EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours

European Journal of Cancer

Volumn 42, Issue 15, 2006, Pages 2433-2453

  Aapro, M S ^a   Cameron, D A ^b   Pettengell, R ^c   Bohlius, J ^d   Crawford, J ^e   Ellis, M ^f   Kearney, N ^g   Lyman, G H ^h   Tjan Heijnen, V C ⁱ   Walewski, J ^j   Weber, D C ^k   Zielinski, C ^l  

^a CLINIQUE DE GENOLIER   (Switzerland)

^b UNIVERSITY OF EDINBURGH   (United Kingdom)

^c ST GEORGE S HOSPITAL   (United Kingdom)

^d UNIVERSITY OF COLOGNE   (Germany)

^e DUKE CANCER INSTITUTE   (United States)

^f UNITED ARAB EMIRATES UNIVERSITY   (United Arab Emirates)

^g UNIVERSITY OF STIRLING   (United Kingdom)

^h UNIVERSITY OF ROCHESTER SCHOOL OF MEDICINE AND DENTISTRY   (United States)

ⁱ RADBOUD UNIVERSITY NIJMEGEN   (Netherlands)

^j INSTITUTE OF ONCOLOGY   (Poland)

^k GENEVA UNIVERSITY HOSPITALS   (Switzerland)

^l UNIVERSITY HOSPITAL INNSBRUCK   (Austria)

more..

Author keywords

Antineoplastic agents; Filgrastim; Granulocyte colony stimulating factor; Guideline; Lenograstim; Neoplasms; Neutropenia; Pegfilgrastim

Indexed keywords

ANTINEOPLASTIC AGENT; BLEOMYCIN; CARBOPLATIN; CISPLATIN; CYCLOPHOSPHAMIDE; CYTARABINE; DACARBAZINE; DOCETAXEL; DOXORUBICIN; EPIRUBICIN; ETOPOSIDE; FLUDARABINE; FLUOROURACIL; GEMCITABINE; GRANULOCYTE COLONY STIMULATING FACTOR; IFOSFAMIDE; IRINOTECAN; METHOTREXATE; METHYLPREDNISOLONE; MITOXANTRONE; NAVELBINE; PACLITAXEL; PREDNISONE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RITUXIMAB; TOPOTECAN; UNINDEXED DRUG; VINBLASTINE; VINCRISTINE; VINDESINE;

ARTICLE; CANCER CHEMOTHERAPY; CLINICAL TRIAL; DRUG DOSE REDUCTION; FEBRILE NEUTROPENIA; HUMAN; INCIDENCE; LYMPHOMA; PRACTICE GUIDELINE; PRIORITY JOURNAL; RISK FACTOR; SOLID TUMOR;

ANTINEOPLASTIC AGENTS; FEMALE; GRANULOCYTE COLONY STIMULATING FACTOR, RECOMBINANT; HUMANS; MALE; NEOPLASMS; NEUTROPENIA; RISK FACTORS;

EID: 33748974393     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejca.2006.05.002     Document Type: Article

References (155)

1. Lyman G.H., Dale D.C., and Crawford J. Incidence and predictors of low dose-intensity in adjuvant breast cancer chemotherapy: a nationwide study of community practices. J Clin Oncol 21 (2003) 4524-4531
2. Lyman G.H., Morrison V.A., Dale D.C., et al., OPPS Working Group, ANC Study Group. Risk of febrile neutropenia among patients with intermediate-grade non-Hodgkin's lymphoma receiving CHOP chemotherapy. Leuk Lymphoma 44 (2003) 2069-2076
3. Wolff D.A., Crawford J., Dale D.C., Poniewierski M.S., and Lyman G.H. Risk of neutropenic complications based on a prospective nationwide registry of cancer patients initiating systematic chemotherapy. Proc Am Soc Clin Oncol 23 (2004) 547 (abstract 6125)
4. Lyman G.H., and Delgado D.J. Risk and timing of hospitalization for febrile neutropenia in patients receiving CHOP, CHOP-R, or CNOP chemotherapy for intermediate-grade non-Hodgkin lymphoma. Cancer 98 (2003) 2402-2409
5. Vogel C.L., Wojtukiewicz M.Z., Carroll R.R., et al. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol 23 (2005) 1178-1183
6. Timmer-Bonte J.N., de Boo T.M., Smit H.J., et al. Prevention of chemotherapy-induced febrile neutropenia by prophylactic antibiotics plus or minus granulocyte colony-stimulating factor in small-cell lung cancer: a Dutch randomised phase III study. J Clin Oncol 23 (2005) 7974-7984
7. Bodey G.P., Buckley M., Sathe Y.S., and Freireich E.J. Quantitative relationships between circulating leukocytes and infection in patients with acute leukemia. Ann Intern Med 64 (1966) 328-340
8. Meza L., Baselga J., Holmes F.A., Liang B., Breddy J., and for the Pegfilgrastim Study Group. Incidence of febrile neutropenia (FN) is directly related to duration of severe neutropenia (DSN) after myelosuppressive chemotherapy. Proc Am Soc Clin Oncol 21 (2002) 255b (abstract 2840)
9. Padilla G., and Ropka M.E. Quality of life and chemotherapy-induced neutropenia. Cancer Nurs 28 (2005) 167-171
10. Ozer H., Armitage J.O., Bennett C.L., et al. 2000 update of recommendations for the use of haematopoietic colony-stimulating factors: evidence-based, clinical practice guidelines. J Clin Oncol 18 (2000) 3558-3585
11. Hughes W.T., Armstrong D., Bodey G.P., et al. 2002 guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clin Infect Dis 34 (2002) 730-751
12. Budman D.R., Berry D.A., Cirrincione C.T., et al. Dose and dose intensity as determinants of outcome in the adjuvant treatment of breast cancer. The Cancer and Leukemia Group B. J Natl Cancer Inst 90 (1998) 1205-1211
13. Kwak L.W., Halpern J., Olshen R.A., and Horning S.J. Prognostic significance of actual dose intensity in diffuse large-cell lymphoma: results of a tree-structured survival analysis. J Clin Oncol 8 (1990) 963-977
14. Bonadonna G., Valagussa P., Moliterni A., Zambetti M., and Brambilla C. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. N Engl J Med 332 (1995) 901-906
15. Lepage E., Gisselbrecht C., Haioun C., et al. Prognostic significance of received relative dose intensity in non-Hodgkin's lymphoma patients: application to LNH-87 protocol. The GELA. (Groupe d'Etude des Lymphomes de l'Adulte). Ann Oncol 4 (1993) 651-656
16. Chang J. Chemotherapy dose reduction and delay in clinical practice: evaluating the risk to patient outcome in adjuvant chemotherapy for breast cancer. Eur J Cancer 36 Suppl. 1 (2000) S11-S14
17. Mayers C., Panzarella T., and Tannock I.F. Analysis of the prognostic effects of inclusion in a clinical trial and of myelosuppression on survival after adjuvant chemotherapy for breast carcinoma. Cancer 91 (2001) 2246-2257
18. Wood W.C., Budman D.R., Korzun A.H., et al. Dose and dose intensity of adjuvant chemotherapy for stage II, node-positive breast carcinoma. N Engl J Med 330 (1994) 1253-1259
19. National Comprehensive Guidelines Network. Myeloid Growth Factors. Available from: http://www.nccn.org. Accessed 7 September 2005.
20. Crawford J., Dale D.C., and Lyman G.H. Chemotherapy-induced neutropenia: risks, consequences, and new directions for its management. Cancer 100 (2004) 228-237
21. Lyman G.H., Lyman C.H., and Agboola O. Risk models for predicting chemotherapy-induced neutropenia. Oncologist 10 (2005) 427-437
22. Komrokji R.S., and Lyman G.H. The colony-stimulating factors: use to prevent and treat neutropenia and its complications. Expert Opin Biol Ther 4 (2004) 1897-1910
23. Cullen M., Steven N., Billingham L., et al., Simple Investigation in Neutropenic Individuals of the Frequency of Infection after Chemotherapy +/- Antibiotic in a Number of Tumours (SIGNIFICANT) Trial Group. Antibacterial prophylaxis after chemotherapy for solid tumors and lymphomas. N Engl J Med 353 (2005) 988-998
24. Bucaneve G., Micozzi A., Menichetti F., et al., Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) Infection Program. Levofloxacin to prevent bacterial infection in patients with cancer and neutropenia. N Engl J Med 353 (2005) 977-987
25. Gafter-Gvili A., Fraser A., Paul M., and Leibovici L. Meta-analysis: antibiotic prophylaxis reduces mortality in neutropenic patients. Ann Intern Med 142 (2005) 979-995
26. van de Wetering M.D., de Witte M.A., Kremer L.C., Offringa M., Scholten R.J., and Caron H.N. Efficacy of oral prophylactic antibiotics in neutropenic afebrile oncology patients: a systematic review of randomised controlled trials. Eur J Cancer 41 (2005) 1372-1382
27. Bonadio M., Morelli G., Mori S., Riccioni R., Papineschi F., and Petrini M. Fluoroquinolone resistance in hematopoietic stem cell transplant recipients with infectious complications. Biomed Pharmacother 59 (2005) 511-516
28. Crawford J. Once-per-cycle pegfilgrastim (Neulasta) for the management of chemotherapy-induced neutropenia. Semin Oncol 30 4 Suppl. 13 (2003) 24-30
29. Green M.D., Koelbl H., Baselga J., et al. A randomised double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol 14 (2003) 29-35
30. Holmes F.A., Jones S.E., O'Shaughnessy J., et al. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol 13 (2002) 903-909
31. Holmes F.A., O'Shaughnessy J.A., Vukelja S., et al. Blinded, randomised, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol 20 (2002) 727-731
32. Hryniuk W.M. The importance of dose intensity in the outcome of chemotherapy. Important Adv Oncol (1988) 121-141
33. Garcia-Carbonero R., Mayordomo J.I., Tornamira M.V., et al. Granulocyte colony-stimulating factor in the treatment of high-risk febrile neutropenia: a multicenter randomized trial. J Natl Cancer Inst 93 (2001) 31-38
34. Clark O.A., Lyman G.H., Castro A.A., Clark L.G., and Djulbegovic B. Colony-stimulating factors for chemotherapy-induced febrile neutropenia: a meta-analysis of randomised controlled trials. J Clin Oncol 23 (2005) 4198-4214
35. Gregory S.A., and Trumper L. Chemotherapy dose intensity in non-Hodgkin's lymphoma: is dose intensity an emerging paradigm for better outcomes?. Ann Oncol 16 (2005) 1413-1424
36. Pfreundschuh M., Trumper L., Kloess M., et al., German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of elderly patients with aggressive lymphomas: results of the NHL-B2 trial of the DSHNHL. Blood 104 (2004) 634-641
37. Pfreundschuh M., Trumper L., Kloess M., et al., German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood 104 (2004) 626-633
38. Thatcher N., Girling D.J., Hopwood P., Sambrook R.J., Qian W., and Stephens R.J. Improving survival without reducing quality of life in small-cell lung cancer patients by increasing the dose-intensity of chemotherapy with granulocyte colony-stimulating factor support: results of a British Medical Research Council Multicenter Randomised Trial. Medical Research Council Lung Cancer Working Party. J Clin Oncol 18 (2000) 395-404
39. Steward W.P., von Pawel J., Gatzemeier U., et al. Effects of granulocyte-macrophage colony-stimulating factor and dose intensification of V-ICE chemotherapy in small-cell lung cancer: a prospective randomised study of 300 patients. J Clin Oncol 16 (1998) 642-650
40. Sonneveld P., van Putten W., Holte H., et al. Intensified CHOP with rituximab for intermediate or high-risk non-Hodgkin's lymphoma: interim analysis of a randomized phase III trial in elderly patients by the Dutch HOVON and Nordic Lymphoma Groups. Blood 106 11 (2005) 16 (abstract)
41. Pfreundschuh M., Kloess M., Schmits R., et al. Six, not eight cycles of bi-weekly CHOP with rituximab (R-CHOP-14) is the preferred treatment for elderly patients with diffuse large B-cell lymphoma (DLBCL): results of the RICOVER-60 trial of the German High-Grade Non-Hodgkin Lymphoma Study Group (DSHNHL). Blood 106 11 (2005) 13 (abstract)
42. Repetto L., Biganzoli L., Koehne C.H., et al. EORTC Cancer in the Elderly Task Force guidelines for the use of colony-stimulating factors in elderly patients with cancer. Eur J Cancer 39 (2003) 2264-2272
43. American Society of Clinical Oncology. ASCO guideline procedures manual available at http://www.asco.org/ac/1,1003,_12-002562-00_18-0026185-00_19-00-00_20-001,00.asp last accessed 20th December 2005.
44. Millward M.J., Boyer M.J., Lehnert M., et al. Docetaxel and carboplatin is an active regimen in advanced non-small-cell lung cancer: a phase II study in Caucasian and Asian patients. Ann Oncol 14 (2003) 449-454
45. Gianni L., Munzone E., Capri G., et al. Paclitaxel by 3-hour infusion in combination with bolus doxorubicin in women with untreated metastatic breast cancer: high antitumor efficacy and cardiac effects in a dose-finding and sequence-finding study. J Clin Oncol 13 (1995) 2688-2699
46. Fosså S., Kaye S.B., Mead G.M., et al. Filgrastim during combination chemotherapy of patients with poor-prognosis metastatic germ cell malignancy. European Organization for Research and Treatment of Cancer, Genito-Urinary Group, and the Medical Research Council Testicular Cancer Working Party, Cambridge, United Kingdom. J Clin Oncol 16 (1998) 716-724
47. Tjan-Heijnen V.C., Postmus P.E., Ardizzoni A., et al. Reduction of chemotherapy-induced febrile leucopenia by prophylactic use of ciprofloxacin and roxithromycin in small-cell lung cancer patients: an EORTC double-blind placebo-controlled phase III study. Ann Oncol 12 (2001) 1359-1368
48. Ravaud A., Chevreau C., Cany L., et al. Granulocyte-macrophage colony-stimulating factor in patients with neutropenic fever is potent after low-risk but not after high-risk neutropenic chemotherapy regimens: results of a randomised phase III trial. J Clin Oncol 16 (1998) 2930-2936
49. Vellenga E., Uyl-de Groot C.A., de Wit R., et al. Randomised placebo-controlled trial of granulocyte-macrophage colony-stimulating factor in patients with chemotherapy-related febrile neutropenia. J Clin Oncol 22 (1996) 619-627
50. Brooks JM, Klesper DG, Chrischilles EA, et al. Estimating derived demand curves for healthcare treatments: the case of primary G-CSF for non-Hodgkin's lymphoma patients. Value Health, in press.
51. Dale D.C., Goldschmidt J.H., Crawford J., Lyman G.H., and for the ANC Study Group. Reduced relative dose intensity (RDI) in patients with aggressive non-Hodgkin's lymphoma (NHL). Blood 104 11 (2004) 3314 (abstract)
52. Dale D.C., Wolff D., Agboola O., et al. Prospective patient registry for the development of risk models of neutropenic complications including febrile neutropenia (FN). Blood 100 (2002) 502b
53. Lyman G.H., Crawford J., Dale D.C., Wolff A., Culakova E., and The ANC Study Group. Predicting the risk of neutropenic complications and reduced dose intensity in patients with early-stage breast cancer (ESBC): results from a prospective nationwide registry. Proc Am Soc Clin Oncol 24 (2004) 70 (abstract 776)
54. Perez E.A., Geeraerts L., Suman V.J., et al. A randomised phase II study of sequential docetaxel and doxorubicin/cyclophosphamide in patients with metastatic breast cancer. Ann Oncol 13 (2002) 1225-1235
55. von Minckwitz G., Raab G., Caputo A., et al. Doxorubicin with cyclophosphamide followed by docetaxel every 21 days compared with doxorubicin and docetaxel every 14 days as preoperative treatment in operable breast cancer: the GEPARDUO study of the German Breast Group. J Clin Oncol 23 (2005) 2676-2685
56. Alba E., Martin M., Ramos M., et al., Spanish Breast Cancer Research Group. Multicenter randomised trial comparing sequential with concomitant administration of doxorubicin and docetaxel as first-line treatment of metastatic breast cancer: a Spanish Breast Cancer Research Group (GEICAM-9903) phase III study. J Clin Oncol 22 (2004) 2587-2593
57. Nabholtz J.M., Falkson C., Campos D., et al., TAX 306 Study Group. Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomised, multicenter, phase III trial. J Clin Oncol 21 (2003) 968-975
58. Biganzoli L., Cufer T., Bruning P., et al. Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: The European Organization for Research and Treatment of Cancer 10961 Multicenter Phase III Trial. J Clin Oncol 20 (2002) 3114-3121
59. Martin M., Lluch A., Seguí M.A., et al. Prophylactic growth factor (GF) support with adjuvant docetaxel, doxorubicin, and cyclophosphamide (TAC) for node-negative breast cancer (BC): an interim safety analysis of the GEICAM 9805 study. Proc Am Soc Clin Oncol 22 (2004) 14S (abstract 620)
60. von Minckwitz G, Blohmer JU, Löhr A, et al. Primary prophylaxis with 3 weekly pegfilgrastim and ciprofloxacin effectively prevent (febrile) neutropenia and infection during neoadjuvant chemotherapy with docetaxel/doxorubicin/cyclophosphamide (TAC) in breast cancer patients. In: ASCO Annual Meeting, 13-17 May, Orlando, Florida, 2005. p. 8008 (abstract).
61. Chevallier B., Chollet P., Merrouche Y., et al. Lenograstim prevents morbidity from intensive induction chemotherapy in the treatment of inflammatory breast cancer. J Clin Oncol 13 (1995) 1564-1571
62. Citron M.L., Berry D.A., Cirrincione C., et al. Randomised trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol 21 (2003) 1431-1439
63. Therasse P., Mauriac L., Welnicka-Jaskiewicz M., et al., EORTC. Final results of a randomised phase III trial comparing cyclophosphamide, epirubicin, and fluorouracil with a dose-intensified epirubicin and cyclophosphamide + filgrastim as neoadjuvant treatment in locally advanced breast cancer: an EORTC-NCIC-SAKK multicenter study. J Clin Oncol 21 (2003) 843-850
64. Norris B., Pritchard K.I., James K., et al. Phase III comparative study of vinorelbine combined with doxorubicin versus doxorubicin alone in disseminated metastatic/recurrent breast cancer: National Cancer Institute of Canada Clinical Trials Group Study MA8. J Clin Oncol 18 (2000) 2385-2394
65. O'Shaughnessy J., Miles D., Vukelja S., et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 20 (2002) 2812-2823
66. Fumoleau P., Chauvin F., Namer M., et al. Intensification of adjuvant chemotherapy: 5-year results of a randomised trial comparing conventional doxorubicin and cyclophosphamide with high-dose mitoxantrone and cyclophosphamide with filgrastim in operable breast cancer with 10 or more involved axillary nodes. J Clin Oncol 19 (2001) 612-620
67. Stöger H., Samonigg H., Krainer M., et al. Dose intensification of epidoxorubicin and cyclophosphamide in metastatic breast cancer: a randomised study with two schedules of granulocyte-macrophage colony stimulating factor. Eur J Cancer 34 (1998) 482-488
68. Levine M.N., Bramwell V.H., Pritchard K.I., et al. Randomised trial of intensive cyclophosphamide, epirubicin, and fluorouracil chemotherapy compared with cyclophosphamide, methotrexate, and fluorouracil in premenopausal women with node-positive breast cancer. National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 16 (1998) 2651-2658
69. Zielinski C., Beslija S., Mrsic-Krmpotic Z., et al. Gemcitabine, epirubicin, and paclitaxel versus fluorouracil, epirubicin, and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: a Central European Cooperative Oncology Group International, multicenter, prospective, randomized phase III trial. J Clin Oncol 23 (2005) 1401-1408
70. French Adjuvant Study Group. Benefit of a high-dose epirubicin regimen in adjuvant chemotherapy for node-positive breast cancer patients with poor prognostic factors: 5-year follow-up results of French Adjuvant Study Group 05 randomised trial. J Clin Oncol 19 (2001) 602-611
71. Tannock I.F., Boyd N.F., DeBoer G., et al. A randomised trial of two dose levels of cyclophosphamide, methotrexate, and fluorouracil chemotherapy for patients with metastatic breast cancer. J Clin Oncol 6 (1988) 1377-1387
72. Ron I.G., Wigler N., Borovik R., et al. CMF (cyclophosphamide, methotrexate, 5-fluorouracil) versus cnf (cyclophosphamide, mitoxantrone, 5-fluorouracil) as adjuvant chemotherapy for stage II lymph-node positive breast cancer: a phase III randomised multicenter study. Am J Clin Oncol 24 (2001) 323-327
73. Jassem J., Pienkowski T., Pluzanska A., et al., Central & Eastern Europe and Israel Paclitaxel Breast Cancer Study Group. Doxorubicin and paclitaxel versus fluorouracil, doxorubicin, and cyclophosphamide as first-line therapy for women with metastatic breast cancer: final results of a randomised phase III multicenter trial. J Clin Oncol 19 (2001) 1707-1715
74. Papaldo P., Lopez M., Marolla P., et al. Impact of five prophylactic filgrastim schedules on haematologic toxicity in early breast cancer patients treated with epirubicin and cyclophosphamide. J Clin Oncol 23 (2005) 6908-6918
75. Crawford J., Kreisman H., Garewal H., et al. The impact of filgrastim schedule variation on haematopoietic recovery post-chemotherapy. Ann Oncol 8 (1997) 1117-1124
76. Crawford J., Ozer H., Stoller R., et al. Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. N Engl J Med 325 (1991) 164-170
77. Ardizzoni A., Manegold C., Debruyne C., et al., Giuseppe Giaccone European organization for research and treatment of cancer (EORTC) lung cancer group. European organization for research and treatment of cancer (EORTC) 08957 phase II study of topotecan in combination with cisplatin as second-line treatment of refractory and sensitive small cell lung cancer. Clin Cancer Res 9 (2003) 143-150
78. Trillet-Lenoir V., Green J., Manegold C., et al. Recombinant granulocyte colony stimulating factor reduces the infectious complications of cytotoxic chemotherapy. Eur J Cancer A 29 (1993) 319-324
79. Von Pawel J., Schiller J.H., Shepherd F.A., et al. Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent small-cell lung cancer. J Clin Oncol 17 (1999) 658-667
80. Lorigan P., Woll P.J., O'Brien M.E., Ashcroft L.F., Sampson M.R., and Thatcher N. Randomised phase III trial of dose-dense chemotherapy supported by whole-blood haematopoietic progenitors in better-prognosis small-cell lung cancer. J Natl Cancer Inst 97 (2005) 666-674
81. Woll P.J., Hodgetts J., Lomax L., Bildet F., Cour-Chabernaud V., and Thatcher N. Can cytotoxic dose-intensity be increased by using granulocyte colony-stimulating factor? A randomised controlled trial of lenograstim in small-cell lung cancer. J Clin Oncol 13 (1995) 652-659
82. Masutani M., Ochi Y., Kadota A., et al. Dose-intensive weekly alternating chemotherapy for patients with small cell lung cancer: randomised trial, can it improve survival of patients with good prognostic factors?. Oncol Rep 7 (2000) 305-310
83. White S.C., Lorigan P., Middleton M.R., et al. Randomised phase II study of cyclophosphamide, doxorubicin, and vincristine compared with single-agent carboplatin in patients with poor prognosis small cell lung carcinoma. Cancer 92 (2001) 601-608
84. Furuse K., Fukuoka M., Nishiwaki Y., et al. Phase III study of intensive weekly chemotherapy with recombinant human granulocyte colony-stimulating factor versus standard chemotherapy in extensive-disease small-cell lung cancer. The Japan Clinical Oncology Group. J Clin Oncol 16 (1998) 2126-2132
85. Edelman M.J., Chansky K., Gaspar L.E., et al. Phase II trial of cisplatin/etoposide and concurrent radiotherapy followed by paclitaxel/carboplatin consolidation for limited small-cell lung cancer: Southwest Oncology Group 9713. J Clin Oncol 22 (2004) 127-132
86. Font A., Moyano A.J., Puerto J.M., et al. Increasing dose intensity of cisplatin-etoposide in advanced non-small-cell lung carcinoma: a phase III randomised trial of the Spanish Lung Cancer Group. Cancer 85 (1999) 855-863
87. Baldini E., Ardizzoni A., Prochilo T., Cafferata M.A., Boni L., and Tibaldi C. Gemcitabine, ifosfamide and Navelbine (GIN): a platinum-free combination in advanced non-small-cell lung cancer (NSCLC). Cancer Chemother Pharmacol 49 Suppl. 1 (2002) S25-S28
88. Schiller J.H., Harrington D., Belani C.P., et al., Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346 (2002) 92-98
89. Fossella F., Pereira J.R., von Pawel J., et al. Randomised, 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 (2003) 3016-3024
90. Wozniak A.J., Crowley J.J., Balcerzak S.P., et al. Randomised trial comparing cisplatin with cisplatin plus vinorelbine in the treatment of advanced non-small-cell lung cancer: a Southwest Oncology Group study. J Clin Oncol 16 (1998) 2459-2465
91. Kelly K., Crowley J., Bunn Jr. P.A., et al. Randomised phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: a Southwest Oncology Group trial. J Clin Oncol 19 (2001) 3210-3218
92. Stathopoulos G.P., Rigatos S.K., Dimopoulos M.A., et al. Treatment of pancreatic cancer with a combination of irinotecan (CPT-11) and gemcitabine: a multicenter phase II study by the Greek Cooperative Group for Pancreatic Cancer. Ann Oncol 14 (2003) 388-394
93. Kosmidis P., Mylonakis N., Dimopoulos A., et al. Combination chemotherapy with paclitaxel plus carboplatin versus paclitaxel plus gemcitabine in inoperable non-small cell lung cancer: a phase III randomised study. Preliminary results. Hellenic Cooperative Oncology Group. Semin Oncol 27 (2000) 3-8
94. Scagliotti G.V., De Marinis F., Rinaldi M., et al., Italian Lung Cancer Project. Phase III randomised trial comparing three platinum-based doublets in advanced non-small-cell lung cancer. J Clin Oncol 20 (2002) 4285-4291
95. Cardenal F., Lopez-Cabrerizo M.P., Anton A., et al. Randomised phase III study of gemcitabine-cisplatin versus etoposide-cisplatin in the treatment of locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 17 (1999) 12-18
96. Velasquez W.S., 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 (1988) 117-122
97. Johnson P.W., Sweetenham J.W., McCallum P., Norton A.J., Rohatiner A.Z., and Lister T.A. E-SHAP: inadequate treatment for poor-prognosis recurrent lymphoma. Ann Oncol 4 (1993) 63-67
98. Ozturk M.A., Barista I., Altundag M.K., et al. Modified ESHAP as salvage chemotherapy for recurrent or refractory non-Hodgkin's lymphoma: results of a single-center study of 32 patients. Modified etoposide, methylprednisolone, cytarabine and cisplatin. Chemotherapy 48 (2002) 252-258
99. Velasquez W.S., 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 (1994) 1169-1176
100. Ösby E., Hagberg H., Kvaloy S., et al., Nordic Lymphoma Group. CHOP is superior to CNOP in elderly patients with aggressive lymphoma while outcome is unaffected by filgrastim treatment: results of a Nordic Lymphoma Group randomised trial. Blood 101 (2003) 3840-3848
101. Pettengell R., Gurney H., Radford J.A., et al. Granulocyte colony-stimulating factor to prevent dose-limiting neutropenia in non-Hodgkin's lymphoma: a randomised controlled trial. Blood 80 (1992) 1430-1436
102. Gisselbrecht C., Haioun C., Lepage E., et al. Placebo-controlled phase III study of lenograstim (glycosylated recombinant human granulocyte colony-stimulating factor) in aggressive non-Hodgkin's lymphoma: factors influencing chemotherapy administration. Groupe d'Etude des Lymphomes de l'Adulte. Leuk Lymphoma 25 (1997) 289-300
103. Martinelli G., Ferrucci P.F., Mingrone W., et al. ACOD, a modified CHOP regimen for elderly patients with aggressive non-Hodgkin's lymphoma. Leuk Lymphoma 44 (2003) 801-806
104. Dimopoulos M.A., Fountzilas G., Papageorgiou E., et al., Hellenic Cooperative Oncology Group. Primary treatment of low-grade non-Hodgkin's lymphoma with the combination of fludarabine and mitoxantrone: a phase II study of the Hellenic Cooperative Oncology Group. Leuk Lymphoma 43 (2002) 111-114
105. Verschraegen C.F., Sittisomwong T., Kudelka A.P., et al. Docetaxel for patients with paclitaxel-resistant Mullerian carcinoma. J Clin Oncol 18 (2000) 2733-2739
106. Omura G.A., Brady M.F., Look K.Y., et al. Phase III trial of paclitaxel at two dose levels, the higher dose accompanied by filgrastim at two dose levels in platinum-pretreated epithelial ovarian cancer: an intergroup study. J Clin Oncol 21 (2004) 2843-2848
107. Guppy A.E., Nelstrop A.E., Foster T., Agarwal R., Seckl M.J., and Rustin G.J. A phase II study of sequential carboplatin, paclitaxel and topotecan in patients with previously untreated advanced ovarian cancer. Br J Cancer 90 (2004) 810-814
108. Creemers G.J., Bolis G., Gore M., et al. Topotecan, an active drug in the second-line treatment of epithelial ovarian cancer: results of a large European phase II study. J Clin Oncol 14 (1996) 3056-3061
109. Bookman M.A., 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 (1998) 3345-3352
110. Gordon A.N., Asmar L., Messing M.J., et al. Phase II study of sequential doublets: topotecan and carboplatin, followed by paclitaxel and carboplatin, in patients with newly diagnosed advanced ovarian cancer. Gynecol Oncol 94 (2004) 533-539
111. du Bois A., Luck H.J., Meier W., et al., Arbeitsgemeinschaft Gynakologische Onkologie Ovarian Cancer Study Group. A randomised clinical trial of cisplatin/paclitaxel versus carboplatin/paclitaxel as first-line treatment of ovarian cancer. J Natl Cancer Inst 95 (2003) 1320-1329
112. Papadimitriou C.A., Fountzilas G., Aravantinos G., et al., Hellenic Cooperative Oncology Group Study. Second-line chemotherapy with gemcitabine and carboplatin in paclitaxel-pretreated, platinum-sensitive ovarian cancer patients. A Hellenic Cooperative Oncology Group Study. Gynecol Oncol 92 (2004) 152-159
113. Vaughn D.J., Malkowicz S.B., Zoltick B., et al. Paclitaxel plus carboplatin in advanced carcinoma of the urothelium: an active and tolerable outpatient regimen. J Clin Oncol 16 (1998) 255-260
114. Sternberg C.N., de Mulder P.H., Schornagel J.H., et al. Randomised phase III trial of high-dose-intensity methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) chemotherapy and recombinant human granulocyte colony-stimulating factor versus classic MVAC in advanced urothelial tract tumors: European Organization for Research and Treatment of Cancer Protocol no. 30924. J Clin Oncol 19 (2001) 2638-2646
115. Miller K.D., Loehrer P.J., Gonin R., and Einhorn L.H. Salvage chemotherapy with vinblastine, ifosfamide, and cisplatin in recurrent seminoma. J Clin Oncol 15 (1997) 1427-1431
116. Motzer R.J., Sheinfeld J., Mazumdar M., et al. Etoposide and cisplatin adjuvant therapy for patients with pathologic stage II germ cell tumors. J Clin Oncol 13 (1995) 2700-2704
117. Van Cutsem E., Hoff P.M., Harper P., et al. Oral capecitabine vs. intravenous 5-fluorouracil and leucovorin: integrated efficacy data and novel analyses from two large, randomised, phase III trials. Br J Cancer 90 (2004) 1190-1197
118. Saltz L.B., Cox J.V., Blanke C., et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med 343 (2000) 905-914
119. Douillard J.Y., Cunningham D., Roth A.D., et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 355 (2000) 1041-1047
120. Mabro M., Louvet C., Andre T., et al., GERCOR. Bimonthly leucovorin, infusion 5-fluorouracil, hydroxyurea, and irinotecan (FOLFIRI-2) for pretreated metastatic colorectal cancer. Am J Clin Oncol 26 (2003) 254-258
121. Leonard P., Seymour M.T., James R., Hochhauser D., and Ledermann J.A. Phase II study of irinotecan with bolus and high dose infusional 5-FU and folinic acid (modified de Gramont) for first or second line treatment of advanced or metastatic colorectal cancer. Br J Cancer 87 (2002) 1216-1220
122. Sorbye H., Glimelius B., Berglund A., et al. Multicenter phase II study of Nordic fluorouracil and folinic acid bolus schedule combined with oxaliplatin as first-line treatment of metastatic colorectal cancer. J Clin Oncol 22 (2004) 31-38
123. Maindrault-Goebel F., de Gramont A., Louvet C., et al., Oncology Multidisciplinary Research Group (GERCOR). High-dose intensity oxaliplatin added to the simplified bimonthly leucovorin and 5-fluorouracil regimen as second-line therapy for metastatic colorectal cancer (FOLFOX 7). Eur J Cancer 37 (2001) 1000-1005
124. Schoemaker N.E., Kuppens I.E., Moiseyenko V., et al. A randomised phase II multicentre trial of irinotecan (CPT-11) using four different schedules in patients with metastatic colorectal cancer. Br J Cancer 91 (2004) 1434-1441
125. Fuchs C.S., Moore M.R., Harker G., Villa L., Rinaldi D., and Hecht J.R. Phase III comparison of two irinotecan dosing regimens in second-line therapy of metastatic colorectal cancer. J Clin Oncol 21 (2003) 807-814
126. Shin D.M., Khuri F.R., Glisson B.S., et al. Phase II study of paclitaxel, ifosfamide, and carboplatin in patients with recurrent or metastatic head and neck squamous cell carcinoma. Cancer 91 (2001) 1316-1323
127. Bui B.N., Chevallier B., Chevreau C., et al. Efficacy of lenograstim on haematologic tolerance to MAID chemotherapy in patients with advanced soft tissue sarcoma and consequences on treatment dose-intensity. J Clin Oncol 13 (1995) 2629-2636
128. Rose P.G., Blessing J.A., Gershenson D.M., and McGehee R. Paclitaxel and cisplatin as first-line therapy in recurrent or advanced squamous cell carcinoma of the cervix: a gynecologic oncology group study. J Clin Oncol 17 (1999) 2676-2680
129. Silvestri F., Fanin R., Velisig M., et al. The role of granulocyte colony-stimulating factor (filgrastim) in maintaining dose intensity during conventional-dose chemotherapy with ABVD in Hodgkin's disease. Tumori 80 (1994) 453-458
130. Fleming G.F., Brunetto V.L., Cella D., et al. Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol 22 (2004) 2159-2166
131. Stathopoulos G.P., Veslemes M., Georgatou N., et al. Front-line paclitaxel-vinorelbine versus paclitaxel-carboplatin in patients with advanced non-small-cell lung cancer: a randomised phase III trial. Ann Oncol 15 (2004) 1048-1055
132. Horning S.J., Hoppe R.T., Breslin S., Bartlett N.L., Brown B.W., and Rosenberg S.A. Stanford V and radiotherapy for locally extensive and advanced Hodgkin's disease: mature results of a prospective clinical trial. J Clin Oncol 20 (2002) 630-637
133. Capotorto A.M., Pavesi L., Pedrazzoli P., et al. Randomised, controlled, multicenter phase III trial of standard-dose fluorouracil-epirubicin-cyclophosphamide (FEC), compared with time-intensive FEC (FEC-G) and mitoxantrone-methotrexate-mitomycin C (MMM-G) in metastatic breast carcinoma. J Chemother 15 (2003) 184-191
134. Frasci G., Comella P., Carreca I., et al., Southern Italy Cooperative Oncology Group. Weekly dose-dense cisplatin-epirubicin-paclitaxel administration with granulocyte colony-stimulating factor support does not substantially improve prognosis in extensive disease small-cell lung cancer. A SICOG phase II study. Oncology 68 (2005) 223-229
135. Masutani M., Tsujino I., Fujie T., et al. Moderate dose-intensive chemotherapy for patients with non-small cell lung cancer: randomised trial, can it improve survival of patients with good performance status?. Oncol Rep 6 (1999) 1045-1050
136. Diehl V., Franklin J., Pfreundschuh M., et al., German Hodgkin's Lymphoma Study Group. Standard and increased-dose BEACOPP chemotherapy compared with COPP-ABVD for advanced Hodgkin's disease. N Engl J Med 348 (2003) 2386-2395
137. Ardizzoni A., Tjan-Heijnen V.C., Postmus P.E., et al. Standard versus intensified chemotherapy with granulocyte colony-stimulating factor support in small-cell lung cancer: a prospective European Organization for Research and Treatment of Cancer-Lung Cancer Group Phase III Trial-08923. J Clin Oncol 20 (2002) 3947-3955
138. Lyman G.H., Kuderer N.M., and Djulbegovic B. Prophylactic granulocyte colony-stimulating factor in patients receiving dose-intensive cancer chemotherapy: a meta-analysis. Am J Med 112 (2002) 406-411
139. Gatzemeier U., Kleisbauer J.P., Drings P., et al. Lenograstim as support for ACE chemotherapy of small-cell lung cancer: a phase III, multicenter, randomised study. Am J Clin Oncol 23 (2000) 393-400
140. Hackshaw A., Sweetenham J., and Knight A. Are prophylactic haematopoietic growth factors of value in the management of patients with aggressive non-Hodgkin's lymphoma?. Br J Cancer 90 (2004) 1302-1305
141. Hidalgo M., Mendiola C., Lopez-Vega J.M., et al. A multicenter randomized Phase II trial of granulocyte-colony stimulating factor-supported, platinum-based chemotherapy with flexible midcycle cisplatin administration in patients with advanced ovarian carcinoma. PSAMOMA Cooperative Group, Spain. Cancer 83 (1998) 719-725
142. Bohlius J., Reiser M., Schwarzer G., and Engert A. Granulopoiesis-stimulating factors to prevent adverse effects in the treatment of malignant lymphoma. Cochrane Database Syst Rev 3 (2004) CD003189
143. Burton C., Linch D., Hoskin P., et al. A phase III trial comparing CHOP to PMitCEBO with or without G-CSF in patients aged 60 plus with aggressive non-Hodgkin's lymphoma. Br J Cancer 94 (2006) 806-813
144. Balducci L., Tam J., Al-Halawani H., et al. A large study of the older cancer patient in the community setting: Initial report of a randomized controlled trial using pegfilgrastim to reduce neutropenic complications. J Clin Oncol 23 16s Suppl. (2005) 8111
145. Lyman G.H., Dale D.C., Friedberg J., Crawford J., and Fisher R.I. Incidence and predictors of low chemotherapy dose-intensity in aggressive non-Hodgkin's lymphoma: a nationwide study. J Clin Oncol 22 (2004) 4302-4311
146. ESMO recommendations for the application of haematopoietic growth factors. Ann Oncol 2005;16(suppl 1):i80-i82.
147. Campbell C, Bramwell V, Charette M, Oliver T and the Systemic Treatment Disease Site Group. The role of colony-stimulating factor (CSF) in patients receiving myelosuppressive chemotherapy for the treatment of cancer. Practice guideline report #12-2 (version 2.2003). Available from: http://www.cancercare.on.ca/pdf/pebc12-2s.pdf.
148. Cosler L.E., Calhoun E.A., Agboola O., and Lyman G.H. Effects of indirect and additional direct costs on the risk threshold for prophylaxis with colony-stimulating factors in patients at risk for severe neutropenia from cancer chemotherapy. Pharmacotherapy 24 (2004) 488-494
149. Cosler L.E., Sivasubramaniam V., Agboola O., Crawford J., Dale D., and Lyman G.H. Effect of outpatient treatment of febrile neutropenia on the risk threshold for the use of CSF in patients with cancer treated with chemotherapy. Value Health 8 (2005) 47-52
150. Lyman G.H., and Kuderer N.M. The economics of colony-stimulating factors in the prevention and treatment of febrile neutropenia. Crit Rev Oncol Haematol 50 (2004) 129-146
151. Lyman G.H. A predictive model for neutropenia associated with cancer chemotherapy. Pharmacotherapy 20 (2000) 11S-104S
152. Klastersky J., Paesmans M., Rubenstein E.B., et al. The Multinational Association for Supportive Care in Cancer risk index: A multinational scoring system for identifying low-risk febrile neutropenic cancer patients. J Clin Oncol 18 (2000) 3038-3051
153. Vose J.M., Crump M., Lazarus H., et al. Randomised, multicenter, open-label study of pegfilgrastim compared with daily filgrastim after chemotherapy for lymphoma. J Clin Oncol 21 (2003) 514-519
154. Grigg A., Solal-Celigny P., Hoskin P., et al. Open-label, randomised study of pegfilgrastim vs. daily filgrastim as an adjunct to chemotherapy in elderly patients with non-Hodgkin's lymphoma. Leuk Lymphoma 44 (2003) 1503-1508
155. Misset J.L., Dieras V., Gruia G., et al. Dose-finding study of docetaxel and doxorubicin in first-line treatment of patients with metastatic breast cancer. Ann Oncol 10 (1999) 553-560