2010NCCN骨髓生长因子使用指南

Continue NCCN Clinical Practice Guidelines in Oncology™ Myeloid Growth Factors V.1.2010 www.nccn.org Version 1.2010, 12/07/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. Practice Guidelines in Oncology – v.1.2010 Guidelines Index Myeloid Growth Factors TOC Discussion, ReferencesMyeloid Growth FactorsNCCN ® NCCN Myeloid Growth Factors Panel Members Jeffrey Crawford, MD/Chair Duke Comprehensive Cancer Center Jeffrey Allen, MD James Armitage, MD Lodovico Balducci, MD H. Lee Moffitt Cancer Center and Research Institute Charles Bennett, MD, PhD, MPP Robert H. Lurie Comprehensive Cancer Center of Northwestern University Douglas W. Blayney, MD University of Michigan Comprehensive Cancer Center † ‡ † St. Jude Children's Research Hospital/University of Tennessee Cancer Institute. Þ † ‡ † ‡ Þ † ‡ ‡ UNMC Eppley Cancer Center at The Nebraska Medical Center Spero R. Cataland, MD The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute David C. Dale, MD Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance Gary H. Lyman, MD, MPH Sarah C. Miyata, RN, MSN, ACNP-CS Robert H. Lurie Comprehensive Cancer Center of Northwestern University Martin S. Tallman, MD Robert H. Lurie Comprehensive Cancer Center of Northwestern University Saroj Vadhan-Raj, MD The University of Texas M. D. Anderson Cancer Center Peter Westervelt, MD, PhD Siteman Cancer Center at Barnes- Jewish Hospital and Washington University School of Medicine Michael Westmoreland, PharmD The University of Texas M. D. Anderson Cancer Center Michael K. Wong, MD, PhD Roswell Park Cancer Institute † ‡ Duke Comprehensive Cancer Center # ‡ Þ † † � * † Medical oncology ‡ Hematology/Hematology oncology Þ Internal medicine Infectious diseases Pharmacology # Nursing � � * Writing Committee Member George D. Demetri, MD Dana-Farber/Brigham and Women’s Cancer Center Harry P. Erba, MD, PhD University of Michigan Comprehensive Cancer Center James Foran, MD University of Alabama at Birmingham Comprehensive Cancer Center Marti Goemann, RPh Vanderbilt-Ingram Cancer Center Mark L. Heaney, MD, PhD Memorial Sloan-Kettering Cancer Center Sally Htoy, PharmD City of Hope Comprehensive Cancer Center Susan Hudock, PharmD The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Dwight D. Kloth, PharmD Fox Chase Cancer Center David J. Kuter, MD, DPhil Massachusetts General Hospital Cancer Center † † ‡ † † ‡ Þ † ‡ � � � Continue NCCN Guidelines Panel Disclosures Version 1.2010, 12/07/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. Practice Guidelines in Oncology – v.1.2010 Guidelines Index Myeloid Growth Factors TOC Discussion, ReferencesMyeloid Growth FactorsNCCN ® These guidelines are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The National Comprehensive Cancer Network makes no representations or warranties of any kind, regarding their content use or application and disclaims any responsibility for their application or use in any way. These guidelines are copyrighted by National Comprehensive Cancer Network. All rights reserved. These guidelines and the illustrations herein may not be reproduced in any form without the express written permission of NCCN. ©2009. Table of Contents NCCN Myeloid Growth Factors Panel Members Evaluation, Risk Assessment and Prophylactic Therapy (MGF-1 Evaluation Prior to Second and Subsequent Chemotherapy Cycles (MGF-2 Examples of Chemotherapy Regimens and Risk of Febrile Neutropenia (MGF-A Patient Risk Factors for Febrile Neutropenia (MGF-B Guidelines Index Print the Myeloid Growth Factors Guideline Summary of the Guidelines Updates ) ) ) ) Therapeutic Use of CSF For Febrile Neutropenia (MGF-3 Disease Settings and ) Developing Myeloid Growth Factors for Prophylaxis and Treatment of Febrile Neutropenia and Maintenance of Scheduled Dose Delivery (MGF-C Toxicity Risks with Growth Factors (MGF-D Patient Risk Factors for Poor Clinical Outcomes or for Developing Infection- Associated Complications (MGF-E ) ) ) Clinical Trials: Categories of Evidence and Consensus: NCCN The believes that the best management for any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. To find clinical trials online at NCCN member institutions, All recommendations are Category 2A unless otherwise specified. See NCCN click here: nccn.org/clinical_trials/physician.html NCCN Categories of Evidence and Consensus For help using these documents, please click here Discussion References Version 1.2010, 12/07/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. Practice Guidelines in Oncology – v.1.2010 Guidelines Index Myeloid Growth Factors TOC Discussion, ReferencesMyeloid Growth FactorsNCCN ® Summary of the Guidelines updates UPDATES MGF-2 MGF-3 MGF-B MGF-C MGF-D MGF-E � � � � � � � Footnote l, “Dose-limiting neutropenic event could be a nadir count or day of treatment count that may otherwise impact planned dose of chemotherapy.” Footnote ‘p’ was modified as, “There are no studies which have addressed therapeutic use of for febrile neutropenia .” First bullet, “Older patient, notably patients age 65 and older” was modified by adding a link, “See NCCN Senior Adult Oncology Guidelines”. Footnote 1, was modified as, “Randomized phase II trials of pegfilgrastim administration the same day as chemotherapy versus administration the day after chemotherapy have shown an increase in febrile neutropenia and/or other adverse events. See discussion for details.” Footnote 4, “Toxicity data are based primarily on studies from leukemia and transplant patients” is new to the page. “Prior episode of febrile neutropenia” was added as a patient risk factor for poor clinical outcome or for developing infection- associated complications. filgrastim in patients who have already received prophylactic pegfilgrastim � MGF-A 1 of 5 Regimens at high risk of febrile neutropenia, the following were added: “HyperCVAD” for treatment of multiple myeloma. “Antithymocyte globulin, rabbit/cyclosporine” for treatment of myelodysplastic syndrome. “Doxorubicin/gemcitabine” for treatment of kidney cancer. � � Summary of the changes in the 1.2010 version of the Myeloid Growth Factors Guidelines from the 1.2009 version include: Version 1.2010, 12/07/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. Practice Guidelines in Oncology – v.1.2010 Guidelines Index Myeloid Growth Factors TOC Discussion, ReferencesMyeloid Growth FactorsNCCN ® Note: All recommendations are category 2A unless otherwise indicated. Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. RISK ASSESSMENT FOR FEBRILE NEUTROPENIAc MGF-1 Evaluation of risk for febrile neutropenia following chemotherapy in adult patients with solid tumors and non-myeloid malignanciesb �Disease �Chemotherapy regimend � High dose therapy � Dose dense therapy � Standard dose therapy �Patient risk factorsd � Treatment intent (curative vs palliative) EVALUATION PRIOR TO FIRST CHEMOTHERAPY CYCLEa CHEMOTHERAPY TREATMENT INTENT CURATIVE/ ADJUVANTh PROLONG SURVIVAL/ QUALITY OF LIFE SYMPTOM MANAGEMENT/ QUALITY OF LIFE High (> 20%) e Intermediate (10 - 20%) Low (< 10%) CSF (category 1 for G-CSF)i CSFk Consider CSF Consider CSFk No CSFNo CSFNo CSFj See Evaluation Prior to Second or Subsequent Chemotherapy Cycles (MGF-2) PROPHYLACTIC USE OF CSF FOR FEBRILE NEUTROPENIAc,f,g Consider CSFk CSF (category 1 for G-CSF)i a b c d e f The NCCN Myeloid Growth Factors Guidelines were formulated in reference to adult patients. For use of growth factors in Myelodysplastic Syndromes, . For use of growth factors in Acute Myeloid Leukemia, . Febrile neutropenia is defined as, s One criterion that places a patient at high risk is a previous neutropenic complication in the immediate previous cycle with no plan to reduce dose intensity. This table applies to prophylaxis for the first cycle of chemotherapy for solid tumors and non-myeloid malignancies. . ingle temperature: 38.3°C orally or 38.0°C over 1 h; neutropenia: < 500 neutrophils/mcL or < 1,000 neutrophils/mcL and a predicted decline to 500/mcL over the next 48 h. . � � � There are many factors that need to be evaluated to determine a patient’s risk categorization; these include type of chemotherapy regimen ( ) and patient risk factors ( ). see the NCCN Myelodysplastic Guidelines see the NCCN Acute Myeloid Leukemia Guidelines See Toxicity Risks With Growth Factors (MGF-D See the NCCN Prevention and Treatment of Cancer-Related Infections Guidelines See Disease Settings and Examples of Chemotherapy Regimens and Risk of Febrile Neutropenia MGF-A See Patient Risk Factors for Developing Febrile Neutropenia MGF-B See Myeloid Growth Factors for Prophylaxis and Treatment of Febrile Neutropenia and Maintenance of Scheduled Dose Delivery (MGF-C) ) . g CSF= Colony stimulating factors hThe confounding effects of anthracycline and alkylating agent dose, radiation dose and field size, and colony stimulating factors use on the slight excess risk of leukemia and MDS in patients treated with these agents and modalities are currently unquantified. The associated risk of leukemia and MDS has been suggested by epidemiologic studies, but has not been observed in the available prospective randomized studies. i j k There is category 1 evidence for G-CSF for a reduction of: risk of febrile neutropenia, hospitalization, intravenous antibiotics during the course of therapy. There is category 2A evidence for G-CSF for a reduction in infection related mortality during the course of treatment. (See discussion for further detail.) Only consider CSF if patients are at significant risk for serious medical consequences of febrile neutropenia, including death. The use of CSF in this setting is a difficult decision and requires careful discussion between the physician and the patient. If patient risk factors determine the risk is10 -20%, CSF is reasonable. However, if the risk is due to the chemotherapy regimen, other alternatives such as the use of less myelosuppressive chemotherapy or dose reduction, if of comparable benefit, should be explored. Version 1.2010, 12/07/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. Practice Guidelines in Oncology – v.1.2010 Guidelines Index Myeloid Growth Factors TOC Discussion, ReferencesMyeloid Growth FactorsNCCN ® Note: All recommendations are category 2A unless otherwise indicated. Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. MGF-2 EVALUATION PRIOR TO SECOND AND SUBSEQUENT CHEMOTHERAPY CYCLES No febrile neutropenia or dose-limiting neutropenic event c l Febrile neutropenia or dose-limiting neutropenic event c l Prior use of CSF No prior use of CSF Consider dose reduction or change in treatment regimen Repeat assessment after each subsequent cycle Consider CSF ) (See MGF-1 Risk Assessment For Febrile NeutropeniaEvaluate patient prior to second and subsequent chemotherapy cycles SECONDARY PROPHYLAXIS cFebrile neutropenia is defined as, single temperature: 38.3°C orally or 38.0°C over 1 h; neutropenia: < 500 neutrophils/mcL or < 1,000 neutrophils/mcL and a predicted decline to 500/mcL over the next 48 h. . Dose-limiting neutropenic event could be a nadir count or day of treatment count that may otherwise impact planned dose of chemotherapy. � � � l See NCCN Prevention and Treatment of Cancer-Related Infections Guidelines Version 1.2010, 12/07/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. Practice Guidelines in Oncology – v.1.2010 Guidelines Index Myeloid Growth Factors TOC Discussion, ReferencesMyeloid Growth FactorsNCCN ® Note: All recommendations are category 2A unless otherwise indicated. Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. MANAGEMENT OF PATIENTS WITH FEBRILE NEUTROPENIAc,m Patients receiving CSF (filgrastim or s prophylactic argramostim) Patients who have received pegfilgrastimprophylactic Patients who did not receive CSFprophylactic Risk factors not presento for an infection-associated complication Risk factors present for an infection-associated complication o Continue CSF No additional CSFp No CSF Consider CSFq c o p Febrile neutropenia is defined as, single temperature: 38.3°C orally or 38.0°C over 1 h; neutropenia: < 500 neutrophils/mcL or < 1,000 neutrophils/mcL and a predicted decline to 500/mcL over the next 48 h. . For antibiotic therapy recommendations for fever and neutropenia, . The decision to use CSF in the therapeutic setting is controversial. See discussion for further detail. There are no studies which have addressed therapeutic use of filgrastim for febrile neutropenia in patients who have already received prophylactic pegfilgrastim. However, pharmacokinetic data of pegfilgrastim demonstrated high levels during neutropenia and suggests that additional CSF will not be beneficial. here is no data on pegfilgrastim in therapeutic setting. Either filgrastim or sargramostim should be used with initial dosing as outlined on and discontinued at time of neutrophil recovery. � � � m n q . See discussion for further detail. T See the NCCN Prevention and Treatment of Cancer-Related Infections Guidelines see the NCCN Prevention and Treatment of Cancer-Related Infections Guidelines See Patient Risk Factors for Poor Clinical Outcomes or for Developing Infection-Associated Complications (MGF-E Myeloid Growth Factors for Prophylaxis and Treatment of Febrile Neutropenia and Maintenance of Scheduled Dose Delivery (MGF-C ) ) THERAPEUTIC USE OF C FOR FEBRILE NEUTROPENIAc,m,nSF CSF USE DURING CURRENT CHEMOTHERAPY CYCLE MGF-3 Present with febrile neutropeniac PRESENTATION Version 1.2010, 12/07/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. Practice Guidelines in Oncology – v.1.2010 Guidelines Index Myeloid Growth Factors TOC Discussion, ReferencesMyeloid Growth FactorsNCCN ® Note: All recommendations are category 2A unless otherwise indicated. Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. MGF-A 1 of 5 Examples of Disease Settings and Chemotherapy Regimens with a High Risk of Febrile Neutropenia (> 20%) See Chemotherapy Regimens with an Intermediate Risk of Febrile Neutropenia MGF-A (2 of 5 Disease Settings and )See Chemotherapy Regimen References MGF-A (3 of 5) � � � � � This list is not comprehensive, there are other agents/regimens that have a high risk for the development of febrile neutropenia. The exact risk includes agent, dose, and the treatment setting (ie, treatment naive versus heavily pretreated patients). ( ) The type of chemotherapy regimen is only one component of the Risk Assessment. ( ) Pegfilgrastim has not been documented to have benefit in regimens given under a 2 week duration. Note: The references listed for each regimen are limited by the specific populations studied, methods, and collection of data for febrile neutropenia in the clinical trial. See MGF-1 See Patient Risk Factors for Developing Febrile Neutropenia MGF-B *In general, dose dense regimens require growth factor support for chemotherapy administration. Bladder Cancer Breast Cancer Kidney Cancer Non-Hodgkin's Lymphoma Melanoma � � � � � � � � � � � � � � � � � � � � � � � � � � MVAC (methotrexate, vinblastine, doxorubicin, cisplatin) (neoadjuvant, adjuvant, metastatic) Docetaxel + trastuzumab (metastatic or relapsed) Dose dense AC T* (doxorubicin, cyclophosphamide, paclitaxel) (adjuvant) AT (doxorubicin, paclitaxel) (metastatic or relapsed) AT (doxorubicin, docetaxel) (metastatic or relapsed) TAC (docetaxel, doxorubicin, cyclophosphamide) (adjuvant) ICE (ifosfamide, carboplatin, etoposide) (Diffuse Large B-Cell Lymphoma, Peripheral T-cell Lymphomas, 2nd line, salvage) RICE (rituximab, ifosfamide, carboplatin, etoposide) CHOP-14* (cyclophosphamide, doxorubicin, vincristine, prednisone) MINE (mesna, ifosfamide, novantrone and etoposide) (Diffuse Large B-Cell Lymphoma, Peripheral T-cell Lymphomas, 2nd line, refractory) DHAP (dexamethasone, cisplatin, cytarabine) (Peripheral T-cell Lymphomas, Diffuse Large B-Cell Lymphoma, 2nd line) ESHAP (etoposide, methylprednisolone, cisplatin, cytarabine) (Diffuse Large B-Cell Lymphoma, Peripheral T-cell Lymphoma, 2nd line, recurrent) BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) HyperCVAD + r (cyclophosphamide, vincristine, doxorubicin, dexamethasone + r ) Dacarbazine-based combination (dacarbazine, cisplatin, vinblastine) (advanced, metastatic, or recurrent) Dacarbazine-based combination with IL-2, interferon alfa (dacarbazine, cisplatin, vinblastine, IL-2, interferon alfa) (advanced, metastatic, or recurrent) Topotecan Paclitaxel Docetaxel Gemcitabine/ MAID (mesna, doxorubicin, ifosfamide, dacarbazine) Doxorubicin VeIP (vinblastine, ifosfamide, cisplatin) V BEP (bleomycin, etoposide, cisplatin 1 2 4 5 10 11 15 16,17 18 18 28 3 6 9 12 13 14 Esophageal and Gastric Cancer Docetaxel/cisplatin/fluorouracil Antithymocyte globulin, rabbit/cyclosporine 7 20 Doxorubicin/gemcitabine Modified HyperCVAD Decitabine docetaxel r Topotecan ) TIP (paclitaxel, ifosfamide, cisplatin) 8 19 21 22 23 24 25 26 27 29 30 * ituximab ituximab Multiple Myeloma Myelodysplastic syndrome Ovarian Cancer Pancreatic Cancer Sarcoma Small Cell Lung Cance Testicular Cancer � � � � � IP (etoposide,ifosfamide, cisplatin) � Version 1.2010, 12/07/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. Practice Guidelines in Oncology – v.1.2010 Guidelines Index Myeloid Growth Factors TOC Discussion, ReferencesMyeloid Growth FactorsNCCN ® Examples of Chemotherapy Regimens with an Intermediate Risk of Febrile Neutropenia (10-20%)Disease Settings and MGF-A 2 of 5 Note: All recommendations are category 2A unless o