ANAL CANCER - Jones & Bartlett Learning

1 10/16/06 11:34 AM Page 1. ANAL CANCER . 5-Fluorouracil Mitomycin Radiation Therapy (Wayne State regimen)..2. 5-Fluorouracil: 1000 mg/m2/day IV continuous infusion on days 1 4 and 29 32. Mitomycin: 15 mg/m2 IV on day 1. A. Radiation therapy: 200 cGy/day on days 1 5, 8 12, and 5 19 (total dose, 3000 cGy). Chemotherapy is given concurrently with radiation therapy1,2. 5-Fluorouracil Mitomycin Radiation Therapy (European Organization for Research and Treatment of CANCER [EORTC] regimen) ..3. 5-Fluorouracil: 750 mg/m2/day IV continuous infusion on days 1 5 and 29 33. Mitomycin: 15 mg/m2 IV on day 1. Radiation therapy: 180 cGy/day over 5-week period (total dose, 4500 cGy). Chemotherapy is given concurrently with radiation therapy. If partial or complete response occurs, a boost of 1500 2000 cGy is given1 3. 5-Fluorouracil cisplatin Radiation Therapy (MD Anderson Regimen) ..4. 5-Fluorouracil: 250 mg/m2/day IV continuous infusion on days 1 5 of each week of radiation therapy cisplatin : 4 mg/m2/day IV continuous infusion on days 1 5 of each week of radiation therapy Radiation therapy: Total dose, 5500 cGy over 6 weeks Chemotherapy is given concurrently with radiation therapy1 4.

2 Metastatic Disease and/or Salvage Chemotherapy 5-Fluorouracil cisplatin ..5. 5-Fluorouracil: 1000 mg/m2/day IV continuous infusion on days 1 5. cisplatin : 100 mg/m2 IV on day 2. Repeat cycle every 21 28 5. 1. 10/16/06 11:34 AM Page 2. 2 Anal CANCER 5-FU Mitomycin Radiation Therapy (Wayne State Regimen). Baseline laboratory tests: CBC: Chemistry and carcinoembryonic antigen (CEA). Baseline procedures or tests: Central line placement Initiate IV: sodium chloride Premedicate: 5-HT3 and dexamethasone 10 in 100 cc of normal saline (NS). Administer: Fluorouracil _____mg (1000 mg/m2/day) IV continuous infusion days 1 4 and 29 32. Available in solution as 50 mg/mL. No dilution required. Can be further diluted with sodium chloride or 5% dextrose and water (D5W). AND. Mitomycin _____ mg (15 mg/m2) IV on day 1. Potent vesicant Available in 5-, 20-, and 40-mg vials for IV use. Dilute with sterile water to give a final concentration of mg/mL.

3 Reconstituted solution is stable for 14 days if refrigerated or 7 days at room temperature. Radiation therapy: 200 cGy/day on days 1 5, 8 12, and 15 19 (total dose, 3000 cGy). Chemotherapy is given concurrently with radiation therapy. Major Side Effects Bone Marrow Depression: Dose limiting and cumulative toxicity, with leukopenia being more common than thrombocytopenia. Nadir counts are delayed at 4 6 weeks. Gastrointestinal Toxicities: Nausea and vomiting usually mild to moderate. Mucositis and diarrhea can be severe and dose limiting. Skin: Mitomycin causes tissue necrosis and chemical thrombophlebitos if extravasated. Local tissue irritation progressing to desquamation can occur in radiation (XRT) fields. Do not use oil-based lotions or creams in radiation field. Hyperpigmentation, photosen- sitivity, and nail changes may occur. Hand-foot syndrome can be dose limiting. Ocular: Photophobia, increased lacrimation, acute and chronic conjunctivitis, blepharitis, and blurred vision.

4 Pulmonary: Interstitial pneumonitis. Presents with dyspnea, non-productive cough, and interstitial infiltiates on CXR. Hemolytic-uremic Syndrome: Hematocrit 25%, platelets 100 103/mm3, and renal failure (serum creatinine mg/dL). Rare event ( 2%). Reproductive: Pregnancy category D. Breast feeding should be avoided. Initiate antiemetic protocol: Mild to moderately emetogenic protocol. Supportive drugs: pegfilgrastim (Neulasta) filgrastim (Neupogen). epoetin alfa (Procrit) darbepoetin alfa (Aranesp). Treatment schedule: Chair time 1 hour on days 1 and 29. Total cycle 32 days. Estimated number of visits: Five visits per treatment course. Dose Calculation by: 1. _____ 2. _____. _____ _____. Physician Date _____ _____. Patient Name ID Number _____ _____/ _____/ _____. Diagnosis Ht Wt M2. 10/16/06 11:34 AM Page 3. Anal CANCER 3. 5-FU Mitomycin Radiation Therapy (EORTC Regimen). Baseline laboratory tests: CBC: Chemistry and CEA.

5 Baseline procedures or tests: Central line placement Initiate IV: sodium chloride Premedicate: 5-HT3 and dexamethasone 10 in 100 cc of NS. Administer: Fluorouracil _____mg (750 mg/m2/day) IV continuous infusion days 1 5 and 29 33. Available in solution as 50 mg/mL. No dilution required. Can be further diluted with sodium chloride or D5W. AND. Mitomycin _____ mg (15 mg/m2) IV bolus on day 1. Available in 5-, 20-, and 40-mg vials for IV use. Potent vesicant Dilute with sterile water to give a final concentration of mg/mL. Reconstituted solution stable for 14 days refrigerated or 7 days at room temperature. Radiation therapy: 180 cGy/day over 5 week period. Total dose, 4500 cGy over 5 weeks Chemotherapy is given concurrently with radiation therapy. If partial or complete response seen, a boost of 1500 2000 cGy is given. Major Side Effects Bone Marrow Depression: Dose limiting, and cumulative toxicity with leukopenia more common than thrombocytopenia.

6 Nadir counts are delayed at 4 6 weeks. Gastrointestinal (GI) Toxicities: Nausea and vomiting usually mild to moderate. Mucositis and diarrhea can be severe and dose limiting. Skin: Mitomycin causes tissue necrosis if extravasated. Local tissue irritation progressing to desquamation can occur in XRT fields. Do not use oil-based lotions or creams in radi- ation field. Hyperpigmentation, photosensitivity, and nail changes may occur. Hand-foot syndrome can be dose limiting. Ocular: Photophobia, increased lacrimation, acute and chronic conjunctivitis, blepharitis, and blurred vision. Pulmonary: Interstitial pneumonitis. Presents with dyspnea, non-productive cough, and interstitial infiltiates on CXR. Hemolytic-uremic syndrome: Hematocrit 25%, platelets 100 103/mm3, and renal failure (serum creatinine mg/dL). Rare event ( 2%). Reproductive: Pregnancy category D. Breast feeding should be avoided. Initiate antiemetic protocol: Mild to moderately emetogenic protocol.

7 Supportive drugs: pegfilgrastim (Neulasta) filgrastim (Neupogen). epoetin alfa (Procrit) darbepoetin alfa (Aranesp). Treatment schedule: Chair time 1 hour on days 1 and 29. Total cycle 33 days. Estimated number of visits: Four visits per treatment course. Dose Calculation by: 1. _____ 2. _____. _____ _____. Physician Date _____ _____. Patient Name ID Number _____ _____/ _____/ _____. Diagnosis Ht Wt M2. 10/16/06 11:34 AM Page 4. 4 Anal CANCER 5-FU cisplatin Radiation Therapy (MD Anderson Regimen). Baseline laboratory tests: CBC: Chemistry (including Mg2 ) and CEA. Baseline procedures or tests: Central line placement Initiate IV: sodium chloride Premedicate: 5-HT3 and dexamethasone 10 20 mg in 100 cc of NS. Administer: Fluorouracil _____mg (250 mg/m2/day) IV continuous infusion days 1 5 of each week of radiation therapy Available in solution as 50 mg/mL. No dilution required. Can be further diluted with sodium chloride or D5W.

8 AND. cisplatin _____mg (4 mg/m2/day) IV continuous infusion days 1 5 of each week of radiation therapy Available in solution as 1 mg/mL. Do not use aluminum needles because precipitate will form. Further dilute solution with 250 cc or more NS. Stable for 96 hours when protected from light and only 6 hours if not protected from light. Radiation therapy: Total dose 5500 cGy over 6 weeks Chemotherapy is given concurrently with radiation therapy. Major Side Effects Hypersensitivity Reactions: Facial edema, wheezing, bronchospasm, and hypotension possible with cisplatin . Bone Marrow Depression: Neutropenia, thrombocytopenia, and anemia are dose related. Can be dose limiting for daily 5 or weekly regimens. GI Toxicities: Moderate to severe nausea and vomiting may be acute or delayed. Mucosi- tis and diarrhea can be severe and dose limiting. Metallic taste to food. Renal: Nephrotoxicity is dose related and dose limiting with cisplatin and presents at 10 20 days.

9 Usually reversible. Electrolyte Imbalance: Decreases Mg2 , K , Ca2 , Na , and P levels. Inappropriate secretion of antidiuretic hormone (SIADH). Skin: Alopecia. Local tissue irritation progressing to desquamation can occur in radiation field. Do not use oil-based lotions or creams in radiation field. Hyperpigmentation, pho- tosensitivity, and nail changes may occur. Hand-foot syndrome can be dose limiting. Ototoxicity: High frequency hearing loss and tinnitus. Ocular: Photophobia, increased lacrimation, acute and chronic conjunctivitis, blepharitis, and blurred vision. Reproductive: Pregnancy category D. Breast feeding should be avoided. Azoospermia, impotence, and sterility. Initiate antiemetic protocol: Moderately to highly emetogenic protocol. Supportive drugs: pegfilgrastim (Neulasta) filgrastim (Neupogen). epoetin alfa (Procrit) darbepoetin alfa (Aranesp). Treatment schedule: Chair time 2 hours on day 1 of each week of radiation therapy.

10 Estimated number of visits: Twelve visits per treatment course. Dose Calculation by: 1. _____ 2. _____. _____ _____. Physician Date _____ _____. Patient Name ID Number _____ _____/ _____/ _____. Diagnosis Ht Wt M2. 10/16/06 11:34 AM Page 5. Anal CANCER 5. Metastatic Disease and/or Salvage Chemotherapy 5-FU and cisplatin Baseline laboratory tests: CBC: Chemistry (including Mg2 ) and CEA. Baseline procedures or tests: Central line placement Initiate IV: sodium chloride Premedicate: 5-HT3 and dexamethasone 10 20 mg in 100 cc of NS. Administer: Fluorouracil _____mg (1000 mg/m2/day) IV continuous infusion on days 1 5. Available in solution as 50 mg/mL. No dilution required. Can be further diluted with sodium chloride or D5W. AND. cisplatin _____mg (100 mg/m2) IV on day 2. Available in solution 1 mg/mL. Do not use aluminum needles because precipitate will form. Further dilute solution with 250 cc or more of NS.