Sancitabin

Adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer. Metastatic CRC. 1st-line treatment of advanced gastric cancer in combination w/ platinum-based regimen. In combination w/ docetaxel for locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Monotherapy for locally advanced or metastatic breast cancer after failure of taxanes & anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

Colon & breast cancer, CRC Monotherapy: 1,250 mg/m² twice daily (morning & evening, equiv to 2,500 mg/m² total daily dose) for 14 days followed by a 7-day rest period. Patients w/ stage III colon cancer Adjuvant treatment: Recommended for a total of 6 mth. 1,250 mg/m² twice daily for 14 days followed by a 7-day rest period, given as 3 wk cycles for a total of 8 cycles (24 wk). Breast cancer Combination therapy w/ docetaxel: Start premed w/ an oral corticosteroid (eg, dexamethasone) prior to docetaxel administration. 1,250 mg/m² twice daily for 14 days followed by a 7-day rest period + docetaxel 75 mg/m² as 1-hr IV infusion every 3 wk. Advanced gastric cancer Combination therapy w/ platinum-based compd: Start premed to maintain adequate hydration & anti-emesis prior to cisplatin administration. 1,000 mg/m² twice daily for 14 days followed by a 7-day rest period. 1st dose should be given on the evening of day 1 & last dose should be given on the morning of day 15. Moderate renal impairment (CrCl 30-50 mL/min) Reduce dose to 75% for starting dose of 1,250 mg/m²) when used as monotherapy or in combination therapy. Elderly ≥60 yr In combination w/ docetaxel, reduce starting dose to 75% (950 mg/m² twice daily). May be cautiously escalated to 1,250 mg/m² twice daily.

Should be taken with food: Swallow whole w/ water w/in 30 min after a meal.

Hypersensitivity to capecitabine & fluorouracil; history of severe & unexpected reactions to fluoropyrimidine therapy. Patients w/ known complete absence of dihydropyrimidine dehydrogenase (DPD) activity. Concomitant use w/ sorivudine or chemically related analogues eg, brivudine. Severe leucopenia, neutropenia, or thrombocytopenia. Severe hepatic & renal (CrCl <30 mL/min) impairment. Pregnancy & lactation.

Dose-limiting toxicities (diarrhea, abdominal pain, nausea, stomatitis & hand-foot syndrome). Discontinue treatment immediately in the event of grade 2-4 acute toxicity in patients w/ unrecognised DPD deficiency; if ≥grade 2 dehydration occurs. Not to be used in patients w/ certain homozygous or compd heterozygous mutations in DPYD gene locus causing complete or near complete absence of DPD activity. Patients w/ severe diarrhea; anorexia, asthenia, nausea, vomiting or diarrhea; complete absence of DPD activity; partial DPD deficiency; history of significant cardiac disease, arrhythmias & angina pectoris. Carefully monitor patients w/ severe diarrhea; give fluid & electrolyte replacement if dehydrated. Cardiac arrhythmias, angina pectoris, MI, heart failure & cardiomyopathy. Permanently discontinue treatment in patients who experience severe skin reaction eg, SJS & TEN. Interrupt administration if grade 2 or 3 hand-foot syndrome; treatment-related bilirubin elevations of >3x ULN or hepatic aminotransferases (ALT, AST) elevations of 2.5x ULN occur. Closely monitor INR or prothrombin time in patients receiving oral coumarin-derivative anticoagulant therapy. Patients w/ hypo- or hypercalcemia; peripheral or CNS disease; DM or electrolyte disturbances; rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May cause dizziness, fatigue & nausea; minor or moderate influence on the ability to drive & use machines. Carefully monitor patients w/ mild to moderate liver dysfunction regardless of the presence or absence of liver metastasis. Renal impairment (CrCl 30-50 mL/min). Women of childbearing potential should avoid becoming pregnant during treatment. Not to be used during pregnancy. Discontinue lactation during treatment. Childn <18 yr. Elderly ≥60 yr.

UTI, oral candidiasis, flu; neutropenia, anaemia, febrile neutropenia, thrombocytopenia, leucopenia; dehydration, decreased appetite, hypokalaemia; headache, lethargy, dizziness, paresthesia, peripheral neuropathy, neuropathy; increased lacrimation; epistaxis, cough; abdominal pain, constipation, dyspepsia, gastritis; hyperbilirubinemia/increased blood bilirubin; alopecia, nail disorder; arthralgia; fatigue, pyrexia, malaise; myalgia; infection, fever. Monotherapy: Herpes simplex, nasopharyngitis, lower resp tract infection, sepsis, cellulitis, tonsilitis, pharyngitis, gastroenteritis, fungal & herpes infection, tooth abscess; lipoma; pancytopenia, granulocytopenia, haemolytic anaemia; hypersensitivity; anorexia, diabetes, appetite disorder, malnutrition, hypertriglyceridaemia; insomnia, depression, confusional state, panic attack, depressed mood, decreased libido; dysgeusia, aphasia, memory impairment, ataxia, syncope, balance & sensory disorder; conjunctivitis, eye irritation, reduced visual acuity, diplopia; vertigo, ear pain; angina unstable, pectoris, myocardial ischaemia, atrial fibrillation, arrhythmia, tachycardia, sinus tachycardia, palpitations; thrombophlebitis, DVT, HTN, petechiae, hypotension, hot flush, peripheral coldness; dyspnea, rhinorrhea, pulmonary embolism, pneumothorax, haemoptysis, asthma, dyspnea exertional; diarrhea, vomiting, nausea, stomatitis, GI haemorrhage, upper & lower abdominal pain, flatulence, dry mouth, loose stools, intestinal obstruction, ascites, enteritis, dysphagia, esophagitis, abdominal discomfort, GERD, colitis; jaundice; palmar-plantar, erythrodysaesthesia syndrome, rash, erythema, dry skin, pruritus, skin hyperpigmentation, desquamation, ulcer, rash macular, dermatitis, pigmentation disorders, urticaria, photosensitivity reaction, palmar erythema, swelling face & joint, purpura; pain in extremity, back, bone & facial pain, musculoskeletal stiffness, muscular weakness; hydronephrosis, urinary incontinence, hematuria, nocturia; vag hemorrhage; asthenia, peripheral edema, non-cardiac chest pain, edema, chills, rigors; decreased wt, LFT abnormalities, blood in stool, increased INR, blood creatinine & body temp; blister, overdose; decreased Hb, neutrophils/granulocytes, platelets, lymphocytes, Na & K; increased alkaline phosphatase, SGPT & SGOT, increased or decreased Ca. Combination w/ cisplatin: Herpes zoster; aleukaemic leukaemia; bone marrow depression; hyponatremia, hyperglycemia; sleep disorder; hypoaesthesia; tinnitus, hypoacusis; upper GI hemorrhage, mouth ulceration; abnormal hepatic function; hyperhidrosis; renal failure, acute renal failure; mucosal inflammation; decreased CrCl. Combination w/ docetaxel: Neutropenic fever; taste disturbance; lower limb edema; sore throat; rash erythematous, nail discolouration, onycholysis; weakness, pain in limb, pain. Combination w/ oxaliplatin: Bleeding.

Altered coagulation parameters (PT or INR) w/ coumarin-derivative anticoagulants. Co-administration w/ CYP450 2C9 substrates. Increased phenytoin plasma conc. Decreased rate of absorption w/ food. Small increase in plasma conc & metabolite (5'-DFCR) w/ antacid. Enhanced toxicity by leucovorin. Possible decreased efficacy of 5-FU w/ allopurinol.

Cytotoxic Chemotherapy

L01BC06 - capecitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.

K