Plombières-lès-Dijon, France
Plombières-lès-Dijon, France

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Bonnetain F.,Biostatistic and Epidemiological Unit EA 4184 | Bosset J.F.,University of Franche Comte | Gerard J.P.,Center Antoine Lacassagne | Calais G.,University of Tours | And 7 more authors.
European Journal of Cancer | Year: 2012

Background: Two phase III trials of neoadjuvant treatment in T3-4 rectal cancer established that adding chemotherapy (CRT) to radiotherapy (RT) improves pathological complete response (pCR) and local control (LC). We combined trials to assess the clinical benefit of CRT on overall (OS) and progression free survival (PFS) and to explore the surrogacy of pCR and LC. Patients and methods: Individual patient data from European Organisation for Research and Treatment of Cancer (EORTC) 22921 (1011 patients) and FFCD 9203 (756 patients) were pooled. Meta-analysis methodology was used to compare neoadjuvant CRT to RT for OS, PFS LC and distant progression (DP). Weighted linear regression was used to estimate trial-level association (surrogacy R 2) between treatment effects on candidate surrogate (pCR, LC, DP) and OS. Results: The median follow-up was 5.6 years. Compared to RT (881 pts), CRT (886 pts) did not prolong OS, DP or PFS. The 5-y OS-rate was 66.3% with CRT versus 65.9% in RT (hazard ratios (HR) = 1.04 {0.88-1.21}). CRT significantly improved LC (HR = 0.54, 95% confidence interval (CI): 0.41-0.72). PFS was validated as surrogate for OS with R 2 = 0.88. Neoadjuvant treatment effects on LC (R 2 = 0.17) or DP (R 2 = 0.31) did not predict effects on OS. Conclusion: Preoperative CRT does not prolong OS or PFS. pCR or LC do not qualify as surrogate for PFS or OS while PFS is surrogate. Phase III trials should use OS or PFS as primary endpoint. © 2012 Elsevier Ltd. All rights reserved.

Bonnetain F.,Biostatistic and Epidemiological Unit EA 4184 | Dahan L.,Aix - Marseille University | Maillard E.,Biostatistic and Epidemiological Unit EA 4184 | Ychou M.,Center Val dAurelle | And 6 more authors.
European Journal of Cancer | Year: 2010

Background: The Fédération Francophone de Cancérologie Digestive phase III trial in patients with metastatic pancreatic adenocarcinoma comparing 5FU, folinic acid and cisplatin combination followed by gemcitabine (Arm A) versus the opposite sequence (Arm B) failed to demonstrate a benefit in overall survival. To longitudinally compare the quality of life (QoL) we explored different definitions of time until definitive deterioration (TUDD) of QoL scores according to minimal clinically important difference (MCID) cut-offs. Methods: QoL was evaluated using the EORTC QLQ-C30 every 8 weeks until death. The following scores were analysed: global health, emotional functioning, physical functioning, fatigue and pain. TUDD was defined as the time interval between randomisation and the first occurrence of a decrease in QLQ-C30 score ≥5 points without any further improvement in QoL score ≥5 points or any further available QoL data. Analyses were repeated using a 10 point MCID and/or including death as event. Results: From 08/2003 to 05/2006, 102 patients in Arm A and 100 in Arm B were included. Using a 5 and a 10 point MCID, TUDD curves of the 5 scores did not differ according to treatment arm., The median TUDD of global health was 5.2 months (4.3-6.2) in Arm A and 6.1 months (5.1-8.5) in Arm B (log-rank p = 0.50) including death as an event for a 5 point MCID. Multivariate Cox model showed that tumour localisation and progression were independently associated with TUDD (p < 0.05). Conclusions: The strategy of chemotherapy did not influence the deterioration of QoL. The TUDD approach seems to provide meaningful clinical results that are adapted to metastatic pancreatic adenocarcinoma trials. © 2010 Elsevier Ltd. All rights reserved.

Pallis A.G.,University of Crete | Ring A.,Royal Sussex County Hospital | Fortpied C.,European Organisation for Research and Treatment of Cancer | Penninckx B.,European Organisation for Research and Treatment of Cancer | And 11 more authors.
Annals of Oncology | Year: 2011

Background: Due to the aging of the population, the number of older patients diagnosed with a malignant disease is increasing. A multidisciplinary approach to the senior adult cancer patient is mandatory, to assure optimal diagnosis and therapeutic management.Design: European Organisation for Research and Treatment of Cancer (EORTC) has currently defined senior adult oncology as one of its priorities and has established an active Elderly Task Force (ETF). Under the auspices of the EORTC, the ETF organized a workshop on clinical trial methodology in older cancer patients and in this article, we present the conclusions of this workshop. Results: Besides the 'classical' efficacy end points, quality of life, functional status and independence of the patient should be assessed in clinical trials in older patients. The participants of the workshop agreed on the use of a minimum dataset for the assessment of global health and functional status in older cancer patients. The panel also recommended that optimization of collaboration with pharmaceutical industry requires reporting of age-related data (subgroup analyses of clinical trials, age-related pooled analyses and obligatory post-marketing studies in vulnerable and frail older patients). Conclusion: The identification of proper clinical outcomes and the validation of geriatric screening tools are needed for conducting sound and comparable clinical trials. © The Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.

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