Indications

Metastatic Colorectal Cancer (see Colorectal Cancer)

Rationale

• Used as Single Agent or in Combination Therapy with Bevacizumab (see Bevacizumab)

Clinical Efficacy

• SUNLIGHT Trial (xxxx)

Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma (see xxxx)

Clinical Efficacy

• xxx

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Pharmacology

XXXXXXXXXXX

• xxx

Metabolism

• xxx

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Administration

XXXXX

• xxx

Dose Adjustment

• Hepatic: xxx
• Renal: xxx

Use in Pregnancy (see Pregnancy)

• Contraindicated (Due to Teratogenicity)

Use During Breast Feeding

• Unknown Effects

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Adverse Effects

Cardiovascular Adverse Effects

Atrial Fibrillation (see xxxx)

• Epidemiology
  • Occurs in 0.4% of Patients Treated with Trifluridine-Tipracil in Combination with Bevacizumab

Gastrointestinal Adverse Effects

Abdominal Pain (see xxxx)

• Epidemiology
  • With Single Agent Use of Trifluridine-Tipracil, Occurs in 20% of Cases (vs 18% of Placebo-Treated Patients)

Anorexia (see xxxx)

• Epidemiology
  • With Single Agent Use of Trifluridine-Tipracil, Occurs in 39% of Cases (vs 29% of Placebo-Treated Patients)

Bowel Perforation (see xxxx)

• Epidemiology
  • Occurs in 0.4% of Patients Treated with Trifluridine-Tipracil in Combination with Bevacizumab

Diarrhea (see xxxx)

• Epidemiology
  • Occurs in 32% of Cases (vs 12% of Placebo-Treated Patients)

Elevated Liver Function Tests (LFT’s) (see xxxx)

• Occurs in Patients Treated with Trifluridine-Tipracil in Combination with Bevacizumab

Intestinal Obstruction (see xxxx)

• Epidemiology
  • Occurs in 2.8% of Patients

Nausea/Vomiting (see Nausea/Vomiting)

• Epidemiology
  • With Single Agent Use of Trifluridine-Tipracil, Nausea Occurs in 48% of Cases (vs 24% of Placebo-Treated Patients)
  • With Single Agent Use of Trifluridine-Tipracil, Vomiting Occurs in 28% of Cases (vs 14% of Placebo-Treated Patients)

Rectal Fistula (see xxxx)

• Epidemiology
  • Occurs in 0.4% of Patients Treated with Trifluridine-Tipracil in Combination with Bevacizumab

Hematologic Adverse Effects

Myelosuppression

• Clinical
  • Anemia (see xxxx)
  • Leukopenia/Neutropenia (see xxxx)
  • Thrombocytopenia (see xxxx)

Neurologic Adverse Effects

Fatigue/Asthenia (see xxxx and xxxx)

• Epidemiology
  • With Single Agent Use of Trifluridine-Tipracil, Occur in 52% of Cases (vs 35% of Placebo-Treated Patients)

Other Adverse Effects

Fever (see xxxx)

• Epidemiology
  • With Single Agent Use of Trifluridine-Tipracil, Occur in 19% of Cases (vs 14% of Placebo-Treated Patients)

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References

General

• xxx