Survival benefit of mantle cell lymphoma patients enrolled in clinical trials; a joint study from the LYSA group and French cancer registries

Alix Augustin; Steven Le Gouill; Remy Gressin; Aurélie Bertaut; Alain Monnereau; Anne Woronoff; Brigitte Tretarre; Patricia Delafosse; Xavier Troussard; Anne Moreau; Olivier Hermine; Marc Maynadié

doi:10.1007/s00432-017-2529-9

Survival benefit of mantle cell lymphoma patients enrolled in clinical trials; a joint study from the LYSA group and French cancer registries

Alix Augustin ^{1, 2} Steven Le Gouill ^{3, 4} Remy Gressin ⁵ Aurélie Bertaut ⁶ Alain Monnereau ⁷ Anne Woronoff Brigitte Tretarre ⁸ Patricia Delafosse ⁸ Xavier Troussard ⁹ Anne Moreau ¹⁰ Olivier Hermine ¹¹ Marc Maynadié ^{1, 2}

1 Registre des hémopathies malignes de Côte d'Or

2 LNC - Lipides - Nutrition - Cancer [Dijon - U1231]

3 CIC Plurithématique de Nantes

4 CRCINA - Département NOHMAD - Equipe 10 - Regulation of Bcl2 and p53 networks in Multiple Myeloma and Mantle Cell Lymphoma

CRCINA - Centre de recherche de Cancérologie et d'Immunologie / Nantes - Angers

5 INSERM U823 - Institut d'oncologie/développement Albert Bonniot de Grenoble

6 Unité de biostatistiques [Centre Georges-François Leclerc]

7 Plateforme de génétique moléculaire des cancers d'Aquitaine

8 FRANCIM

9 Francim : Réseau français des registres des cancers

10 LMA-Poitiers - Laboratoire de Mathématiques et Applications

11 UPD5 - Université Paris Descartes - Paris 5

Abstract : Purpose Mantle cell lymphoma (MCL) is a rare non-Hodgkin’s lymphoma entity with a poor prognosis. Therapeutic advances have improved the survival of patients enrolled in clinical trials; however, their impact on patients outside clinical trials remains unclear. In this work, we compared patient outcome inside and outside clinical trials. Methods We identified MCL patients recorded in six French population-based registries between 2008 and 2012 to perform a comparison with patients enrolled in two prospective multicenter MCL clinical trials conducted by the LYSA group during the same period. Variables associated with inclusion in a clinical trial were identified using a logistic regression. Pohar-Perme estimator and Nelson et al. flexible parametric model was used to estimate net survival probabilities and prognosis factors on excess mortality. Results A total of 312 registry patients were compared to the 372 patients enrolled in LYSA clinical trials. Patients included in clinical trials were younger (median age 60 vs 74, p < 0.001). Age and Ann Arbor stage IV were independently associated with enrollment [OR = 0.09 (0.06–0.12) and OR = 1.61 (1.11–2.34), respectively]. The 4 year net survival was better in clinical trials [79.9% (75.9–84.7) vs 60.3% (53.6–67.0)]. This result was confirmed in multivariate analysis in patients older than 65 years with a lower excess mortality rate [0.33 (0.17–0.66)]. Conclusions MCL included in trials are highly selected patients who are not representative of MCL patients who are encountered in everyday practice. With widened inclusion criteria, clinical trial patients could be more representative of the general population.

Keywords : Clinical trial inclusion Mantle cell lymphoma Non-Hodgkin’s lymphoma Population-based registry Prognostic factors

Type de document :

Article dans une revue

Journal of Cancer Research and Clinical Oncology, Springer Verlag, 2018, 144 (4), pp.629-635. 〈https://link.springer.com/article/10.1007%2Fs00432-017-2529-9〉. 〈10.1007/s00432-017-2529-9〉

Domaine :

Sciences du Vivant [q-bio] / Médecine humaine et pathologie

Liste complète des métadonnées

https://www.hal.inserm.fr/inserm-01624838
Contributeur : Alix Augustin <>
Soumis le : jeudi 26 octobre 2017 - 18:08:29
Dernière modification le : jeudi 7 février 2019 - 14:50:50

Survival benefit of mantle cell lymphoma patients enrolled in clinical trials; a joint study from the LYSA group and French cancer registries

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Survival benefit of mantle cell lymphoma patients enrolled in clinical trials; a joint study from the LYSA group and French cancer registries

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