Smith et al 102. Rougier P, Bugat R, Douillard JY, et al: Phase cetaxel plus platinum combinations versus viorel. 120. Pettengell R, Gurney H, Radford JA, et al ll study of irinotecan in ne plus cisplatin for advanced non-small-cell lung Granulocyte colony-stimulating factor to in chemosh ancer: The TAX 326 study group. J Clin Oncol dose-limiting and patients pretreated with fluorouracilbased che 21:3016-3024,2003 1a: A randomized controlled trial. blood motherapy. J Clin Oncol 15: 251-260, 1997 111. Hanna N, Shepherd FA, Fossella FV, et al: 14 103. Saltz LB, Cox Jv, Blanke C, et al: Irinotecan Randomized phase Ill trial of pemetrexed versus 121. Velasquez WS, Cabanillas F, Salvador P, et al docetaxel in patients with non-small-cell lung cancer Effective salvage therapy for lymphoma with cispla- tudy Group. N Engl J Med 22:1589-1597.2004 methasone(DHAP). Blood 71: 117-122. 1988 104. Ross P, Nicolson M, Cunningham D, et al 112 Noda K, Nishiwaki Y, Kawahara M, et al rospective randomized trial comparing mitomycin, Irinotecan plus cisplatin compared with etoposide ESHAP-an effective chemotherapy regimen in re- cisplatin, and protracted venous-infusion fluorouracil plus cisplatin for extensive small-cell lung cancer fractory and relapsing ly ma: A4-year follow-up VI 5-FU)with epirubicin, cisplatin, and PV1 5-FU in N Engl J Med 346: 85-91, 2002 dy. J Clin Oncol12:1169-1176,1994 advanced esophagogastric cancer. J Clin Oncol 20: 113. Roth B, Johnson DH. Einhorn LH, et a 123. Gertz MA, Kalish LA, Kyle RA, et al: Phase Ill 1996-2004.2002 Randomized study of cyclophosphamide, doxorubi study comparing vincristine, doxorubicin (Adria 105. Nichols CR, Catalano PJ, Crawford ED, et al: cin, and vincristine versus etoposide and cisplatin cin), and dexamethasone (vAD) chemotherapy with sus alternation of these two regimens in exten. VAD plus recombinant interferon alfa.2 in refractor and either bleomycin or ifosfamide in treatment of re small-cell lung cancer: a phase lll trial of the or relapsed multiple myeloma: An Eastern Cooper advanced diseeminated germ cell tumors: An East. Southeastem Cancer Study Group. J Clin Oncol ative Oncology Group study. Am J Clin Oncol em Cooperative Oncology Group, Southwest Oncol. 10: 282-291, 1992 475-480.1995 ogy Group, and Cancer and Leukemia Group B 114. Schiller JH, Harrington D, Belani CP, et 124. Salmon SE, Crowley JJ, Grogan TM, et al Study. J Clin Oncol 16: 1287-1293, 1998 Comparison of four chemotherapy regimens for Combination chemotherapy, glucocorticoids, and in- 106. Nichols CR, Catalano PJ, Crawford ED, et al advanced nonsmall-cell lung cancer. N Engl J Med terferon alfa in the treatment of multiple myeloma Randomized comparison of cisplatin and etoposide 346: 92-98, 2002 A Southwest Oncology Group study. J Clin Oncol and either bleomycin or ifosfamide in treatment of 115. Skarlos DV, Samantas E. Kosmidis P et al: 12: 2405-2414. 199 advanced disseminated germ cell tumors: An East. andomized comparison of etoposide-cisplatin vs 125. Bookman MA, Malmstrom H, Bolis G, et al em Cooperative Oncology Group, Southwest Oncol- oposide-carboplatin and iradiation in small-cell Topotecan for the treatment of advanced epithelial eukemia Group B lung cancer: A Hellenic Co-operative Oncology ovarian cancer: An open-label phase Il study Study. J Clin Oncol 16: 1287-1293, 1998 Group study. Ann Oncol 5: 601-607, 1994 107. Forastiere AA Metch B, Schuller DE, et al: 116. von Pawel J, Schiller JH, Shepherd FA, et al: tained cisplatin or carboplatin and paclitaxel. J Clin nco16:3345-3352,1998 cil and carboplatin plus fluorouracil versus metho- and vincristine for the treatment of recurrent 126. Ozols RF, Bundy BN, Greer BE, et at: Phase ll trexate in advanced squamous-cell carcinoma of the small-cell lung cancer. J Clin Oncol 17: 658-667, trial of carboplatin and paclitaxel compared with displa head and neck: A Southwest Oncology group study tin and paclitaxel in patients with optimally resecte J Clin Oncol10:1245-1251,1992 117. Wozniak AJ, Crowley JJ, Balcerzak SP, et al: stage Ill ovarian cancer: A Gynecologic Oncology 108. Glisson BS, Murphy BA, Frenette G, et al: roup study. J Clin Oncol 21: 3194-3200, 2003 Phase ll Trial of docetaxel and cisplatin combination plus vinorelbine in the treatment of advanced non- 127. Antman K, Crowley J, Balcerzak SP, et al: An hemotherapy in patients with squamous cell ca small-cell lung gy tergroup phase Ill randomized study of doxorubi noma of the head and neck. J Clin Oncol 20: 1593. Group study. J Clin Oncol 16: 2459-2465, 1998 sfamide and 1599.2002 118. Canellos GP. Anderson JR, Propert K, et al esna in advanced soft tissue and bone sarcomas Chemotherapy of advanced Hodgkins disease with J Clin Oncol 11: 1276-1285, 1993 Multicenter phase l-ll trial of docetaxel, cisplatin, MOPP, ABVD, or MOPP alternating with ABVD and fluorouracil induction chemotherapy for N Engl J Med 327: 1478-1484, 1992 doxorubicin patients with locally advanced squamous cell can. 119. Fisher Rl, Gaynor ER, Dahlberg s, et al: plus ifosfamide in first-ine treatment of advanced cer of the head and neck. J Clin Oncol 19: 1096- Comparison of a standard regimen (CHOP) with soft tissue sarcomas: a randomized study of the ree intensive chemotherapy regimens for ad- European Organization for Research and Treatment 110. Fossella F, Pereira JR, von Pawel J, et al: vanced non-Hodgkins lymphoma. N Engl J Med of Cancer Soft Tissue and Bone Sarcoma Group Randomized, multinational, phase Ill study of do. 328: 1002-1006, 1993 J Clin oncol13:1537-1545,1995 Acknowledge ent The Update Expert Committee wishes to thank Drs Bruce Hillner and Joseph Jacobson, and the Health Services Committee membership for heir thoughtful reviews of earlier drafts Appendix A For the 2004 update, a methodology similar to that applied in the original ASco practice guidelines for use of hematopoietic growth factors was used. Pertinent information published from 1999 through September 2005 was reviewed. The Medline database(National Library of Medicine, Bethesda, MD)was searched to identify relevant information from the published literature for this update. A series of searches was conducted using the medical subject headings or text words, granulocyte colony-stimulating factors, ""granulocyte-macrophage colony-stimulating factors, "filgrastim, "lenogras tim,sargramostim, "and"pegfilgrastim. These terms were combined with the study design-related subject headings or text words(in truncated forms to allow for variations of the root word): "meta-analysis, ""random, " and"phase Ill; " with the subject heading" drug administration schedule"and the text word"dose dense;and with the text word, child. Search results were limited to human studies and English-language articles. The Cochrane Library was searched with the phrase, colony-stimulating factors. Directed searches based on the bibliographies of primary articles were also performed. Finally, Update Committee members contributed articles from their personal collections. Update Committee members reviewed the sulting abstracts and titles that corresponded to their assigned section. 3200 OURNAL OF CLINICAL ONCOLOGY Information downloaded from jco. ascopubs org and 33b halesworth on august 12, 2009 from 202. 120.79.222 Copyright 2006 by the American Society of Clinical Oncology. All rights reserved
102. Rougier P, Bugat R, Douillard JY, et al: Phase II study of irinotecan in the treatment of advanced colorectal cancer in chemotherapy-naive patients and patients pretreated with fluorouracil-based chemotherapy. J Clin Oncol 15:251-260, 1997 103. Saltz LB, Cox JV, Blanke C, et al: Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med 343:905-914, 2000 104. Ross P, Nicolson M, Cunningham D, et al: Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) with epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer. J Clin Oncol 20: 1996-2004, 2002 105. Nichols CR, Catalano PJ, Crawford ED, et al: Randomized comparison of cisplatin and etoposide and either bleomycin or ifosfamide in treatment of advanced disseminated germ cell tumors: An Eastern Cooperative Oncology Group, Southwest Oncology Group, and Cancer and Leukemia Group B Study. J Clin Oncol 16:1287-1293, 1998 106. Nichols CR, Catalano PJ, Crawford ED, et al: Randomized comparison of cisplatin and etoposide and either bleomycin or ifosfamide in treatment of advanced disseminated germ cell tumors: An Eastern Cooperative Oncology Group, Southwest Oncology Group, and Cancer and Leukemia Group B Study. J Clin Oncol 16:1287-1293, 1998 107. Forastiere AA, Metch B, Schuller DE, et al: Randomized comparison of cisplatin plus fluorouracil and carboplatin plus fluorouracil versus methotrexate in advanced squamous-cell carcinoma of the head and neck: A Southwest Oncology Group study. J Clin Oncol 10:1245-1251, 1992 108. Glisson BS, Murphy BA, Frenette G, et al: Phase II Trial of docetaxel and cisplatin combination chemotherapy in patients with squamous cell carcinoma of the head and neck. J Clin Oncol 20:1593- 1599, 2002 109. Posner MR, Glisson B, Frenette G, et al: Multicenter phase I-II trial of docetaxel, cisplatin, and fluorouracil induction chemotherapy for patients with locally advanced squamous cell cancer of the head and neck. J Clin Oncol 19:1096- 1104, 2001 110. Fossella F, Pereira JR, von Pawel J, et al: Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: The TAX 326 study group. J Clin Oncol 21:3016-3024, 2003 111. Hanna N, Shepherd FA, Fossella FV, et al: Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 22:1589-1597, 2004 112. Noda K, Nishiwaki Y, Kawahara M, et al: Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer. N Engl J Med 346:85-91, 2002 113. Roth BJ, Johnson DH, Einhorn LH, et al: Randomized study of cyclophosphamide, doxorubicin, and vincristine versus etoposide and cisplatin versus alternation of these two regimens in extensive small-cell lung cancer: A phase III trial of the Southeastern Cancer Study Group. J Clin Oncol 10:282-291, 1992 114. Schiller JH, Harrington D, Belani CP, et al: Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346:92-98, 2002 115. Skarlos DV, Samantas E, Kosmidis P, et al: Randomized comparison of etoposide-cisplatin vs. etoposide-carboplatin and irradiation in small-cell lung cancer: A Hellenic Co-operative Oncology Group study. Ann Oncol 5:601-607, 1994 116. von Pawel J, Schiller JH, Shepherd FA, et al: Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent small-cell lung cancer. J Clin Oncol 17:658-667, 1999 117. Wozniak AJ, Crowley JJ, Balcerzak SP, et al: Randomized trial comparing cisplatin with cisplatin plus vinorelbine in the treatment of advanced nonsmall-cell lung cancer: A Southwest Oncology Group study. J Clin Oncol 16:2459-2465, 1998 118. Canellos GP, Anderson JR, Propert KJ, et al: Chemotherapy of advanced Hodgkin’s disease with MOPP, ABVD, or MOPP alternating with ABVD. N Engl J Med 327:1478-1484, 1992 119. Fisher RI, Gaynor ER, Dahlberg S, et al: Comparison of a standard regimen (CHOP) with three intensive chemotherapy regimens for advanced non-Hodgkin’s lymphoma. N Engl J Med 328:1002-1006, 1993 120. Pettengell R, Gurney H, Radford JA, et al: Granulocyte colony-stimulating factor to prevent dose-limiting neutropenia in non-Hodgkin’s lymphoma: A randomized controlled trial. Blood 80:1430- 1436, 1992 121. Velasquez WS, Cabanillas F, Salvador P, et al: Effective salvage therapy for lymphoma with cisplatin in combination with high-dose Ara-C and dexamethasone (DHAP). Blood 71:117-122, 1988 122. Velasquez WS, McLaughlin P, Tucker S, et al: ESHAP–an effective chemotherapy regimen in refractory and relapsing lymphoma: A 4-year follow-up study. J Clin Oncol 12:1169-1176, 1994 123. Gertz MA, Kalish LA, Kyle RA, et al: Phase III study comparing vincristine, doxorubicin (Adriamycin), and dexamethasone (VAD) chemotherapy with VAD plus recombinant interferon alfa-2 in refractory or relapsed multiple myeloma: An Eastern Cooperative Oncology Group study. Am J Clin Oncol 18: 475-480, 1995 124. Salmon SE, Crowley JJ, Grogan TM, et al: Combination chemotherapy, glucocorticoids, and interferon alfa in the treatment of multiple myeloma: A Southwest Oncology Group study. J Clin Oncol 12:2405-2414, 1994 125. Bookman MA, Malmstrom H, Bolis G, et al: Topotecan for the treatment of advanced epithelial ovarian cancer: An open-label phase II study in patients treated after prior chemotherapy that contained cisplatin or carboplatin and paclitaxel. J Clin Oncol 16:3345-3352, 1998 126. Ozols RF, Bundy BN, Greer BE, et al: Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: A Gynecologic Oncology Group study. J Clin Oncol 21:3194-3200, 2003 127. Antman K, Crowley J, Balcerzak SP, et al: An intergroup phase III randomized study of doxorubicin and dacarbazine with or without ifosfamide and mesna in advanced soft tissue and bone sarcomas. J Clin Oncol 11:1276-1285, 1993 128. Santoro A, Tursz T, Mouridsen H, et al: Doxorubicin versus CYVADIC versus doxorubicin plus ifosfamide in first-line treatment of advanced soft tissue sarcomas: A randomized study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. J Clin Oncol 13:1537-1545, 1995 ■■■ Acknowledgment The Update Expert Committee wishes to thank Drs Bruce Hillner and Joseph Jacobson, and the Health Services Committee membership for their thoughtful reviews of earlier drafts. Appendix A For the 2004 update, a methodology similar to that applied in the original ASCO practice guidelines for use of hematopoietic growth factors was used. Pertinent information published from 1999 through September 2005 was reviewed. The Medline database (National Library of Medicine, Bethesda, MD) was searched to identify relevant information from the published literature for this update. A series of searches was conducted using the medical subject headings or text words, “granulocyte colony-stimulating factors,” “granulocyte-macrophage colony-stimulating factors,” “filgrastim,” “lenograstim,” “sargramostim,” and “pegfilgrastim.” These terms were combined with the study design-related subject headings or text words (in truncated forms to allow for variations of the root word): “meta-analysis,” “random,” and “phase III;” with the subject heading “drug administration schedule” and the text word “dose dense;” and with the text word, “child.” Search results were limited to human studies and English-language articles. The Cochrane Library was searched with the phrase, “colony-stimulating factors.” Directed searches based on the bibliographies of primary articles were also performed. Finally, Update Committee members contributed articles from their personal collections. Update Committee members reviewed the resulting abstracts and titles that corresponded to their assigned section. Smith et al 3200 JOURNAL OF CLINICAL ONCOLOGY Copyright © 2006 by the American Society of Clinical Oncology. All rights reserved. Information downloaded from jco.ascopubs.org and provided by charlesworth on August 12, 2009 from 202.120.79.222. 第 231 页
2006 Recommendations for wBC Growth Factors Appendix B. Summary of Recomm Specific Recommendations 2005 Recommendations Use of Primary Prophylaxis eneral Circumstances Primary pro nded for the prevention of Factors TREATMENT myelotoxicity the ris f FN is in the range of 20% or higher In the absence gimens have risks of FN of 20%(see Table 1). In actic CsF or not en but also the individual patient f ChoP or CHOp stances might benefit from relatively nonmye chemotherapy but who have potential risk factors for arrow compromise or comorbidity. It is possible that ay ot condusive. Certain clinical ng: patient age gre episodes of FN; extensive prior treatment including large tumor producing cytopenias: poor nutritional status: the advanced cancer. as well as other senous comorbidities In such situations primary prophy with CSF is often appropriate even with regimens with FN rates of 20% Os CSF quidelines nces have recognition that there patient factors that predict for the everity of febrile neutropenia. special circumstances have been maintained from previc versions of the guideline. The rate at which the use of ed from 40% to 20%, consistent with the new evidence that demonstrates efficacy in reducing FN rates when the risk is approximately 20% rY prophylaxis was not received), in which a reduced dose treatment outcome. In many clinical situations, dose reduction or delay may be a reasonable alternativ With Neutropenia CSFs should not be routinely used for patients with Therapeutic Use of CSF's With Neutropenia CSFs should not be rout treatment with antibiotic therapy for patients with fever no neutra risk for infection-associated complications, or who have prognostic factors that are predictive of poor clinical prolonged ( 10 d)and profound(<0.1 x 109/) infection, or being hospitalized at the time of the development of feve Continued on following page) co.org 33y阻 arlesworth on August 12, 2009 from 202. 120.79.222 Copyright 2006 by the American Society of Clinical Oncology. All rights reserved
Appendix B. Summary of Recommendations Specific Recommendations 2005 Recommendations Recommendations for the Use of Hematopoietic Colony-Stimulating Factors TREATMENT Primary Prophylaxis General Circumstances Primary prophylaxis is recommended for the prevention of FN in patients who have a high risk of FN based on age, medical history, disease characteristics, and myelotoxicity of the chemotherapy regimen. For “dose dense” regimens CSFs are required and recommended. Clinical trial data support the use of CSF when the risk of FN is in the range of 20% or higher. In the absence of special circumstances, most commonly used regimens have risks of FN of 20% (see Table 1). In making the decision to use prophylactic CSF or not, oncologists should consider not only the optimal chemotherapy regimen but also the individual patient risk factors and the intention of treatment, that is, curative, prolongation of life, or symptom control and palliation. Examples of appropriate use in the curative setting include adjuvant treatment of early-stage breast cancer with more intensive regimens such as TAC or FEC100 or the use of CHOP or CHOP-like regimens in older patients with aggressive non-Hodgkin’s lymphoma. Special Circumstances Clinicians may occasionally be faced with patients who might benefit from relatively nonmyelosuppressive chemotherapy but who have potential risk factors for febrile neutropenia or infection because of bone marrow compromise or comorbidity. It is possible that primary CSF administration may be exceptionally warranted in patients at higher risk for chemotherapyinduced infectious complications even though the data supporting such use are not conclusive. Certain clinical factors predispose to increased complications from prolonged neutropenia, including: patient age greater than 65 yr; poor performance status; previous episodes of FN; extensive prior treatment including large radiation ports; administration of combined chemoradiotherapy; bone marrow involvement by tumor producing cytopenias; poor nutritional status; the presence of open wounds or active infections; more advanced cancer, as well as other serious comorbidities. In such situations primary prophylaxis with CSF is often appropriate even with regimens with FN rates of 20%. The special circumstances have always been part of ASCO’s CSF guidelines, in recognition that there patient factors that predict for the rate and severity of febrile neutropenia. These special circumstances have been maintained from previous versions of the guideline. The rate at which the use of CSFs should be considered has changed from 40% to 20%, consistent with the new evidence that demonstrates efficacy in reducing FN rates when the risk is approximately 20%. Secondary Prophylaxis Secondary prophylaxis with CSFs is recommended for patients who experienced a neutropenic complication from a prior cycle of chemotherapy (for which primary prophylaxis was not received), in which a reduced dose may compromise disease-free or overall survival or treatment outcome. In many clinical situations, dose reduction or delay may be a reasonable alternative. Patients With Neutropenia Who Are Afebrile CSFs should not be routinely used for patients with neutropenia who are afebrile. Therapeutic Use of CSF’s Patients With Neutropenia Who Are Febrile CSFs should not be routinely used as adjunctive treatment with antibiotic therapy for patients with fever and neutropenia. However, CSFs should be considered in patients with fever and neutropenia who are at highrisk for infection-associated complications, or who have prognostic factors that are predictive of poor clinical outcomes. High-risk features include expected prolonged ( 10 d) and profound ( 0.1 109/L) neutropenia, age greater than 65 yr, uncontrolled primary disease, pneumonia, hypotension and multiorgan dysfunction (sepsis syndrome), invasive fungal infection, or being hospitalized at the time of the development of fever. (continued on following page) 2006 Recommendations for WBC Growth Factors www.jco.org 3201 Copyright © 2006 by the American Society of Clinical Oncology. All rights reserved. Information downloaded from jco.ascopubs.org and provided by charlesworth on August 12, 2009 from 202.120.79.222. 第 232 页