Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial

Salles, Gilles; Seymour, John F.; Offner, Fritz; López‐Guillermo, Armando; Belada, David; Xerri, Luc; Feugier, Pierre; Bouabdallah, Réda; Catalano, John; Brice, Pauline; Caballero, Dolores; Haı̈oun, Corinne; Pedersen, Lars Møller; Delmer, Alain; Simpson, David; Leppä, Sirpa; Soubeyran, Pierre; Hagenbeek, Anton; Casasnovas, Olivier; Intragumtornchai, Tanin; Fermé, Christophe; Silva, Maria Gomes da; Sebban, Catherine; Lister, Andrew; Estell, Jane; Milone, Gustavo; Sonet, Anne; Mendila, Myriam; Coiffier, Bertrand; Tilly, Hervé

doi:10.1016/s0140-6736(10)62175-7

Cited by 944 publications

(697 citation statements)

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“…The clinical benefit of rituximab maintenance in FL is equivocal according to previous studies 16, 17, 18, 19. Although PFS is improved in patients receiving rituximab maintenance, there is no difference in OS 16.…”

Section: Discussionmentioning

confidence: 96%

“…Although PFS is improved in patients receiving rituximab maintenance, there is no difference in OS 16. On the other hand, limited clinical data are available regarding the clinical use of rituximab maintenance in Asian patients.…”

Section: Discussionmentioning

confidence: 99%

“…Rituximab combined with cytotoxic chemotherapies is superior to chemotherapies alone, regardless of frontline treatments or in relapse and/or refractory FL 8, 9, 10, 12, 13, 14, 15. Several prospective trials tried to address the clinical benefits of rituximab maintenance in the patients with FL, but rituximab maintenance only improves progression‐free survival instead of overall survival 16, 17, 18, 19. The clinical benefit of rituximab maintenance is still uncertain.…”

Section: Introductionmentioning

confidence: 99%

“…The clinical benefit of rituximab maintenance is still uncertain. The PRIMA study was a phase III randomized study performed to compare the benefit of rituximab maintenance in FL patients previously treated with frontline immune‐chemotherapy 16. Although the study revealed longer progression‐free survival (PFS) in patients undergoing rituximab maintenance, no advantage for overall survival (OS) was demonstrated 16.…”

Section: Introductionmentioning

confidence: 99%

“…The PRIMA study was a phase III randomized study performed to compare the benefit of rituximab maintenance in FL patients previously treated with frontline immune‐chemotherapy 16. Although the study revealed longer progression‐free survival (PFS) in patients undergoing rituximab maintenance, no advantage for overall survival (OS) was demonstrated 16. Other studies also demonstrated only a progression‐free benefit of rituximab maintenance after re‐induction therapies in relapse FL 17, 18.…”

Section: Introductionmentioning

confidence: 99%

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Rituximab maintenance improves overall survival in follicular lymphoma: A retrospective nationwide real‐world analysis from Taiwan Cancer Registry Database

et al. 2018

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Follicular lymphoma (FL) is the most frequent indolent lymphoma in Western countries, but it is less frequent in Asia. Several trials have demonstrated the progression‐free benefit of rituximab maintenance for FL patients in Western countries. However, the overall survival (OS) benefits and effectiveness of rituximab maintenance in Asian FL patients remain uncertain. We utilized the Taiwan Cancer Registry Database and the National Health Insurance Research Database to investigate the roles of rituximab maintenance for newly diagnosed FL patients in Taiwan. Among 836 patients with newly diagnosed FL during 2009‐2012, we enrolled patients with stage II‐IV diseases receiving 4‐8 cycles of rituximab‐containing induction chemotherapies (R‐induction). We excluded those who died or received additional chemotherapy within 180 days after R‐induction. Among the 396 enrolled patients, 260 underwent rituximab maintenance (R‐maintenance group), and 136 served as the observation group. The R‐maintenance group received less anthracycline and fewer cycles of R‐induction than the observation group, but they exhibited a significantly better OS both in the univariate and multivariate analyses [hazard ratio, 0.42; 95% confidence interval, 0.19‐0.91] after adjusting for age, sex, and Ann Arbor stages. Meanwhile, we also found more patients required further therapies in the first 6 months after the cease of rituximab maintenance. In the subgroup analysis, patients older than 60 years or with stage IV diseases benefited more from rituximab maintenance. Conclusively, our nationwide study is the first one to demonstrate the OS benefit of rituximab maintenance after induction therapies in newly diagnosed FL patients from Asian populations.

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