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

Autor: 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, Sanchez, Blanca, Lopez, Andres, Salar, Antonio, Rodriguez-Caravaca, Gil, Canales, Miguel, Caballero, Maria-Dolores, Bello Lopez, Jose Luis, Carbonell, Felix, Ferrer Bordas, Secundino, Font Lopez, Patricia, Perez Persona, Ernesto, Lopez Guillermo, Armando, Hernandez Martin, Roberto, Ramon Mayans, Jose, Palomera, Luis, Perez Ceballos, Elena, Queizan Hernandez, Jose Antonio, Riaza Grau, Rosalia, de la Cruz, Fatima, Sanchez Salinas, Andres, GELTAMO Spanish Lymphoma Cooperati
Přispěvatelé: [Peñalver FJ] Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain. [Márquez JA] Hospital de Basurto, Vizcaya, Spain. [Durán S] Complejo Hospitalario de Jaén, Jaén, Spain. [Giraldo P] Hospital Universitario Miguel Servet, Zaragoza, Spain. [Martín A] Hospital Universitario de Salamanca, IBSAL, CIBERONC, Salamanca, Spain. [Montalbán C] Hospital Universitario Ramón y Cajal, Madrid, Spain. [López A] Vall d'Hebron Hospital Universitari, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus
Rok vydání: 2019
Předmět:
Male
0301 basic medicine
Limfomes
Cancer Research
Lymphoma
dexametasona
humanos
resistencia a medicamentos
neoplasias::neoplasias por tipo histológico::linfoma::linfoma no Hodgkin::linfoma folicular [ENFERMEDADES]
Drug Resistance
Follicular lymphoma
Salvage therapy
Gastroenterology
Dexamethasone
Medicaments antineoplàstics
0302 clinical medicine
Maintenance therapy
Antineoplastic Combined Chemotherapy Protocols
Bendamustine Hydrochloride
antineoplásicos
Lymphoma
Follicular
inmunoterapia
mediana edad
Original Research
anciano
protocolos de quimioterapia antineoplásica combinada
terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada [TÉCNICAS Y EQUIPOS ANALÍTICOS
DIAGNÓSTICOS Y TERAPÉUTICOS]
Therapeutics::Therapeutics::Drug Therapy::Therapeutics::Drug Therapy::Drug Therapy
Combination::Antineoplastic Combined Chemotherapy Protocols [ANALYTICAL
DIAGNOSTIC AND THERAPEUTIC TECHNIQUES
AND EQUIPMENT]
Middle Aged
adulto
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Progression-Free Survival
Oncology
030220 oncology & carcinogenesis
Female
Rituximab
Immunotherapy
Refractory Follicular Lymphoma
medicine.drug
Adult
Bendamustine
medicine.medical_specialty
Prognosi
Antineoplastic Agents
Neutropenia
lcsh:RC254-282
03 medical and health sciences
follicular lymphoma
Internal medicine
Neoplasms::Neoplasms by Histologic Type::Lymphoma::Lymphoma
Non-Hodgkin::Lymphoma
Follicular [DISEASES]
medicine
Humans
Radiology
Nuclear Medicine and imaging
linfoma
bendamustine
Diagnosis::Prognosis [ANALYTICAL
DIAGNOSTIC AND THERAPEUTIC TECHNIQUES
AND EQUIPMENT]
Aged
Salvage Therapy
business.industry
Clinical Cancer Research
medicine.disease
tratamiento de última línea
immunochemotherapy
relapsed
refractory
mitoxantrona
030104 developmental biology
Drug Resistance
Neoplasm
Neoplasm Recurrence
Local
Mitoxantrone
business
Febrile neutropenia
Diagnóstico::Pronóstico [TÉCNICAS Y EQUIPOS ANALÍTICOS
DIAGNÓSTICOS Y TERAPÉUTICOS]
Zdroj: Cancer medicine
r-FISABIO: Repositorio Institucional de Producción Científica
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Cancer Medicine. 2019;00:1–13.
RODIN. Repositorio de Objetos de Docencia e Investigación de la Universidad de Cádiz
instname
Scientia
Cancer Medicine
r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
Cancer Medicine, Vol 8, Iss 16, Pp 6955-6966 (2019)
ISSN: 2045-7634
Popis: 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 http://clinicaltrials.gov # NCT01133158.
RBMD using a response‐adapted strategy followed by rituximab maintenance is an effective and safe salvage treatment for relapsed/refractory follicular lymphoma following first‐line immunochemotherapy, thereby improving tolerability without compromising efficacy.
Databáze: OpenAIRE
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