EORTC Headquarters

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Nordlinger B.,University of Versailles | Sorbye H.,University of Bergen | Glimelius B.,Uppsala University | Poston G.J.,University of Liverpool | And 14 more authors.
The Lancet Oncology | Year: 2013

Background: Previous results of the EORTC intergroup trial 40983 showed that perioperative chemotherapy with FOLFOX4 (folinic acid, fluorouracil, and oxaliplatin) increases progression-free survival (PFS) compared with surgery alone for patients with initially resectable liver metastases from colorectal cancer. Here we present overall survival data after long-term follow-up. Methods: This randomised, controlled, parallel-group, phase 3 study recruited patients from 78 hospitals across Europe, Australia, and Hong Kong. Eligible patients aged 18-80 years who had histologically proven colorectal cancer and up to four liver metastases were randomly assigned (1:1) to either perioperative FOLFOX4 or surgery alone. Perioperative FOLFOX4 consisted of six 14-day cycles of oxaliplatin 85mg/m2, folinic acid 200 mg/m2 (DL form) or 100 mg/m2 (L form) on days 1-2 plus bolus, and fluorouracil 400 mg/m2 (bolus) and 600 mg/m2 (continuous 22 h infusion), before and after surgery. Patients were centrally randomised by minimisation, adjusting for centre and risk score and previous adjuvant chemotherapy to primary surgery for colorectal cancer, and the trial was open label. Analysis of overall survival was by intention to treat in all randomly assigned patients. This trial is registered with ClinicalTrials.gov, number NCT00006479. Findings: Between Oct 10, 2000, and July 5, 2004, 364 patients were randomly assigned to a treatment group (182 patients in each group, of which 171 per group were eligible and 152 per group underwent resection). At a median follow-up of 8·5 years (IQR 7·6-9·5), 107 (59%) patients in the perioperative chemotherapy group had died versus 114 (63%) in the surgery-only group (HR 0·88, 95% CI 0·68-1·14; p=0·34). In all randomly assigned patients, median overall survival was 61·3 months (95% CI 51·0-83·4) in the perioperative chemotherapy group and 54·3 months (41·9-79·4) in the surgery alone group. 5-year overall survival was 51·2% (95% CI 43·6-58·3) in the perioperative chemotherapy group versus 47·8% (40·3-55·0) in the surgery-only group. Two patients in the perioperative chemotherapy group and three in the surgery-only group died from complications of protocol surgery, and one patient in the perioperative chemotherapy group died possibly as a result of toxicity of protocol treatment. Interpretation: We found no difference in overall survival with the addition of perioperative chemotherapy with FOLFOX4 compared with surgery alone for patients with resectable liver metastases from colorectal cancer. However, the previously observed benefit in PFS means that perioperative chemotherapy with FOLFOX4 should remain the reference treatment for this population of patients. Funding: Norwegian and Swedish Cancer Societies, Cancer Research UK, Ligue Nationale Contre Cancer, US National Cancer Institute, Sanofi-Aventis. © 2013 Elsevier Ltd.


Verleye L.,EORTC Headquarters | Vergote I.,University Hospitals Leuven | Van Der Zee A.G.J.,University of Groningen
European Journal of Surgical Oncology | Year: 2010

Quality of surgery is one of the most important determinants of the outcome in ovarian cancer patients. Surgery by a gynaecological oncologist in a specialised, high-volume environment and removal of all visible tumours are associated with a higher likelihood of favourable outcome for patients with advanced-stage ovarian cancer. Population-based studies in Europe however show that a substantial number of patients do not receive optimal surgical care. Less than half of the patients suffering from advanced-stage ovarian cancer are operated by a gynaecological oncologists. Also the proportion of patients operated in a high-volume or specialised hospital is lower than 50%. In a substantial number of patients, minimum standard procedures are not performed and optimal tumor debulking is not achieved. To improve the quality of care, efforts are needed to develop and implement robust evidence-based European guidelines, provide surgical training for gynaecological oncologists and establish comprehensive cancer networks with sufficient resources. © 2010 Elsevier Ltd. All rights reserved.


Studer U.E.,University of Bern | Whelan P.,St James Hospital | Wimpissinger F.,Rudolfstiftung Hospital | Casselman J.,Damiaan Ziekenhuis | And 6 more authors.
European Urology | Year: 2014

Background Trials assessing the benefit of immediate androgen-deprivation therapy (ADT) for treating prostate cancer (PCa) have often done so based on differences in detectable prostate-specific antigen (PSA) relapse or metastatic disease rates at a specific time after randomization. Objective Based on the long-term results of European Organization for Research and Treatment of Cancer (EORTC) trial 30891, we questioned if differences in time to progression predict for survival differences. Design, setting, and participants EORTC trial 30891 compared immediate ADT (n = 492) with orchiectomy or luteinizing hormone-releasing hormone analog with deferred ADT (n = 493) initiated upon symptomatic disease progression or life-threatening complications in randomly assigned T0-4 N0-2 M0 PCa patients. Outcome measurements and statistical analysis Time to first objective progression (documented metastases, ureteric obstruction, not PSA rise) and time to objective castration-resistant progressive disease were compared as well as PCa mortality and overall survival. Results and limitations After a median of 12.8 yr, 769 of the 985 patients had died (78%), 269 of PCa (27%). For patients receiving deferred ADT, the overall treatment time was 31% of that for patients on immediate ADT. Deferred ADT was significantly worse than immediate ADT for time to first objective disease progression (p < 0.0001; 10-yr progression rates 42% vs 30%). However, time to objective castration-resistant disease after deferred ADT did not differ significantly (p = 0.42) from that after immediate ADT. In addition, PCa mortality did not differ significantly, except in patients with aggressive PCa resulting in death within 3-5 yr after diagnosis. Deferred ADT was inferior to immediate ADT in terms of overall survival (hazard ratio: 1.21; 95% confidence interval, 1.05-1.39; p [noninferiority] = 0.72, p [difference] = 0.0085). Conclusions This study shows that if hormonal manipulation is used at different times during the disease course, differences in time to first disease progression cannot predict differences in disease-specific survival. A deferred ADT policy may substantially reduce the time on treatment, but it is not suitable for patients with rapidly progressing disease. © 2013 European Association of Urology. Published by Elsevier B.V. All rights reserved.


Roupret M.,University Paris - Sud | Babjuk M.,Charles University | Comperat E.,University Paris - Sud | Zigeuner R.,Medical University of Graz | And 8 more authors.
European Urology | Year: 2013

Context: The European Association of Urology (EAU) guideline group for upper tract urothelial carcinoma (UTUC) has prepared updated guidelines to aid clinicians in assessing the current evidence-based management of UTUC and to incorporate present recommendations into daily clinical practice. Objective: To provide a brief overview of the EAU guidelines on UTUC as an aid to clinicians in their daily clinical practice. Evidence acquisition: The recommendations provided in the current guidelines are based on a thorough review of available UTUC guidelines and articles identified using a systematic search of Medline. Data on urothelial malignancies and UTUCs in the literature were searched using Medline with the following keywords: urinary tract cancer; urothelial carcinomas; upper urinary tract, carcinoma; renal pelvis; ureter; bladder cancer; chemotherapy; nephroureterectomy; adjuvant treatment; instillation; neoadjuvant treatment; recurrence; risk factors; nomogram; and survival. References were weighted by a panel of experts. Evidence synthesis: There is a lack of data in the current literature to provide strong recommendations (ie, grade A) due to the rarity of the disease. A number of recent multicentre studies are now available, and there is a growing interest in UTUC in the recent literature. Overall, 135 references have been included here, but most of these studies are still retrospective analyses. The TNM 2009 classification is recommended. Recommendations are given for diagnosis as well as radical and conservative treatment (ie, imperative and elective cases); additionally, prognostic factors are discussed. Recommendations are also provided for patient follow-up after different therapeutic options. Conclusions: These guidelines contain information for the management of individual patients according to a current standardised approach. Physicians must take into account the specific clinical characteristics of each individual patient when determining the optimal treatment regimen including tumour location, grade, and stage; renal function; molecular marker status; and medical comorbidities. © 2013 European Association of Urology.


Scosyrev E.,University of Rochester | Messing E.M.,University of Rochester | Sylvester R.,EORTC Headquarters | Campbell S.,Cleveland Clinic | Van Poppel H.,University Hospital
European Urology | Year: 2014

Background In the European Organization for Research and Treatment of Cancer (EORTC) randomized trial 30904, nephron-sparing surgery (NSS) was associated with reduced overall survival compared with radical nephrectomy (RN) over a median follow-up of 9.3 yr (hazard ratio: 1.50; 95% confidence interval [CI], 1.03-2.16). Objective To examine the impact of NSS relative to RN on kidney function in EORTC 30904. Design, setting, and participants This phase 3 international randomized trial was conducted in patients with a small (≤5 cm) renal mass and normal contralateral kidney who were enrolled from March 1992 to January 2003. Intervention Patients were randomized to RN (n = 273) or NSS (n = 268). Outcome measurements and statistical analysis Follow-up estimated glomerular filtration rates (eGFR; milliliters per minute per 1.73 m 2) were recorded for 259 subjects in the RN arm and 255 subjects in the NSS arm. Percentages of subjects developing at least moderate renal dysfunction (eGFR <60), advanced kidney disease (eGFR <30), or kidney failure (eGFR <15) were calculated for each treatment arm based on the lowest recorded follow-up eGFR (intent-to-treat analysis). Results and limitations With a median follow-up of 6.7 yr, eGFR <60 was reached by 85.7% with RN and 64.7% with NSS, with a difference of 21.0% (95% CI, 13.8-28.3); eGFR <30 was reached by 10.0% with RN and 6.3% with NSS, with a difference of 3.7% (95% CI, -1.0 to 8.5); and eGFR <15 was reached by 1.5% with RN and 1.6% with NSS, with a difference of -0.1% (95% CI, -2.2 to 2.1). Lack of longer follow-up for eGFR is a limitation of these analyses. Conclusions Compared with RN, NSS substantially reduced the incidence of at least moderate renal dysfunction (eGFR <60), although with available follow-up the incidence of advanced kidney disease (eGFR <30) was relatively similar in the two treatment arms, and the incidence of kidney failure (eGFR <15) was nearly identical. The beneficial impact of NSS on eGFR did not result in improved survival in this study population. Registration EORTC trial 30904; ClinicalTrials.gov identifier NCT00002473. © 2013 European Association of Urology.


Babjuk M.,Charles University | Burger M.,University of Würzburg | Zigeuner R.,Medical University of Graz | Shariat S.F.,Medical University of Vienna | And 8 more authors.
European Urology | Year: 2013

Context The first European Association of Urology (EAU) guidelines on bladder cancer were published in 2002 [1]. Since then, the guidelines have been continuously updated. Objective To present the 2013 EAU guidelines on non-muscle-invasive bladder cancer (NMIBC). Evidence acquisition Literature published between 2010 and 2012 on the diagnosis and treatment of NMIBC was systematically reviewed. Previous guidelines were updated, and the levels of evidence and grades of recommendation were assigned. Evidence synthesis Tumours staged as Ta, T1, or carcinoma in situ (CIS) are grouped as NMIBC. Diagnosis depends on cystoscopy and histologic evaluation of the tissue obtained by transurethral resection (TUR) in papillary tumours or by multiple bladder biopsies in CIS. In papillary lesions, a complete TUR is essential for the patient's prognosis. Where the initial resection is incomplete, where there is no muscle in the specimen, or where a high-grade or T1 tumour is detected, a second TUR should be performed within 2-6 wk. The risks of both recurrence and progression may be estimated for individual patients using the EORTC scoring system and risk tables. The stratification of patients into low-, intermediate-, and high-risk groups is pivotal to recommending adjuvant treatment. For patients with a low-risk tumour, one immediate instillation of chemotherapy is recommended. Patients with an intermediate-risk tumour should receive one immediate instillation of chemotherapy followed by 1 yr of full-dose bacillus Calmette-Guérin (BCG) intravesical immunotherapy or by further instillations of chemotherapy for a maximum of 1 yr. In patients with high-risk tumours, full-dose intravesical BCG for 1-3 yr is indicated. In patients at highest risk of tumour progression, immediate radical cystectomy should be considered. Cystectomy is recommended in BCG-refractory tumours. The long version of the guidelines is available from the EAU Web site: http://www.uroweb.org/guidelines/. Conclusions These abridged EAU guidelines present updated information on the diagnosis and treatment of NMIBC for incorporation into clinical practice. Patient summary The EAU Panel on Non-muscle Invasive Bladder Cancer released an updated version of their guidelines. Current clinical studies support patient selection into different risk groups; low, intermediate and high risk. These risk groups indicate the likelihood of the development of a new (recurrent) cancer after initial treatment (endoscopic resection) or progression to more aggressive (muscle-invasive) bladder cancer and are most important for the decision to provide chemo- or immunotherapy (bladder installations). Surgical removal of the bladder (radical cystectomy) should only be considered in patients who have failed chemo- or immunotherapy, or who are in the highest risk group for progression. © 2013 European Association of Urology.


Pallis A.G.,EORTC Headquarters | Shepherd F.A.,University of Toronto | Lacombe D.,EORTC Headquarters | Gridelli C.,S G Moscati Hospital
Cancer | Year: 2010

Small-cell lung cancer (SCLC) represents 15% to 20% of all lung carcinomas. Approximately 30% to 40% of these cases are diagnosed in patients older than 70 years of age. Staging of SCLC classifies patients as having either limited or extensive-stage disease. The standard treatment for limited-stage disease is platinum-based chemotherapy, combined with external-beam thoracic radiotherapy, whereas platinum-based regimens alone represent the standard of care for extensive-stage disease. In the elderly population, treatment of SCLC is more challenging given the decline in physiological organ reserve and the presence of comorbidities. The majority of data are drawn from retrospective studies, which are likely to suffer from selection bias. However, limited prospective data are available to guide treatment decisions in that special population. Nonetheless, these data demonstrate that standard approaches are feasible in carefully selected elderly patients. The purpose of this article is to review the currently available evidence on treatment of SCLC in patients older than 65-70 years of age. © 2010 American Cancer Society.


Studer U.E.,University of Bern | Collette L.,EORTC Headquarters
Urologic Oncology: Seminars and Original Investigations | Year: 2010

Objectives: The interim analyses of the long-awaited erSPC and PlCo trial data have generated conflicting conclusions regarding the value of screening for prostate cancer based on measurements of PSA. Materials and methods: We review the two publications and speculate on reasons underlying the contradicting conclusion of the two studies. Results: The apparently negative results of the PlCO trial may be in part because a part of the patients enrolled were "prescreened", because of failure to biopsy some patients with PSA > 4 ng/ml, because of contamination in the control arm and because of the relatively short follow-up. However, both reports address the serious problem of overdetection and subsequent overtreatment, as the positive predictive value of positive biopsies triggered by positive PSA in the ERPC study was only 24% and many detected cancers were of low-risk. Conclusions: Until more sensitive and more specific screening tools are available that can detect the few cases of prostate cancer with aggressive biological potential among the majority of indolent cases, physicians and patients must understand that most diagnosed prostate cancers will never lead to death and that men can only profit from early detection if local and systemic treatment are limited to those patients who truly need it. © 2010 Elsevier Inc.


Ehdaie B.,Sloan Kettering Cancer Center | Sylvester R.,EORTC Headquarters | Herr H.W.,Sloan Kettering Cancer Center
European Urology | Year: 2013

Context Despite the effectiveness of bacillus Calmette-Guérin (BCG) therapy in non-muscle-invasive bladder cancer (NIMBC) to delay recurrence and disease progression, the evidence supporting maintenance treatment and its optimal duration is unkown. Objective The purposes of this paper are to critically review the evidence supporting the use of maintenance BCG after an initial series of induction instillations and to illustrate the factors contributing to current dilemmas in establishing the optimal duration of BCG treatment. Evidence acquisition The following terms were used in Medline database searches for original articles published before February 1, 2013: bladder cancer, urothelial cancer, bacillus Calmette-Guérin, maintenance, and induction. All randomized controlled trials and meta-analyses, including those based on indirect comparisons, were evaluated. Evidence synthesis Seven randomized studies compared induction BCG plus maintenance to induction alone, with or without retreatment with BCG on recurrence. All but one of these studies were underpowered and the largest study used a broad, composite end point: worsening-free survival. Seven meta-analyses have been conducted, three of which included data from observational cohort studies. They demonstrated the benefit of maintenance BCG to reduce disease recurrence and delay progression compared to various control groups; however, the analyses were based on suboptimal data. Although there is new evidence that 1 yr of maintenance BCG is sufficient treatment in intermediate-risk patients, the optimal duration of BCG maintenance remains unknown. A new randomized trial is proposed, which includes induction BCG with retreatment on recurrence as a control arm, to study this question. Conclusions The optimal duration of BCG treatment in patients with NMIBC remains unknown and should be the subject of further studies. We recommend that in addition to 3 yr of maintenance BCG, guideline panels also include 1 yr of therapy and induction BCG with retreatment on recurrence as a possible treatment options for patients with NMIBC, albeit with a lower level of evidence and grade of recommendation. © 2013 European Association of Urology.


Hall J.A.,EORTC Headquarters
Expert reviews in molecular medicine | Year: 2013

The integration of molecular information in clinical decision making is becoming a reality. These changes are shaping the way clinical research is conducted, and as reality sets in, the challenges in conducting, managing and organising multi-disciplinary research become apparent. Clinical trials provide a platform to conduct translational research (TR) within the context of high quality clinical data accrual. Integrating TR objectives in trials allows the execution of pivotal studies that provide clinical evidence for biomarker-driven treatment strategies, targeting early drug development trials to a homogeneous and well defined patient population, supports the development of companion diagnostics and provides an opportunity for deepening our understanding of cancer biology and mechanisms of drug action. To achieve these goals within a clinical trial, developing translational research infrastructure and capabilities (TRIC) plays a critical catalytic role for translating preclinical data into successful clinical research and development. TRIC represents a technical platform, dedicated resources and access to expertise promoting high quality standards, logistical and operational support and unified streamlined procedures under an appropriate governance framework. TRIC promotes integration of multiple disciplines including biobanking, laboratory analysis, molecular data, informatics, statistical analysis and dissemination of results which are all required for successful TR projects and scientific progress. Such a supporting infrastructure is absolutely essential in order to promote high quality robust research, avoid duplication and coordinate resources. Lack of such infrastructure, we would argue, is one reason for the limited effect of TR in clinical practice beyond clinical trials.

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