ANAPLASTIC LARGE CELL LYMPHOMA TREATMENT ROAD MAP (Modified ALCL99)

Transcription

1 ANAPLASTIC LARGE CELL LYMPHOMA TREATMENT ROAD MAP (Modified ALCL99) CLASSIFICATION OF TREATMENT GROUPS: 1. Isolated Skin lesions, < 5 skin lesions. Treatment course: ( No treatment, wait and see approach) 2. Low Risk ( completely resected isolated skin lesion): TREATMENT COURSE : ProPhase Cycle A1 cycle B1, Cycle A2 (3 cycles) 3. Standard Risk (No skin involvement proven by biopsy, No mediastinal involvement, no liver, lung, or spleen involvement) TREATMENT COURSE: Prophase Cycle A1 Cycle B1, Cycle A2 Cycle B2 Cycle A3, Cycle B3 (6 cycles) 4. High Risk( Presence of biopsy proven skin lesions, mediastinal involvement, liver enlargement 5 cm, or nodular liver, spleen enlargement or nodular spleen, lung involvement. TREATMENT COURSE: Prophase Cycle A1 Cycle B1, Cycle A2 Cycle B2 Cycle A3, Cycle B3 (6 cycles) REQUIREMENTS FOR STARTING CHEMOTHERAPY TREATMENT COURSE Cycle 1: should begin on Day 6 of the prophase. Subsequent Cycles: should begin on Day 22 of the previous cycle when peripheral counts have recovered with ANC 500/mm3 and platelets 50,000/mm3 (whichever occurs later). Therapy may be delayed for sever complication. TREATMENT SCHEDULE Cycle Day Given date Cycle Length Chemotherapy treatment Pro-Phase 0 5 Days Cyclophosphamide Day 1&2 Dexamethasone Day 1-5 Triple Intrathecal Day 1 Cycle A Days Dexamethasone Day1-5 Ifosfamide Days 1-5 Cytarabine days 4&5 Etoposide Days 4 &5 Cycle B Days Dexamethasone Day 1-5 Cyclophosphamide Days 1-5 Doxorubicine Days 4 & 5 Cycle A Days Dexamethasone Day1-5 Ifosfamide Days 1-5 Cytarabine days 4&5 Etoposide Days 4 &5 Cycle B Days Dexamethasone Day 1-5 Cyclophosphamide Days 1-5 Doxorubicine Days 4 & 5 Cycle A Days Dexamethasone Day1-5 Ifosfamide Days 1-5 Cytarabine days 4&5 Etoposide Days 4 &5 Cycle B Days Dexamethasone Day 1-5 Cyclophosphamide Days 1-5 Doxorubicine Days 4 & 5 Work up CBC/diff/plts, Renal Profile, Electrolytes, LFT s,urinalysis BM aspirate, Scans ( CT or MRI, Bone Scan for bone primary disease only, ECHO/EKG CBC/diff/plts, Renal Profile, Electrolytes, LFT s,urinalysis CBC/diff/plts, Renal Profile, Electrolytes, LFT s,urinalysis BM aspirate, Scans ( CT or MRI, Bone Scan for bone primary disease only All sites of disease should be evaluated after CycleB1 and after Cycle B2 if not in CR or CRU after Cycle B1. (After cycle B1, if positive at diagnosis) CBC/diff/plts, Renal Profile, Electrolytes, LFT s,urinalysis CBC/diff/plts, Renal Profile, Electrolytes, LFT s,urinalysis, Echo/EKG BM aspirate, Scans ( CT or MRI, Bone Scan for bone primary disease only All sites of disease should be evaluated after CycleB1 and after Cycle B2 if not in CR or CRU after Cycle B1. (After cycle B1, if positive at diagnosis) CBC/diff/plts, Renal Profile, Electrolytes, LFT s,urinalysis CBC/diff/plts, Renal Profile, Electrolytes, LFT s,urinalysis BM aspirate, Scans ( CT or MRI, Bone Scan for bone primary disease only, ECHO/EKG KING FAISAL SPECIALIST HOSPITAL (General Organization)

2 ANAPLASTIC LARGE CELL LYMPHOMA TREATMENT ROAD MAP (Modified ALCL99) DOSES AND ADMINISTRATION SCHEDULE Drug Route Dosage Patient weight < 10 Kg Pro- Phase Cyclophosphamide (CPM) IV over minutes PO /IV 0.17mg/kg/dose once a day on days 1 Dexamethasone and 2 (DEX) 0.17 mg/kg/dose BID on days 3-5 Intrathecal Triple Therapy (ITT) Cycle A1, A2, and A3 IT Patient weight 10 Kg 7 mg/kg/dose Daily 200 mg/m2/dose Daily Days 1& 2 Age(yrs) Dose MTX: 8mg, HC: 8mg, ARAC: 15mg MTX: 10mg, HC: 10mg, ARAC: 20mg MTX: 12mg, HC: 12mg, ARAC: 25mg 3 MTX: 15mg, HC: 15mg, ARAC: 30mg 5 mg/m2/dose once a day on days 1 and 2 5 mg/m2/dose BID on days 3-5 Administration Schedule Once daily on Days 1 & 2 BID Days 3-5 Dexamethasone (DEX) PO /IV 0.17 mg/kg/dose BID on days mg/m2/dose BID on days 1-5 BID on Days 1-5 Ifosfamide (IFOS) IV over 2 27 mg/kg /dose once daily Days mg/m 2 /dose once daily Days 1-5 On day 1 administer prior to MTX hours Mesna IV 6 mg/kg /dose ( total 16mg/kg/day) 160 mg/m 2 /dose ( total 480 mg/m2/day) On days 1-5, at hours 0,4,and 8 following ifosfamide on days 1-5 Methotrexate (MTX) IV over 3 hours 100mg/kg/dose once on day one 3000 mg/m 2 /dose once on day one Leucovorine IV /PO 15 mg/m2/dose every 6 hours, Start 24 hours from the start of MTX infusion, continue till MTX level < 0.1µM/L Cytrabine( ARAC) IV Over 1 hour Etoposide (ETOP) IV over 2 hours * Cycle B1, B2, and B3 5 mg/kg/dose every 12 hours on days 4 and mg/kg/dose once daily on days 4 and mg/m 2 /dose every 12 hours on days 4 and mg/m 2 /dose once daily on days 4 and 5 Day 1 Give over 1 hour every 12 hours for total of 4 doses Begin after completion of Cytarabine dose each day Dexamethasone (DEX) PO /IV 0.17 mg/kg/dose BID on days mg/m 2 /dose BID on days 1-5 BID on Days 1-5 Cyclophosphamide (CPM) IV over 1 7 mg/kg/dose Daily days mg/m 2 /dose Daily days 1-5 Give prior to MTX on day 1 hour Methotrexate (MTX) IV over 3 hours 100mg/kg/dose once on day one 3000 mg/m 2 /dose once on day one Leucovorine IV /PO 15 mg/m2/dose every 6 hours, Start 24 hours post the start of MTX infusion, continue till MTX level < 0.1µM/L DOXOrubicin(DOXO) IV over 30 min 0.8 mg/m2/dose days 4&5 25mg/m 2 /dose days 4&5 Given IV over 30 minutes *Or as per Pharmacy approved administration guidelines KING FAISAL SPECIALIST HOSPITAL (General Organization)

3 DATE / TIME CHEMOTHERAPY (Cyclophosphamide/Dexamethasone/Triple intrathecal) Anaplastic large Cell Lymphoma (Pro-Phase) Diagnosis: ANL Week: Allergies: CHE CK Height: cm Weight: kg BSA: m 2 Dose reduction: No Yes % dose reduction IV Access: Peripheral Central Labs: CBCD, RHP, UA, MRD Lab Value Parameters: Initiate chemotherapy if ANC 500,Platelets 50,000, Normal ALT, Normal Bilirubin Normal creatinine, urine specific gravity Pre and Post Hydration: for all patients D5- ½ NS+ mmol per liter KCL, at (125ml/m2/hr) = ml/hr for day 1 and 2 Or Pre-chemotherapy: Check appropriate dose Ondansetron (0.15mg/kg/dose ) 1mg, 2mg, 4mg, 8mg IVPB 30 minutes prior to chemotherapy and then PO every 8 hours for 2 days Granisetron (20-40 Mcg/Kg/dose) 0.1mg 0.2mg 0.4mg 0.6mg 0.8mg 1mg 15 min prior to chemotherapy daily for 2 days. Chemotherapy: Begin chemotherapy on: (Specify date): / / (dd/mm/yyyy) Children with body weight 10kg: Dexamethasone (0.17mg/kg/dose) = mg IV/ PO over 10 minutes on day 1&2 Dexamethasone (0.17mg/kg/dose) = mg IV/ PO BID over 10 minutes on day 3-5 Cyclophosphamide (7 mg/kg)= mg IVPB over 30 minuts on days 1 &2 Children with body weight >10 kg: Dexamethasone (5 mg/m 2 /dose) = mg IV/ PO over 10 minutes on day 1&2 Dexamethasone (5 mg/m 2 /dose) = mg IV/ PO BID over 10 minutes on day 3-5 Cyclophosphamide (200mg/m 2 /dose)= mg IVPB over 30 minuts on days 1 &2 Triple Intrathecal Therapy Begin therapy on (Specify date): / / / (dd/mm/yyyy) yrs Methotrexate 8mg, Hydrocortisone 8mg, Cytarabine 15mg yrs Methotrexate 10mg, Hydrocortisone 10mg, Cytarabine 20mg Yrs Methotrexate 12mg, Hydrocortisone 12mg, Cytarabine 25mg >3 Yrs Methotrexate 15mg, Hydrocortisone 15mg, Cytarabine 30mg Physician Signature: Physician Co-Signature: (Page 1 of 1) Pager: Pager: Date: Date:

4 DATE / TIME Or Chemotherapy(Ifosfamide/Methotrexate/Cytarabine/Etoposide) ANAPLASTIC LARGE CELL LYMPHOMA (Cycle A) Diagnosis: Standard Risk ANPL High Risk ANPL Cycle Day: Allergies: Height: cm Weight: kg BSA: m 2 Dose reduction: No Yes % dose reduction Nursing Orders: Strict intake/output Daily weight Urine specific gravity every 4 hrs, notify MD for specific gravity > 1.01 Dipstick urine every shift to maintain urine ph between 7-8(Until MTX level <0.1 micromolar) IV Access: Peripheral Central Chemotherapy Parameters: Initiate chemotherapy if ANC 500,Platelets 50,000, Alt 300units/L, normal Bilirubin Normal Creatinine, urine ph 7.0, urine specific gravity MTX level 24, 48 & 72 hours after the start of Methotrexate until MTX level <0.1 micromolar Pre-chemotherapy: Check appropriate dose Ondansetron (0.15mg/kg) 1mg, 2mg, 4mg, 8mg IVPB 30 minutes prior to chemotherapy and then every 8 hours daily for 5 days. Granisetron (20-40mcg/kg/dose) 0.1mg 0.2mg 0.3mg 0.4mg 0.6mg 0.8mg 1mg IVPB over 15 minutes prior to chemotherapy and every 12 hours if needed daily for 5 days. PRE- IFOSFAMIDE HYDRATION: D 5 W-½ NS + Potassium Chloride mmol per liter + Magnesium sulfate - mmol per liter to run at (125ml/m 2 /hr)= ml/hr to achieve urine specific gravity prior start of ifosfamide PRE AND POST METHOTREXATE HYDRATION ( to start post Ifosfamide infusion) D5-1/2 NS + Sodium Bicarbonate 40 mmol per liter + Potassium Chloride mmol per liter at (125ml/m 2 /hr)= ml/hr until MTX level < 0.1 micromolar (1x10-7 molar) Post- IFOSFAMIDE HYDRATION (tostart following clearance of methotrexate) D 5 W-½ NS + Potassium Chloride mmol per liter + Magnesium sulfate - mmol per liter to run at (125ml/m 2 /hr)= ml/hr to continue for 12 hours post last Ifosfamide dose (Page 1 of 3)

5 DATE / TIME Chemotherapy(Ifosfamide/Methotrexate/Cytarabine/Etoposide) ANAPLASTIC LARGE CELL LYMPHOMA (Cycle A) Chemotherapy: Begin chemotherapy on (Specify date): ( / / ) (dd/mm/yyyy) Children with body weight 10kg: Ifosfamide (27 mg / kg/dose)= mg IVPB Once daily for 5days( Day1-5). Mesna (6 mg / kg/dose) = mg IVPB over 15 minutes immediately prior to Ifosfamide and then at 4 and 8 hours after start of Ifosfamide daily for 5 days. Methotrexate (100mg/kg/dose )= mg in 500 ml Dextrose to run over 3 hours once on day one to start after compleation of ifosfamide infusion Leucovorin (15mg/m 2 /dose)= mg IV/PO every 6 hrs until MTX level 0.1 micromolar (1x10-7 molar). Begin 24 hrs after the completion of the Methotrexate infusion Cytarabine (5mg/kg/dose)= mg IVPB every 12 hoursfor 2 doses ( days 4 and 5) Etoposide (3.5 mg/kg/dose)= mg IVPB once daily for 2 doses( Days 4 and 5) Children with body weight >10kg: Ifosfamide (800 mg / m 2 /dose)= mg IVPB Once daily for 5days( Day1-5). Mesna (160mg / m 2 /dose) = mg IVPB over 15 minutes immediately prior to Ifosfamide and then at 4 and 8 hours after start of Ifosfamide daily for 5 days. Methotrexate (3000mg/ m 2 /dose )= mg in 500 ml Dextrose to run over 3 hours once on day one to start after compleation of ifosfamide infusion Leucovorin (15mg/m 2 /dose)= mg IV/PO every 6 hrs until MTX level 0.1 micromolar (1x10-7 molar). Begin 24 hrs after the start of the Methotrexate infusion Cytarabine (150mg/ m 2 /dose)= mg IVPB every 12 hours for 2 doses ( days 4 and 5) Etoposide (100mg/ m 2 /dose)= mg IVPB once daily for 2 doses( Days 4 and 5) Physician Signature ID: Pager Date: KING FAISAL SPECIALIST HOSPITAL (Page 2 of 3)

6 DATE / TIME Chemotherapy(Ifosfamide/Methotrexate/Cytarabine/Etoposide) ANAPLASTIC LARGE CELL LYMPHOMA (Cycle A) In-case of reaction to Etoposide: Epinephrine ( in case of anaphylactic reaction) 1:1000 (0.01ml/kg) ml SC (max-0.5ml) Hydrocortisone (5 mg/kg)= mg IVP Diphenhydramine (0.5 mg/kg- max 50mg)= mg IVP Additional medications/orders: (for delayed nausea and vomiting post Cisplatin) Metoclopramide (0.5mg/kg-max 10mg)= mg IVPB every 6 hours PRN. Diphenhydramine (0.5mg/kg-max 25mg)= mg IV every 6 hours PRN. Begin with first dose of Metoclopramide and d/c after last dose of Metoclopramide given. Chemotherapy Precautions Avoid administration of Septra, Penicillins, Tazocin, any nonsteroidal antiinflamatory medications,penicillins, proton pump inhibitors, and Imatinib during MTX infusion and for At least 72 hours after the start of the infusion, and until MTX level < 0.1 Micromolar/L (Page 3 of 3)

7 DATE / TIME Or Chemotherapy (Dexamethasone/Methotrexate/Cyclophosphamide/Doxorubicin) ANAPLASTIC LARGE CELL LYMPHOMA (Cycle B) Diagnosis: Standard Risk ANPL High Risk ANPL Cycle Day: Allergies: Height: cm Weight: kg BSA: m 2 Dose reduction: No Yes % dose reduction IV Access: Peripheral Central Nursing Orders: Strict intake/output Daily weight Urine specific gravity every 4 hrs, notify MD for specific gravity > Dipstick urine every shift to maintain urine ph between 7-8(Until MTX level <0.1 micromolar) Labs: CBCD, RHP, UA, MRD before starting, ECHO Laboratory Parameters: Initiate chemotherapy if ANC 500,Platelets 50,000, Alt 300units/L, normal Bilirubin Normal Creatinine, urine ph 7.0, urine specific gravity MTX level 24, 48 & 72 hours after the start of Methotrexate until MTX level <0.1 micromolar Pre-chemotherapy: Check appropriate dose Ondansetron (0.15mg/kg) 1mg, 2mg, 4mg, 8mg IVPB 30 minutes prior to chemotherapy and then every 8 hours daily for 5 days. Granisetron (20-40mcg/kg/dose) 0.1mg 0.2mg 0.4mg 0.6mg 0.8mg 1mg IVPB over 15 minutes prior to chemotherapy and every 12 hours if needed daily for 5 days. PRE-HYDRATION D5-1/2 NS + Sodium Bicarbonate 40 mmol per liter + Potassium Chloride mmol per liter at (125ml/m 2 /hr)= ml/hr until MTX level < 0.1 micromolar (1x10-7 molar) Post- MTX HYDRATION (tostart following clearance of methotrexate) D 5 W-½ NS + Potassium Chloride mmol per liter + Magnesium sulfate - mmol per liter to run at (125ml/m 2 /hr)= ml/hr to continue for 5 days till last dose Of cyclophosphamide Chemotherapy Precautions Avoid administration of Septra, Penicillins, Tazocin, any nonsteroidal antiinflamatory medications,penicillins, proton pump inhibitors, and Imatinib during MTX infusion and for At least 72 hours after the start of the infusion, and until MTX level < 0.1 Micromolar/L (Page 1 of 2)

8 DATE / TIME Chemotherapy (Dexamethasone/Methotrexate/Cyclophosphamide/Doxorubicin) ANAPLASTIC LARGE CELL LYMPHOMA (Cycle B) Chemotherapy: Begin chemotherapy on (Specify date): ( / / ) (dd/mm/yyyy) Children with body weight 10kg: Dexamethasone (0.17mg/kg/dose) = mg IV/ PO BID over 10 minutes on day 1-5 Cyclophosphamide (7 mg/kg)= mg IVPB over 30 minutes on days 1-5 Methotrexate (100mg/kg/dose )= mg in 500 ml Dextrose to run over 3 hours once on day one to start after compleation of cyclophosphsamind infusion Leucovorin (15mg/m 2 /dose)= mg IV/PO every 6 hrs until MTX level 0.1 micromolar (1x10-7 molar). Begin 24 hrs after the completion of the Methotrexate infusion DoxoRubicin (0.8 mg/kg/dose)= mg IVPB over 30 minutes on days 4 and 5 Children with body weight >10kg: Dexamethasone (5 mg/m 2 /dose) = mg IV/ PO BID over 10 minutes on days 1-5 Cyclophosphamide (200mg/m 2 /dose)= mg IVPB over 30 minutes on days 1-5 Methotrexate (3000mg/ m 2 /dose )= mg in 500 ml Dextrose to run over 3 hours once on day one to start after compleation of cyclophosphsamind infusion Leucovorin (15mg/m 2 /dose)= mg IV/PO every 6 hrs until MTX level 0.1 micromolar (1x10-7 molar). Begin 24 hrs after the completion of the Methotrexate infusion DoxoRubicin (25mg/m2/dose)= mg IVPB over 30 minutes on days 4 and 5 In-case of reaction to Etoposide: Epinephrine ( in case of anaphylactic reaction) 1:1000 (0.01ml/kg) ml SC (max-0.5ml) Hydrocortisone (5 mg/kg)= mg IVP Diphenhydramine (0.5 mg/kg- max 50mg)= mg IVP Additional medications/orders: (for delayed nausea and vomiting post Cisplatin) Metoclopramide (0.5mg/kg-max 10mg)= mg IVPB every 6 hours PRN. Diphenhydramine (0.5mg/kg-max 25mg)= mg IV every 6 hours PRN. Begin with first dose of Metoclopramide and d/c after last dose of Metoclopramide given. Physician Signature ID: Pager Date: (Page 2 of 2)