We treated 87 patients with carcinoma in situ of the bladder in a prospective randomized trial of 2 dose levels of intravesically administered alpha-2b-interferon. Patients received either low dose (10 million units) or high dose (100 million units) recombinant alpha-2b-interferon weekly for 12 weeks and then monthly for a maximum of 1 year. Of the 47 high and 38 low dose patients 20 (43%) and 2 (5%), respectively, achieved a complete response. Additionally, partial responses (cytology results positive with no histological evidence of carcinoma in situ) were noted in 23% of the high dose group. Notably, 6 of 9 patients who had failed prior intravesical bacillus Calmette-Guerin therapy responded to alpha-2b-interferon treatment. Preliminary assessment has shown that among the complete responders 18 of 20 (90%) in the high dose group have maintained responses for at least 6 months after the completion of treatment (10 for more than 12 months). Seven patients in each treatment group have undergone radical cystectomy. All 14 patients had progressive disease except 1 who chose cystectomy although she was still responding to treatment. The median intervals from initial treatment to cystectomy were 18 and 32 weeks in the low and high dose groups, respectively. Local irritation or toxicity did not occur and other adverse effects were rare except for mild to moderate flu-like symptoms (8% in the low dose and 17% in the high dose groups). No patient discontinued therapy due to treatment-related adverse effects. Intravesical alpha-2b-interferon demonstrated a high level of activity in the treatment of carcinoma in situ of the bladder with the 100 million unit dose producing a significantly greater response rate (43% complete response, p less than 0.0001) than the low dose (5% complete response). Safety and tolerance were excellent with no local irritative toxicity.
Cardiovascular complications in patients with carcinoma of the prostate have been studied in relation to 3 methods of treatment, namely stilboestrol, estramustine phosphate (Estracyt) and bilateral orchiectomy. One hundred and sixteen patients were studied over a 4-year period on a prospective basis, 48 being treated with stilboestrol, 31 with estramustine and 37 with bilateral orchiectomy. The incidence of the cardiovascular side effects of these 3 treatment regimes in the first year of treatment was recorded after the patients had been divided into those with localised (MO) disease and advanced disease with metastases (M1). In patients treated with stilboestrol 29% had cardiovascular complications with a mortality rate of 16%. With estramustine 25% had complications with a 16% mortality rate, but with orchiectomy the complication rate was only 8% with a 3% mortality rate. It is recommended that stilboestrol and estramustine phosphate should not be used in the presence of cardiovascular disease and that the primary form of treatment in prostatic carcinoma should be bilateral orchiectomy, especially in patients with localised disease.
SUMMARY Results are given of a case-control study on bladder cancer in West Yorkshire. The aim of the study was to assess what risks exist for cigarette smoking in the United Kingdom and also to investigate if a dose response effect was present. The study shows for the first time in the United Kingdom a positive but weak relationship between cigarette smoking and bladder cancer. Close examination of the data with regard to this effect shows that a complex set of relationships result when the quantity smoked and the period of smoking are taken into account. A dose response effect is weakly demonstrated when a medium quantity of cigarettes are smoked but it is not present at all in those who smoked most cigarettes for the longest periods. No risk appears to exist for those who have smoked only filter cigarettes. The results are contrasted with similar studies and the significance of the observations are discussed.An association between cigarette consumption and bladder cancer is known as a result of various types of epidemiological inquiry. Correlation studies by Lea,' Fraumeni,2 and Stevens and Moolgavkar,3 several follow up and birth cohort studies," and some case control studies7-13 all indicate that risks exist. There are, however, some deficiencies in our knowledge, in particular no other English case-control study has yet shown a risk.14 Part of the work presented here has already been published in a preliminary form15 but it is the purpose of this study to Tables 1 and 2 show the number of cases and controls in the analyses and their place of interview. Some of the later present fewer results than shown here due to lack of certain information. Table 3 gives the overall result of "ever" versus "never" cigarette smokers from the entire series. These results are similar to those reported in a preliminary study15 for men Table 4 indicates that for men the risks from cigarette smoking decline after abstinence of at least five years; the resulting risk for current smokers Table 5 shows that the risk of the current smokers varies slightly with age at diagnosis but not to any significant degree.
In a randomized phase III trial performed by the Urological Group of the European Organization for Research on Treatment of Cancer low dose estramustine phosphate (280 mg. twice daily for 8 weeks and 140 mg. twice daily thereafter) was compared to diethylstilbestrol (1 mg. 3 times daily) in patients with stages T3 to T4, M0 or M1 prostatic cancer. Of 248 patients entered 227 were evaluable for analysis: 115 received estramustine phosphate and 112 received diethylstilbestrol. The best response of the local tumor as assessed by palpation was seen in patients receiving diethylstilbestrol. There was no significant difference between treatments for response rate of metastases, interval to local progression, distant progression, over-all survival and death of carcinoma of the prostate. Duration of survival was correlated with the assessment of local response as determined by palpation. The response of distant lesions also was correlated closely with survival. Diethylstilbestrol (1 mg. 3 times daily) was associated with a significantly worse degree of cardiovascular toxicity than estramustine phosphate. This finding was especially obvious in patients who had no history of cardiovascular disease. Gastrointestinal toxicity occurred in 25 patients treated with estramustine phosphate, including 6 in whom cessation of treatment was necessary. Further studies are required to determine the optimum dose of diethylstilbestrol and estramustine phosphate, and to establish the best form of hormonal treatment for prostatic carcinoma.
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