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Efficacy and safety profile of generic imatinib in patients with newly diagnosed chronic myeloid leukemia-chronic phase: sharing experience of a hemato-oncology center from eastern India

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Abstract

In India, CML is the commonest adult leukemia. Imatinib is the gold standard for frontline treatment of newly diagnosed CML-CP patients. The present study was conducted to assess the efficacy and safety of generic imatinib in newly diagnosed CML-CP patients. In this prospective study, 76 newly diagnosed CML-CP patients received generic imatinib. They were monitored as per the ELN2013 recommendation. Karyotyping and BCR-ABL transcript level were done at specified time points. Adverse effects, if any, were documented as per the NCI-CTCAE criteria v4.03. Statistical analysis was done using standard methods. A total of 76 patients included in the study; median age was 36 years. The most common (71%) presenting symptom was fatigue; splenomegaly was found in all patients. CHR was achieved in 97% cases. At 3 months, 64.5% patients achieved ERM. At 6 months, CCyR and MCyR had seen in 65% and 68% cases, respectively. MMR achieved at 12 months in 44% cases. Most common hematological and non-hematological toxicity were anemia and skin changes seen in 89.5% and 71% cases, respectively. With generic imatinib therapy, the results of treatment outcome and safety profile were comparable with original imatinib. The added advantage was gross reduction in cost of therapy meeting unmet needs in CML patients in countries with resource constraints.

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Abbreviations

CML-CP:

Chronic myelogenous leukemia-chronic phase

ELN:

European LeukemiaNet

NCI-CTCAE:

National Cancer Institute Common Terminology Criteria for Adverse Events

CHR:

Complete hematological remission

ERM:

Early molecular response

CCyR:

Complete cytogenetic response

MCyR:

Major cytogenetic response

MMR:

Major molecular response

TKI:

Tyrosine kinase inhibitor

CBC:

Complete blood counts

PBS:

Peripheral blood smear

BMA:

Bone marrow aspiration

BMB:

Bone marrow biopsy

RT-PCR:

Reverse transcriptase-polymerase chain reaction

DMR:

Deep molecular response

OS:

Overall survival

PFS:

Progression-free survival

References

  1. Höglund M, Sandin F, Simonsson B (2015) Epidemiology of chronic myeloid leukaemia: an update. Ann Hematol 94:241–247. https://doi.org/10.1007/s00277-015-2314-2

    Article  Google Scholar 

  2. National Cancer Registry Programme (2016) Three year report of the population based cancer registries 2012–14. New Delhi: Indian Council of Medical Research; Bengaluru, India. https://ncdirindia.org/NCRP/ALL_NCRP_REPORTS/PBCR_REPORT_2012_2014/index.htm. Accessed March 2016

  3. Singhal MK, Sengar M, Nair R (2016) Summary of the published Indian data on chronic myeloid leukemia. South Asian J Cancer 5:162–165. https://doi.org/10.4103/2278-330X.187593

    Article  PubMed  PubMed Central  Google Scholar 

  4. Nowell PC, Hungerford DA (1960) Chromosome studies on normal and leukemic human leukocytes. J Natl Cancer Inst 25:85–109. https://doi.org/10.1093/jnci/25.1.85

    Article  CAS  PubMed  Google Scholar 

  5. Rowley JD (1973) A new consistent chromosomal abnormality in chronic myelogenous leukaemia identified by quinacrine fluorescence and Giemsa staining. Nature 243:290–293. https://doi.org/10.1038/243290a0

    Article  CAS  PubMed  Google Scholar 

  6. Lugo TG, Pendergast AM, Muller AJ, Witte ON (1990) Tyrosine kinase activity and transformation potency of bcr-abl oncogene products. Science 247:1079–1082. https://doi.org/10.1126/science.2408149

    Article  CAS  PubMed  Google Scholar 

  7. Soverini S, Martinelli G, Iacobucci I, Baccarani M (2008) Imatinib mesylate for the treatment of chronic myeloid leukemia. Expert Rev Anticancer Ther 8(6):853–864. https://doi.org/10.1586/14737140.8.6.853

    Article  CAS  PubMed  Google Scholar 

  8. Druker BJ, Tamura S, Buchdunger E, Ohno S, Segal GM, Fanning S, Zimmermann J, Lydon NB (1996) Effects of a selective inhibitor of the Abl tyrosine kinase on the growth of Bcr-Abl positive cells. Nat Med 2:561–566. https://doi.org/10.1038/nm0596-561

    Article  CAS  PubMed  Google Scholar 

  9. Johnson JR, Bross P, Cohen M, Rothmann M, Chen G, Zajicek A, Gobburu J, Rahman A, Staten A, Pazdur R (2003) Approval summary: imatinib mesylate capsules for treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase. Clin Cancer Res 9:1972–1979

    CAS  PubMed  Google Scholar 

  10. Soverini S, Branford S, Nicolini FE, Talpaz M, Deininger MWN, Martinelli G, Müller MC, Radich JP, Shah NP (2014) Implications of BCR-ABL1 kinase domain-mediated resistance in chronic myeloid leukemia. Leuk Res 38:10–20. https://doi.org/10.1016/j.leukres.2013.09.011

    Article  CAS  PubMed  Google Scholar 

  11. Lindauer M, Hochhaus A (2014) Dasatinib. Recent Results Cancer Res 201:27–65. https://doi.org/10.1007/978-3-642-54490-3_2

    Article  CAS  PubMed  Google Scholar 

  12. Ostendorf BN, le Coutre P, Kim TD, Quintás-Cardama A (2014) Nilotinib. Recent Results Cancer Res 201:67–80. https://doi.org/10.1007/978-3-642-54490-3_3

    Article  CAS  PubMed  Google Scholar 

  13. Wang J, Shen ZX, Saglio G, Jin J, He Huang YH, Xin D, Li J, Meng F, Zhu H, Hu J, Wang J, Hou M, Hertle S, Menssen HD, Ortmann CE, Tribouley C, Yuan Y, Baccarani M, Huang X (2015) Phase 3 study of nilotinib vs imatinib in Chinese patients with newly diagnosed chronic myeloid leukemia in chronic phase: ENESTchina. Blood 125:2771–2778. https://doi.org/10.1182/blood-2014-09-601674

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  14. Hjorth-Hansen H, Stenke L, Söderlund S, Dreimane A, Ehrencrona H, Gedde-Dahl T, Gjertsen BT, Höglund M, Lotfi K, Majeed W, Markevärn B, Ohm L, Olsson-Strömberg U, Remes K, Suominen M, Simonsson B, Porkka K, Mustjoki S, Richter J (2015) Dasatinib induces fast and deep responses in newly diagnosed chronic myeloid leukaemia patients in chronic phase: clinical results from a randomisedphase-2 study (NordCML006). Eur J Haematol 94:243–250. https://doi.org/10.1111/ejh.12423

    Article  CAS  PubMed  Google Scholar 

  15. Horowitz MM, Rowlings PA, Passweg JR (1996) Allogeneic bone marrow transplantation for CML: a report from the International Bone Marrow Transplant Registry. Bone Marrow Transplant 17(3):S5–S6

    PubMed  Google Scholar 

  16. Radich J (2010) Stem cell transplant for chronic myeloid leukemia in the imatinib era. Semin Hematol 47(4):354–361. https://doi.org/10.1053/j.seminhematol.2010.06.008

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  17. O'Brien SG, Guilhot F, Larson RA, Gathmann I, Larson RA, Gathmann I, Baccarani M, Cervantes F, Cornelissen JJ, Fischer T, Hochhaus A, Hughes T, Lechner K, Nielsen JL, Rousselot P, Reiffers J, Saglio G, Shepherd J, Simonsson B, Gratwohl A, Goldman JM, Kantarjian H, Taylor K, Verhoef G, Bolton AE, Capdeville R, Druker BJ (2003) Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med 348(11):994–1004. https://doi.org/10.1056/NEJMoa022457

    Article  CAS  PubMed  Google Scholar 

  18. Hasford J, Baccarani M, Hoffmann V, Guilhot J, Saussele S, Rosti G, Guilhot F, Porkka K, Ossenkoppele G, Lindoerfer D, Simonsson B, Pfirrmann M, Hehlmann R (2011) Predicting complete cytogenetic response and subsequent progression-free survival in 2060 patients with CML on imatinib treatment: the EUTOS score. Blood 118(3):686–692. https://doi.org/10.1182/blood-2010-12-319038

    Article  CAS  PubMed  Google Scholar 

  19. Baccarani M, Deininger MW, Rosti G, Hochhaus A, Soverini S, Apperley JF, Cervantes F, Clark RE, Cortes JE, Guilhot F, Hjorth-Hansen H, Hughes TP, Kantarjian HM, Kim DW, Larson RA, Lipton JH, Mahon FX, Martinelli G, Mayer J, Müller MC, Niederwieser D, Pane F, Radich JP, Rousselot P, Saglio G, Saußele S, Schiffer C, Silver R, Simonsson B, Steegmann JL, Goldman JM, Hehlmann R (2013) European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood 122(6):872–884. https://doi.org/10.1182/blood-2013-05-501569

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  20. National Cancer Institute Common Terminology Criteria for Adverse Events (2010) National Cancer Institute Updates CTCAE to v4.03. http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf (Accessed August 6, 2010)

  21. Tardieu S, Brun-Strang C, Berthaud P, Michallet M, Guilhot F, Rousselot P, Sambuc R (2005) Management of chronic myeloid leukemia in France: a multicentered cross-sectional study on 538 patients. Pharmacoepidemiol Drug Saf 14:545–553. https://doi.org/10.1002/pds.1046

    Article  PubMed  Google Scholar 

  22. Cortes JE, Richard TS, Hagop K (2007) Chronic myelogenous leukemia. In: Padzur R, Coia LR, Hoskins WJ, Wagman LD (eds) Cancer management: a multidisciplinary approach, 10th edn. Lawrence: CMPMedica, p 789

  23. Gratwohl A, Hermans J, Goldman JM, Arcese W, Carreras E, Devergie A, Arcese W, Carreras E, Devergie A, Frassoni F, Gahrton G, Kolb HJ, Niederwieser D, Ruutu T, Vernant JP, de Witte T, Apperley J (1998) Risk assessment for patients with chronic myeloid leukaemia before allogeneic blood or marrow transplantation. Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation. Lancet 352:1087–1092. https://doi.org/10.1016/s0140-6736(98)03030-x

    Article  CAS  PubMed  Google Scholar 

  24. Prasad RR, Singh P (2013) Report of chronic myeloid leukemia from Indira Gandhi Institute of Medical Sciences, Regional Cancer Center, 2002-2009. Indian J Med Paediatr Oncol 34(3):172–174. https://doi.org/10.4103/0971-5851.123719

    Article  PubMed  PubMed Central  Google Scholar 

  25. Mishra P, Seth T, Mahapatra M, Saxena R (2013) Report of chronic myeloid leukemia in chronic phase from All India Institute of Medical Sciences, 1990-2010. Indian J Med Paediatr Oncol 34:159–163. https://doi.org/10.4103/0971-5851.123712

    Article  PubMed  PubMed Central  Google Scholar 

  26. Mark HF, Sokolic RA, Mark Y (2006) Conventional cytogenetics and FISH in the detection of BCR/ABL fusion in chronic myeloid leukemia (CML). Exp Mol Pathol 81(1):1–7. https://doi.org/10.1016/j.yexmp.2006.03.004

    Article  CAS  PubMed  Google Scholar 

  27. Druker BJ, Talpaz M, Resta DJ, Peng B, Buchdunger E, Ford JM, Lydon NB, Kantarjian H, Capdeville R, Ohno-Jones S, Sawyers CL et al (2001) Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med 344(14):1031–1037. https://doi.org/10.1056/NEJM200104053441401

    Article  CAS  PubMed  Google Scholar 

  28. Kantarjian H, Sawyers C, Hochhaus A, Guilhot F, Schiffer C, Carlo G-P, Niederwieser D, Resta D, Capdeville R, Zoellner U, Talpaz M, Druker B (2002) Hematologic and cytogenetic responses to imatinib mesylate in chronic myelogenous leukemia. N Engl J Med 346(9):645–652. https://doi.org/10.1056/NEJMoa011573

    Article  CAS  PubMed  Google Scholar 

  29. Yeung DT, Osborn MP, White DL, Branford S, Braley J, Herschtal A, Kornhauser M, Issa S, Hiwase DK, Hertzberg M, Schwarer AP, Filshie R, Arthur CK, Kwan YL, Trotman J, Forsyth CJ, Taper J, Ross DM, Beresford J, Tam C, Mills AK, Grigg AP, Hughes TP (2015) TIDEL-II: first-line use of imatinib in CML with early switch to nilotinib for failure to achieve time-dependent molecular targets. Blood 125(6):915–923. https://doi.org/10.1182/blood-2014-07-590315

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  30. Neelakantan P, Gerrard G, Lucas C, Milojkovic D, May P, Wang L, Paliompeis C, Bua M, Reid A, Rezvani K, O'Brien S, Clark R, Goldman J, Marin D (2013) Combining BCR-ABL1 transcript levels at 3 and 6 months in chronic myeloid leukemia: implications for early intervention strategies. Blood 121(14):2739–2742. https://doi.org/10.1182/blood-2012-11-466037

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  31. Jabbour E, Kantarjian HM, Saglio G, Steegmann JL, Shah NP, Boqué C, Chuah C, Pavlovsky C, Mayer J, Cortes J, Baccarani M, Kim DW, Bradley-Garelik MB, Mohamed H, Wildgust M, Hochhaus A (2014) Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION). Blood 123(4):494–500. https://doi.org/10.1182/blood-2013-06-511592

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  32. Cortes J, Jabbour E, Kantarjian H, Yin CC, Shan J, O'Brien S, Garcia-Manero G, Giles F, Breeden M, Reeves N, Wierda WG, Jones D (2007) Dynamics of BCR-ABL kinase domain mutations in chronic myeloid leukemia after sequential treatment with multiple tyrosine kinase inhibitors. Blood 110(12):4005–4011. https://doi.org/10.1182/blood-2007-03-080838

    Article  CAS  PubMed  Google Scholar 

  33. Kim DD, Hamad N, Lee HG, Kamel-Reid S, Lipton JH (2014) BCR/ABL level at 6 months identifies good risk CML subgroup after failing early molecular response at 3 months following imatinib therapy for CML in chronic phase. Am J Hematol 89(6):626–632. https://doi.org/10.1002/ajh.23707

    Article  CAS  PubMed  Google Scholar 

  34. Talpaz M, Silver RT, Druker BJ, Goldman JM, Gambacorti-Passerini C, Guilhot F, Schiffer CA, Fischer T, Deininger MWN, Lennard AL, Hochhaus A, Ottmann OG, Gratwohl A, Baccarani M, Stone R, Tura S, Mahon FX, Fernandes-Reese S, Gathmann I, Capdeville R, Kantarjian HM, Sawyers CL (2002) Imatinib induces durable hematologic and cytogenetic responses in patients with accelerated phase chronic myeloid leukemia: results of a phase 2 study. Blood 99(6):1928–1937. https://doi.org/10.1182/blood.v99.6.1928

    Article  CAS  PubMed  Google Scholar 

  35. Hughes TP, Hochhaus A, Branford S, Müller MC, Kaeda JS, Druker BJ, Guilhot F, Larson RA, O'Brien SG, Rudoltz MS, Mone M, Wehrle E, Modur V, Goldman JM, Radich JP (2010) Long-term prognostic significance of early molecular response to imatinib in newly diagnosed chronic myeloid leukemia: an analysis from the International Randomized Study of Interferon and STI571 (IRIS). Blood 116(19):3758–3765. https://doi.org/10.1182/blood-2010-03-273979

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  36. Luatti S, Castagnetti F, Marzocchi G, Baldazzi C, Gugliotta G, Iacobucci I, Specchia G, Zanatta L, Rege-Cambrin G, Mancini M, Abruzzese E, Zaccaria A, Grimoldi MG, Gozzetti A, Ameli G, Capucci MA, Palka G, Bernasconi P, Palandri F, Pane F, Saglio G, Martinelli G, Rosti G, Baccarani M, Testoni N, Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) Working Party on CML (2012) Additional chromosomal abnormalities in Philadelphia-positive clone: adverse prognostic influence on frontline imatinib therapy: a GIMEMA Working Party on CML analysis. Blood 120(4):761–767. https://doi.org/10.1182/blood-2011-10-384651

    Article  CAS  PubMed  Google Scholar 

  37. Kuntegowdanahalli LC, Kanakasetty GB, Thanky AH, Dasappa L, Jacob LA, Mallekavu SB, Lakkavalli RK, Kadabur LN, Haleshappa RA (2016) Prognostic and predictive implications of Sokal, Euro and EUTOS scores in chronic myeloid leukaemia in the imatinib era—experience from tertiary oncology centre in southern India. Ecancer 10:679. https://doi.org/10.3332/ecancer.2016.679

    Article  Google Scholar 

  38. Kagita S, Uppalapati S, Jiwatani S, Linga VG, Gundeti S, Nagesh N, Digumarti R (2014) Incidence of Bcr-Abl kinase domain mutations in imatinib refractory chronic myeloid leukemia patients from South India. Tumour Biol 35(7):7187–7193. https://doi.org/10.1007/s13277-014-1926-9

    Article  CAS  PubMed  Google Scholar 

  39. Mukhopadhyay A, Dasgupta S, Mukhopadhyay S, Bose CK, Sarkar S, Gharami F, Koner S, Basak J, Roy UK (2012) Imatinib mesylate therapy in patients of chronic myeloid leukemia with Philadelphia chromosome positive: an experience from eastern India. Indian J Hematol Blood Transfus 28(2):82–88. https://doi.org/10.1007/s12288-011-0108-9

    Article  CAS  PubMed  Google Scholar 

  40. Babu G (2013) Report of patients with chronic myeloid leukemia Kidwai Memorial Institute of Oncology, Bangalore over 15 years. Indian J Med Paediatr Oncol 34(3):196–198. https://doi.org/10.4103/0971-5851.123736

    Article  PubMed  PubMed Central  Google Scholar 

  41. Salie R, Silver RT (2010) Uncommon or delayed adverse events associated with imatinib treatment for chronic myeloid leukemia. Clin Lymphoma Myeloma Leuk 10(5):331–335. https://doi.org/10.3816/CLML.2010.n.065

    Article  CAS  PubMed  Google Scholar 

  42. Mughal TI, Schrieber A (2010) Principal long-term adverse effects of imatinib in patients with chronic myeloid leukemia in chronic phase. Biologics 4:315–323. https://doi.org/10.2147/BTT.S5775

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  43. Ray SS, Chakraborty P, Chaudhuri U, Ganesh (2013) Report of chronic myeloid leukemia in chronic phase from eastern India, Institute of Hematology and Transfusion Medicine, Kolkata, 2001-2009. Indian J Med Paediatr Oncol 34(3):175–176. https://doi.org/10.4103/0971-5851.123721

    Article  PubMed  PubMed Central  Google Scholar 

  44. Eskazan AE, Sadri S, Keskin D, Ayer M, Kantarcioglu B, Demirel N, Aydin D, AydinliF YO, Ozunal IE, Berk S, Yalniz FF, Elverdi T, Salihoglu A, Ar MC, Ongoren S, Baslar Z, Aydin Y, Tuzuner N, Ozbek U, Soysal T (2017) Outcomes of chronic myeloid leukemia patients with early molecular response at 3 and 6 months: a comparative analysis of generic imatinib and Glivec. Clin Lymphoma Myeloma Leuk 17(12):804–811. https://doi.org/10.1016/j.clml.2017.07.255

    Article  PubMed  Google Scholar 

  45. Lejniece S, Udre I, Rivkina A (2017) Generic imatinib in the treatment of chronic myeloid leukemia: two years’ experience in Latvia. Exp Oncol 39(2):151–154

    Article  CAS  PubMed  Google Scholar 

  46. Danthala M, Gundeti S, Kuruva SP, Puligundla KC, Adusumilli P, PillaiKarnam A, Bala S, Konatam ML, Maddali LS, Digumarti RR (2017) Generic imatinib in chronic myeloid leukemia: survival of the cheapest. Clin Lymphoma Myeloma Leuk 17(7):457–462. https://doi.org/10.1016/j.clml.2017.05.006

    Article  PubMed  Google Scholar 

  47. Bhatwadekar SS, Deshpande SV, Mehta A, Shah P (2019) Efficacy and safety of generic imatinib compared to Glivec in chronic phase - chronic myeloid leukemia-single center retrospective analysis. Blood 134:4162. https://doi.org/10.1182/blood-2019-126495

    Article  Google Scholar 

  48. Samrat S, Meena LP, Chakravarty J, Rai M (2019) Treatment of chronic myeloid leukemia with generic imatinib in patients from northeastern part of India. Int J Res Pharm Sci 10:3107–3113. https://doi.org/10.26452/ijrps.v10i4.1604

    Article  CAS  Google Scholar 

  49. Abou Dalle I, Kantarjian H, Burger J, Estrov Z, Ohanian M, Verstovsek S, Ravandi F, Borthakur G, Garcia-Manero G, Jabbour E (2019) Efficacy and safety of generic imatinib after switching from original imatinib in patients treated for chronic myeloid leukemia in the United States. Cancer Med 8:6559–6565. https://doi.org/10.1002/cam4.2545

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  50. Supreme Court rules for cheap cancer drug. Updated: Apr 2, 2013, 05:42 IST. Read more at: https://timesofindia.indiatimes.com/business/india-business/Supreme-Court-rules-for-cheap-cancer-drug/articleshow/19331267.cms. Accessed 2 April 2013

  51. Glivec from Novartis India. https://dir.indiamart.com/impcat/glivec-tablets.html

  52. Imatinib Price of 22 Brands in India. https://www.medindia.net/drug-price/imatinib.htm. Accessed 2 February 2017

  53. Imatinib brands in India. http://www.drugsupdate.com/brand/showavailablebrands/65

  54. de Almeida Filho TP, Maia Filho PA, Barbosa MC, Dutra LLA, Castro MFD, Duarte FB et al (2019) Does BCR-ABL transcript type influence the prognosis of patients in chronic myelogenous leukemia chronic phase? Hematol Transfus Cell Ther 41:114–118. https://doi.org/10.1016/j.htct.2018.10.003

    Article  PubMed  PubMed Central  Google Scholar 

  55. Baccarani M, Castagnetti F, Gugliotta G, Rosti G, Soverini S, Albeer A et al (2019) The proportion of different BCR-ABL1 transcript types in chronic myeloid leukemia. An international overview. Leukemia 33:1173–1183. https://doi.org/10.1038/s41375-018-0341-4

    Article  CAS  PubMed  Google Scholar 

  56. Jinawath N, Norris-Kirby A, Smith BD, Gocke CD, Batista DA, Griffin CA, Murphy KM (2009) A rare e14a3 (b3a3) BCR-ABL fusion transcript in chronic myeloid leukemia. J Mol Diagn 11:359–363. https://doi.org/10.2353/jmoldx.2009.090008

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  57. Hughes TP, Kaeda J, Branford S, Rudzki Z, Hochhaus A, Hensley ML, Gathmann I, Bolton AE, van Hoomissen I, Goldman JM, Radich JP, International Randomised Study of Interferon versus STI571 (IRIS) Study Group (2003) Frequency of major molecular responses to imatinib or interferon-alpha plus cytarabine in newly diagnosed chronic myeloid leukemia. N Engl J Med 349(15):1423–1432

    Article  CAS  PubMed  Google Scholar 

  58. Hughes TP, Deininger M, Hochhaus A, Branford S, Radich J, Kaeda J, Baccarani M, Cortes J, Cross NC, Druker BJ, Gabert J, Grimwade D, Hehlmann R, Kamel-Reid S, Lipton JH, Longtine J, Martinelli G, Saglio G, Soverini S, Stock W, Goldman JM (2006) Monitoring CML patients responding to treatment with tyrosine kinase inhibitors: review and recommendations for harmonizing current methodology for detecting BCR-ABL transcripts and kinase domain mutations and for expressing results. Blood 108(1):28–37

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  59. Branford S, Fletcher L, Cross NC, Muller MC, Hochhaus A, Kim DW et al (2008) Desirable performance characteristics for BCR-ABL measurement on an international reporting scale to allow consistent interpretation of individual patient response and comparison of response rates between clinical trials. Blood 112(8):3330–3338. https://doi.org/10.1182/blood-2008-04-150680

    Article  CAS  PubMed  Google Scholar 

  60. Cross NC, White HE, Müller MC, Saglio G, Hochhaus A (2012) Standardized definitions of molecular response in chronic myeloid leukemia. Leukemia 26(10):2172–2175. https://doi.org/10.1038/leu.2012.104

    Article  CAS  PubMed  Google Scholar 

  61. Arora R, Press RD (2017) Measurement of BCR-ABL1 transcripts on the international scale in the United States: current status and best practices. Leuk Lymphoma 58(1):8–16. https://doi.org/10.1080/10428194.2016.1190974

    Article  CAS  PubMed  Google Scholar 

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  1. Department of Hematology, NRS Medical College, 138, AJC Bose Road, Kolkata, 700014, India

    Abhijit Phukan, Prakas Kumar Mandal & Tuphan K. Dolai

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Phukan, A., Mandal, P.K. & Dolai, T.K. Efficacy and safety profile of generic imatinib in patients with newly diagnosed chronic myeloid leukemia-chronic phase: sharing experience of a hemato-oncology center from eastern India. Ann Hematol 100, 85–96 (2021). https://doi.org/10.1007/s00277-020-04289-8

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