{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T04:33:20Z","timestamp":1786422800233,"version":"build-2736575974"},"reference-count":23,"publisher":"Scientific Scholar","issue":"03","license":[{"start":{"date-parts":[[2024,9,18]],"date-time":"2024-09-18T00:00:00Z","timestamp":1726617600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["South Asian J Cancer"],"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Tyrosine kinase inhibitors like imatinib have become the cornerstone of therapy in chronic phase-chronic myeloid leukemia (CML-CP). However, the role of hydroxyurea (HU), a deoxyribonucleic acid synthesis inhibitor, has been less explored in the disease. Hence, the present study was conducted to compare the efficacy of structured dose of HU based on baseline total leukocyte count (TLC) with imatinib in CML patients.<\/jats:p>\n                  <jats:p>An open-label randomized controlled trial was conducted in 90 newly diagnosed CML-CP patients, aged \u2265 18 years. Patients were randomized to receive either baseline leucocyte count-based structured dose of HU with imatinib or imatinib monotherapy for 3 months. Quantitative real-time polymerase chain reaction for BCR-ABL1 to assess early molecular response (EMR) and safety evaluation according to the Common Terminology Criteria for Adverse Events version 5 was done.<\/jats:p>\n                  <jats:p>Median age of patients was 36.5 years (36 [interquartile range [IQR]: 30\u201345] in I-HU, 38 [IQR: 31\u201347] in imatinib monotherapy) with male predominance. Fatigue was the most common symptom at diagnosis. Splenomegaly was seen in 89% (median spleen size: 10 [IQR: 6\u201315] cm). At 3 months, complete hematological response was seen in 74 patients (36 in I-HU, 38 in imatinib monotherapy). Overall, 68 patients achieved EMR (34 in I-HU, 34 in imatinib monotherapy, p\u2009=\u20090.53). The most common hematological toxicity, anemia, was seen in 80 patients (41 in I-HU, 39 in imatinib monotherapy). In 37 patients, nonhematological toxicities seen were nausea and vomiting (20 in I-HU, 17 in imatinib monotherapy). No dose limiting toxicities were reported.<\/jats:p>\n                  <jats:p>Addition of upfront TLC-based dosing of HU to imatinib was not found to significantly improve the hematological response and EMR at 3 months. However, long-term studies with a larger sample size with structured dose of HU can be undertaken as it forms a preferred adjunctive therapy for initial, rapid cytoreduction in hyperviscosity or leukostasis-related symptoms in patients of CML.<\/jats:p>","DOI":"10.1055\/s-0044-1789579","type":"journal-article","created":{"date-parts":[[2024,9,18]],"date-time":"2024-09-18T19:09:46Z","timestamp":1726686586000},"page":"608-614","source":"Crossref","is-referenced-by-count":1,"title":["Upfront Combined Hydroxyurea and Imatinib versus Imatinib Monotherapy in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: A Randomized Controlled Trial"],"prefix":"10.25259","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6972-2365","authenticated-orcid":false,"given":"Rituparna","family":"Chetia","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Haematology, All India Institute of Medical Science, Guwahati, Guwahati, Assam, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6534-2149","authenticated-orcid":false,"given":"Sarika","family":"Palepu","sequence":"additional","affiliation":[{"name":"Department of Community and Family Medicine, All India Institute of Medical Science, Kalyani, Kalyani, West Bengal, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4555-8633","authenticated-orcid":false,"given":"Vikramjeet","family":"Dutta","sequence":"additional","affiliation":[{"name":"Department of Microbiology, Vardhman Mahavir Medical College (VMMC) and Safdarjung Hospital, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9755-0233","authenticated-orcid":false,"given":"Arkapal","family":"Bandyopadhyay","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, All India Institute of Medical Science, Kalyani, Kalyani, West Bengal, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3151-7603","authenticated-orcid":false,"given":"Anisha","family":"Mathew","sequence":"additional","affiliation":[{"name":"Department of Biochemistry, Lady Harding Medical College, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sudeep","family":"Vaniyath","sequence":"additional","affiliation":[{"name":"Clinical Haematology and BMT, Aster Malabar Institute of Medical Sciences, Calicut, Kerala, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anamika","family":"Bakliwal","sequence":"additional","affiliation":[{"name":"Department of Haemato-oncology and BMT, Venketshwar Hospital, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Debranjani","family":"Chattopadhyay","sequence":"additional","affiliation":[{"name":"Department of Clinical Haematology and BMT, Tata Medical Centre, Kolkata, West Bengal, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashok","family":"Rajoreya","sequence":"additional","affiliation":[{"name":"RJN Apollo Spectra Hospital, Gwalior, Madhya Pradesh, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2890-4939","authenticated-orcid":false,"given":"Puneet","family":"Dhamija","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, All India Institute of Medical Science, Rishikesh, Rishikesh, Uttarakhand, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0984-4176","authenticated-orcid":false,"given":"Manisha","family":"Naithani","sequence":"additional","affiliation":[{"name":"Department of Biochemistry, All India Institute of Medical Science, Rishikesh, Rishikesh, Uttarakhand, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1870-0131","authenticated-orcid":false,"given":"Neha","family":"Singh","sequence":"additional","affiliation":[{"name":"Department of Pathology, All India Institute of Medical Science, Rishikesh, Rishikesh, Uttarakhand, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7762-803X","authenticated-orcid":false,"given":"Uttam Kumar","family":"Nath","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Haematology, All India Institute of Medical Science, Rishikesh, Rishikesh, Uttarakhand, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10894","published-online":{"date-parts":[[2024,9,18]]},"reference":[{"issue":"01","key":"ref1","first-page":"42","article-title":"WHO 2016 definition of chronic myeloid leukemia and tyrosine kinase inhibitors","volume":"37","author":"\u0130C Haznedaro\u011flu","year":"2020","journal-title":"Turk J Haematol"},{"issue":"01","key":"ref2","doi-asserted-by":"crossref","first-page":"e2014007","DOI":"10.4084\/mjhid.2014.007","article-title":"Imatinib in chronic myeloid leukemia: an overview","volume":"6","author":"T Sacha","year":"2014","journal-title":"Mediterr J Hematol Infect Dis"},{"issue":"01","key":"ref3","doi-asserted-by":"crossref","first-page":"64","DOI":"10.1200\/JGO.2015.002667","article-title":"Chronic myeloid leukemia in India","volume":"3","author":"P Ganesan","year":"2016","journal-title":"J Glob Oncol"},{"issue":"04","key":"ref4","doi-asserted-by":"crossref","first-page":"315","DOI":"10.1016\/j.mjafi.2014.07.005","article-title":"Monitoring of response to therapy with imatinib mesylate in chronic myeloid leukemia in chronic phase (CML-CP)","volume":"70","author":"V Nair","year":"2014","journal-title":"Med J Armed Forces India"},{"issue":"01","key":"ref5","doi-asserted-by":"crossref","first-page":"35","DOI":"10.1007\/s00280-024-04644-w","article-title":"Predictive performance of population pharmacokinetic models of imatinib in chronic myeloid leukemia patients","volume":"94","author":"J S Dilli Batcha","year":"2024","journal-title":"Cancer Chemother Pharmacol"},{"issue":"01","key":"ref6","doi-asserted-by":"crossref","first-page":"401","DOI":"10.1038\/s41420-023-01700-x","article-title":"AMPK-induced novel phosphorylation of RUNX1 inhibits STAT3 activation and overcome imatinib resistance in chronic myelogenous leukemia (CML) subjects","volume":"9","author":"M B Gayatri","year":"2023","journal-title":"Cell Death Discov"},{"issue":"03","key":"ref7","doi-asserted-by":"crossref","first-page":"145","DOI":"10.4103\/0971-5851.123699","article-title":"Chronic myeloid leukemia in the Imatinib era - compilation of Indian data from 22 centers involving 8115 patients","volume":"34","author":"P Parikh","year":"2013","journal-title":"Indian J Med Paediatr Oncol"},{"key":"ref8","first-page":"1615","article-title":"Imatinib in combination with hydroxyurea showed significantly lower major molecular response rates at 6 months but similar MMR at 18 months in patients with CML1st CP compared to IM alone. Final results of the CML2004 study. NCT 02480608","volume":"130","author":"T Lange","year":"2017","journal-title":"Blood"},{"issue":"04","key":"ref9","doi-asserted-by":"crossref","first-page":"258","DOI":"10.4103\/sajc.sajc_244_17","article-title":"Comparative analysis of the Sokal, Euro and European Treatment and Outcome Study score in prognostication of Indian chronic myeloid leukemia-chronic phase patients on imatinib","volume":"7","author":"S Chhikara","year":"2018","journal-title":"South Asian J Cancer"},{"issue":"03","key":"ref10","doi-asserted-by":"crossref","first-page":"117","DOI":"10.4103\/sajc.sajc_57_17","article-title":"Comparison of the applicability of Hasford score and European Treatment and Outcome Study score in Indian patients with chronic phase chronic myeloid leukemia on imatinib therapy","volume":"6","author":"N C Narang","year":"2017","journal-title":"South Asian J Cancer"},{"issue":"03","key":"ref11","doi-asserted-by":"crossref","first-page":"686","DOI":"10.1182\/blood-2010-12-319038","article-title":"Predicting complete cytogenetic response and subsequent progression-free survival in 2060 patients with CML on imatinib treatment: the EUTOS score","volume":"118","author":"J Hasford","year":"2011","journal-title":"Blood"},{"issue":"03","key":"ref13","doi-asserted-by":"crossref","first-page":"154","DOI":"10.4103\/0971-5851.123711","article-title":"Chronic myeloid leukemia data from India","volume":"34","author":"S Bansal","year":"2013","journal-title":"Indian J Med Paediatr Oncol"},{"issue":"03","key":"ref14","doi-asserted-by":"crossref","first-page":"159","DOI":"10.4103\/0971-5851.123712","article-title":"Report of chronic myeloid leukemia in chronic phase from All India Institute of Medical Sciences, 1990-2010","volume":"34","author":"P Mishra","year":"2013","journal-title":"Indian J Med Paediatr Oncol"},{"issue":"06","key":"ref15","doi-asserted-by":"crossref","first-page":"1336","DOI":"10.1038\/leu.2015.73","article-title":"The EUTOS population-based registry: incidence and clinical characteristics of 2904 CML patients in 20 European countries","volume":"29","author":"V S Hoffmann","year":"2015","journal-title":"Leukemia"},{"issue":"07","key":"ref16","doi-asserted-by":"crossref","first-page":"1411","DOI":"10.3109\/10428194.2012.745525","article-title":"Trends in chronic myeloid leukemia incidence and survival in the United States from 1975 to 2009","volume":"54","author":"Y Chen","year":"2013","journal-title":"Leuk Lymphoma"},{"issue":"01","key":"ref17","doi-asserted-by":"crossref","first-page":"433","DOI":"10.1182\/hematology.2019000050","article-title":"Meeting the needs of CML patients in resource-poor countries","volume":"2019","author":"H Malhotra","year":"2019","journal-title":"Hematology (Am Soc Hematol Educ Program)"},{"issue":"11","key":"ref18","doi-asserted-by":"crossref","first-page":"1459","DOI":"10.1016\/j.leukres.2010.03.033","article-title":"Chronic myeloid leukemia in the Asia-Pacific region: current practice, challenges and opportunities in the targeted therapy era","volume":"34","author":"D W Kim","year":"2010","journal-title":"Leuk Res"},{"issue":"S 01","key":"ref19","doi-asserted-by":"crossref","first-page":"4542","DOI":"10.1182\/blood-2023-181369","article-title":"To study outcomes in young CML treated with TKI. A registry data from Hematological Cancer Consortium (HCC) of India","volume":"142","author":"R Kapoor","year":"2023","journal-title":"Blood"},{"issue":"01","key":"ref20","doi-asserted-by":"crossref","first-page":"87","DOI":"10.4103\/ijmr.ijmr_1090_21","article-title":"Feasibility of treatment-free remission with generic imatinib: results of generic imatinib-free trial-in-chronic myeloid leukaemia-chronic phase study","volume":"157","author":"D Goni","year":"2023","journal-title":"Indian J Med Res"},{"issue":"02","key":"ref21","doi-asserted-by":"crossref","first-page":"148","DOI":"10.2174\/2772432817666220315144253","article-title":"Prevalence of anemia among chronic myeloid leukemia patients treated with imatinib: a evidence-based meta-analysis","volume":"18","author":"A K Singh","year":"2023","journal-title":"Curr Rev Clin Exp Pharmacol"},{"key":"ref22","doi-asserted-by":"crossref","first-page":"675609","DOI":"10.3389\/fonc.2021.675609","article-title":"Patterns of tyrosine kinase inhibitor utilization in newly treated patients with chronic myeloid leukemia: an exhaustive population-based study in France","volume":"11","author":"M Pajiep","year":"2021","journal-title":"Front Oncol"},{"issue":"11","key":"ref23","doi-asserted-by":"crossref","first-page":"2614","DOI":"10.3109\/10428194.2014.885515","article-title":"Correlation of plasma trough levels of imatinib with molecular response in patients with chronic myeloid leukemia","volume":"55","author":"H Malhotra","year":"2014","journal-title":"Leuk Lymphoma"},{"issue":"12","key":"ref24","doi-asserted-by":"crossref","first-page":"2821","DOI":"10.1080\/10428194.2020.1786556","article-title":"No advantage of imatinib in combination with hydroxyurea over imatinib monotherapy: a study of the East German Study Group (OSHO) and the German CML study group","volume":"61","author":"T Lange","year":"2020","journal-title":"Leuk Lymphoma"}],"container-title":["South Asian Journal of Cancer"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1055\/s-0044-1789579.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T11:13:13Z","timestamp":1781176393000},"score":1,"resource":{"primary":{"URL":"https:\/\/journal.sajc.org\/upfront-combined-hydroxyurea-and-imatinib-versus-imatinib-monotherapy-in-newly-diagnosed-chronic-phase-chronic-myeloid-leukemia-a-randomized-controlled-trial\/"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9,18]]},"references-count":23,"journal-issue":{"issue":"03","published-online":{"date-parts":[[2025,12,23]]},"published-print":{"date-parts":[[2025,7]]}},"URL":"https:\/\/doi.org\/10.1055\/s-0044-1789579","archive":["Portico","CLOCKSS"],"relation":{},"ISSN":["2278-330X","2278-4306"],"issn-type":[{"value":"2278-330X","type":"print"},{"value":"2278-4306","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,9,18]]}}}