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Introduction RTXM83, a biosimilar of rituximab, was approved after physicochemical, functional, non-clinical, and clinical studies demonstrated their similarity; these studies included RTXM83-AC-01-11, a multicentric double-blind international prospective pivotal study. Long-term data on biosimilars can potentially elucidate their clinical robustness and facilitate their broader adoption. Methods In this retrospective observational study, we analyzed a dataset from a Brazilian cohort previously randomized in the RTXM83-AC-01-11 study followed by the assessment of long-term outcomes in an observational extension phase from randomization in the RTXM83-AC-01–11 study to the last recorded evaluation. Patients with diffuse large B cell lymphoma (DLBCL) received either reference rituximab (R) or RTXM83 plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) as adjuvant treatment. Results The median follow-up period was 77.0 months. Patients with initial DLBCL stages III and IV comprised 50% of the R-CHOP group and 40% of the biosimilar group. Five (18.5%) patients, including two RTXM83-CHOP-treated and three R-CHOP-treated individuals, experienced late adverse events (AEs) of interest. No new safety signs were established. At the final assessment, the progression-free survival (PFS) rates were 93.3% and 50.0% in the RTXM83-CHOP and R-CHOP groups, respectively. Median PFS was not achieved in the RTXM83-CHOP group, which was 40.5 months in the R-CHOP group. The overall survival (OS) rates were 100% and 66.7% in the RTXM83-CHOP and R-CHOP groups, respectively. The median OS was not reached in any group. Conclusion This study demonstrated the long-term safety and effectiveness of RTXM83 in treating DLBCL; outcomes comparable to those of the reference product and potentially improved access to treatment have been indicated. However, further research with more diverse patient groups can validate these findings and advocate the broader adoption of biosimilars in cancer care. Trial Registration ClinicalTrials.gov Identifier : NCT04928573. June 16, 2021, “retrospectively registered”. Supplementary Information The online version contains supplementary material available at 10.1007/s40487-024-00282-7.
Introduction RTXM83, a biosimilar of rituximab, was approved after physicochemical, functional, non-clinical, and clinical studies demonstrated their similarity; these studies included RTXM83-AC-01-11, a multicentric double-blind international prospective pivotal study. Long-term data on biosimilars can potentially elucidate their clinical robustness and facilitate their broader adoption. Methods In this retrospective observational study, we analyzed a dataset from a Brazilian cohort previously randomized in the RTXM83-AC-01-11 study followed by the assessment of long-term outcomes in an observational extension phase from randomization in the RTXM83-AC-01–11 study to the last recorded evaluation. Patients with diffuse large B cell lymphoma (DLBCL) received either reference rituximab (R) or RTXM83 plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) as adjuvant treatment. Results The median follow-up period was 77.0 months. Patients with initial DLBCL stages III and IV comprised 50% of the R-CHOP group and 40% of the biosimilar group. Five (18.5%) patients, including two RTXM83-CHOP-treated and three R-CHOP-treated individuals, experienced late adverse events (AEs) of interest. No new safety signs were established. At the final assessment, the progression-free survival (PFS) rates were 93.3% and 50.0% in the RTXM83-CHOP and R-CHOP groups, respectively. Median PFS was not achieved in the RTXM83-CHOP group, which was 40.5 months in the R-CHOP group. The overall survival (OS) rates were 100% and 66.7% in the RTXM83-CHOP and R-CHOP groups, respectively. The median OS was not reached in any group. Conclusion This study demonstrated the long-term safety and effectiveness of RTXM83 in treating DLBCL; outcomes comparable to those of the reference product and potentially improved access to treatment have been indicated. However, further research with more diverse patient groups can validate these findings and advocate the broader adoption of biosimilars in cancer care. Trial Registration ClinicalTrials.gov Identifier : NCT04928573. June 16, 2021, “retrospectively registered”. Supplementary Information The online version contains supplementary material available at 10.1007/s40487-024-00282-7.
por ter aceitado me orientar mesmo sem me conhecer, por sua compreensão, paciência, confiança e por todas as oportunidades proporcionadas. Á Dra. Juliana Pereira por sua importantíssima participação neste trabalho. Á Dra. Débora Levy por sua participação essencial ao desenvolvimento deste trabalho, como também, por sua total compreensão, ajuda, companheirismo, paciência e amizade. Ao Dr. Felipe Rodrigues Vieira e à Dra. Flávia Xavier pela valiosa colaboração na obtenção das informações de todos os pacientes nos prontuários médicos. À Linha Akemi Fukuya por sua amizade, companheirismo e carinho em todos os momentos. À Cleide Menarbini Appolonio pela ajuda e pelo carinho. Aos funcionários, enfermeiras e enfermeiros do Hospital das Clínicas e Hospital Dia que gentilmente contribuíram ao desenvolvimento deste trabalho. Aos pacientes, que de forma bondosa e generosa, contribuíram á realização deste trabalho. Aos colegas do laboratório pelo ótimo convívio. Ao Conselho Nacional de Pesquisa, CNPq, pela bolsa de mestrado concedida. Aos meus pais, por tudo que fizeram por mim, por me amarem e por estarem sempre presentes na minha vida. As minhas queridas irmãs, Priscila e Paloma, pelo simples fato de serem minhas irmãs e verdadeiras amigas. As minhas queridas avós, Iza e Jô, pelo carinho, amor de vó que é muito bom, presença carinhosa e atenciosa da vó Iza na minha vida e eterna saudade da amada vó Jô. Aos meus cunhados, Adriano e Renan, grandes amigos. Ao meu marido, Hernando, pela ajuda final à concetrização deste trabalho e por termos enfrentado e vencido juntos todas as dificuldades que surgiram. Ao meu querido e amado cachorrinho, Sulley, fiel amigo e companheiro de todos os momentos, meu filhote, que sempre me traz alegria. Grande presente da minha vida!
A third of non-Hodgkin lymphoma (NHL) patients are diagnosed at over 75 years of age and the predominance of the Diffuse Large B-cell Lymphoma (DLBCL) sub-type is found in 40% of the cases. 1 In spite of this, the number of aged patients in clinical trials is rather small with the median age being about 50 years old. Three DLBCL patients, including one suffering from a severe heart comorbidity, who were treated with an alternative oral chemotherapeutic regimen at the Hematology Service of HC-FMUSP are described. Case 1An 86-year-old woman with dilated myocardiopathy taking digitals, with 40% ejection fraction measured by echocardiography, history of several hospitalizations due to heart complications was referred to the Hematology Service of the HC-FMSP and diagnosed as DLBCL, ECIIB with low intermediate IPI. Therapy used etoposide (50 mg/day) for 5 days plus dexamethasone (20 mg/day) for 5 days during 6 cycles. After the 2 nd cycle the patient presented with complete remission but did not suffer from clinical toxicity during the treatment. Complete remission was maintained to the last evaluation with overall survival and disease-free survival rates of 35.1 and 31.9 months, respectively. The patient died of heart failure. Case 2A 90-year-old female Jehovah's Witness, with no pathological records, was referred to the Hematology Service of the HC-FMSP and diagnosed as DLBCL, Ki 67 ranging from 80 to 90%, ECIIx A, (bulky cervical tumor of 15 cm) with low intermediate IPI. Prescribed treatment involved etoposide (100 mg/day) for 21 days and dexamethasone (20 mg/day) for 7 days, although 250 mg/day for 8 days was incorrectly used. The patient evolved to Grade 3 non-febrile neutropenia with no clinical evidence of infection, which was reverted by using GCSF, obtaining a 60% mass tumor reduction soon after the 1 st cycle. After the 2 nd cycle the patient achieved complete remission and was submitted to 3 cycles in total when, in a joint decision, consolidation with radiotherapy was chosen. Complete remission was kept up to the last evaluation, with overall survival and diseasefree survival rates of 39.4 and 38.2 months, respectively.Case 3 A 94-year-old woman was referred the Hematology Service of the HC-FMUSP and diagnosed as DLBCL, EC IIIsxA (x = bulky cervical tumor of 13 cm) with high risk IPI. Treatment was started using etoposide (50 mg/day) and dexamethasone (12 mg/day) in both alternate and continuous schemes. She achieved complete remission after the 4 th cycle, with a total of 8 cycles being performed. She kept complete remission up to the last evaluation with overall survival and disease-free survival rates of 20.3 and 17.1, respectively.In Brazil 49.9% of deaths among over 65-year-old patients are with malignant tumors proving to be the third most common cause of death in this group. Data from IBGE (Brazilian Institute of Geography and Statistics) show an increase in the aged population from the current 7.8% to 13% by 2020. An increased life expectancy will thus require clinical trials directed at the elder...
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