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Biomedical subjects

E A Gehan

Publications and source records attributed to E A Gehan.

At least 73 records · Page 4Linked to original sources
PubMed1983

Multivariate analysis of prognostic factors in metastatic breast cancer.

Univariate and multivariate analyses were conducted on data collected from the records of 619 patients with metastatic breast cancer in whom an Adriamycin-containing chemotherapeutic regimen was used. Using a forward, stepwise logistic regression procedure, several models or equations in which a small number of pretreatment factors were incorporated were generated and the probability of response to therapy was accurately predicted. The predictive ability of these models was tested retrospectively in 546 of the 619 patients from whom the data were derived and prospectively in a new population of 200 patients with metastatic breast cancer also treated with a therapeutically equivalent Adriamycin combination. Using similar univariate techniques, pretreatment factors were correlated with the length of survival after therapy. The proportional hazard model of Cox was used to develop a regression model relating survival to pretreatment characteristics in much the same manner as that of the response model. The total population of the initial group of patients was divided according to four levels of hazard ratio, and survival distributions were compared. This model also was tested progressively and its predictive capability was confirmed. The prediction of individual outcome is a valuable capability in the comparison of clinical trials and the continuing evaluation of biologic changes in patients with metastatic carcinoma; such a method is described in this paper.

Analysis of Variance↗
PubMed1982

Bladder and prostatic tumors in the intergroup Rhabdomyosarcoma study (IRS-I): results of therapy.

Sixty-four children with primary rhabdomyosarcoma of the bladder or prostate were enrolled in the IRS during the initial five years (October 1972-November 1977). Observation of these patients for from 2 1/2-8 years forms the basis of this report. The chemotherapy-radiotherapy regimens employed (IRS) for each Clinical Group were: (1) Group I (completely excised tumor), sequential actinomycin-D (ACD), vincristine (VCN), and cyclophosphamide (CYP), i.e., standard (VAC), with or without radiotherapy (RT); (2) Group II (resected local disease with node involvement, "microscopic" residual, or local extension), RT plus sequential ACD and VCN, or RT plus standard VAC; (3) Group III, (gross residual disease); and (4) Group IV (dissemination), RT and either pulse VAC or pulse VAC plus Adriamycin (ADR). Pulse VAC consisted of VCN (day 1), plus daily intravenous ACD and CYP (days 1-5). Relapse rates were: Group I, 0/8; Group II, 6/23; and the mortality in Group III, 6/23; and in Group IV, 7/10. Among patients with bladder tumors, the rate of relapse was 2/11 following pelvic exenteration (anterior, 10; total 1); 5/12 following partial cystectomy or gross tumor excision; and 3/5 following a primary chemotherapy-radiotherapy (PCR) regimen. In patients with prostatic tumors (Groups I-III), relapse occurred in 0/14 patients treated initially by pelvic exenteration (anterior, 12; total, 2); and in 2/11 patients treated by a PCR regimen.

Adolescent↗
PubMed1982

A prognostic factor analysis for use in development of predictive models for response in adult acute leukemia.

The pretreatment characteristics of 325 adults with acute leukemia who were treated at the M. D. Anderson Hospital between 1973 and 1977 have been evaluated to assess their value as prognostic indicators. The patient population includes all patients treated with an anthracycline (Adriamycin or rubidazone), cytosine arabinoside, vincristine, and prednisone during the time period. Most patients had one of the variants of acute myelogenous leukemia (75%), and the remaining patients had acute lymphoblastic leukemia (16%) or undifferentiated leukemia (8%). Twenty-one factors were found to be significantly associated with probability of obtaining a complete response. In addition to characteristics previously known to provide prognostic information such as age, temperature status at the start of treatment, morphology, the presence of Auer rods, sex, and hemoglobin level, we identified the presence of a documented antecedent hematologic disorder and the finding of insufficient metaphases on cytogenetic analysis using the squash technique as being major prognostic variables. In addition, the pretreatment biochemical characteristics of hypoalbuminemia and elevated blood urea nitrogen and creatinine were found to adversely influence prognosis. The prognostic significance of factors such as the leukocyte count and platelet count, identified in earlier studies, was not confirmed in this group of patients. From this natural-history analysis predictive models for response have been developed using multivariate logistic regression techniques. One of these models has been used to evaluate the effect of morphology, treatment, and cytogenetic pattern on response to the combination of drugs used.

Acute Disease↗
PubMed1982

Prediction of remission in adult acute leukemia: development and testing of predictive models.

Logistic regression methods were applied to derive a set of models relating achievement of CR to prognostic characteristics in a group of 300 adult acute leukemia patients treated with cytosine arabinoside, vincristine, and prednisone combined with adriamycin (ADOAP) or rubidazone (ROAP). These models were tested prospectively in an independent group of 107 subsequent patients treated with ADOAP or ROAP therapy, by comparing observed outcomes to predictions of response based on the models. Several models were able to identify subgroups of patients with good, intermediate, and poor prognoses. A model regarded as clinically useful and which provided a good fit to both the population from which it was derived and the test population included the pretreatment factors age, history of an antecedent hematologic disorder, temperature, blood urea nitrogen, hemoglobin, and liver size.

Acute Disease↗
PubMed1982

Soft-tissue sarcoma of the trunk in childhood. Results of the intergroup rhabdomyosarcoma study.

Disease-free survival data were obtained on 30 children with soft-tissue sarcoma of the trunk. The children were clinically grouped and treated in accord with the IRS protocol (Cancer 1977; 40:2015) from November 1972 through December 1976. Histologically, 40% of the tumors were alveolar rhabdomyosarcoma (RMS), 20% were embryonal RMS, 20% were extraosseous Ewing's sarcoma, 17% were undifferentiated sarcoma, and 3% were pleomorphic RMS. In 13 patients with primary tumors of the chest wall, the male-to-female (M:F) ratio was 3:11, and the median age was 12.5 yr. Five of the ten patients (50%) with localized tumor (Groups I-III) were disease-free at a median of 4.7 yrs. after diagnosis; two died of locally recurrent tumor, two died of metastases to lungs or bones, and 1 died of intracranial hemorrhage. None of the four with chest wall tumors and distant metastases (Group IV) survived. In ten patients with localized paraspinal primary tumors, the M:F ratio was 8:2, and the median age was 3.5 yrs. None had metastases. Seven of ten (70%) were disease-free at a median of 4.7 yrs. after diagnosis. Two died after regional recurrence developed (one retroperitoneal, one meningeal), and one died of lung metastases. In six patients with primary tumors of the abdominal wall, the M:F ratio was 3:3 and the median age was 9.5 yrs. Three of five with localized tumor (Groups I-III) were disease-free at a median of 5 yr. after diagnosis; one died after regional recurrence, and one died from accidental trauma. The one Group IV patient died of tumor. Overall, 15 of 30 patients (50%) are alive and free of recurrent disease at a median of 5+ yr. after initiation of treatment. The authors conclude that prognosis is most favorable for patients with paraspinal tumors, least favorable for those with chest wall tumors, and intermediate in patients with abdominal wall tumors. Prognostic differences appeared to be influenced by extent of disease at diagnosis and histologic subtype of the sarcoma.

Abdominal Neoplasms↗
PubMed1982

Three-year relapse-free survival rates in childhood rhabdomyosarcoma of the head and neck: report from the Intergroup Rhabdomyosarcoma Study.

In 202 patients with rhabdomyosarcoma of the head and neck who registered in the first Intergroup Rhabdomyosarcoma Study, the primary lesions arose about the eye and orbit in 26%, in parameningeal sites in 46%, and in other head and neck areas in 28%. Histopathologically, 78% were embryonal-botryoid, 9% alveolar, 10% undifferentiated, and 3% extraosseous Ewing's types. Actual three-year relapse-free survival rates were calculated from data on 103 of these patients who were free of distant metastases at diagnosis and in whom follow-up had been completed for a three-year period. The actual relapse-free survival rates were 91% (21/23) for those with eye/orbit primaries, 46% (20/44) for those with parameningeal primaries, and 75% (27/36) for those with other head and neck sites affected. Among those with no clinical evidence of tumor activity at two years, 8% (6/75) had subsequent relapses.

Child↗
PubMed1982

Extremity lesions in the Intergroup Rhabdomyosarcoma Study (IRS-I): a preliminary report.

The sites in which rhabdomyosarcoma occurs most frequently in children and young adults are the head and neck, genitourinary tract, and the extremities. Among these three sites, tumors of the extremities have been associated with the highest relapse rate and lowest survival rate in patients treated by protocols of the Intergroup Rhabdomyosarcoma Study (IRS). In five of six patients treated by primary extremity amputation, tumor recurred. Seven of 21 patients in Clinical Group I (completely resected tumors), and 9 of 27 patients in Clinical Group II (patients with gross tumor excision but positive lymph nodes, "microscopic residual" disease, or extension beyond the muscle of origin) had relapse. Thirteen of 18 patients (72%) in Clinical Group III (gross residual disease) responded to a chemotherapy-radiotherapy regimen, but ten have subsequently had relapses; and 13 of 18 are dead. Of 30 patients in Clinical Group IV (disseminated disease on entry), 15 initially responded to chemotherapy, but 25 of 30 are dead. The period of surveillance is 2 1/2 to 7 1/2 years, with a mean of 46.3 months at least examination. Increased rates of relapse were seen in patients with extremity tumors, as opposed to tumors in other sites, irrespective of the specific IRS chemotherapy-radiotherapy regimen employed. In Clinical Group I (nonamputation), relapse rates by histologic subtype of rhabdomyosarcoma were alveolar subtype, 5/8; embryonal, 1/7; and all other subtypes, 1/6. Clinical Group II, relapse rates were alveolar, 6/12; embryonal, 5/11; all other subtypes, 3/10.

Amputation, Surgical↗
PubMed1982

A Southwest Oncology Group: chemotherapy versus chemotherapy plus radiotherapy in treatment of stage III Hodgkin's disease.

The Southwest Oncology Group (SWOG) performed a randomized study (SWOG 7518, CAR 2) of chemotherapy using ten courses of nitrogen mustard, vincristine, procarbazine, and prednisone (MOPP) plus low-dose bleomycin (LDB), versus three courses of combined therapy, MOPP + LDB plus radiotherapy (XRT) from October, 1974, to April 1980, in pathologic stage III Hodgkin's disease. The present report includes data on 136 registered patients, of whom 112 are fully or partially evaluable. At this preliminary analysis, complete remission rates are 82% for chemotherapy alone and 82% for combined treatment. There are no statistically significant differences in survival or relapse-free survival between the two treatment programs, and no specific trends for stage IIIA versus IIIB. The estimated 3-year survival rate for all patients was 82%. Toxicities are comparable when considering the highest grades. There was one case of acute myeloblastic leukemia on combined treatment. Preliminary evidence suggests that patients with nodular sclerosis histologic type are more likely to relapse on chemotherapy alone than on combined treatment.

Bleomycin↗
PubMed1982

Effect of timing of initiation of adjuvant chemotherapy on disease-free survival in breast cancer.

Four hundred and sixty patients with stage II or III breast cancer following regional therapy were treated with an adjuvant combination chemotherapy consisting of fluorouracil, doxorubicin, and cyclophosphamide (FAC). The relationship between the length of disease-free survival and length of delays in initiation of chemotherapy after surgery was evaluated. Patients were divided into four subgroups according to the length of delay in initiation of chemotherapy (less than 10 weeks, 10-13, 14-17, and greater than or equal to 18 weeks). Overall four year disease-free survival was 64%, 68%, 60%, and 63% for patient groups with delays of less than 10 weeks, 10-13, 14-17, or greater than or equal to 18 weeks respectively (p = 0.39). There was no trend for longer delay in treatment to be associated with shorter disease-free survival, except in poor prognosis patients.

Adult↗
PubMed1982

Progress of therapy in acute leukemia 1948-1981: randomized versus nonrandomized clinical trials.

This paper gives a review of selected clinical studies in acute leukemia over the last 33 years and addresses two questions: What advances in the practice of medicine have resulted from clinical trials, both randomized and nonrandomized? What generalizations can be made about clinical trials which have led to advances in treatment? The review demonstrates that nonrandomized studies have been the primary mechanism for establishing the efficacy of new therapies. Such studies have also been utilized to determine patient characteristics related to prognosis and some important concepts of treatment (e.g., independent action of some drugs). Randomized studies have tended to yield positive results concerning treatment differences when there were prior suggestions of activity from nonrandomized studies. Analyses of randomized studies have been made to determine patient features related to prognosis and concepts for the treatment of patients (e.g., independent action of some drugs and the importance of treating patients in a disease-free state).

Acute Disease↗
PubMed1981

Prolonged remissions in adults with acute leukemia following late intensification chemotherapy and immunotherapy.

Sixty-two patients with acute leukemia who remained in continuous complete remission for 8 to 45 months received three courses of intensified therapy with new chemotherapeutic agents, after which they received no further chemotherapy. Immunotherapy with BCG was then administered to 55 of these patients. They have been observed for up to 117 months off all chemotherapy, and 37 patients have relapsed. Thirty-two relapses occurred within 24 months, and 22 occurred within six months after completion of late intensification therapy. Only 1 of 24 patients who remained in unmaintained remission for four years after late intensification therapy has relapsed subsequently. Toxicity from intensification therapy was usually mild, and the most serious side effects were liver function abnormalities. These results suggest that late intensification therapy plus BCG immunotherapy results in prolonged disease-free survival for some patients with acute leukemia.

Adult↗
PubMed1981

Rhabdomyosarcoma of the female urogenital tract.

During the initial 6 yr (1972-1978) of the Intergroup Rhabdomyosarcoma Study (IRS), 27 patients with rhabdomyosarcoma of the female urogenital tract were treated, and the results of therapy were evaluated on the basis of 3-7 yr of observation. By primary site these tumors were: bladder, 14; vagina, 9; vulva, 2; and cervix uterus, 2. Twenty-three presented with localized tumors; the four remaining patients (1 bladder, 1 vagina, and 2 cervix) had distant metastases at diagnosis. Two patients with bladder tumors underwent pelvic exenteration, local irradiation, and chemotherapy (2 yr), and were without relapse. Ten patients were treated by partial cystectomy and postoperative chemotherapy (with or without local irradiation) and fatal recurrence occurred in three. The remaining seven patients are disease-free for 36-74 mo (mean, 51.8 mo). Six of the eight patients with nondisseminated vaginal tumors were treated by initial pelvic exenteration (2), hysterectomy-vaginectomy (2), or hemivaginectomy (2). All received postoperative chemotherapy and three received local irradiation. Delayed hysterectomy-vaginectomy after primary chemotherapy was performed in the two additional patients with vaginal tumors. Relapse has occurred in one of these eight patients with localized vaginal disease. The remaining seven have been observed for 3-5.5 yr (mean, less than 4 yr). Two patients with vulval lesions treated by a combined therapy regimen are without recurrence. Our conclusion is that chemotherapy has significantly increased survival in females with urogenital tract rhabdomyosarcomas.

Adolescent↗
PubMed1981

Sarcomas of bone in childhood: pathologic aspects.

Some sarcomas of bone are not characteristically childhood tumors. Within the context of osteosarcomas, telangiectatic and parosteal (juxtacortical) variants deserve recognition. Among chondrosarcomas, which ordinarily are not tumors that occur in children, the mesenchymal variant should be recognized in children especially, this lesion may be extraosseous. Fibrous histiocytoma and its malignant variant have recently emerged as morphologically specific lesions, occasionally osseous, among other spindle cell tumors. Ewing's sarcoma, which is predominantly of osseous origin, consists of undifferentiated fragile cells. The elaborate spectrum of topographic, cytologic, nuclear, and other morphologic features that fall within the designation Ewing's sarcoma are described.

Adolescent↗
PubMed1981

Multimodal therapy for the management of primary, nonmetastatic Ewing's sarcoma of bone: an Intergroup Study.

A randomized study of 264 children and adults with previously untreated localized Ewing's sarcoma of bone was undertaken between 1973 and 1978 by 83 institutions of three national study groups: Children's Cancer Study Group, Southwest Oncology Group, and Cancer and Leukemia Group B. The Intergroup Study was designed to determine if the addition of adriamycin (ADR) or bilateral pulmonary radiotherapy (RT) to vincristine, dactinomycin, and cyclophosphamide (VAC therapy) would improve survival and reduce local recurrences and metastases. All patients received RT to the primary lesion, and the survival rate after 3 years was 65%. The most effective treatment regimen was VAC plus ADR; 74% of the patients were free of disease at 2 years. The lengths of disease-free status and survival of patients treated with VAC plus ADR or VAC plus RT did not differ. However, both regimens were significantly superior to treatment with VAC alone. The addition of ADR or bilateral pulmonary RT to VAC was highly advantageous to patients with nonpelvic primaries. Bone and lung were the major sites of distant relapse, but the addition of bilateral pulmonary RT showed no advantage over that of ADR in reducing the occurrence of lung metastases. These recent results should eliminate some of the pessimism that has accompanied a diagnosis of Ewing's sarcoma, although distant metastases continued to be a major reason for failure in the control of this tumor. Survival of these patients can be improved through well-controlled clinical trials designed to determine optimal adjuvant chemotherapy and treatment of the primary lesion.

Adolescent↗