RESUMO
Background & objectives: Both innovator and generic imatinib are approved for the treatment of Chronic Myeloid Leukaemia-Chronic phase (CML-CP). Currently, there are no studies on the feasibility of treatment-free remission (TFR) with generic imatinib. This study attempted to determine the feasibility and efficacy of TFR in patients on generic Imatinib. Methods: In this single-centre prospective Generic Imatinib-Free Trial-in-CML-CP study, twenty six patients on generic imatinib for ≥3 yr and in sustained deep molecular response (BCR ABLIS ≤0.01% for more than two years) were included. After treatment discontinuation, patients were monitored with complete blood count and BCR ABLIS by real-time quantitative PCR monthly for one year and three monthly thereafter. Generic imatinib was restarted at single documented loss of major molecular response (BCR ABLIS>0.1%). Results: At a median follow up of 33 months (interquartile range 18.7-35), 42.3 per cent patients (n=11) continued to be in TFR. Estimated TFR at one year was 44 per cent. All patients restarted on generic imatinib regained major molecular response. On multivariate analysis, attainment of molecularly undetectable leukaemia (>MR5) prior to TFR was predictive of TFR [P=0.022, HR 0.284 (0.096-0.837)]. Interpretation & conclusions: The study adds to the growing literature that generic imatinib is effective and can be safely discontinued in CML-CP patients who are in deep molecular remission.
Assuntos
Leucemia Mielogênica Crônica BCR-ABL Positiva , Humanos , Mesilato de Imatinib , Estudos de Viabilidade , Indução de Remissão , Resultado do Tratamento , Medicamentos GenéricosRESUMO
Recent studies in iron-depleted women have challenged the current approach of treating iron-deficiency anemia (IDA) with oral iron in divided daily doses. Alternate day dosing leads to more fractional absorption of iron. In this randomized controlled trial, we looked at the efficacy and safety of alternate-day (AD) versus twice-daily (BD) oral iron in all severity of IDA. Total of 62 patients were randomized, 31 patients in BD arm received 60 mg elemental iron twice daily while 31 patients in AD arm received 120 mg iron on alternate days. The primary endpoint of 2 g/dl rise in hemoglobin was met in significantly more patients in the BD arm at 3 weeks (32.3% vs. 6.5%, p < 0.0001) and 6 weeks (58% vs. 35.5%, p = 0.001). There was a significant rise in the median hemoglobin at 3 (1.6 vs. 1.1, p = 0.02) and 6 weeks (2.9 vs. 2.0 g/dl, p = 0.03) in the BD arm. However, the median hemoglobin rise in the AD arm at 6 weeks was not significantly different than the BD arm at 3 weeks. Alternate-day dosing for 6 weeks and twice-daily dosing for 3 weeks resulted in the provision of the same total amount of iron. There were more reports of nausea in the BD arm (p = 0.03). In conclusion, the choice of twice-daily or alternate-day oral iron therapy should depend on the severity of anemia, the rapidity of response desired, and patient preference to either regimen due to adverse events. Trial Registration: CTRI reg. no. CTRI/2018/07/015106 http://ctri.nic.in/Clinicaltrials/login.php.
Assuntos
Anemia Ferropriva/tratamento farmacológico , Ferro/administração & dosagem , Administração Oral , Idoso , Anemia Ferropriva/sangue , Feminino , Hemoglobinas/metabolismo , Humanos , Ferro/sangue , Masculino , Pessoa de Meia-Idade , Fatores de TempoRESUMO
Leukaemia cutis or cutaneous infiltration of neoplastic myeloid or lymphoid cells is usually seen in the acute myelomonocytic and acute monocytic variants of acute myeloid leukaemia. Here, we report a case of acute promyelocytic leukaemia who achieved remission, presenting with skin lesions, the biopsy of which revealed leukaemia cutis, heralding the relapse of the disease. After establishing the diagnosis with bone marrow analysis, the patient was started on daunorubicin chemotherapy along with arsenic trioxide and all-trans retinoic acid. Afterwards, the skin lesions resolved, and the patient is planned for consolidation with bone marrow transplantation.
Assuntos
Leucemia Promielocítica Aguda/patologia , Infiltração Leucêmica/patologia , Pele/patologia , Antibióticos Antineoplásicos/administração & dosagem , Antineoplásicos/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Trióxido de Arsênio , Arsenicais/administração & dosagem , Biópsia , Quimioterapia de Consolidação , Daunorrubicina/administração & dosagem , Feminino , Humanos , Leucemia Promielocítica Aguda/tratamento farmacológico , Infiltração Leucêmica/tratamento farmacológico , Óxidos/administração & dosagem , Tretinoína/administração & dosagemRESUMO
Diffuse large B-cell lymphoma (DLBCL) is the commonest sub-type of non-Hodgkin lymphoma. However, lung consolidation is a rare presentation of DLBCL. Moreover, in view of poor general condition, it poses clinical dilemma of when to start chemotherapy and whether chemotherapy should be given at full dose or truncated doses till improvement in general condition. A 48-years-old lady was admitted with complaints of non-productive cough for 2 months duration. She was febrile and hypoxemic requiring oxygen supplementation. She had bilateral axillary lymphadenopathy, and bronchial breath sounds on chest auscultation. Chest X-ray showed non-homogenous opacities involving bilateral lower zones. A diagnosis of DLBCL was confirmed on lymph node biopsy and Immunohistochemistry. She received chemotherapy, following which a gradual, improvement in her breathlessness and cough was noted over ensuing week and she got discharged from the hospital and received rest of her chemotherapy on outpatient basis. In a case of DLBCL with lung consolidation, a high index of suspicion can clinch the diagnosis of secondary lymphomatous involvement. Presence of respiratory failure at presentation doesn't necessarily warrants truncation of chemotherapy doses.