Adverse Events of Systemic Anti-Cancer Therapies (SACT)

Instructor: Shereen Nabhani-Gebara, PharmD, BCOP, SFHEA, MBOPA
Course: PY6011


Role of the Cancer Pharmacist

  • Significance: The role of the cancer pharmacist is becoming increasingly important due to several factors:

    • Increasing number of SACT: There is a growing array of systemic anti-cancer therapies being employed.

    • Complexity of regimens: Regimens involving SACT are becoming more complicated.

    • Specialized therapies: New therapies demand more specialized understanding and management.

  • Improved survival rates: Patients are living longer due to advancements in cancer treatment.

  • Co-morbidities: With longer patient survival, there is a rise in co-morbid conditions that need to be managed.

  • Management of toxicities: There is a crucial need for the prevention and management of both short and long-term toxicities associated with cancer treatment.

  • Pharmacist-led clinics: These clinics are vital for addressing the medication-related needs and complications of patients undergoing SACT.


Blood and Bone Marrow

Components of Bone Marrow
  • The bone marrow is essential for producing:

    • Red Blood Cells (RBCs)

    • White Blood Cells (WBCs)

    • Platelets

    • Typical counts include:

    • Total WBC count: 6300

      • Breakdown of WBC types:

      • Lymphocyte, Monocyte, Eosinophil, Basophil, Neutrophil.


Bone Marrow Suppression

Neutropenia
  • Definition: A condition characterized by a low neutrophil count, leading to a high risk of infection.

  • Management: Often managed with education about hygiene practices such as:

    • Handwashing for visitors

    • Wearing masks in crowded areas

    • Avoiding contact with sick individuals

    • Preventing activities that increase infection risk (e.g., changing nappies, swimming, etc).

Anemia
  • Symptoms of anemia: Includes fatigue, pallor, and shortness of breath.

  • Transfusions: Might be needed to address severe anemia.

Thrombocytopenia
  • Risk: Patients are at risk of bleeding.

  • Management: Transfusions might be necessary for critically low platelet counts.

  • Erythrocytes (RBCs): Frequently administered to quickly elevate hemoglobin levels.

Nadir
  • Definition: Refers to the lowest point of blood cell count following chemotherapy, typically occurring 7-14 days post-chemotherapy.

  • Absolute Neutrophil Count (ANC): Calculated using the formula:
    extANC=extPercentageofneutrophilsimesextWBCcount/100ext{ANC} = ext{Percentage of neutrophils} imes ext{WBC count} / 100


Complications of Neutropenia

Counseling Points
  • Hygiene and Safety: Recommendations include:

    • Wash hands regularly

    • Avoid crowded places and sick individuals

    • Caution with pets and flowers.


Nausea and Vomiting

Emetogenic Potentials
  • Classification of drugs by emetogenic potential:

    • High ( >90%): Cisplatin, Doxorubicin and Cyclophosphamide

    • Moderate (30-90%): Doxorubicin, Carboplatin

    • Low (10-30%): Docetaxel

    • Minimal ( <10%): Bevacizumab, Vincristine

Pathophysiology of Nausea & Vomiting
  • Involves an interaction among various mediators including:

    • 5-HT3 receptors

    • Dopamine receptors (D2)

    • Histamine (H1)

    • Acetylcholine (ACh)

    • Substance P

  • The vomiting center is located in the brain stem and can be triggered by:

    • Vagal and sympathetic afferents.

Management of Nausea and Vomiting
  • Prokinetics: Metoclopramide

  • Antihistamines: Cyclizine, Promethazine

  • Dopamine antagonists: Haloperidol, Olanzapine

  • 5-HT3 antagonists: Ondansetron

  • NK1 antagonists: Aprepitant

Types of Nausea/Vomiting
  • Acute: Managed with prophylactic combinations within 30 minutes before chemotherapy.

  • Delayed: Managed with dexamethasone in combinations.

  • Anticipatory: Managed with Lorazepam for anxiety and nausea.


High Emetic Risk Anti-Emetic Regimen Recommendations

  • Day 1 Options:

    • Treatment Option A (preferred):

    1. Olanzapine 2.5–10 mg PO once daily

    2. NK1 receptor antagonist

      • Aprepitant 125 mg PO once

      • Or its injectable form

    3. 5-HT3 receptor antagonist; select one based on specific treatment

      • Dolasetron 100 mg PO once, or others as specified

    4. Dexamethasone 12 mg PO/IV once

    • Follow-up Dose Management for Days 2-4:

    • Continue the use of combinations including Olanzapine and CORTICOSTEROIDS depending on patient needs.


Gastrointestinal Toxicities

Diarrhea
  • Causes: 5FU (Capecitabine), irinotecan

  • Treatment: - Loperamide 2 mg every 2 hrs until 12 hrs of being stool-free.

Constipation
  • Causes: Opioids, Vinca alkaloids (e.g. Vincristine)

  • Management: Use appropriate laxatives for prophylaxis and treatment.

Mucositis
  • Causes: 5FU, significant complication observed with combinations

  • Management: Good oral hygiene, mouthwashes, and ice chips during infusion (particularly with oxaliplatin).


Nephrotoxicity

Overview
  • Culprit Drug: Cisplatin, noted for having a 25-40% incidence rate of nephrotoxicity.

  • Mechanism of Action (MOA): Involves inter-strand cross-links with DNA in renal tubular cells altering water and electrolyte handling.

  • Indicators: Increase in serum creatinine and decrease in urine output, potassium and magnesium levels.

Prevention
  • Hydration: Strategic hydration protocols to mitigate nephrotoxicity.

  • Use of Mannitol: To protect kidneys mens synch
    e.

  • Required urine output (UOP): Maintain at 100 ml/hr.


Hemorrhagic Cystitis

  • Associated Drug: Ifosfamide

  • Mechanism: Bi-product of acrolein is toxic.

  • Prevention Methods: Using Mesna and ensuring hydration during treatment.


Neurotoxicity

Peripheral Nervous System
  • Symptoms: Peripheral neuropathy, paresthesia developing slowly.

  • Notable Drugs: Vinca alkaloids, monitored for cumulative doses (e.g., Cisplatin at 300 mg/m²).

Central Nervous System
  • Notable Drugs: Cytarabine (ARA-C) can cause cerebellar toxicity at high doses (1-3 g/m²) with symptoms like ataxia.

  • Intrathecal Methotrexate: Can lead to chemical meningitis characterized by headaches, nausea/vomiting, and stiff neck; requires steroids for management.


Hepatotoxicity

Overview
  • Mainly asymptomatic but drug dosages require caution due to hepatic metabolism involvement.

  • Key Drugs: Anthracyclines (e.g., Doxorubicin, Epirubicin, Daunorubicin) necessitate careful monitoring of liver enzymes (e.g. bilirubin).


Dermatological Toxicities

Palmar-Plantar Erythrodysesthia (PPE)
  • Commonly Associated With: Capecitabine leading to skin conditions and discomfort.


Extravasation

Mechanism
  • Definition: Leakage of chemotherapeutic agents outside the vessel due to needle dislodgement.

  • Drugs Involved: Doxorubicin, Vincristine, Taxotere.

Effects:
  • Irritants: Pain, inflammation

  • Vesicants: Significant risks include indurations, burning, or necrosis.


Ocular Toxicity

Symptoms
  • Associated with targeted therapies leading to chemical conjunctivitis, blurred vision, and pain particularly following high doses of Cytarabine.

Management
  • Preventive measures include using steroid eye drops throughout treatment and 2 days post-therapy.


Otological Toxicity

Symptoms
  • Cisplatin associated with high frequency hearing loss and coclear damage, irreversible damage without baseline hearing evaluations prior to treatment.


Immune Checkpoint Inhibitors (ICIs)

Overview
  • Mechanism: Tumors exploit CTLA-4 and PD1/PD-L1 pathways, downregulating T-cell activity; ICIs help prevent this.

  • Efficacy: ICIs have transformed outcomes for melanoma and NSCLC (Non-Small Cell Lung Cancer).

Prominent Drugs Include:
  • Atezolizumab (PD-L1 Inhibitor)

  • Pembrolizumab (PD-1 Inhibitor)


Mechanism of Action Comparison: Chemotherapy vs. Immune Checkpoint Inhibitors

  • Chemotherapy: Targets rapidly dividing cells indiscriminately, including both cancer and healthy cells.

  • ICIs: Modulates the immune system by inhibiting checkpoints, preferentially enhancing anti-tumor immune response.

Toxicity Management Differences:
  1. Chemotherapy: Commonly includes nausea, vomiting, anemia, enhanced infection susceptibility. Treatment requires supportive care (antiemetics, antivirals).

  2. ICIs: Immune-related side effects may include skin reactions, colitis, endocrinopathies, etc. Require corticosteroids, monitoring, and potential treatment delays.


Immune-Related Adverse Events (irAEs)

Characteristics
  • Delayed onset: occur weeks to months post-therapy.

Common Organ Systems Affected:
  • Skin: Rash, pruritus

  • Gastrointestinal: Diarrhea, colitis

  • Endocrine: Hypothyroidism, adrenal insufficiency, diabetes

  • Lungs: Pneumonitis

  • Liver: Hepatitis

  • Kidneys: Nephritis

  • Cardiac: Myocarditis

  • Hematologic: Immune thrombocytopenia


Treatment Strategies for irAEs

Management based on Severity:
  • Mild (Grade 1): Symptomatic care without stopping immunotherapy.

  • Moderate (Grade 2): May require pausing treatment, starting corticosteroids.

  • Severe (Grade 3-4): Need high-dose corticosteroids; potential reassessment if rechallenge indicated.

Endocrine Toxicity:
  • Requires lifelong hormone replacement therapy, treatment does not stop immunotherapy.


Follow-Up and Quality of Life Monitoring

Key Aspects
  • Long-Term Monitoring: Continuous organ function assessment and blood counts are vital to identify delayed irAEs.

  • Late-Onset Toxicity: Monitoring extends beyond one year post-treatment is critical.

  • Quality of Life Assessment: Evaluating physical, emotional, and psychosocial wellness facilitates targeted therapeutic interventions.

Specialized Follow-Up Programs
  • Clinics that provide lifelong care to manage chronic complications post-immunotherapy.


Reflect and Feedback

Key Reflection Questions
  • How can equitable cancer care be provided for diverse populations?

  • What protected characteristics and factors may lead to suboptimal experiences? Examples include age, race/ethnicity, and religion.


Cardio-Oncology

Definition
  • The rapidly developing field that addresses the cardiovascular care of individuals receiving anti-cancer therapies.

  • Focuses on prevention, early detection, and management of cardiotoxicities.

Contextual Overview
  • The rising incidence of cardiovascular disease among cancer patients: aging populations, improving survival rates, and increased prevalence of pre-existing cardiovascular disease.


Monitoring Cardiotoxicity in Cancer Patients

Risk Factors
  • Pre-existing cardiovascular disease and its risk factors (modifiable).

Cancer Treatments with Risks
  • Chemotherapy Regimens: Notably anthracyclines and trastuzumab are linked to left ventricular dysfunction.

  • Regular monitoring recommended for baseline cardiovascular risk factors and with continued assessments.


Cardiotoxicity Management

Commonly Identified Conditions
  1. Heart Failure: Cumulative life-time doses (e.g., doxorubicin at 450 mg/m²) may lead to irreversible conditions unless monitored and treated appropriately.

  2. Hypertension and QTc Prolongation: Assessment tools for cardiovascular management during therapy are essential.

  3. Arrhythmias and Atrial Fibrillation: Early cardio-oncology consultations facilitate proper management of risks, engendering lifestyle adjustments and medication evaluations.


Drug Interactions in Cancer Therapy

Overview
  • Complex regimens increase the risk of pharmacological interactions impacting both efficacy and toxicity.

Common Interactions
  • Pharmacokinetic Interactions: Involve multiple liver enzyme pathway interactions including CYP450 enzymes affecting drug metabolism.


Identifying and Managing Cardiotoxicity in Study Cohort

Study Design
  • A retrospective cohort study approved by The Royal Marsden NHS Foundation Trust with a target period spanning from 2017-2019.

Patient Inclusion
  • Non-small cell lung cancer (NSCLC) patients who received anti-cancer agents aligning with study constraints.


Conclusion

Summary of Findings
  • Data detailing distributions of cardiotoxicities, risk factors for developing cardiotoxicities, and therapeutic management will remain the focus of ongoing analysis in future sessions.

Emphasis on Monitoring Practices
  • Continuous assessment protocols are imperative for successful interventions and patient safety.


Case Study Patient GH

Overview
  • A cis-gender woman diagnosed with Grade 3 invasive ductal breast cancer undergoing chemotherapy.

Treatment and Monitoring Outcomes
  • Regular cardiac evaluations post-treatment to measure ejection fraction changes, adapting therapeutic approaches in response to evolving cardiovascular health throughout her treatment informs both oncology and cardiology teams.


Final Thoughts

  • Collaboration among healthcare professionals, continuous education, and patient engagement are foundational for advancing cancer care and achieving optimal outcomes.