ABSTRACT
Introduction: Acute lymphoblastic leukemia (ALL) is the commonest childhood cancer. With the evolution of minimal residual disease (MRD)-adapted intensive pediatric treatment regimens in children and Adolescent & young Adult (AYA) ALL, survival rates have improved significantly. Multiple randomized studies compared the efficacy of dexamethasone & prednisolone in childhood ALL and showed dexamethasone had a superior response in high-risk ALL and decreased cumulative incidence of relapse, but at the cost of increased toxicity. Aims & Objectives: To compare the adverse events (AE) in the two treatment groups (dexamethasone vs prednisolone) in induction therapy phase IA of ALL BFM 2009 protocol. Material(s) and Method(s): The present randomized controlled study enrolled newly diagnosed ALL patients in age group of 1-25 years at AIIMS Rishikesh between April 2021 & July 2022 after obtaining informed consent & ethical approval. Patients were randomized to receive either Dexamethasone 10 mg/m2/day administered intravenously on days 1-14 or Prednisolone 60 mg/m2/day per orally on days 1-28 during Induction Phase IA of modified ALL BFM 2009 regimen. Steroid dose was tapered off over next 7 days in both groups. Patients of infantile ALL (age<1 year), lymphoblastic lymphoma (LBL), & patients who had already received steroid or any chemotherapy prior to enrollment in the study were excluded. The adverse events of all grade, and grade 3-4 as per CTCAE version-5 were compared in the two treatment groups. Result(s): The differences in incidence of common steroid related AE's namely gastritis, proximal myopathy, hypokalemia, febrile neutropenia/ sepsis, enterocolitis/typhlitis, hyperglycemia, hypertension, invasive fungal infection and septic shock were not statistically significant in the two steroid groups. There were seven deaths in induction [Pred: 2/7;Dexa: 5/7], three were not in remission, two had MDR-bacterial infection, two had invasive fungal infection (pulmonary aspergillosis & mucormycosis), and one had COVID-19 and was not statistically significant in the treatment groups. Conclusion(s): In the present single-center experience, the toxicity profile of dexamethasone & prednisolone used in induction phase IA of ALL BFM 2009 protocol in pediatric& adolescent ALL were comparable, with no statistically significant increase in steroid-related adverse events in the dexamethasone group.
ABSTRACT
Introduction: COVID19 can be considered as one of the worstpandemics humans have faced. There haven't been many casesreported, specifically looking at its severity and outcome in patientswith hematological malignancies.Aims &Objectives: Presenting a diagnosed case of AML, on Azacytidine therapy, manifesting with COVID19 disease.Materials &Methods: On 13th July 2021, a 43 year old female,diagnosed with AML came to the OPD with history of cough, feverand running nose from last 7 days. She was receiving antimicrobialprophylaxis with levofloxacin and fluconazole. Her temperature was38 °C, BP 110/60 mm Hg, heart rate 88 bpm, and SpO2 was 97% inroom air. She tested positive for COVID19 the same day. She wasstarted on Azithromycin, Ivermectin and vitamin supplements. Herstay in COVID ward was uneventful, except for the significantchanges in her laboratory data [Table 1].Result: The patient's cell lineages went down after the chemotherapy.During COVID19 infection, she developed leukocytosis with 60%blast cells while still having neutropenia. Despite persistent neutropenia, she didn't develop any major respiratory symptoms orcomplications. Chest X-ray was normal. Her KFT, RBS, electrolytes,LFT and PT-INR were in normal range. CRP and D-Dimer wereraised. On day 10, after testing negative for COVID 19, third cycle ofchemotherapy was started, and she was discharged on day 17.Conclusions: Typical Covid19 presentation is neutrophilia and lymphopenia, which is in contrast to our result depicting increased totalleucocyte count (lymphocytosis and blasts), with consistent neutropenia. This difference could be attributed to underlying AML andtreatment received. Although there are few published reports indicating patients with myeloid malignancies and COVID19 havinghigher mortality, our patient with active AML and no other comorbidities, made a full recovery without any antiviral therapy, and hadmild respiratory symptoms only. This also calls for the need ofadditional studies to further delineate risk factors contributing tomortality in this subgroup of patients.