorable. In group IV, primary site (genitourinary, favorable) was related to length of time on study and survival. Sex (male, favorable) was related to survival experience.

Adolescent↗
PubMed1980

Intergroup Ewing's Sarcoma Study: local control related to radiation dose, volume, and site of primary lesion in Ewing's sarcoma.

One hundred ninety-three patients with localized Ewing's sarcoma treated at participating instutitions of the Intergroup Ewing's Sarcoma Study form the basis for this report. All patients received radiation therapy to the primary lesion and were randomized to receive vincristine, actinomycin-D, and cyclophosphamide (VAC) plus adriamycin (Regimen I); VAC alone (Regimen II); or VAC and bilateral pulmonary irradiation (Regimen III). Local control was achieved in 96% of the patients in Regimen I, and 86% of the patients in both Regimens II and III. The median duration of follow up was 83 weeks and median survival time was 172 weeks. Incremental doses of irradiation did not result in significant changes in the rate of local control of primary lesions. The local control rate was the same (92%) for tumors treated by means of whole-bone irradiation or with at least 5 cm of free margin around the lesion. The local control rate decreased to 79% for lesions treated with less than 5-cm margin. Excellent control was obtained for lesions involving the skull or spine (100%), and distal bones (fibula, 96% and tibia, 91%). Less favorable control rates were noted for pelvic and humeral lesions (84% and 79%, respectively). Bilateral pulmonary irradiation for subclinical disease played a role in lowering the incidence of lung metastases from 38% to 20% for patients treated with VAC. Lung metastases were similarly decreased (10%) when adriamycin was added to VAC chemotherapy.

Bone Neoplasms↗
PubMed1980

Factors related to length of complete remission in adult acute leukemia.

Two hundred and two adult patients with acute leukemia were analyzed to determine pretreatment and treatment factors that could predict for duration of bone marrow remission. Several factors had a significant effect on remission duration, including morphologic diagnosis (AML greater than ALL greater than AUL), initial blast cell count, age, serum LDH, fibrinogen level, labeling index, and in vitro agar colony growth. Patients who attained a remission quickly or in whom leukemic cells in blood and bone marrow were rapidly cleared had long remissions. After applying regression model fitting methods, the six major factors, in order of significance, were the initial serum LDH level, pretreatment fibrinogen level, the number of courses of treatment to obtain a remission, morphologic diagnosis, the halving rate of leukemic cells in the blood, and the age of the patient. The model derived from this study was applied to the 202 patients and suggested that patients likely to have short or long bone marrow remission can be identified.

Adolescent↗
PubMed1980

Evaluation of the significance of prognostic factors in stage III Hodgkin's disease treated with MOPP and radiotherapy.

One hundred consecutive Stage IIIA and IIIB Hodgkin's disease patients were treated between July 1969 and September 1976, on a combined chemotherapy-radiotherapy program consisting of two courses of MOPP followed by radiotherapy to the mantle, abdomen, and pelvis. Eighty-eight patients completed radiotherapy to all disease sites. At the time of this analysis, the mean follow-up period for the 100 patients was 45 months; 70 patients had been followed three to seven years. Projected five-year survival and disease-free survival figures for the 100 patients were 80% and 68% respectively; corresponding results for the 88 patients were 90% and 78%. To determine whether any of the following prognostic factors influenced results for either the 100 or the 88 patients, survival curves were calculated for age, sex, constitutional symptoms, histopathology, method of staging, and status of the mediastinum. Other than age, none of these factors influenced survival significantly. However, disease-free survival figures were influenced adversely by mediastinal disease as well as age.

Adult↗
PubMed1980

Knowledge acquisition from historical data: application to breast cancer patients.

The thesis of this paper is that knowledge acquired from historical data collected in a clinical research program may be used for planning future clinical trials and evaluating the effect of treatment. In a breast cancer study comparing adjuvant, treatment with FAC-BCG to control treatment Cox's regression model including number of involved nodes, stage of disease, and menopausal status was used to demonstrate that FAC-BCG patients have superior disease-free survival. A logistic regression model for acute leukemia involving age, cytogenetics, prior hematologic abnormality, temperature, serum creatinine, and hemoglobin was obtained by fitting to 325 previously untreated adult patients who received treatment between March, 1973 and April, 1977. The model was validated by prospective application to 107 patients treated between May, 1977 and December, 1978. Results in this trial will be compared with those in similar patients for the historical control series.

Acute Disease↗
PubMed1980

The training of statisticians for cooperative clinical trials: a working statistician's viewpoint.

The methods of training statisticians for clinical trials can take diverse forms: attendance at courses and lectures, personal study, observing and doing, or working as an apprentice. Desirable qualifications for an effective working statistician are: adequate knowledge of biostatistics and the field of application for the clinical trial, an ability to communicate statistical ideas verbally at meetings and in the writing of reports and collaborative research papers, an awareness of potential sources of bias, an understanding of ethical issues, and an ability to set priorities for projects. These issues are discussed in the context of training, and personal comments are made from the viewpoint of a statistician with substantial experience of clinical trials in cancer.

Clinical Trials as Topic↗
PubMed1979

Postoperative adjuvant chemotherapy with fluorouracil, doxorubicin, cyclophosphamide, and BCG vaccine. A follow-up report.

Two hundred twenty-two patients with stage II or III breast cancer following regional therapy were treated with a combination of fluorouracil, doxorubicin hydrochloride (Adrimycin), cyclophosphamide, and BCG vaccine. At 54 months of study (median follow-up, 30 months), the estimated proportions remaining disease-free two and three years after surgery were 83%and 78%, respectively, in the chemotherapy group and 64% and 55%, respectively, in 151 historical control patients. Estimated two- and three-year survival rates were 93% and 89%, respectively, in the chemotherapy group and 84% and 58%, respectively, in the control patients. Congestive heart failure has developed in three patients, possibly related to the use of doxorubicin. Adjuvant chemotherapy with these drugs was effective in prolonging the disease-free interval and survival of patients irrespective of menopausal status, degree of nodal involvement, or stage of the disease.

Antineoplastic Agents↗
PubMed1979

Adjuvant chemoimmunotherapy following regional therapy for isolated recurrences of breast cancer (stage IV NED).

A combination of 5-fluorouracil, Adriamycin, cyclophosphamide, and BCG (FAC-BCG) was evaluated as adjuvant treatment in breast cancer patients following surgical excision and/or radiation of first site of recurrent disease. In a group of 68 patients treated with FAC-BCG, the estimated proportion remaining free of disease at 2 years from first recurrence was 69%, compared to 24% in 60 historical control patients (P less than 0.01). Estimated 2-year survival rate from first recurrence was 85% for the FAC-BCG patients and 78% for the controls (P = 0.07). This regimen has significantly prolonged the disease-free interval from the first recurrence, but additional follow-up is needed to determine its effect on long-term survival.

Antineoplastic Agents↗
PubMed1979

Necrotizing colitis in patients with cancer.

Necrotizing lesions of the colon occur in patients with malignancy. We identified 26 patients with cancer (23 with acute leukemia and three with solid tumors) who died from necrotizing colitis. Autopsies revealed three pathologic categories: pseudomembranous colitis in 69 per cent, agranulocytic colitis in 19 per cent and ischemic colitis in 12 per cent. Most died from sepsis. A comparison of characteristics was made with a control population matched for diagnosis, age, cause of death and duration of neoplasia. Nearly all patients in both groups had fever and were granulocytopenic secondary to chemotherapy. Most received antineoplastic and antimicrobial regimens during the month prior to their terminal illness. Abdominal pain and distention, stomatitis and necrotizing pharyngitis were frequently associated with colitis. Hyperbilirubinemia was a frequent late complication in those with colitis and the control group. Single and multiorganism septicemia were found more frequently in patients with colitis. As antemortem diagnosis was unusual, aggressive attempts at diagnosis are necessary to assess the true incidence of this disorder and the best therapy.

Adolescent↗
PubMed1979

Clinical trials in cancer research.

This is a review paper which gives a discussion of various aspects of clinical trials in cancer research. Since the conduct of the first randomized controlled clinical trial in cancer patients in the mid-1950's, substantial progress has been made in the utilization of the clinical trial technique for the evaluation of therapeutic efficiacy. The important elements of a protocol are given with some discussion of items to be considered in designing a protocol. The types of clinical trial (phase I, II, III) are defined, and the place of each phase of study in the context of the search for new treatments is delineated. A comprehensive discussion is given of the elements in the comparative clinical trial (phase III), including objectives, consierations in planning (comparability of treatment groups stratification of patients, feasibility and size of study, and prospective versus retrospective studies). Brief descriptions are given of designs for comparative clinical trials and a trial in oat cell lung carcinoma is discussed in some detail. Finally, some comments and references are given concerning the analysis of clinical trials.

Carcinoma, Small Cell↗