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Background: Standard 3 + 7 induction (anthracycline + cytarabine) and consolidation high-dose cytarabine are toxic, expensive, and resource intensive. Objectives: The objective was to evaluate response rates and survival with PRednisolone, Etoposide and 6-Mercaptopurine (PREM) metronomic chemotherapy in treatment-naïve, and partially treated acute myeloid leukemia (AML). Materials and Methods: All patients with AML, registered between June 01, 2017, and May 31, 2019, not willing for standard 3 + 7 induction (Group A) due to financial constraints and those who refused to complete at least two cycles of cytarabine consolidation (Group B) and received oral PREM therapy were analyzed. Bone marrow aspiration/biopsy was used for response evaluation in the 3rd month in Group A. Descriptive statistics and survival according to the Kaplan-Meier method were used to evaluate outcomes with SPSS v. 17. The follow-up was calculated using reverse Kaplan–Meier method. Results: Fifteen patients were included in the study, 11 in Group A and 4 in Group B. The median follow-up was 13 months in Group A (range, 10–14 months). 5/11 (46%) and 2/11 (18%) achieved complete response (CR) and partial response (PR), respectively. The 1-year survival of patients in Group A (n = 11) was 45% with a median overall survival of 9 months (95% confidence interval [CI], 5.4–11.6 months). Among the 7 out of 11 patients (64%) who responded (CR + PR), the 1-year survival was 70% with a median survival of 12 months, versus 3 months for patients who failed to attain a response, P = 0.005 with hazard ratio of 0.05 (95% CI, 0.01–65.65). In the patients in Group B (n = 4), all patients sustained/achieved CR and were alive without relapse at a median follow-up of 24.5 months (range, 22–26 months). The ratio of total inpatient admissions in Group A patients (n = 11) was 1.7 in the first 3 months with median duration of 7 days (range, 4–14 days). Conclusion: Oral PREM metronomic chemotherapy led to favorable responses in treatment naive AML patients. The regimen also led to sustained remissions in patients with partially treated AML. ]]>

Cancer Research, Statistics, and Treatment 2020 3(2):183-191

Background: The impact of minimal residual disease (MRD) on overall survival (OS) is insufficiently studied in pediatric, adolescent, and young adults (AYA) with acute lymphoblastic leukemia (ALL) treated with modified MCP 841 protocol. Objectives: We planned to evaluate the outcomes (post-induction response rates, MRD, and OS) with modified MCP 841 in pediatric and AYA ALL. Materials and Methods: This was a retrospective audit of patients with ALL registered between March 01, 2017, and August 31, 2019. Patients who received at least 7 days of therapy on modified MCP 841 protocol were analyzed. Response evaluation was done on day 35 of induction with bone marrow aspiration, and MRD was assessed with flow cytometry with <0.01% as a “cutoff” for MRD-negative status. The primary endpoint was OS defined from start of therapy till death from any cause after day 35 of induction. Survival was evaluated by the Kaplan–Meier method, and log-rank test was used to compare the impact of variables on outcome in Statistical Package for the Social Sciences version 17.0. Results: 130/167 (78%) patients were started on MCP 841 protocol; the remaining 37 (22%) patients defaulted after the first visit. B-cell ALL was more common at 78 (60%). 94 (72%) had National Cancer Institute High Risk. Day 8 good prednisolone response (GPR) was seen in 76 (58%) patients. Morphological remission was noted in 90/107 (84%) patients. MRD status was available in 84 (78%) patients. 46 (43%) patients achieved MRD-negative status. The median follow-up was 21 months (range, 10–31 months). The median OS was 30 months (95% CI, 15.5–42.8 months). One-year and 2-year survival was 87% and 60%, respectively. Patients who were MRD negative did better than those with MRD positive, 29 versus 22 months (P = 0.03). GPR performed better than those with Poor Prednisolone Response (PPR), 29 versus 15 months (P = 0.01). Conclusion: Post-induction MRD is a useful prognostic tool for ALL patients treated with modified MCP 841 protocol. Outcomes are suboptimal compared to those reported from the developed western world. ]]>

Cancer Research, Statistics, and Treatment 2020 3(2):192-200

Background: Adrenocortical carcinoma (ACC) is a rare malignancy with poor outcomes. Objectives: To analyze the clinicopathologic features, treatment patterns and outcomes of patients with ACC who received systemic therapy at our center. Patients and Methods: This was a retrospective study conducted in a tertiary cancer center in India. Patients aged 15 years and older who were diagnosed with ACC between January 2011 and December 2018 and received systemic therapy were included in this study. For tumor staging, the European Network for the Study of Adrenal Tumors (ENSAT) system was used. The outcomes were reported as progression-free survival (PFS) and overall survival (OS). All statistical calculations were performed using the SPSS statistical software for Windows version 20.0. Results: Out of the 106 patients with ACC, 54 who received systemic therapy were included in this study. The median age of the cohort was 43 years (range, 15–72); 32 (59.3%) were men. Five (9.2%) patients had ENSAT Stage II, 31 (57.4%) had Stage III, and 18 (33.3%) had Stage IV (metastatic) disease at baseline. The chemotherapy drugs used in the palliative setting included etoposide (E), doxorubicin (D), and cisplatin (P), with or without mitotane. The median OS was 140 months (95% confidence interval [CI], 38.2–241.8) for ENSAT Stage II patients; 43 months for Stage III patients (95% CI, 27.2–58.7); and 22 months (95% CI, 9.4–34.6) for Stage IV patients, P = 0.012. The median PFS for patients treated with etoposide and platin (EP) and etoposide, doxorubicin, and platin (EDP) regimens was similar at 7 months (95% CI, 0–14.9) and 6 months (95% CI: 0–14.6) (P = 0.633), respectively. The corresponding median OS was 20.9 months (95% CI, 11.7–30.2) and 13.0 months (95% CI, 2.1–23.8) (P = 0.454), respectively. The patients who received palliative intent mitotane had a median PFS of 13 months (95% CI, 0–26.3) and those who did not had a median PFS of 6 months (95% CI, 1.2–10.7) (P = 0.492). The corresponding median OS was 22.6 months (95% CI, 17.8–27.5) and 15.5 months (95% CI, 5.8–25.2) (P = 0.351), respectively. Grade 3 or higher toxicities were observed in 25% of the patients receiving EP chemotherapy and 76.9% receiving EDP chemotherapy (P = 0.013). Conclusions: The use of mitotane is limited in the real-world setting in view of the financial constraints. The results with palliative chemotherapy in patients with ACC continue to remain poor. Patients with ACC treated with EDP and EP protocols had similar survival, but the three-drug protocol was associated with higher toxicities. ]]>

Cancer Research, Statistics, and Treatment 2020 3(2):201-206

Background: Sinonasal tumors are a rare group of neoplasms with limited data available regarding their treatment. Objectives: To estimate the 5 year outcomes and late adverse events of locally advanced sinonasal tumors treated with neoadjuvant therapy (NACT) followed by local therapy. Methods: Twenty-five patients with locally advanced esthesioneuroblastoma or sinonasal neuroendocrine tumors treated between August 2010 and August 2014 with NACT followed by local therapy were selected. The 5-year outcome and late adverse events (CTCAE version 4.02) were noted. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan–Meier method. COX regression analysis was used to identify factors impacting PFS and OS. Results: The median follow-up was 5.15 years. The 5-year PFS in the esthesioneuroblastoma cohort and in the sinonasal neuroendocrine carcinoma (SNEC) cohort was 63.5% (95% confidence interval [CI]: 28.9–84.7) and 34.6% (95% CI: 10.1–61.1), respectively (P = 0.1). The only factor impacting PFS on multivariate analysis was a response to NACT (P = 0.033). The 5-year OS in the esthesioneuroblastoma cohort and in the SNEC cohort was 91.7% (95% CI: 53.9–98.9) and 46.2% (95% CI: 19.2–69.6), respectively (P = 0.024). Any grade late adverse events were seen in 20 patients (80%). Metabolic late adverse events were seen in 19 patients (76%). Conclusion: NACT in advanced sinonasal cancers is associated with an improvement in 5-year outcomes. However, late side effects, especially metabolic, are seen in these patients and should be evaluated during follow-up. ]]>

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Background: Little is known about the comprehensive geriatric assessment (CGA) profile of Indian patients. We aimed to describe the CGA results of the Indian geriatric oncology patients and identify the incidence of polypharmacy. Methods: The study is a retrospective analysis of the data collected in the geriatric oncology clinic at Tata Memorial Hospital, a tertiary cancer hospital in India. Patients aged 60 years and over with malignancy were evaluated. The baseline social, demographic, and disease details were recorded. All patients underwent a CGA, in which the domains of nutrition, function and falls, psychological status, cognition, comorbidities, social support, fatigue, and polypharmacy were evaluated using various validated tools. Life expectancy and the risk of toxicity from chemotherapy were calculated. Based on the results of the CGA, the patients were referred to various specialists and advised methods to address any identified vulnerabilities. The study was approved by the Institutional Review Board, which granted a waiver of the requirement for written informed consent. Results: A total of 251 patients were assessed between June 2018 and March 2020. All patients had solid tumor malignancies, commonly lung (41%) and gastrointestinal (28%). Fifty-nine percent of the patients were planned for palliative intent therapy. The median age was 70 years (range, 60–100). The median number of caregivers was 4 (interquartile range [IQR], 3–6). The median body mass index (BMI) was 21.9 kg/m2 (IQR, 18.9–24.2). The BMI of 109 patients (44%) was < 21 kg/m2. Seventy-eight percent of the patients had comorbidities, commonly hypertension (45%), diabetes (26%), and heart disease (17%). The median number of medications was 5 (IQR, 2–7), and 51% of the patients were on were on 5 or more medications. Only 4 patients (2%) scored normally in all the geriatric domains tested. Abnormalities were noted in the domains of comorbidities (79%), fatigue (77%), nutrition (65%), function and falls (52%), psychological status (32%), and cognition (18%). Seventy percent of the patients had an estimated >51% risk of developing Grade 3 or higher toxicity if treated with full-dose combination chemotherapy. Conclusion: Ninety-eight percent of the Indian geriatric oncology patients had vulnerabilities in at least one geriatric domain. Polypharmacy was noted in more than 50% of the patients. There was an over 50% predicted risk of severe toxicity from combination chemotherapy in at least two out of every three patients. ]]>

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In December 2019, cases of pneumonia of unknown etiology were reported in the Wuhan city in China. In January 2020, the causative agent for this outbreak was discovered to be a novel strain of coronavirus, the severe acute respiratory syndrome-coronavirus-2. With Wuhan being the epicenter, the coronavirus disease 2019 (COVID-19) spread rapidly to other countries and soon took over every continent in the world except Antarctica. As the infection primarily presents as pneumonia, especially in patients with underlying comorbidities, radiological studies play an indispensable role in the early detection and further assessment of the course of COVID-19. The current pandemic is unprecedented with regard to the rate of spread, mortality rate, and palpable lack of our understanding of the mode of transmission and spread of the virus. This review is focused on the etiology, epidemiology, clinical symptoms, diagnosis, complications, and management of COVID-19. It emphasizes the need to integrate symptomatology, social history, and radiological findings, even in the absence of positive serological tests, to identify and isolate infected individuals. ]]>

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Background: Coronavirus disease 2019 (COVID-19) has posed a new challenge to the entire world. Many speculations revolve around its treatment. Numerous theories have been put forth and several medications have been tried, but not many promising results have been achieved. Objective: We aim to provide an overview of the various treatment modalities for patients with COVID-19. Methodology: A systematic search was performed to identify all the relevant studies on PubMed, Embase, and Google Scholar published until May 23, 2020, as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Articles that reported the various treatment modalities for COVID-19 were included in the analysis. Results: Currently, only remdesivir has been approved by the Food and Drug Administration (FDA) for the treatment of severe COVID-19. Corticosteroids and anticoagulant therapy have been recommended in patients with severe acute respiratory distress syndrome (ARDS). Some drugs such as lopinavir–ritonavir and Chinese herbal medicine have been shown to be beneficial in a few trials, while others such as chloroquine/hydroxychloroquine, tocilizumab, sarilumab, oseltamivir, and plasma therapy are being tested in ongoing trials. Conclusion: No treatment has been definitively proven to be effective against COVID-19 to date. The only FDA-approved drug is remdesivir, and several others are under investigation. Anticoagulant therapy and corticosteroids (weak recommendation) have been recommended in patients with severe ARDS. ]]>

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The coronavirus disease 2019 (COVID-19) started as a pneumonia of unknown etiology in 44 patients in the Wuhan city of China and has progressed into a pandemic affecting more than 4.7 million people to date. The morbidity, mortality, and socioeconomic consequences of the disease are grave. Personal protective measures taken by the general public and health-care providers along with the implementation of strategies, policies, and legislation at the state, national, and international levels are important to limit the community spread of COVID-19. Well-articulated protocols decrease confusion and increase the efficiency of the working staff, thus playing an important role in the protection of both the patients and health-care providers. In this review, we discuss the guidelines and protocols for the preventive measures to be implemented when dealing with patients in health-care establishments, especially with regard to performing imaging studies, surgeries, admission to the intensive care unit (ICU), disposal of medical waste, and the last rites of the body of the deceased. ]]>

Cancer Research, Statistics, and Treatment 2020 3(2):254-263

Background: Leptomeningeal metastasis (LM) is a dreaded complication associated with solid tumors which is increasing due to the advances in cancer-directed therapy. Proper diagnostic and treatment criteria are still not established for the handling of LM. This article aims to help outline a management plan for LM. Methods: A systematic review of the articles on LM and solid tumors was done in PubMed for the past 15 years and eligible articles were eligible articles were considered. The articles related to hematological malignancies and brain tumors were excluded. Results and Discussion: LM usually requires a strong suspicion based on the natural history of the disease and symptoms for diagnosis. Symptomatology, cerebrospinal fluid (CSF) examination, and magnetic resonance imaging aid in the diagnosis. The treatment involves a multimodal institution of intra-CSF therapy, systemic chemotherapy, craniospinal irradiation, and surgical interventions for relief of symptoms. The prognosis is usually poor despite treatment and expected survival is between 4 and 6 months. Conclusion: The different options for the treatment of LM should be discussed in a multidisciplinary clinic. The treatment must be decided based on the neurological and general health condition of the patient, previous lines of treatment, and the presence of other metastatic sites. The improvement of levels of evidence for the various therapeutic procedures for patients with LM requires dedicated trials. ]]>

Cancer Research, Statistics, and Treatment 2020 3(2):264-269

Cancer-associated thrombosis is a challenging problem when treating patients with cancer. It is recurrent and difficult to treat because of the increased risk of bleeding. Low-molecular-weight heparin is the standard of care for treating cancer-associated venous thromboembolism/pulmonary embolism (VTE/PE). Recently, there have been emerging data favoring the use of direct oral anticoagulants (DOACs) for treating cancer-associated VTE/PE. They are well tolerated because of oral administration and favorable side effect profile. Rivaroxaban was the first DOAC to be approved by the US Food and Drug Administration in 2012. In this comprehensive review, we discuss the history, chemistry, mechanism of action, indications, dose modifications, and drug–drug interactions of rivaroxaban. We also discuss briefly the results of various clinical trials related to DOACs. ]]>

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Background: Fulvestrant has been shown to improve survival in hormone-positive, HER2-negative advanced breast cancer (ABC). There is no study on fulvestrant from India. Objectives: This study was done to assess the prognostic factors and outcome of patients with ABC treated with fulvestrant. Materials and Methods: This was a retrospective study from the case records of patients who received fulvestrant for hormone receptor (HR)-positive breast cancer from May 2011 to July 2019. Results: A total of 37 women were included in this analysis, with a median follow-up of 9 months. The median age was 63 years. The Eastern Cooperative Oncology Group performance status (ECOG PS) was 0–2 (78%) and 3–4 (22%). The sites of metastasis were bone (59%), lung (43%), liver (32%), lymph node (24%), and bone only (20%). Patients with visceral metastasis and visceral crisis constituted 60% and 13%, respectively. The median number of lines of prior systemic therapy for metastatic disease was 2 (range, 0–6). The dose of fulvestrant used was 500 mg in 76% and 250 mg in 24%. There were no Grade 3 or 4 toxicities due to fulvestrant. The median progression-free survival and overall survival were 10 months (95% confidence interval [CI], 4–15.9 months) and 21 months (95% CI, 8.9–33.1 months), respectively. Univariate analysis showed that patients with ECOG PS 3–4 had a worse survival as compared to patients with PS 0–2. Conclusion: This is the first study on the outcomes of fulvestrant in advanced breast cancer from India. Fulvestrant is safe, well-tolerated, and effective in patients with hormone-positive ABC. Fulvestrant can be recommended even in heavily pretreated HR-positive advanced breast cancer and in those with a poor general condition (ECOG PS 3 or 4) who are ineligible for chemotherapy. ]]>

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Introduction: From a practicing oncologist's perspective, sample size calculation is a very intriguing aspect of medical statistics. Methods: Basic aspects of sample size calculation in relevant case scenarios are discussed. Results: The formulae are illustrated with examples for easier understanding. Discussion: This article is a brief account of sample size calculation methods in different clinical research scenarios. The derivation of formulae is beyond the scope of this article. The discussion is kept simple by illustrations matching real life studies. More complex methods will be discussed in the next session of this series. ]]>

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