Rituximab versus a watch-and-wait approach in patients with advanced-stage, asymptomatic, non-bulky follicular lymphoma: an open-label randomised phase 3 trial

Ardeshna, Kirit M.; Qian, Wendi; Smith, Paul J.; Braganca, Nivette; Lowry, Lisa; Patrick, Pip; Warden, June; Stevens, Lindsey; Pocock, Christopher; Miall, Fiona; Cunningham, David; Davies, J. M.; Jack, Andrew; Stephens, Richard; Walewski, Jan; Ferhanoğlu, Burhan; Bradstock, Ken; Linch, David C.

doi:10.1016/s1470-2045(14)70027-0

Cited by 310 publications

(282 citation statements)

References 17 publications

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“…Interpretation of rituximab-ibrutinib results in treatment-naïve FL are limited, given reported response rates of 77% to single-agent rituximab with CR rates of 37%. 28 Two randomized trials of rituximab vs rituximab plus ibrutinib in untreated FL are ongoing (NCT0245111 and NCT02947347). A phase 1 trial of rituximab, lenalidomide, and ibrutinib in 22 previously untreated FL patients showed a response rate of 91% (CR, 63%), but the regimen was intolerable because of the high incidence of clinically significant rash.…”

Section: Bartlett Et Almentioning

confidence: 99%

Single-agent ibrutinib in relapsed or refractory follicular lymphoma: a phase 2 consortium trial

Bartlett

Costello

LaPlant

et al. 2018

Blood

136

115

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Section: Bartlett Et Almentioning

confidence: 99%

Single-agent ibrutinib in relapsed or refractory follicular lymphoma: a phase 2 consortium trial

Bartlett

Costello

LaPlant

et al. 2018

Blood

136

115

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“…2,3 The frequency is 10% in children and 25-30% in young adults, but does not increase further with age. 4 Treatment could be directed at the underlying genetic pattern with BCR-ABL inhibitors (e.g.…”

Section: Diagnosticsmentioning

confidence: 96%

“…2 The use of rituximab in FL subsequently expanded as results of randomized trials emerged showing remission prolongation with maintenance rituximab after single agent rituximab and combined rituximab-chemotherapy and then similar results in mantle cell lymphoma. [3][4][5][6][7] A theme began to develop: rituximab maintenance was most useful in B-cell NHL subtypes in which the majority of patients do not have durable remissions. However, in diffuse large B-cell lymphoma (DLBCL), the most common NHL, in which the majority of patients who achieve a complete remission after rituximab-chemotherapy are cured, maintenance rituximab therapy has not been felt to be efficacious.…”

mentioning

confidence: 99%

Rituximab maintenance therapy in diffuse large B-cell lymphoma: is XY the most important variable?

Lunning

Armitage

2015

Haematologica

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Editorialshaematologica | 2015; 100 (7) 853 I n B-cell non-Hodgkin lymphomas (NHL) rituximab has extended the disease-free intervals of hundreds of thousands of patients. At the inception of rituximab a considerable amount of academic vigor was invested in finding the appropriate dose and frequency during induction therapy. This was followed by consideration of rituximab maintenance or extended dosing strategies. However, if maintenance rituximab does not significantly improve treatment outcomes it only represents expensive plasma. An integral step in harnessing the excitement for maintenance rituximab is to look for patients' characteristics that can help to tailor or risk-adapt rituximab dose and/or duration of use with the goal of providing benefit to all. The primary endpoint of interest, improvement in overall survival, has only been seen in meta-analyses, leaving surrogate markers of benefit, such as event-free survival and progression-free survival in trials, to be debated at podiums and in patients' examination rooms without a clear consensus being reached. 1The original report that triggered the spark of enthusiasm for maintenance rituximab was published by Dr. Ghielmini and colleagues and concerned patients with follicular lymphoma (FL) in whom prolonged rituximab treatment extended the duration of remission.2 The use of rituximab in FL subsequently expanded as results of randomized trials emerged showing remission prolongation with maintenance rituximab after single agent rituximab and combined rituximab-chemotherapy and then similar results in mantle cell lymphoma.3-7 A theme began to develop: rituximab maintenance was most useful in B-cell NHL subtypes in which the majority of patients do not have durable remissions. However, in diffuse large B-cell lymphoma (DLBCL), the most common NHL, in which the majority of patients who achieve a complete remission after rituximab-chemotherapy are cured, maintenance rituximab therapy has not been felt to be efficacious.Nevertheless, Huang and colleagues reported a randomized trial of maintenance rituximab in patients with an objective response after six cycles of R-CHOP-14 (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). The maintenance rituximab was administered monthly during the first 12 months and once every 3 months during the second year.8 Patients who received maintenance rituximab had a progression-free survival rate at 5 years of 45% compared to 34% in the patients who were observed (P=0.006). The overall survival rate at 5 years was 62% with maintenance rituximab and 49% with observation (P=0.03). Maintenance rituximab improved the progression-free and overall survival of patients in all International Prognostic Index groupings. The lower progression-free and overall survival rates might be expected and were probably related to the fact that all patients who had an objective response (i.e., not just complete remissions) were included in the analysis. In this study, the results were not reported by gender, so it is not possible ...

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“…Although in most countries rituximab is not licensed as a single-agent therapy in the initial treatment of follicular lymphoma, a recent Phase 3 trial in this setting revealed that monotherapy with originator rituximab was effective in deferring disease progression and the introduction of chemotherapy or radiotherapy compared with watchful waiting. 92 …”

Section: Biosimilar Monoclonal Antibody Therapies Relevant To Oncologmentioning

confidence: 99%

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

Scheinberg

Pineda

Castañeda‐Hernández

et al. 2018

mAbs

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Biological therapies have revolutionized the treatment of several cancers and systemic immune-mediated inflammatory conditions. Expiry of patents protecting a number of biologics has provided the opportunity to commercialize highly similar versions, known as biosimilars. Biosimilars are approved by regulatory agencies via an independent pathway that requires extensive head-to-head comparison with the originator product. Biosimilars have the potential to provide savings to healthcare systems and expand patient access to biologics. In Latin American countries, regulatory frameworks for biosimilar approval have been introduced in recent years, and biosimilars of monoclonal antibody and fusion protein therapies are now emerging. However, the situation in this region is complicated by the presence of “non-comparable biotherapeutics” (also known as “intended copies”), which have not been rigorously compared with the originator product. We review the considerations for clinicians in Latin American countries, focusing on monoclonal antibody biosimilars relevant to oncology, rheumatology, gastroenterology, and dermatology.

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Rituximab versus a watch-and-wait approach in patients with advanced-stage, asymptomatic, non-bulky follicular lymphoma: an open-label randomised phase 3 trial

Cited by 310 publications

References 17 publications

Single-agent ibrutinib in relapsed or refractory follicular lymphoma: a phase 2 consortium trial

Single-agent ibrutinib in relapsed or refractory follicular lymphoma: a phase 2 consortium trial

Rituximab maintenance therapy in diffuse large B-cell lymphoma: is XY the most important variable?

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

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