A randomized controlled trial investigating the survival benefit of dose-intensified multidrug combination chemotherapy (LSG9) for intermediate- or high-grade non-Hodgkin's lymphoma: Japan Clinical Oncology Group Study 9002

International Journal of Hematology

Volumn 80, Issue 4, 2004, Pages 341-350

  Kinoshita, Tomohiro ^a   Hotta, Tomomitsu ^b   Tobinai, Kensei ^c   Kobayashi, Tohru ^d   Ishizuka, Naoki ^e   Tomonaga, Masao ^f   Sai, Toshiaki ^g   Ohno, Youichiro ^h   Kasai, Masaharu ⁱ   Ogura, Michinori ^j   Mikuni, Chikara ^k   Toki, Hironobu ^l   Sano, Masayuki ^m   Masaki, Yasufumi ⁿ   Ohtsu, Tomoko ^o   Matsuno, Yoshihiro ^c   Takenaka, Takeaki ^c   Shirakawa, Shigeru ^d   Shimoyama, Masanori ^c  

^a NAGOYA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b TOKAI UNIVERSITY   (Japan)

^c NATIONAL CANCER CENTER HOSPITAL   (Japan)

^d MIE UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^e NATIONAL CANCER CENTER RESEARCH INSTITUTE   (Japan)

^f NAGASAKI UNIVERSITY   (Japan)

^g Iwaki Kyoritsu Gen Hosp   (Japan)

^h TENRI HOSPITAL   (Japan)

ⁱ SAPPORO HOKUYU HOSPITAL   (Japan)

^j AICHI CANCER CENTER HOSPITAL   (Japan)

^k HOKKAIDO CANCER CENTER   (Japan)

^l NATIONAL HOSPITAL ORGANIZATION SHIKOKU CANCER CENTER   (Japan)

^m SAGA UNIVERSITY   (Japan)

ⁿ KANAZAWA MEDICAL UNIVERSITY   (Japan)

^o NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

more..

Author keywords

Combination chemotherapy; Dose intensity; Doxorubicin; Non Hodgkin's lymphoma; Randomized controlled trial

Indexed keywords

ALANINE AMINOTRANSFERASE; ANTINEOPLASTIC AGENT; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; BLEOMYCIN; CD15 ANTIGEN; CD20 ANTIGEN; CD3 ANTIGEN; CD30 ANTIGEN; CD56 ANTIGEN; COMMON ACUTE LYMPHOBLASTIC LEUKEMIA ANTIGEN; CREATININE; CYCLIN D1; CYCLOPHOSPHAMIDE; DOXORUBICIN; ETOPOSIDE; FOLINIC ACID; LACTATE DEHYDROGENASE; METHOTREXATE; PREDNISOLONE; PROCARBAZINE; PROTEIN BCL 2; VINCRISTINE; VINDESINE;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADULT; AGED; CANCER COMBINATION CHEMOTHERAPY; CANCER GRADING; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG TOLERABILITY; FEMALE; FOLLOW UP; HEART ARRHYTHMIA; HUMAN; IMMUNOHISTOCHEMISTRY; INFECTION; JAPAN; LEUKOPENIA; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MUSCLE WEAKNESS; NAUSEA; NEUTROPENIA; NEUTROPHIL; NONHODGKIN LYMPHOMA; PARESTHESIA; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; REVIEW; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTE COUNT; THROMBOCYTOPENIA; VOMITING;

ADOLESCENT; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BLEOMYCIN; CYCLOPHOSPHAMIDE; DOXORUBICIN; FEMALE; HUMANS; LYMPHOMA, NON-HODGKIN; MALE; MIDDLE AGED; PREDNISOLONE; TREATMENT OUTCOME; VINCRISTINE;

EID: 9444287115     PISSN: 09255710     EISSN: None     Source Type: Journal    
DOI: 10.1532/IJH97.04085     Document Type: Review

References (44)

1. Armitage JO. Treatment of non-Hodgkin's lymphoma. N Engl J Med. 1993;328:1023-1030.
2. Shipp MA, Harrington DP, Klatt MM, et al. Identification of major prognostic subgroups of patients with large-cell lymphoma treated with m-BACOD or M-BACOD. Ann Intern Med. 1985;104:757-765.
3. Longo DL, DeVita VT Jr, Duffey PL, et al. Superiority of Pro-MACE-CytaBOM over ProMACE-MOPP in the treatment of advanced diffuse aggressive lymphoma: results of a prospective randomized trial. J Clin Oncol. 1991;9:25-38.
4. Klimo P, Connors JM. MACOP-B chemotherapy for the treatment of diffuse large-cell lymphoma. Ann Inlern Med. 1985;102:596-602.
5. Gordon LI, Harrington D, Andersen J, et al. Comparison of a second-generation combination chemotherapeutic regimen (m-BACOD) with a standard regimen (CHOP) for advanced diffuse non-Hodgkin's lymphoma. N Engl J Med. 1992;327:1342-1349.
6. 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. 1993;328:1002-1006.
7. Cooper IA, Wolf MM, Robertson TI, et al. Randomized comparison of MACOP-B with CHOP in patients with intermediate-grade non-Hodgkin's lymphoma: the Australian and New Zealand Lymphoma Group. J Clin Oncol. 1994;12:769-778.
8. Montserrat E, Garcia-Conde J, Vinolas N, et al. CHOP vs. Pro-MACE-CytaBOM in the treatment of aggressive non-Hodgkin's lymphomas: long-term results of a multicenter randomized trial. (PETHEMA: Spanish Cooperative Group for the Study of Hematological Malignancies Treatment, Spanish Society of Hematology). Eur J Haematol. 1996;57:377-383.
9. Linch DC, Vaughan Hudson B, Hancock BW, et al. A randomised comparison of a third-generation regimen (PACEBOM) with a standard regimen (CHOP) in patients with histologically aggressive non-Hodgkin's lymphoma: a British National Lymphoma Investigation report. Br J Cancer. 1996;74:318-322.
10. Jerkeman M, Anderson H, Cavallin-Stahl E, et al. CHOP versus MACOP-B in aggressive lymphoma: a Nordic Lymphoma Group randomised trial. Ann Oncol. 1999;10:1079-1086.
11. Hryniuk WM. Average relative dose intensity and the impact on design of clinical trials. Semin Oncol. 1987;14:65-74.
12. Frei E 3rd, Elias A, Wheeler C, Richardson P, Hryniuk W. The relationship between high-dose treatment and combination chemotherapy: the concept of summation dose intensity. Clin Cancer Res. 1998;4:2027-2037.
13. Meyer RM, Hryniuk WM, Goodyear MD. The role of dose intensity in determining outcome in intermediate-grade non-Hodgkin's lymphoma. J Clin Oncol. 1991;9:339-347.
14. Kwak LW, Halpern J, Olshen RA, Horning SJ. Prognostic significance of actual dose intensity in diffuse large-cell lymphoma: results of a tree-structured survival analysis. J Clin Oncol. 1990;8:963-977.
15. Jones SE, Grozea PN, Metz EN, et al. Superiority of Adriamycin-containing combination chemotherapy in the treatment of diffuse lymphoma: a Southwest Oncology Group study. Cancer. 1979;43:417-425.
16. Gams R, Rainey M, Dandy M, Bartolucci A, Silberman H, Omura G. Phase III study of BCOP v CHOP in unfavorable categories of malignant lymphoma: a Southeastern Cancer Study Group trial. J Clin Oncol. 1985;3:1188-1195.
17. Hagberg H, Bjorkholm M, Glimelius B, Lindemalm C, Mellstedt H, Killander A. CHOP vs MEV for the treatment of non-Hodgkin's lymphoma of unfavourable histopathology: a randomized clinical trial. Eur J Cancer Clin Oncol. 1985;21:175-179.
18. Meyer RM, Quirt IC, Skillings JR, et al. Escalated as compared with standard doses of doxorubicin in BACOP therapy for patients with non-Hodgkin's lymphoma. N Engl J Med. 1993;329:1770-1776.
19. The Non-Hodgkin's Lymphoma Pathologic Classification Project. National Cancer Institute sponsored study of classifications of non-Hodgkin's lymphomas: summary and description of a working formulation for clinical usage. Cancer. 1982;49:2112-2135.
20. Tobinai K, Shimoyama M, Minato K, et al. Japan Clinical Oncology Group (JCOG) trial of second-generation "LSG4 protocol" in aggressive lymphoma including ATL: prognostic factors and a predictive model [abstract]. Proc Am Soc Clin Oncol. 1994;13:378.
21. World Health Organization. WHO Handbook for Reporting Results of Cancer Treatment. Geneva, Switzerland: World Health Organization; 1979. WHO offset publication No. 48.
22. Harris NL, Jaffe ES, Diebold J, et al. World Health Organization classification of neoplastic diseases of the hematopoietic and lymphoid tissues: report of the Clinical Advisory Committee meeting-Airlie House, Virginia, November 1997. J Clin Oncol. 1999;17:3835-3849.
23. Jaffe ES, Harris NL, Stein H, Vardiman JW, eds. World Health Organization Classification of Tumours. Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues. Lyon, France: IARC Press; 2001.
24. The International Non-Hodgkin's Lymphoma Prognostic Factors Project. A predictive model for aggressive non-Hodgkin's lymphoma. N Engl J Med. 1993;329:987-994.
25. Shipp M, Neuberg D, Janicek M, Canellos G, Shulman L. High-dose CHOP as initial therapy for patients with poor-prognosis aggressive non-Hodgkin's lymphoma: a dose-finding pilot study. J Clin Oncol. 1995;13:2916-2923.
26. Santoro A, Balzarotti M, Tondini C, et al. Dose-escalation of CHOP in non-Hodgkin's lymphoma. Ann Oncol. 1999;10:519-525.
27. Itoh K, Ohtsu T, Wakita H, et al. Dose-escalation study of CHOP with or without prophylactic G-CSF in aggressive non-Hodgkin's lymphoma. Ann Oncol. 2000;11:1241-1247.
28. Tanosaki R, Okamoto S, Akatsuka N, et al. Dose escalation of biweekly cyclophosphamide, doxorubicin, vincristine, and prednisolone using recombinant human granulocyte colony stimulating factor in non-Hodgkin's lymphoma. Cancer. 1994;74:1939-1944.
29. Pronzato P, Lionetto R, Botto F, Pensa F, Tognoni A. High-dose intensity cyclophosphamide, epidoxorubicin, vincristine and prednisone by shortened intervals and granulocyte colony-stimulating factor in non-Hodgkin's lymphoma: a phase II study. Br J Cancer. 1998;78:777-780.
30. Balzarotti M, Spina M, Sarina B, et al. Intensified CHOP regimen in aggressive lymphomas: maximal dose intensity and dose density of doxorubicin and cyclophosphamide. Ann Oncol. 2002;13:1341-1346.
31. Itoh K, Ohtsu T, Fukuda H, et al. Randomized phase II study of biweekly CHOP and dose-escalated CHOP with prophylactic use of lenograstim (glycosylated G-CSF) in aggressive non-Hodgkin's lymphoma: Japan Clinical Oncology Group Study 9505. Ann Oncol. 2002;13:1347-1355.
32. Budman DR, Berry DA, Cirrincione CT, 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. 1998;90:1205-1211.
33. Haioun C, Lepage E, Gisselbrecht C, et al. Survival benefit of high-dose therapy in poor-risk aggressive non-Hodgkin's lymphoma: final analysis of the prospective LNH87-2 protocol: a Groupe d'Etude des Lymphomes de l'Adulte study. J Clin Oncol. 2000;18:3025-3030.
34. Gianni AM, Bregni M, Siena S, et al. High-dose chemotherapy and autologous bone marrow transplantation compared with MACOP-B in aggressive B-cell lymphoma. N Engl J Med. 1997;336:1290-1298.
35. Milpied N, Deconinck E, Gaillard F, et al. Initial treatment of aggressive lymphoma with high-dose chemotherapy and autologous stem-cell support. N Engl J Med. 2004;350:1287-1295.
36. Santini G, Salvagno L, Leoni P, et al. VACOP-B versus VACOP-B plus autologous bone marrow transplantation for advanced diffuse non-Hodgkin's lymphoma: results of a prospective randomized trial by the non-Hodgkin's Lymphoma Cooperative Study Group. J Clin Oncol. 1998;16:2796-2802.
37. Verdonck LF, van Putten WLJ, Hagenbeek A, et al. Comparison of CHOP chemotherapy with autologous bone marrow transplantation for slowly responding patients with aggressive non-Hodgkin's lymphoma. N Engl J Med. 1995;332:1045-1051.
38. Gisselbrecht C, Lepage E, Molina T, et al. Shortened first-line high-dose chemotherapy for patients with poor-prognosis aggressive lymphoma. J Clin Oncol. 2002;20:2472-2479.
39. McLaughlin P, Grillo-Lopez AJ, Link BK, et al. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998;16:2825-2833.
40. Coiffier B, Haioun C, Ketterer N, et al. Rituximab (anti-CD20 monoclonal antibody) for the treatment of patients with relapsing or refractory aggressive lymphoma: a multicenter phase II study. Blood. 1998;92:1927-1932.
41. Grillo-Lopez AJ. Monoclonal antibody therapy for B-cell lymphoma. Int J Hematol. 2002;76:385-393.
42. Tobinai K. Monoclonal antibody therapy for B-cell lymphoma: clinical trials of an anti-CD20 monoclonal antibody for B-cell lymphoma in Japan. Int J Hematol. 2002;76:411-419.
43. Coiffier B, Lepage E, Briere J, et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002;346:235-242.
44. Pfreundschuh M, Trumper L, Kloess M, et al. 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. 2004;104:634-641.