Multivariate analysis of prognostic variables in patients with disseminated non-seminomatous testicular cancer: results from an EORTC multi-institutional phase III study.
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Biomedical subjects
Publications and source records attributed to W G Jones.
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After combination chemotherapy, 19 patients underwent salvage surgery for testicular neoplasia. Active malignancy was found in nine patients, three of whom have died of the disease. Those with benign residual disease have had a good prognosis without further treatment. Biopsy alone of the residual masses proved reliable in determining which patients were to be simply followed or given further chemotherapy. If active malignancy was not resected fully, the prognosis was very poor. Our policy continues to be to attempt complete excision of residual masses after induction chemotherapy and to give salvage chemotherapy to patients with residual active malignancy.
Tumour markers which occur in blood or urine are of value in the management of cancer patients because they allow disease status to be monitored by non-invasive techniques at low cost. An antigen, 'B5', on erythrocytes has been shown to become enhanced when cancer develops, regardless of tumour type, and thus the B5 antigen may be utilised as a 'universal' tumour marker. A simple haemagglutination test gives reliable quantitative assessment of the B5 marker status. Here, serial measurements of B5 status in 63 patients presenting with testicular cancer confirms a preliminary finding that both teratoma and seminoma are marked by B5. Of 28 patients with seminoma, 2 had a raised BHCG, whilst 20 (71%) were B5-positive, including 13 of 20 patients with stage-1 disease. After successful treatment, the large majority of patients showed a significant downward shift in their B5 status. Control subjects differed in that their B5 status remained constant and was often also very weak.
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A retrospective study was undertaken to examine the incidence and clinical significance of enterococcal bacteremia in burned patients with enterococcal burn-wound infections. During a 26-month period from 1983 to 1985, 38 patients were found to have enterococcal burn-wound infections. Twenty of these patients developed positive blood cultures for enterococcus with no other identifiable source for the bacteremia. Cases occurred sporadically during the study period without evidence of a specific epidemic. Ten patients died within ten days of the bacteremia, while nine others eventually died from other complications. Only one patient survived to discharge. Prior antibiotic therapy did not appear to increase the risk for enterococcal infection, and specific therapy against the enterococcus after the bacteremia was identified appeared to have no effect on mortality. Mortality was significantly greater for bacteremic patients than for patients with enterococcal wound infection alone or for burned patients without enterococcal infections. Although previously not considered pathogenic, enterococcal burn-wound infections should prompt aggressive therapy to prevent the development of enterococcal sepsis with its associated high mortality.
Two hundred fourteen patients with disseminated non-seminomatous testicular cancer were randomized to receive induction chemotherapy with cisplatin, vinblastine, and bleomycin (PVB). The randomization was for vinblastine 0.4 mg/kg/cycle or 0.3 mg/kg/cycle. The complete response (CR) rates to both regimens were identical: 68% and 71%, respectively. In addition, there was no significant difference in disease-free and overall survival. There was a significant decrease in the incidence of WBC nadirs below 1,000/microL: 29% and 13%, respectively (P = .01). Of the non-hematologic toxicities, there was a significant reduction in the incidence of mucositis: 53% and 37%, respectively (P = .006). The major prognostic factor was tumor volume. This study confirms that vinblastine 0.3 mg/kg/cycle in PVB chemotherapy is as effective and less toxic than vinblastine 0.4 mg/kg/cycle.
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The levels of serum placental alkaline phosphatase (PLAP) have been examined in 81 male controls, 51 untreated testicular tumours (41 seminomas and ten non-seminomatous testicular tumours) and 34 patients in complete remission (11 seminoma and 23 non-seminoma). Smoking induced a significant rise of serum PLAP in the controls, with a median level of 0.055 U/1 in non-smokers compared to 0.25 U/l in smokers. The levels found in pre-treatment seminoma (median 1.7 U/1) were significantly higher than in untreated teratoma (median 0.7 U/1). Treatment produced a significant fall in seminomas in remission (median 0.07 U/1). The role of PLAP in routine monitoring of seminomas was evaluated in 17 patients studied for 1-4 yr. PLAP shows similar trends to beta HCG but is an independent variable. The main role of PLAP is to help determine that the response to treatment has been satisfactory and that there are no unexpected foci of tumour.
Two hundred and twenty-eight patients with advanced testicular cancer were entered into a randomized study of chemotherapy comprising cis-platinum (P) 20 mg/m2-, days 1-5 every 3 weeks for four courses, bleomycin (B) 30 mg weekly for 12 weeks, and vinblastine (V) at either the low dose of 0.15 mg/kg or the high dose of 0.20 mg/kg on days 1 and 2 every 3 weeks for four courses. In this interim analysis, 64 patients were randomized to high dose PVB. Forty-five (71%) achieved a complete response, and 13 (25%) a partial response. Seventy patients received low dose PVB of whom 50 (71%) achieved a complete response and 16 (23%) a partial response. Thus there is no difference in the efficacy of this combination chemotherapy with respect to the dose of vinblastine, but the low dose schedule was less toxic (particularly to bone marrow). It was also apparent that the response rate varied with the volume of metastatic disease, irrespective of the dose of vinblastine. Patients with low volume metastases had a complete response rate (CR) of 88%, while those with high volume had a CR rate of 60%. In a second randomization, 68 patients achieving CR were randomized to receive either 1 year of further (maintenance) chemotherapy with cis-platinum and vinblastine, or no further chemotherapy. One of 37 patients (3%) receiving treatment and 2 of 31 patients (6%) not receiving treatment relapsed, with a follow-up of at least 10 months. Thus maintenance chemotherapy appears not to be necessary in the treatment of advanced testicular cancer.
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A study to assess the role of computed tomography (CT) in the management of testicular seminoma showed that CT was of value in defining the extent of bulky abdominal disease at initial staging. After radiotherapy for Stage IIc disease, relapse by 1 year was common and predominantly extra-abdominal. Mediastinal relapse was detected by CT in the absence of raised serum tumour markers or changes on the chest radiograph. It was concluded that CT should be used at initial staging only to assess the volume of bulk disease shown by lymphangiography, that no benefit seemed to accrue from CT scanning of Stage I and IIa patients and that the follow-up of Stage IIb and IIc patients requires regular CT surveillance in the first year, irrespective of clinical status.
A comparison has been undertaken between conventional radiographic imaging and computed tomography (CT) in 35 patients with testicular teratoma as part of an audit of our investigative approach to staging and follow-up. The CT examination included alternate cuts from the carina of the trachea to the lung bases as the thoracic assessment as well as the standard examination of the abdomen. Lymphangiography appeared to detect Stage IIa lesions better than did CT; however, CT was able to define the volume of abdominal disease more accurately. During the follow-up of Stage I patients, CT detected progressive disease in the absence of tumour marker elevation. Such progressive disease presented within 4 months in the majority of cases. The selective thoracic CT scanning conferred no advantage over whole-lung tomography, only one additional lesion being detected in 123 examinations. It is recommended that CT should be reserved for examining the area above the renal hila, for cases where lymphangiography is equivocal or positive, and that CT scanning of the abdomen in Stage I patients not receiving therapy should be repeated every 3 months following orchidectomy for the first year, irrespective of clinical status.
Workers in the "non-textile" cotton industry breathe a dust which is similar to the dust in the cotton spinning and weaving or "textile" industry. This exposure prompts the question of byssinosis prevalence and other respiratory disease in the non-textile cotton industry. NIOSH has completed a cross-sectional medical and environmental study evaluating the prevalence of byssinosis in five segments of the non-textile cotton industry. A total of 92 non-textile cotton facilities were evaluated, including cotton gins, cotton classing offices, cottonseed oil mills, cotton compress-warehouses, and waste utilization plants. This paper presents the results of the measurements of cotton dust levels and particle size distributions in these segments. Average elutriated dust concentrations for individual plants ranged from 101 to 2050 micrograms per cubic meter of air (micrograms/m3) in 35 cotton gins, 81 to 376 micrograms/m3 in 13 classing offices, 502 to 2041 micrograms/m3 in 18 cottonseed oil mills, 39 to 831 micrograms/m3 in 13 compress-warehouses, and 237 to 3968 micrograms/m3 in 13 waste utilization facilities. Results tend to be lower than those reported in the literature for non-textile operations.
A phase II study of 4'-epi-doxorubicin in 39 fully evaluable patients with advanced postmenopausal breast cancer has been performed. The patients received 20 mg of 4'-epi-doxorubicin iv weekly, irrespective of surface area. This dose schedule follows previous work with doxorubicin, showing good therapeutic effect with very low toxicity. The preliminary results of this study of 4'-epi-doxorubicin confirm that the drug is very active in breast cancer (51% objective response rate) and that the low-dose weekly approach is well-accepted with remarkably low toxicity (59% of patients had no complaints of toxic effects).
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