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Survival in renal cell carcinoma -a randomized evaluation of tamoxifen vs interleukin 2, a-interferon (leucocyte) and tamoxifen R Henriksson', S Nilsson2, S Colleen3, P WersaII4, M HeIsing5, R Zimmerman6 and K Engman7 'Department of Oncology, UmeA University Hospital; 2Department of Oncology, Uppsala University Hospital; 4Karolinska Institute, 6Sbdersjukhuset, Stockholm, 5Orebro Hospital; 3Department of Urology, Lund University Hospital, Sweden; and 7BioNative AB, Umec, Sweden Summary Metastatic renal cell carcinoma (RCC) has a poor prognosis. Conventional treatment strategies, including chemotherapy and hormonal therapy, have limited value. Although encouraging results have been achieved in terms of objective response using immunological manipulations, no conclusive studies yet exist with a controlled comparative evaluation of survival. Therefore, the present study was undertaken, which compared one of the present (and presumed best) treatments, interleukin 2/interferon-a (IL-2/IFN-a) and tamoxifen, with a control arm of tamoxifen only. Tamoxifen has been shown to potentiate in vivo anti-tumour activity of IL-2, and because of its non-toxic behaviour it was included in both groups. The study was open, randomized and included seven institutions in Sweden. The patients were stratified according to the different centres involved. An interim analysis was planned when a minimum of 100 patients were evaluable. The 128 patients finally included had a histologically documented metastatic RCC, with a life expectancy of more than 3 months, a performance status WHO 0-2 and no prior chemo-or immunotherapy. Informed consent was obtained from each patient. The patients randomized to the control arm (n = 63) received only tamoxifen 40 mg p.o. daily for at least 1 year or until progression. The patients (n = 65) randomized to biotherapy received subcutaneous recombinant IL-2, leucocyte IFN-a in a treatment cycle of 42 days, as well as tamoxifen p.o. In the absence of undue toxicity or disease progression, these patients received one additional treatment cycle of 42 days followed by maintenance treatment, consisting of 5 days therapy every 4 weeks, for 1 year, or until proven progression. Only two patients in the tamoxifen-only group received immunotherapy when the disease progressed, but without any beneficial effect. All patients received appropriate local treatment when indicated. The interim analysis demonstrated no survival advantage for either group, and therefore further inclusion of patients was stopped. The median follow-up was 11 months (range 0.4-48 months). The final survival analysis showed no significant differences between the two treatment arms in so far as comparison from the day of diagnosis of primary disease, from the day of first evidence of metastatic spread, or from the onset of treatment. This was valid both when the evaluation was performed with regard to intention to treat and when the analysis was directed only to patients that managed at least one treatment cycle (42 days) of IL-2/IFN-a. The adver...

Carcinoembryonic antigen (CEA) levels in urine and serum from 294 patients with bladder cancer in varying stages have been clinically evaluated. All urine samples were obtained from patients with intact renal function and without bacterial infection in the bladder. The samples were collected before, during, and at follow-up examination after radiotherapy. They were perchloric acid extracted before being assayed in a double-antibody radioimmunoassay. The geometric mean of urine CEA levels for patients with primary tumors of Stage T1 or T2 was significantly lower than that for those with Stage T3 or T4 disease. The urine CEA levels for patients with tumors of various histologic grades did not differ. The urine CEA levels decreased from before to after radiation treatment of the primary tumor. Patients with recurrence within six months after undergoing primary treatment had higher initial mean urine CEA levels than did those without evidence of recurrence. The prognostic information for recurrence was limited to the more advanced tumors. Differences were also found between the means of samples taken before recurrence and after treatment of recurrent tumors; with regression of the tumor, a lower mean urine CEA level was found; with progression, a higher value. Urine CEA levels before any treatment were higher when the patients had a short survival time. Serum CEA levels were not related to stage or grade of the primary bladder tumor but levels were slightly elevated with metastases. The determination of urine CEA levels seems to be useful in the follow-up of patients with bladder carcinoma because when initially high, it adds to the information of the T classification and predicts early recurrence, and the monitoring of individual patients after primary treatment is useful for detecting recurrence.

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(2007) Clinical outcome in patients with prostate cancer treated with external beam radiotherapy and high dose-rate iridium 192 brachytherapy boost: A 6-year follow-up, Acta Oncologica, 46:7,[909][910][911][912][913][914][915][916][917]