EORTC – Translating results of clinical trials into clinical urological practice
Uitgegeven: 23-03-2007
 | Dr. Th.M. de Reijke Uroloog Academisch Medisch Centrum, Amsterdam |
» View the slides (PDF) In the past 30 years many clinical trials have been done in all urological cancers within the EORTC GU group. Based on the outcome of these studies, clinical uro-oncological practice has been adapted. The attractiveness of the EORTC trials is the multidisciplinary aspect and independent data analysis. During the joint EORTC/ESOU session this will be clear when the results of studies are presented.The role of lymphadenectomy in renal cell cancer has never been clearly defined and for this reason a randomized study was initiated in 1988. In this trial 772 patients with a resectable T1-3 No Mo renal cell cancer were randomized between radical nephrectomy with or without lymphadenectomy. The incidence of unsuspected positive lymph nodes was only 3.3%. The recent update with a median follow-up of 12.6 years has shown no improvement in outcome with the lymphadenectomy. It is generally accepted that surgery is the best treatment for a patient with renal cell cancer also in case of a resectable local recurrence or metastatic lesion. Combination of radical nephrectomy and immunotherapy in case of concomitant multiple metastatic lesions has been shown to improve the survival rate, although this is only moderate. New targeted therapies are now available and the EORTC-GU group is developing new protocols in this field, which will be discussed. Hormonal therapy in patients with locally advanced and metastatic prostate cancer has been proven to be beneficial, however, more and more negative aspects of androgen deprivation are being reported. For this reason the question is very relevant if hormonal therapy is indicated for patients with locally advanced prostate cancer who are not candidates for potential curative therapy. 985 patients with T0-4N0-2M0 prostate cancer were randomized between immediate orchidectomy or LHRH treatment versus treatment once symptomatic progression was demonstrated. A 23% increase in risk of death was demonstrated for patients in the deferred arm, however, no difference in prostate cancer deaths and symptom-free survival were found. In order to find the patients at risk of dying in the deferred arm, a follow-up analysis demonstrated that patients in the deferred arm with a PSA doubling time of less than 12 months are at risk for early death. Patients with non-invasive bladder cancer can be divided in low-, intermediate-, and high risk groups for recurrence and progression. Based on the evaluation of individual patient data available for 2596 patients with TaT1 tumors entered in 7 EORTC-GU Group protocols, risk tables could be constructed. Based on these tables the patients can be counselled for adjuvant treatment. However, the schemes for chemotherapy and immunotherapy are not based on scientific grounds. Trials in these areas should be developed, but this is very difficult to accomplish. The risk of relapse in patients with a locally advanced bladder cancer is in the range of 20-50%. At this moment an adjuvant chemotherapy trial is ongoing within the EORTC GU group in order to define the role of adjuvant chemotherapy (M-VAC or gemcitabine/cisplatin) in patients with pT3-4, and /or N+M0 transitional cell carcinoma of the bladder. The accrual is slow and no data can be given yet. In 1989 a big collaborative group under the leadership of the MRC and the EORTC GU group initiated a neo-adjuvant trial in patients with cT2G3 T3-4aN0-xM0 bladder cancer. 976 patients were randomized before radical cystectomy or external beam radiation therapy between CMV treatment or immediate treatment. In 1999 a non-significant of 5.5% in 3 year survival was reported. A recent update, however, shows a significant 6% increase in 3 year survival from 50 to 56% (HR 0.84, p=0.037). The majority of patients with germ cell tumors present with a stage I seminoma and most of the patients are treated with a course of adjuvant radiotherapy to the para/aortic lymph nodes. Recently, data from a joint randomised study (n= 1477) with the MRC showed that the relapse-fee rates at 3 years were 95.9 and 94.8% for the radiotherapy and chemotherapy, respectively. As can be expected, side effects were different as were sites of relapse. All 27 patients with a relapse were salvaged by additional BEP, EP or radiotherapy treatment. Long-term follow-up of this study is necessary to evaluate late relapses and long-term side effects of both treatments. All these results of uro-oncological studies performed within the EORTC GU group will be put into perspective by the presenters and the clinical impact is discussed in a interactive forum. Laatste berichten van auteur(s)
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