Identifier to cite or link to this item: http://hdl.handle.net/20.500.13003/14609
Response-adapted treatment with rituximab, bendamustine, mitoxantrone, and dexamethasone followed by rituximab maintenance in patients with relapsed or refractory follicular lymphoma after first-line immunochemotherapy: Results of the RBMDGELTAMO08 phase II trial
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DOI: 10.1002/cam4.2555
ISSN: 2045-7634
WOS ID: 000488578100001
Scopus EID: 2-s2.0-85073995928
PMID: 31573746
Embase PUI: L2003441578
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Penalver, Francisco-Javier; Marquez, Jose-Antonio; Duran, Soledad; Giraldo, Pilar; Martin, Alejandro; Montalban, Carlos; Sancho, Juan-Manuel; Ramirez, Maria-Jose; Terol, Maria-Jose; Capote, Francisco-Javier; Gutierrez, Antonio

Publication date
2019-11Document type
research articleCitation
Penalver FJ, Marquez JA, Duran S, Giraldo P, Martin A, Montalban C, et al. Response-adapted treatment with rituximab, bendamustine, mitoxantrone, and dexamethasone followed by rituximab maintenance in patients with relapsed or refractory follicular lymphoma after first-line immunochemotherapy: Results of the RBMDGELTAMO08 phase II trial. Cancer Med. 2019 Nov;8(16):6955-66. Epub 2019 Oct 1.Abstract
Background Consensus is lacking regarding the optimal salvage therapy for patients with follicular lymphoma who relapse after or are refractory to immunochemotherapy. Methods This phase II trial evaluated the efficacy and safety of response-adapted therapy with rituximab, bendamustine, mitoxantrone, and dexamethasone (RBMD) in follicular lymphoma patients who relapsed after or were refractory to first-line immunochemotherapy. Sixty patients received three treatment cycles, and depending on their response received an additional one (complete/unconfirmed complete response) or three (partial response) cycles. Patients who responded to induction received rituximab maintenance therapy for 2 years. Results Thirty-three (55%) and 42 (70%) patients achieved complete/unconfirmed complete response after three cycles and on completing induction therapy (4-6 cycles), respectively (final overall response rate, 88.3%). Median progression-free survival was 56.4 months (median follow-up, 28.3 months; 95% CI, 15.6-51.2). Overall survival was not reached. Progression-free survival did not differ between patients who received four vs six cycles (P = .6665), nor between patients who did/did not receive rituximab maintenance after first-line therapy (P = .5790). Median progression-free survival in the 10 refractory patients was 25.5 months (95% CI, 0.6-N/A) and was longer in patients who had shown progression of disease after 24 months of first-line therapy (median, 56.4 months; 95% CI, 19.8-56.4) than in those who showed early progression (median, 42.31 months; 95% CI, 24.41-NA) (P = .4258). Thirty-six (60%) patients had grade 3/4 neutropenia. Grade 3/4 febrile neutropenia and infection were recorded during induction (4/60 [6.7%] and 5/60 [8.3%] patients, respectively) and maintenance (2/43 [4.5%] and 4/43 [9.1%] patients, respectively). Conclusions This response-adapted treatment with RBMD followed by rituximab maintenance is an effective and well-tolerated salvage treatment for relapsed/refractory follicular lymphoma following first-line immunochemotherapy. Clinical trial registration # NCT01133158.
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https://dx.doi.org/10.1002/cam4.2555MeSH
AgedAdult
Humans
Antineoplastic Combined Chemotherapy Protocols
Mitoxantrone
Progression-Free Survival
Antineoplastic Agents
Middle Aged
Lymphoma, Follicular
Rituximab
Immunotherapy
Male
Neoplasm Recurrence, Local
Salvage Therapy
Female
Drug Resistance, Neoplasm
Dexamethasone
Bendamustine Hydrochloride
DeCS
Resistencia a AntineoplásicosDexametasona
Supervivencia sin Progresión
Rituximab
Femenino
Terapia Recuperativa
Inmunoterapia
Linfoma Folicular
Clorhidrato de Bendamustina
Recurrencia Local de Neoplasia
Masculino
Antineoplásicos
Humanos
Persona de Mediana Edad
Mitoxantrona
Protocolos de Quimioterapia Combinada Antineoplásica
Anciano
Adulto
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Hospital Universitario Son Espases - HUSE > Comunicación científicaInstituto de Investigación Sanitaria Islas Baleares - IDISBA > Comunicación científica