RESUMEN

METHODS: Some 329 military high-performance pilots were anonymously surveyed to determine the occurrence rates for a symptom complex of acceleration-induced neurologic manifestations. The premise for this symptom complex is the theory that acceleration-induced neurologic effects are not always an all-or-none phenomenon with G-LOC as the operational endpoint. RESULTS: A significant number of aircrew in selected types of aircraft reported symptoms such as euphoria, apathy, displacement, depersonalization, poor response to auditory stimuli, immediate memory difficulties, sensory abnormalities, motor abnormalities, confusion, and dream-like state without loss of consciousness. CONCLUSION: These findings may signal a need for alterations in G-awareness training.

Asunto(s)

RESUMEN

PURPOSE: To evaluate the effect of immediate androgen suppression in conjunction with standard external beam irradiation vs. radiation alone on a group of pathologically staged lymph node-positive patients with adenocarcinoma of the prostate. METHODS AND MATERIALS: A national prospective randomized trial (RTOG 85-31) of standard external beam irradiation plus immediate androgen suppression vs. external beam irradiation alone was initiated in 1985 for patients with locally advanced adenocarcinoma of the prostate. One hundred seventy-three of the patients in this trial had biopsy-proven pathologically involved lymph nodes. Ninety-eight of these patients received radiation plus the immediate androgen suppression (LHRH agonist), while 75 received radiation alone with hormonal manipulation instituted at the time of relapse. RESULTS: With a median followup of 4.9 years, estimated progression-free survival with PSA < 1.5 ng/ml at 5 years was 55% for the patients who received radiation plus immediate LHRH agonist vs. 11% of the patients who received radiation alone with hormonal manipulation at relapse (p = 0.0001). Because all of these patients had locally advanced disease (i.e., pathologically positive lymph nodes), stage does not explain this difference in outcome, and Gleason grade was not statistically different between the two groups. Estimated absolute survival at 5 years for the radiation and LHRH group was 73 vs. 65% for the radiation alone group who received androgen suppression at relapse. Estimated disease-specific survival at 5 years was 82% for the radiation and immediate LHRH agonist group and 77% for the radiation-alone group. CONCLUSION: Patients with adenocarcinoma of the prostate and pathologically involved pelvic lymph nodes (pN+ or clinical stage D1) should be seriously considered for external beam irradiation plus immediate hormonal manipulation over radiation alone with hormonal manipulation at the time of relapse.

Asunto(s)

RESUMEN

PURPOSE: RTOG 83-07 is a Phase II randomized protocol designed to compare the efficacy and toxicity of Megestrol vs. Diethylstilbestrol (DES) used as cytoreductive agents prior to and during radiotherapy. The end points of this study include tumor clearance rate, effect on serum testosterone, loco-regional control, disease-free interval, and survival. METHODS AND MATERIALS: Eligible patients were those with histologically confirmed locally advanced adenocarcinoma, clinical Stage B2 (T2B) and C (T3) without regional lymph node involvement, or with lymph node involvement limited to the pelvis. Patients were stratified by clinical stage, histological grade, and nodal status, and were randomized to receive either Megestrol 40 mg three times per day by mouth, or Diethylstilbestrol 1 mg three times per day by mouth. The drugs were started 2 months prior to initiation of radiotherapy and were continued throughout the radiotherapy course. Radiotherapy consisted of 44-46 Gy, 1.8-2 Gy per day to the regional lymphatics, followed by a boost to the prostate consisting of 20-25 Gy, 1.8-2 Gy per day, to a total of 65-70 Gy. Serum testosterone levels were recorded throughout the treatment course. Tumor response was assessed clinically and radiographically (CT scan). From March 1983 through June 1986 a total of 203 patients were accessioned to the study; 198 were analyzable. RESULTS: Correlation of the incidence of drug-related toxicity and treatment arm assignment revealed a significantly higher incidence of complications in the Diethylstilbestrol (DES) arm. The most prominent were the differences in the incidence of gynecomastia (55% vs. 7%) and fluid retention (21% vs. 6%). The incidence of thromboembolic phenomena was comparable (8% vs. 5% in the Megestrol arm). Patients on the DES arm demonstrated a significantly greater median decrease in testosterone level. Correlation of the treatment arm assignment and the rate of tumor regression and the incidence of complete response revealed no significant difference between the arms. At 7 years, 16% of patients on the Megace arm and 21% of patients on the DES arm manifested evidence of local failure. CONCLUSIONS: The results of the study indicate comparable efficacy (using tumor clearance as an end point) of DES and Megestrol. Although DES appears more effective in suppressing testosterone, it is also associated with a higher incidence of drug-related toxicity.

Asunto(s)

RESUMEN

The objectives of the study were to estimate the cost of medical care for patients recruited into the Trans Canada trial of Metastron (89Sr-chloride) as adjunct therapy in patients with prostate cancer metastatic to bone and to compare the costs of those receiving Metastron with those receiving placebo. Data from case report forms, hospital records and, where necessary, telephone follow-up were used. Twenty-nine patients, recruited into the trial at the Cross Cancer Institute, were followed from time of entry into the trial over the balance of their lifetime. Data were costed by reference to fee schedule, pharmacy and government and hospital defined costs as indirect (investigations, outpatient visits and total and tertiary hospital inpatient days) and direct (analgesics, hormones, radiotherapy and transfusions). Meaningful differences in analgesic, hormone and radiotherapy costs were seen between the two groups, with the group receiving Metastron showing a lifetime reduction of Can $1720 per person when compared with placebo. A reduction of Can $5696 per patient in the Metastron group was shown based upon requirements for admission for tertiary care; however, if total hospital stay costs are calculated there is no difference between the two groups. This retrospective study suggests that treatment with Metastron can bring about meaningful reductions in lifetime management costs in patients with advanced prostate cancer. These findings should be correlated with the significant improvement in quality of life reported in the Trans Canada study and appear to offer financial support to the clinical rationale for the use of Metastron in the palliative treatment of these patients.

Asunto(s)

RESUMEN

A retrospective study was performed on the cost-effectiveness of treatment for advanced prostate cancer metastatic to bone. Patients (n = 29) recruited into the trans Canada trial at the Cross Cancer Institute, Edmonton and randomized to treatment with Metastron (strontium-89 chloride) (n = 14) or placebo (n = 15) after local field irradiation therapy for pain palliation were studied over their entire survival time. Estimates were made of the direct costs of treatment, i.e. drugs (analgesics and hormonal agents) and external radiotherapy, and the indirect costs (investigations, outpatient visits and inpatient days, either total or for tertiary care) based on records from the referring hospital, the cancer clinic and any hospitals to which the patients may subsequently have been referred. Meaningful differences were apparent between the two groups in direct costs with the group receiving Metastron showing a reduction over the entire survival time of Can$ 1,720/person compared with placebo; it should be noted that in this analysis neither the costs of the Metastron, nor of the initial radiotherapy, have been included. The Metastron group also showed a reduction in costs of hospitalization for tertiary care of Can$ 5,696/person, though the total cost of hospitalization was similar in the two groups. These results suggest that treatment with Metastron can bring about reductions in management costs for patients with advanced prostate cancer and, coupled with the findings of the Trans Canada trial on the improvement in quality of life for patients given Metastron, they add financial support to the clinical rationale for the use of Metastron for the palliative treatment of patients with bone metastases resulting from prostate cancer.

Asunto(s)

RESUMEN

PURPOSE: A large proportion of the practice of radiotherapy in the management of metastatic adenocarcinoma of the prostate is associated with palliation of pain from osseous metastases and improving quality of life. Radiation therapy is well known to be effective in treating painful sites and may also be effective in reducing the propensity for adjuvantly treated disease to become symptomatic. Strontium-89 is a systemic radionuclide that has clinical efficacy in the palliation of pain from bony metastases. METHODS AND MATERIALS: The study was a Phase-III randomized placebo control trial performed in eight Canadian Cancer Centers to evaluate the effectiveness of strontium-89 as an adjunct to local field radiotherapy. Patients with endocrine refractory metastatic prostate cancer received local field radiotherapy and either strontium-89 as a single injection of 10.8 mCi or placebo. RESULTS: One hundred twenty-six patients were recruited. No significant differences in survival or in relief of pain at the index site where noted. Intake of analgesics over time demonstrated a significant reduction in the arm treated with strontium-89. Progression of pain as measured by sites of new pain or the requirement for radiotherapy showed statistically significant differences between the arms in favor of strontium-89. Tumor makers including prostate specific antigen, acid phosphatase, and alkaline phosphatase were also reduced in patients receiving strontium-89. A Quality-of-Life analysis was performed as a multivariate data set and demonstrated an overall superiority of strontium-89 with alleviation of pain and improvement in physical activity being statistically significant. Toxicity was evaluated and demonstrated increased hematological toxicity in the group receiving strontium-89. CONCLUSIONS: It is concluded that the addition of strontium-89 is an effective adjuvant therapy to local field radiotherapy reducing progression of disease as evidenced by new sites of pain and the requirement of further radiotherapy and improving quality-of-life and need for analgesic support in this group of patients.

Asunto(s)

RESUMEN

From January 1970 to June 1983, a total of 702 patients received radical external beam radiation therapy for carcinoma of the prostate. The estimated 5- to 10-year disease-free survival are 67% and 52%. A comparison was made between those patients whose diagnosis was established by needle biopsy as compared with those who had a positive transurethral resection of the prostate (TURP). Within Stages B & C combined, the 5-year disease-free survival was 65% for needle biopsy as compared with 59% for TURP. The corresponding figures at 10 years are 50% and 43%. This difference is significant with a p-value of less than 0.01. In addition to histological grade, identifiable prognostic factors in the literature are clinical stage, serum acid phosphatase, and extent of radiation (local only or prophylactic pelvic nodal radiation). Assessment of histological grade using the Gleason method has been carried out in all except 7 cases. The amount of tissue from a needle biopsy constitutes less than 3% of the material obtained from a TURP. As a result, there is a potential sampling error. The Gleason grading can be used in at least three ways: (a) the conventional Gleason score, (b) the most malignant grade identified, or, (c) the primary (most frequent) grade identified. Analyzing use of these three methods of histological stratification yields conflicting results. The difference between the needle and TURP groups is present in late stage disease when the primary grade is used for stratification but absent when the worst grade is used. The significance of these results remains more or less constant irrespective of end point (uncorrected, disease specific or disease-free survival). However, when stratified by Gleason score, it is significant for disease specific survival, approaches significance for uncorrected survival but not for disease free survival. Since the significance can be altered by changing one stratification factor, there must be some doubt about the validity of other studies which either confirm or refute the hypothesis that TURP has an adverse influence on the disease process.

Asunto(s)

RESUMEN

An analysis of 77 consecutive patients with a histologic diagnosis of seminoma testis, assessed and treated at the Cross Cancer Institute between 1977 and 1982, is presented. Ga-67 citrate was first used in the assessment of patients with malignant testicular tumors in 1973. Following three years of study that supported the observation of the gallium-avid nature of seminoma, gallium scans became routine in the initial staging assessment and were used also when recurrence was suspected. From 1977 through 1982, 72 patients with biopsy-proven seminoma testis were assessed initially for extent of disease by Ga-67 scanning. Comparison with intravenous pyelography and bipedal lymphography was possible for accuracy of tumor assessment. The scan sensitivity was 83%, and the specificity was 95%. During the same period, gallium was studied in nonseminomatous testicular tumors but the results were disappointing and its use was discontinued. The gallium-avid nature of seminoma testis may be useful in determining the extent of disease.

Asunto(s)

RESUMEN

An analysis is presented of 188 patients with a histological diagnosis of seminoma testis, treated by radical orchiectomy and radiation therapy between 1960 and 1981 at the Cross Cancer Institute. Using the Walter Reed Hospital staging classification, 149 (79%) patients were Stage I, 34 (18%) were Stage II, and 5 (3%) were Stage III. The 5-year survival for all stages was 90%, and for Stage I was 98%, Stage II, 71%, and Stage III, 0%. All were treated primarily with radiation therapy. Prophylactic mediastinal radiation was not employed for Stage I, and was employed in half of Stage II patients. Eleven patients with Stage I relapsed, five in the mediastinum and/or neck nodes. Eight of 11 were cured with further treatment. Stage II patients were subdivided according to the presence or absence of a palpable abdominal mass. Palpable disease (Stage IIB) carried a poorer prognosis. Three of 20 patients without a palpable mass (Stage IIA) died of disease; there was an 82% five-year survival rate. Eight of 14 with a palpable mass (Stage IIB) were cured by radiotherapy; there was a 54% five-year survival rate. All five Stage III patients died within 1 year of diagnosis. Stage I and IIA seminoma is curable by radiation alone. Prophylactic mediastinal radiation is not indicated in either Stage I or IIA disease. Long term toxicity from radiation is not seen. Optimal treatment for Stage IIB disease is undetermined and new treatment regimens should be explored. Stage III disease requires primary chemotherapy.

Asunto(s)

RESUMEN

Data on the management of carcinoma of the prostate by radiation therapy were obtained from 12 centres in Canada. The outcome in a total of 1496 patients has been analysed as a medical audit. The crude five-year survival is 69% and at eight years it is 51%.

Asunto(s)

Asunto(s)

RESUMEN

The value of the Gleason system of histological grading in carcinoma of the prostate is a subject of considerable controversy. The value of this system is demonstrated in a group of 488 patients treated radically with radiation therapy. Analysis, utilizing the Gleason system in these patients, indicates that the worst histological grade identified is most important in determining the prognosis. Since nearly 18% of our patients have more than two grades identified, simple identification of primary and secondary grades, ie, the two predominating grades, is inadequate and may underestimate the aggressiveness of the tumor. This finding has implications in the analysis of the results of treatment and in determining the method of treatment in individual patients.

Asunto(s)

Asunto(s)

Asunto(s)

RESUMEN

Since 1970 a total of 107 patients has been treated radically with radiation therapy for carcinoma of the prostate. The local control with this form of treatment is over 90%. The five year actuarial survival is 74% and the disease-free survival 58%. Serious morbidity has been minimal. Survival is related to the extent of initial involvement and the histology of the tumor, but is not influenced by elevation of the acid phosphatase. Radical radiation therapy is an effective method of local control for carcinoma of the prostate and is potentially curative.

Asunto(s)

RESUMEN

Gallium-67 citrate was found to localize in the salivary glands of eight patients after therapeutic doses of radiation to a treatment field including the glands. In two patients, autopsy evidence to the effect that no primary disease was present to explain such uptake was obtained. In another two patients the abnormal uptake was not observed on follow-up. The recognition that radiation sialadenitis is a potential cause of false-positive gallium scintiscans is important in their interpretation.

Asunto(s)

RESUMEN

Gallium-67 citrate was found to localize in the salivary glands of eight patients after therapeutic doses of radiation to a treatment field including the glands. In two patients, autopsy evidence to the effect that no primary disease was present to explain such uptake was obtained. In another two patients the abnormal uptake was not observed on follow-up. The recognition that radiation sialadenitis is a potential cause of false-positive gallium scintiscans is important in their interpretation.

Asunto(s)

Asunto(s)

Asunto(s)