Approach to Treatment in Leukemia

Treatments by Leukemia Type

Acute Lymphoblastic Leukemia

Treatment of ALL can consist of chemotherapy, immunotherapy, and targeted therapy, as well as hematopoietic stem cell transplantation and/or radiation therapy.15

Chemotherapy for ALL consists of four phases: remission induction, postremission consolidation, interim maintenance and intensification, and maintenance. There are typically three to four cycles of chemotherapy over the first 9 to 12 months followed by maintenance therapy for up to three years. Remission is the goal of induction therapy, which is defined as less than 5% blast cells in the bone marrow and resolution of cytopenias.1,15

Patients with negative MRD have a better prognostic outlook than those with positive MRD. MRD classification is also defined as molecular remission and refers to microscopic disease detectable in a bone marrow aspirate sample.6,15

Acute Myeloid Leukemia

Treatment of AML in pediatric patients consists of intensive multiagent chemotherapy.1 In adults, the approach to treatment differs based on the patient’s underlying medical status. Patients who are more medically frail receive less intensive treatment regimens, while those who are considered medically fit are treated with chemotherapy with or without hematopoietic stem cell transplantation.9,14

Medically fit patients undergo induction chemotherapy followed by consolidation with a potential for re-induction between these phases if residual leukemia is detectable on day 14. Allogeneic stem cell transplantation may take place during the first complete remission for patients with intermediate or adverse-risk cytogenetics.14

Older patients are more likely to have medical comorbidities, high-risk cytogenetic abnormalities, or AML with multidrug resistance, all of which may lead them to be classified as medically frail. These patients typically undergo less intensive initial treatment, which may be followed by allogeneic stem cell transplantation if their performance status allows.14 

Chronic Lymphocytic Leukemia

Although chemotherapy, targeted therapy, and radiation therapy are all used in the treatment of CLL, it is considered an incurable disease, so treatment is directed more at symptom management.10,16

Indications for treatment initiation in CLL include the development of symptoms attributable to the disease such as fever, fatigue, symptomatic anemia or thrombocytopenia, or recurrent infections, an increase in lymphocytosis by greater than or equal to 50% in a two month period, or a lymphocyte doubling time of less than 6 months.16

Initial therapy for CLL consists of chemoimmunotherapy with the intent to relieve symptoms, induce durable remissions, and prolong survival. Allogeneic stem cell transplantation may be considered in medically fit patients with relapsed or refractory disease and radiation therapy may be used for lymphadenopathy, hepatomegaly, or splenomegaly that do not respond to chemotherapy.10,16 

Chronic Myeloid Leukemia

Similar to CLL, treatment for CML is not considered curative. However, TKIs, which are the mainstay of therapy, provide effective treatment that has increased the 10-year survival rate to 85%.13,17

While TKIs are most effective when administered in the asymptomatic chronic phase as initial treatment, they are sometimes used in the accelerated or blast phase as well.17

Allogeneic stem cell transplantation may also be used in the treatment of CML. Patients usually undergo transplant during the accelerated or blast phase but it may be done earlier in patients with resistance to TKIs.17

Complications during treatment for ALL can be related to toxicity from pharmacotherapy or breakdown of tumor burden. Tumor lysis syndrome, thrombotic events such as dural sinus thrombosis, deep vein thrombosis, or pulmonary embolism, hemorrhage from thrombocytopenia, and bacterial, fungal, or viral infections can all be life-threatening.20,21

Other potential treatment-related effects of chemotherapy for ALL include mucositis, pancreatitis, hyperglycemia, neuropathy, anaphylaxis, and hypothalamic-pituitary-adrenal axis suppression.20,21

Bleeding, anemia, infection, and tumor lysis syndrome can also occur during treatment for AML. Differentiation syndrome is another potential complication following treatment of AML with certain medications. This presents as fever, edema, and hypotension days to weeks after treatment and requires immediate treatment to prevent life-threatening complications.22

Complications related to anemia, thrombocytopenia, and neutropenia, including infection, can also occur during treatment for CLL. Potentially fatal colitis and hepatotoxicity can occur following treatment with certain agents for CLL, as can pneumonitis.23

As CML is treated with TKIs, treatment complications are generally related to side effects of this medication class. Most side effects are mild to moderate such as fatigue, fluid retention, periorbital edema, weight gain, nausea, diarrhea, skin rashes, and bone or muscle aches. Up to 10% of patients may experience a serious side effect, including arterio-occlusive events.12

Medication by Leukemia Type

Pediatric Acute Lymphoblastic Leukemia

The approach to pediatric ALL treatment involves risk-directed therapy. This approach considers age at diagnosis, initial WBC count, immunophenotype, cytogenetics, early response to treatment and MRD assessment at the end of induction therapy. Patients who are considered to be higher risk generally receive more intensive therapy.1

Remission induction is the first stage of therapy and consists of vincristine, a corticosteroid, and pegylated asparaginase. Daunomycin is added for high-risk patients. In addition, intrathecal chemotherapy is given twice during this stage of treatment. 98% of patients achieve remission following this 4 to 5 week regimen.1

Remission induction is followed by consolidation, which focuses on reducing the risk of future central nervous system (CNS) relapses with intensive CNS therapy, in addition to continued intensive systemic therapy. Consolidation is followed by 14-28 weeks of intensification therapy, which can vary in composition based on risk stratification.1

Maintenance therapy then lasts for 2 to 3 years and consists of mercaptopurine, methotrexate, vincristine, and a corticosteroid.1

Patients with Ph+ ALL may also be treated with imatinib during the course of therapy, a TKI targeting BCR-ABL kinase. This has greatly improved survival in this group of patients from 30% to 70%.1

Relapse may occur and has a much poorer prognosis than initial diagnosis. Duration from diagnosis and site of relapse are important prognostic factors. Bone marrow relapse, which carries the most significant risk, occurs in 15 to 20% of patients. Treatment consists of intensive chemotherapy not previously used followed by allogeneic stem cell transplantation. Immunotherapy may also be used in treatment of relapsed or refractory disease.1 

Pediatric Acute Myeloid Leukemia

Pediatric patients with AML are typically treated with two courses of intensive induction chemotherapy followed by either consolidation therapy using cytarabine or hematopoietic stem cell transplantation.1,24

Induction chemotherapy for AML consists of high-dose cytarabine and an anthracycline. A third agent, such as etoposide or 6-thioguanine, is sometimes used as well. Up to 5% of patients may die before reaching remission of either infection or bleeding.1,24

The induction phase is followed by post-remission therapy. Specific treatment options used in post-remission therapy depend on a patient’s cytogenetic and molecular markers as well as MRD assessment.1,24

Children with high-risk cytogenetics are usually treated with hematopoietic stem cell transplantation during first clinical remission. Patients with lower-risk disease are treated with chemotherapy and usually offered hematopoietic stem cell transplantation only after a relapse has occurred.1,24

Acute promyelocytic leukemia (APL) is a rare subtype of AML that is highly responsive to a combination of anthracyclines, cytarabine, and all-trans-retinoic acid (ATRA, tretinoin). Arsenic trioxide is an additional effective agent for treatment of APL.1,24

Adult Acute Lymphoblastic Leukemia

Treatment for ALL in adults begins with the remission induction phase, much like pediatric ALL treatment. This is followed by post-remission management, which is aimed at eliminating any remaining leukemic cells following remission.25

There are multiple chemotherapy protocols for the induction treatment phase in adults with ALL and none have been shown to be superior to any other.26 These generally consist of vincristine, a glucocorticoid, and an anthracycline in addition to some form of CNS prophylaxis. Some protocols have additional agents such as cyclophosphamide, cytarabine, methotrexate, 6-mercaptopurine, etoposide and teniposide, or asparaginase. 80% of patients achieve complete remission with one of these protocols.26

Examples of these regimens include:25

  • CALGB 8811/9111 ALL regimen
  • CALGB 10403 regimen
  • BFM regimen
  • Hyper-CVAD
  • GRAALL 2003 regimen
  • GRAALL 2005 regimen

Adults with Ph+ ALL can be treated during remission induction with a TKI and patients with CD20 positive B-lymphoblastic leukemia may be treated with rituximab. Examples of TKIs that may be us used in the treatment of Ph+ ALL include dasatinib, imatinib, ponatinib, nilotinib, and bosutinib.15

Post-remission management begins with consolidation therapy, which typically lasts several months and combines medications with different mechanisms of action. Allogeneic stem cell transplantation is recommended in patients with Ph+ ALL as consolidation therapy.15

Following consolidation therapy, patients undergo interim maintenance and late/delayed intensification therapy. This phase involves a variety of possible chemotherapeutic regimens that are less intense than those used during induction and consolidation.15

Following this phase, patients enter maintenance therapy. This typically consists of a combination of vincristine, methotrexate, mercaptopurine, and corticosteroids for a duration of up to three years.15

Relapsed or refractory ALL in adults generally does not respond well to further chemotherapy, which induces a typically brief remission in only one third of patients. However, newer immunotherapies have demonstrated improved outcomes for adults with relapsed or refractory ALL.15

Immunotherapy agents used for relapsed or refractory ALL:15,27

  • Blinatumomab: A bispecific T-cell engager (BiTE) that binds to CD19 on B-cells and CD3 on T-cells and mediates cytolytic protein production, inflammation, and lysis of CD19-positive cells. It is approved for use in children and adults with CD19-positive ALL who are MRD positive in first or second complete remission or who have relapsed or refractory disease.15,27,28
  • Inotuzumab ozogamicin: A CD22-directed monoclonal antibody that releases ​​calicheamicin once internalized. It is approved for treatment of relapsed or refractory B-cell precursor ALL in adults.15,27,29
  • Tisagenlecleucel: A CD19-directed CAR T-cell therapy. It is approved for use in treatment of refractory or B-cell precursor ALL and second or later relapse for patients up to 25 years old.15,27,30
  • Brexucabtagene autoleucel: A CD19-directed CAR T-cell therapy. It is approved for relapsed or refractory B-cell precursor ALL in adults.27,30 

Adult Acute Myeloid Leukemia

Treatment of adults with ALL is approached differently in those who are considered medically fit than those who are not. Once remission is obtained, those who are able undergo intensive remission induction followed by further treatment. In the consolidation phase, patients may receive additional chemotherapy or undergo allogeneic stem cell transplantation.8,14

Induction therapy for adults with AML typically consists of 7 days of intravenous cytarabine with daunorubicin or idarubicin also administered intravenously for three days during this time. With this regimen, which induces significant cytopenias and related side effects, 70% to 85% of patients with favorable genetics, 60% to 75% of those with intermediate genetics, and 25% to 40% of patients with adverse genetics will achieve complete remission. However, there is a high rate of relapse.14

Re-induction may be recommended for patients with residual disease on day 14 of treatment. This may include the same chemotherapy regimen and/or targeted therapies.

Targeted therapy agents used for treatment of AML:8,14,32

  • Midostaurin: A TKI that inhibits FLT3 receptor signaling and cell proliferation. It is approved for use in adults with newly diagnosed FLT3 mutation-positive AML. It can be used in combination with cytarabine and daunorubicin for induction and cytarabine for consolidation therapy.8,14,32,33
  • Gilteritinib: A TKI that inhibits FLT3 receptor signaling and cell proliferation. It is approved for use in adults with relapsed or refractory FLT3 mutation-positive AML.8,32,34
  • Ivosidenib: An oral small-molecule inhibitor of isocitrate dehydrogenase 1 (IDH1). It is approved for use in adults with a new diagnosis of AML and an IDH1 mutation who are >75 years old or unable to undergo intensive induction chemotherapy. It is also approved for use in adults with relapsed or refractory IDH1 mutation-positive AML.8,32,35
  • Enasidenib: A small-molecule inhibitor of IDH1. It is approved for use in adults with relapsed or refractory IDH1 mutation-positive AML.8,32,36
  • Gemtuzumab ozogamicin: An anti-CD33 humanized monoclonal antibody-drug conjugate. It is approved for use in treatment of newly diagnosed CD33-positive AML in patients > 1 month old and relapsed or refractory CD33-positive AML in patients > 2 years old.8,14,32,37
  • Venetoclax: A selective inhibitor of the anti-apoptotic protein BCL-2, which is overexpressed in AML cells. It is approved for use in treatment of patients with newly-diagnosed AML who are ≥75 years of age or unable to undergo intensive induction chemotherapy when used in combination with azacitidine, decitabine, or low-dose cytarabine.8,14,32,38
  • Glasdegib: A small molecule inhibitor of the Hedgehog pathway. It is approved for use in treatment of patients with newly-diagnosed AML who are ≥75 years old or unable to undergo intensive induction chemotherapy when used in combination with low-dose cytarabine.8,14,32,39
  • Azacitidine: A hypomethylating agent. It is approved for use in maintenance treatment of adults with AML in first complete remission or complete remission with incomplete blood count recovery after intensive induction chemotherapy who are not able to complete intensive curative therapy.8,14,40 

Chronic Lymphocytic Leukemia

There is no standard chemoimmunotherapy protocol for the treatment of CLL. Instead, agents are selected based on patient and disease characteristics and the goals of therapy.16

Chemotherapy agents used in the treatment of CLL include purine analogs (​​fludarabine, pentostatin, and cladribine), alkylating agents (chlorambucil, bendamustine, and cyclophosphamide), and corticosteroids.16,41

Monoclonal antibodies used for treatment of CLL:11,16,42

  • Rituximab: A CD20-directed monoclonal antibody. It is approved for use in treatment of adults with previously untreated or treated CLL in combination with fludarabine and cyclophosphamide.11,16,42,43
  • Obinutuzumab: A type II CD20-directed monoclonal antibody. It is approved for use in treatment of previously untreated CLL in combination with chlorambucil.11,16,42,44
  • Ofatumumab: A CD20-directed monoclonal antibody. It is approved for use in ​​treatment of previously untreated CLL in combination with chlorambucil when fludarabine-based therapy is unable to be used. It is also approved for use in treatment of relapsed CLL in combination with fludarabine and cyclophosphamide and in CLL that is refractory to fludarabine and alemtuzumab. It can also be used for extended treatment of CLL when patients are in complete or partial response after at least two lines of therapy for recurrent or progressive disease.11,16,42,45
  • Alemtuzumab: A CD52-directed monoclonal antibody. It is approved for treatment of chronic B-cell CLL.11,42,46

Targeted therapy agents used for treatment of CLL:11,16,47

  • Ibrutinib: A Bruton’s tyrosine kinase (BTK) inhibitor. It is approved for use in the treatment of adults with CLL, including those with 17p deletion.11,16,47,48
  • Acalabrutinib: A second-generation BTK inhibitor. It is approved for use in the treatment of adults with CLL.11,47,49
  • Idelalisib: A ​​small molecule inhibitor of phosphatidylinositol 3-kinase (PI3K)-delta. It is approved for use in the treatment of relapsed CLL with rituximab when rituximab monotherapy is not possible secondary to comorbidities.11,16,47,50
  • Duvelisib: An oral inhibitor of PI3K-delta and PI3K-gamma. It is approved for use in the treatment of relapsed or refractory CLL in adults following at least two prior therapies.11,47,51
  • Venetoclax: A selective inhibitor of the anti-apoptotic protein BCL-2, which is overexpressed in CLL cells. It is approved for use in the treatment of adults with CLL.11,16,38,47 

Chronic Myeloid Leukemia

TKIs are the mainstay of treatment for CML and are generally initiated during the asymptomatic chronic phase when possible, but can also be used in the accelerated or blast phases.

Tyrosine kinase inhibitors used for the treatment of CML:12,17,52

  • Imatinib: A TKI targeting BCR-ABL kinase. It is approved for use in the treatment of adults with newly diagnosed Ph+ CML in the chronic phase. It can also be used for treatment in any phase of CML after failure of interferon-alfa therapy.12,17,52,53
  • Dasatinib: A TKI targeting BCR-ABL kinase. It is approved for use in the treatment of adults and children >1 year old with newly diagnosed Ph+ CML in the chronic phase. It can also be used for treatment of chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy.12,17,52,54
  • Nilotinib: A TKI targeting BCR-ABL kinase. It is approved for use in the treatment of adults and children >1 year old with newly diagnosed Ph+ CML in the chronic phase. It can also be used for treatment of chronic or accelerated phase Ph+ CML in adults resistant or intolerant to prior therapy that included imatinib or pediatric patients >1 year old with resistance or intolerance to prior TKI therapy.12,17,52,55
  • Bosutinib: A TKI targeting BCR-ABL kinase. It is approved for use in the treatment of adults with newly diagnosed Ph+ CML in the chronic phase. It can also be used for treatment of patients in any phase of CML with resistance or intolerance to prior therapy.12,17,52,56
  • Ponatinib: A TKI targeting BCR-ABL kinase. It is approved for use in the treatment ​​of adults with CML in the chronic phase with resistance or intolerance to at least two prior TKIs. It can also be used for treatment of CML in adults in the accelerated or blast phase for whom no other TKIs are indicated and treatment of T315I-positive CML in any phase.12,17,52,57
  • Asciminib: A TKI targeting BCR-ABL kinase. It is approved for use in the treatment of adults with Ph+ CML in the chronic phase who were previously treated with two or more TKIs or those with the T315I mutation.12,52,58

Occasionally, additional medications are used palliatively in the treatment of CML. Hydroxyurea can be used to reduce splenomegaly or lymphadenopathy and reduce the risk of tumor lysis syndrome and gout. Interferon is occasionally used and may lead to clinical remission in a minority of patients.17

 

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