In this phase II study, 41 patients with locally advanced urothelial bladder cancer (T2-4, N0, M0) were treated with primary chemotherapy (cisplatin, epirubicin, methotrexate: PEM-3). All the patients were assessable for response and toxicity. Clinical monitoring was performed with computerized tomography and cystoscopy. Nineteen clinical complete remissions (46%) and 10 partial remissions (24.5%) were obtained (CR + PR, 70.5%; 95% confidence interval, 57%-85%). Ten patients were considered to have clinically stable disease (24.5%), and 2 patients progressed (5%). Surgery after chemotherapy was performed in 22 cases: in 6 patients (27%) a pathologic complete response was achieved. The pathologic stage was lower than the initial clinical stage in 13 patients (59%). After a median follow-up of 3 years (range, 1-4), the median time to progression was 104 weeks. At this writing, 20 patients, 12 of which were submitted to surgery and 8 were not operated, are disease-free. The 3-year survival rate is 52%. No one had to interrupt the treatment because of toxicity. In conclusion, the PEM-3 regimen is a very active and well-tolerated regimen in locally advanced bladder cancer.

Aged↗

PubMedDate not supplied

Hospital-at-Home for advanced cancer patients within the framework of the Bologna Eubiosia project: an evaluation.

AIMS AND BACKGROUND: An evaluation of the Bologna Hospital-at-Home (BHH) was undertaken to examine the following aspects: 1) median daily costs of the BHH; 2) delivery of medical services; 3) patient satisfaction with the care received and frequency of requests for transfer to the alternative setting. Delivery of services and patient's satisfaction in the BHH were compared with data collected for a traditional hospital (Ospedale Sant'Orsola Malpighi, Bologna--OSM). METHODS: Our analysis was performed as a cost analysis considering two periods of time in 1992 and 1993/94. Included were direct and indirect costs; no intangible costs were found. The patient's perspective was selected for the analysis. The observational study examining delivery of service and quality of life of patients admitted to the two care settings, BHH and OSM, considered patient's clinical history and an interview conducted by the evaluation team 6 weeks after admission to either facility. Data included patient's characteristics, quantity of diagnostic and therapeutic measures, circumstances of life, satisfaction with the care received, and intention for transfer to the alternative setting of nursing. The statistical significance of our assumption of comparable care intensity and better patient quality of life in the BHH was tested by the Pearson Chi-square test. RESULTS: A survey was carried out of 236 patients treated in the BHH or the OSM. The setting of assistance did not influence the provision of services. The time of "talking to the doctor" was notably higher for BHH than for OSM patients. The analysis of satisfaction showed that 98% of the surveyed BHH patients believed it matched the actual needs. The quality of life was considered to be reduced/bad in 67% of the OSM patients but in only 51% of BHH patients. An opinion was also requested with regard to transfer to the alternative setting of nursing: 47% of OSM patients judged BHH care would be better than traditional hospital. The median daily costs in BHH reached 118,789 Lire (range, 108,569-129,027 Lire, depending on performance status). CONCLUSIONS: Although the economic advantage of hospital-at-home care certainly is important, we would like to stress that better quality and dignity of life should be the main point supporting the idea of hospital-at-home care.

Cost-Benefit Analysis↗

PubMedDate not supplied

CA-125 monitoring during chemotherapy for ovarian cancer.

Serum CA-125 was determined in 60 patients with variously extended ovarian cancer and monitored during and after chemotherapy. The study indicates that: 1) prechemotherapy CA-125 shows the presence of an active disease with an accuracy greater than 85%. The antigen is elevated in 97% of patients with greater than 2 cm disease, but sensitivity is low (67%) in patients with minimal residual disease (less than 2 cm); 2) changes in CA-125 correspond well with the response to chemotherapy. CA-125 becomes negative in every patient having clinical CR and increases in every patient with progressive disease. These changes can indicate the type of response some months ahead of time; 3) CA-125 indicates in advance the recurrence of the disease after an objective remission: 4) In the conditions studied CA-125 basal levels do not seem to have prognostic value as regarding either response or survival.

Antigens, Neoplasm↗

PubMedDate not supplied

CA 15.3 and CEA plasma level monitoring in patients with breast cancer.

CA 15.3 and CEA were determined in the serum of 217 patients with early and advanced breast carcinoma. CA 15.3 was high (greater than 30 U/ml) in 1/6 (17%) patients with stage I-II primary tumor, in 4/77 (5%) patients without clinical signs of disease after mastectomy, in 67/102 (65%) patients with advanced disease in progression, and in 13/32 (41%) patients with advanced disease not in progression and undergoing therapy. The corresponding incidences of pathological CEA values (greater than 2.5 ng/ml) were 33, 8, 55 and 14%. The combination of the two markers brings about a certain improvement in the sensitivity for recognising patients with advanced disease in progression (79/102 = 77%). The presence of high values of CA 15.3 is statistically correlated to the prevalent site of metastases (bone and viscera greater than soft tissues). Monitoring the two markers during antitumor therapy in 36 patients showed good accordance (56%) between CA 15.3 changes and response to therapy. The decrease of the marker in patients who achieved partial remission was statistically significant. In conclusion, CA 15.3 is more sensitive than CEA in recognising patients with advanced disease in progression and gives better accordance with the response to therapy. The simultaneous use of the two markers may be useful in the follow-up of operated patients and in monitoring the disease during treatment.

Antigens, Neoplasm↗

PubMedDate not supplied

CA-549 serum levels in breast cancer monitoring.

CA-549 serum levels were assessed in 288 patients, 156 with early breast cancer (after surgery) and 132 with advanced breast cancer. CA-549 was abnormal (> 12 U/ml) in 25/156 patients (16%) without clinical signs of disease after surgery (median 9 U/ml), in 49/60 patients (82%) with disease in progression (P) (median 50 U/ml), in 19/27 patients (70%) with stationary disease (NC) (median 14 U/ml), in 25/33 patients (76%) with partial remission (PR) (median 18 U/ml) and in 4/12 patients (33%) with complete remission (CR) (median 9 U/ml). CA-549 serum levels correlated mainly with the extent of disease and secondarily with the prevalent metastatic site, higher values being observed in patients with visceral involvement (median 32.5 U/ml). CA-549 serum levels were also assessed in 51 patients at the start of treatment and at the time of objective evaluation: the results underline the concordance of CA-549 behavior with the clinical outcome in 71% of the cases. We conclude that CA-549 is a useful marker for monitoring breast cancer patients during the advanced stages of the disease.

Adult↗

PubMedDate not supplied

A double-blind evaluation of the analgesic efficacy and toxicity of oral ketorolac and diclofenac in cancer pain. The TD/10 recordati Protocol Study Group.

AIM: To compare the analgesic efficacy and toxicity of the nonsteroidal anti-inflammatory analgesic drug, ketorolac (Toradol, Recordati spa, Milan) 10 mg p.o. (t.i.d.) with diclofenac (Voltaren, Novartis Farma, Origglo, VA) 50 mg p.o. (t.i.d.) in cancer patients with moderate to severe chronic pain. METHODS AND STUDY DESIGN: The study was a multicenter randomized double-blind cross-over trial. Each treatment lasted 7 days, after which the patients crossed over to the other drug. Pain intensity was evaluated by the visual analogue scale (VAS) after the first dose and by the 5-point verbal rating scale (VRS) by the patient and by the physician following the 7-day treatment. RESULTS AND CONCLUSIONS: A total of 138 advanced cancer patients were enrolled in the study. Overall 251 single-dose administrations (117 cross-over observations) and 257 multiple treatments (127 cross-over experiments) were assessable. After a single administration of ketorolac and diclofenac, no significant difference could be observed in analgesic activity, as indicated by the area under the pain-intensity time curve (AUC0-8), in the maximum efficacy, or the duration of efficacy of the two drugs. The Westlake confidence intervals of the AUC0-8 ratio (ketorolac: diclofenac) (1.07; 90% CI, 0.94-1.19), of the maximum efficacy ratio (1.03; 90% CI, 0.92-1.14), and the duration of efficacy ratio (1.05; 90% CI, 0.97-1.11) showed the bioequivalence of the two drugs. Satisfactory pain relief was reported for multiple 7-day treatments, with no significant differences between the two therapies: according to the physician's evaluation, in 93/128 (73%; 95% CI, 65-80%) ketorolac treatments and 91/129 (71%; 95% CI, 63-78%) diclofenac treatments; according to the patient's evaluation, in 83/128 cases (65%; 95% CI, 57-73%) after ketorolac and in 74/129 cases (57%; 95% CI, 49-66%) after diclofenac. Adverse symptoms were acceptable with both drugs. Interestingly, a pronounced sequence effect was found: gastric disturbances after ketorolac were observed mainly (10 out of 15 observed events) when the drug was given to patients pretreated with diclofenac.

Administration, Oral↗

PubMedDate not supplied

[The "Eubiosia" project].

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Euthanasia↗

PubMedDate not supplied

The Bologna Hospital-at-Home: a model for cost-effective care of advanced cancer patients in developing countries.

BACKGROUND: There are two options for India, if it intends to build up an adequate level of assistance for advanced cancer patients: increase the number of hospital beds (including hospice care); or introduce home care. We have used the home care approach in Italy and found it to be cost-effective. METHODS: Costs of the Bologna Hospital-at-Home (BHH) were analysed in 1992 (550 patients) and 1993 (152 patients). Direct and indirect costs were included; no intangible costs were found. The patient's perspective was also analysed. In 1995, an observational study was performed to determine the quality of life of patients admitted to two alternative care settings--the BHH and a traditional hospital, the Ospedale Sant' Orsola Malpighi (OSM), Bologna. RESULTS: Delivery of services was not different in both settings--the OSM and BHH. The analysis of satisfaction showed that 98% of the BHH patients surveyed felt it matched the actual needs. The quality of life was considered to be 'reduced/bad' in 67% of the OSM patients but in only 51% of BHH patients. With regard to transfer to the alternative setting of nursing, 47% of patients receiving care in the traditional hospital felt that hospital-at-home care would be better. The daily costs for BHH patients ranged between US$ 63.9 and US$ 75.9. CONCLUSION: Hospital-at-Home care merits consideration in the palliative care of advanced cancer patients in developing countries. Detailed quality of life studies and cost-benefit assessments would need to be done before such a strategy is implemented. The BHH could be a model adaptable to developing countries. Our first experiences with such a model in Albania and India were encouraging.

Cost-Benefit Analysis↗

PubMedDate not supplied

Weekly regimen of 5-FU vs 5-FU + intermediate dose folinic acid in the treatment of advanced colorectal cancer.

Sixty-four patients with advanced colorectal cancer were randomized to receive 5-fluorouracil (5-FU) at the dose of 600 mg/sm weekly or the same regimen of 5-FU administered halfway through a 1 hour i.v. infusion of folinic acid (FA) at the dose of 200 mg/sm. A partial remission (PR) was obtained in 1/30 patients (3%) treated with 5-FU and in 9/34 patients (26%) treated with 5-FU + FA (P = 0.028). The objective response was accompanied by an improvement in subjective status and general conditions. The median duration of PR in 5-FU + FA arm was 10 months (range: 6-17). The median time to progression was 5 and 6 months in patients treated with 5FU and 5FU + FA, respectively (not a statistically significant difference). There were no cases of grade 4 toxicity. A higher, but not statistically significant, incidence and intensity of diarrhoea was observed in the 5-FU + FA arm. However, 14 patients on 5-FU + FA as opposed to 3 on 5-FU had to stop the treatment temporarily because of side-effects (P = 0.011). Median survival was higher with 5-FU + FA treatment (10 vs 7 months), but the difference is not statistically significant. This study confirms that the addition of an intermediate dose of FA enhances the cytotoxicity of 5-FU. Although its clinical advantage was limited, this weekly 5-FU + FA regimen appears useful in the treatment of advanced colo-rectal cancer on a outpatient basis.

Adenocarcinoma↗

PubMedDate not supplied

Massive-dose progestational therapy in oncology (medroxyprogesterone). Preliminary results.

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Adenocarcinoma, Scirrhous↗

PubMedDate not supplied

[New trends in hormone therapy].

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Androgens↗