Subcutaneous Omacetaxine Mepesuccinate in Patients With Chronic-Phase Chronic Myeloid Leukemia Previously Treated With 2 or More Tyrosine Kinase Inhibitors Including Imatinib

Cortes, Jorge; Nicolini, Franck E.; Wetzler, Meir; Lipton, Jeffrey H.; Akard, Luke P.; Craig, Adam; Nanda, Nisha; Benichou, Annie Claude; Leonoudakis, Janis; Khoury, H. Jean; Hochhaus, Andreas; Baccarani, Michele; Kantarjian, Hagop M.

doi:10.1016/j.clml.2013.03.020

Cited by 53 publications

(45 citation statements)

References 33 publications

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“…Both dasatinib 30 and nilotinib 31 are available for patients who have experienced failure or intolerance to imatinib; other drugs will hopefully soon become available, including bosutinib, 51 ponatinib, 32,33 and omacetaxine. 52 All are valuable agents that have offered clear benefit to many of our patients. Our choice of a second TKI is based on the presence of mutations (which helps only in ϳ 20% of our patients) and the presence of comorbidities that may help select one drug over another.…”

Section: When Do We Change Therapy?mentioning

confidence: 99%

How I treat newly diagnosed chronic phase CML

Cortes

Kantarjian

2012

Blood

102

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The progress made in the understanding of chronic myeloid leukemia (CML) since the recognition of a common chromosomal abnormality to the introduction of ever more effective tyrosine kinase inhibitors is unprecedented in cancer. The expected survival for patients diagnosed with CML today, if properly managed, is probably similar to that of the general population. When managing patients with CML the goal is to achieve the best longterm outcome and we should base the treatment decisions on the data available. The results from cytogenetic and molecular analyses have to be interpreted judiciously and all available treatment options integrated into the treatment plan properly. The availability of several treatment options in CML is an asset, but the temptation of rapid succession of treatment changes because of perceived suboptimal response or for adverse events that could be managed needs to be avoided. Any decision to change therapy needs to weigh the expected long-term outcome with the current option versus the true expectations with any new option, particularly as it relates to irreversible outcomes, such as transformation to blast phase and death. In this manuscript, we discuss the treatment approach that has helped us manage successfully a large CML population. (Blood. 2012;120(7):1390-1397)

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Section: When Do We Change Therapy?mentioning

confidence: 99%

How I treat newly diagnosed chronic phase CML

Cortes

Kantarjian

2012

Blood

102

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“…Accelerated approval was based on the safety and efficacy results from two phase II trials enrolling patients with CP or AP CML (one study involving 202 patients who had failed one or more TKIs and a T315I mutation; the second study involving 203 patients who had failed treatment with two or more TKIs) [73,74].…”

Section: Semi-synthetic Productmentioning

confidence: 99%

Current Management Approaches of Chronic Myeloid Leukemia

Fentie¹,

Woldu²

2017

J Cancer Sci Ther

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Chronic myeloid leukemia is a slowly progressive and clonal myeloproliferative disorder characterized by the presence of Philadelphia chromosome. Even if the global incidence is unknown, CML accounts for 15% to 20% cases of adult leukemia's in USA and is predominantly the disease of adults. It has three phases reflecting the grade of malignancy; chronic phase, accelerated phase and blast crisis phase. Initial diagnosis and monitoring of treatment response is based on hematologic, cytogenetic and molecular assessments that need to be regularly checked. The treatment in each phase had undergone a profound progress over a relatively short period of time, starting with arsenic therapy, radiotherapy, allogeneic hematopoietic stem cell transplantation, recombinant interferon-alfa, busulfan, and hydroxyurea, and more recently with the tyrosine kinase inhibitors. Among tyrosine kinase inhibitors national comprehensive cancer network puts imatinib, dastinib and nilotinib as category 1 recommendation for initial treatment of chronic phase chronic myeloid leukemia. Second generation tyrosine kinase inhibitors; nilotinib, dasatinib, bosutinib and ponatinib had shown inducing higher rates of early optimal responses, although their impact on long-term overall survival remains to be determined. There are also drugs for the treatment of chronic myeloid leukemia such as histone deacetylase inhibitors, proteasome inhibitors and farnesyl transferase inhibitors which are under investigation. In addition to these vaccines are under investigation as a part of treatment for chronic myeloid leukemia which still needs further research.

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“…22 Selected therapeutic regimens of omacetaxine appear in Table 2. [24][25][26] ; pyrexia 23% to 29%, 24,25 (grade 3 or 4) 2% 24 ; asthenia 17% to 27% 24,25 ; peripheral edema 13%, 24 (grade 3 or 4) 5% to 9%.…”

Section: Pharmacokineticsmentioning

confidence: 99%

“…24 F. Infection: Bacterial, viral, fungal, and nonspecified 42%, 24 (grade 3 or 4) 2% to 14%. 24,26,29 G. Musculoskeletal: Arthralgia 23%, 24 (grade 3 or 4) 2% 24 ; back pain 11%, 24 (grade 3 or 4) 2% 26 ; pain in extremity 11%. …”

mentioning

confidence: 99%

“…Gastrointestinal: Diarrhea 32% to 45%, [24][25][26] (grade 3 or 4) 2% 23 ; constipation 18% 23 ; nausea 26% to 64%, (grade 3 or 4) 2% 24 ; vomiting 17% 25 ; abdominal pain 16%. 24 E. Hematologic: Anemia 22% to 100%, 24,25,27 (grade 3 or 4) 22% to 39% [24][25][26][27]29 ; febrile neutropenia 7% to 12% 26,29 ; neutropenia 22% to 54%, [24][25][26][27] (grade 3 or 4) 22% to 47% [24][25][26][27]31 ; thrombocytopenia 56% to 82%, [24][25][26][27][28] (grade 3 or 4) 43% to 76% [24][25][26][27][28] ; lymphopenia 18%, 25 (grade 3 or 4) 16%. 24 F. Infection: Bacterial, viral, fungal, and nonspecified 42%, 24 (grade 3 or 4) 2% to 14%.…”

mentioning

confidence: 99%

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