What is the treatment regimen, including drugs, administration, duration, and potential side effects, for a 75-year-old patient with newly diagnosed Acute Myeloid Leukemia (AML), who is in good health and being treated intensively in a hospital setting?

Treatment Regimen for Intensive AML Therapy in a Fit 75-Year-Old Patient

For a 75-year-old patient in excellent health receiving intensive therapy, the standard regimen is "7+3" induction consisting of cytarabine 100-200 mg/m² continuous infusion for 7 days combined with an anthracycline (daunorubicin 60-90 mg/m² or idarubicin 12 mg/m²) for 3 days, followed by multiple cycles of consolidation chemotherapy. 1

Induction Phase: Days 1-7

Drug Administration:

• Cytarabine: 100-200 mg/m² as continuous IV infusion for 7 consecutive days 1
• Anthracycline (choose one):
  • Daunorubicin 60-90 mg/m² IV push on days 1,2, and 3 1
  • Idarubicin 12 mg/m² IV push on days 1,2, and 3 1
  • Mitoxantrone 12 mg/m² IV on days 1,2, and 3 (alternative) 1

Critical Decision Point: At age 75 with good performance status and favorable/intermediate cytogenetics (especially core-binding factor AML or NPM1-mutated AML), this intensive approach achieves 75% complete remission rates with only 16% early death rate, making it a very reasonable option 1

Consolidation Phase: Post-Remission Therapy

If complete remission is achieved (typically assessed around day 14-28), consolidation consists of:

• Multiple cycles (typically 3-6 cycles) of chemotherapy 1
• Intermediate-dose cytarabine: 1-2 g/m² every 12 hours for 6 doses (3 days) per cycle 1
• Cycles repeated every 4-6 weeks depending on count recovery 1

Duration: The entire consolidation phase spans approximately 3-6 months, with 6 cycles of outpatient consolidation showing superior disease-free survival and overall survival compared to single-cycle consolidation 1

Mutation-Specific Modifications

For FLT3-mutated AML:

• Add midostaurin 50 mg orally every 12 hours on days 8-21 during induction 1
• Continue midostaurin through consolidation and maintenance for total of 12 months 1

For favorable genetics (CBF-AML, NPM1-mutated):

• Consider dose escalation during consolidation with higher-dose cytarabine 1

Major Side Effects and Toxicities

Hematologic Toxicity (Universal):

• Profound myelosuppression lasting 3-4 weeks after each cycle 1, 2
• Severe neutropenia requiring transfusion support (red cells and platelets) 1
• Febrile neutropenia occurs in 30-68% of patients 3

Infectious Complications:

• High risk of bacterial, fungal, and viral infections during neutropenic periods 3, 4
• Requires prophylactic antibiotics, antifungals, and antivirals 3, 4

Cardiac Toxicity:

• Anthracyclines cause dose-dependent cardiotoxicity 3, 4
• Risk of heart failure, especially with cumulative doses 3
• Requires baseline cardiac assessment and monitoring 3, 4

Gastrointestinal Effects:

• Severe nausea and vomiting 2
• Mucositis (mouth sores) 2
• Diarrhea 2

Tumor Lysis Syndrome:

• Risk during initial treatment, especially with high blast counts 1
• Requires aggressive hydration and allopurinol/rasburicase prophylaxis 3, 4

Early Mortality Risk:

• 30-day mortality ranges from 8-14% even in selected fit patients 5, 4
• 8-week mortality can reach 16-31% depending on additional risk factors 6

Critical Monitoring Requirements

During Induction (Hospital Stay: 4-6 weeks):

• Daily complete blood counts 2
• Twice-weekly chemistry panels for tumor lysis syndrome 3, 4
• Frequent vital signs and infection surveillance 3
• Bone marrow assessment around day 14 to evaluate response 1

During Consolidation (Outpatient with frequent visits):

• Weekly blood counts initially, then as needed 1
• Pre-treatment counts must show adequate recovery (typically ANC >1000, platelets >75,000) 2

Common Pitfalls to Avoid

Age alone should not exclude intensive therapy - the guidelines explicitly state that age 75 or older with good performance status and no comorbidities can receive standard intensive therapy, particularly with favorable cytogenetics 1

Do not underestimate early mortality risk - even with careful patient selection, 26-30% of patients may die during or shortly after induction 1, 5, 6

Cytogenetics matter critically - patients with adverse cytogenetics have poor outcomes even with intensive therapy and may be better served by alternative approaches or clinical trials 1

Consolidation cannot be abbreviated - the French ALFA 9803 trial demonstrated that 6 cycles of consolidation provided superior outcomes compared to 1 cycle, despite longer duration 1

Cardiac monitoring is mandatory - anthracycline cardiotoxicity is cumulative and can be life-threatening, requiring baseline echocardiogram and periodic reassessment 3, 4