The role of dose size in a chemotherapy regimen (ProMECE-CytaBOM) for the first-line treatment of large B-cell lymphomas: A randomized trial by the Gruppo Italiano Studio Linfomi (GISL)

Annals of Oncology

Volumn 17, Issue 4, 2006, Pages 676-682

  Gobbi, P G ^a   Broglia, C ^a   Valentino, F ^a   Mammi, C ^b   Lombardo, M ^c   Merli, F ^d   Luminari, S ^b   Polimeno, G ^e   Riezzo, A ^f   Lambelet, P ^g   Rovati, A ^h   Corazza, G R ^a   Federico, M ^b  

^a UNIVERSITY OF PAVIA   (Italy)

^b UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^c SPIRITO SANTO HOSPITAL   (Italy)

^d Servizio di Ematologia   (Italy)

^e MIULLI GENERAL HOSPITAL   (Italy)

^f Ospedale San Nicola Pellegrino   (Italy)

^g Ospedale di Viareggio   (Italy)

^h MAGGIORE HOSPITAL   (Italy)

Author keywords

Chemotherapy; Dose density; Dose intensity; Dose size; Large B cell lymphoma

Indexed keywords

ANTIBIOTIC AGENT; ANTINEOPLASTIC AGENT; BLEOMYCIN; CREATININE; CYCLOPHOSPHAMIDE; CYTARABINE; EPIRUBICIN; ETOPOSIDE; FOLINIC ACID; GRANULOCYTE COLONY STIMULATING FACTOR; MESNA; METHOTREXATE; PREDNISONE; UREA; VINCRISTINE;

ADULT; AGED; ANEMIA; ARTICLE; B CELL LYMPHOMA; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER RELAPSE; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE REGIMEN; DRUG FATALITY; FEMALE; FOLLOW UP; HEPATITIS B; HUMAN; INFECTION; KIDNEY DYSFUNCTION; LARGE CELL LYMPHOMA; LIVER DYSFUNCTION; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; NEUTROPENIA; NONHODGKIN LYMPHOMA; PRIMARY HEALTH CARE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SEPTIC SHOCK; THROMBOCYTOPENIA;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BLEOMYCIN; CYCLOPHOSPHAMIDE; CYTARABINE; DOSE-RESPONSE RELATIONSHIP, DRUG; EPIRUBICIN; ETOPOSIDE; FEMALE; HUMANS; LYMPHOMA, B-CELL; LYMPHOMA, LARGE-CELL; MALE; METHOTREXATE; MIDDLE AGED; PREDNISONE; VINCRISTINE;

EID: 33645299288     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdl002     Document Type: Article

References (31)

1. Goldie JH, Coldman AJ. A mathematical model for relating the drug sensitivity of tumors to thier spontaneous mutation rate. Cancer Treat Rep 1979; 63: 1727-1733.
2. Coldman AJ, Goldie JH. Impact of dose-intense chemotherapy on the development of permanent drug resistance. Semin Oncol 1987; 14 (Suppl 4): 29-33.
3. 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.
4. 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.
5. Hryniuk WM. Average relative dose intensity and the impact on design of clinical trials. Semin Oncol 1987; 14: 65-74.
6. Meyer RM, Hryniuk WM, Goodyear MDE. The role of dose intensity in determining outcome in intermediate-grade non-Hodgkin's lymphoma. J Clin Oncol 1991; 9: 339-347.
7. Santoro A, Balzarotti M, Castagna L. Intensified CHOP in non-Hodgkin's lymphoma: What we know and what we need to know. (Editorial). Ann Oncol 1999; 10: 875-876.
8. Philip T, Guglielmi C, Somers R et al. Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's lymphoma. N Eng J Med 1995; 333: 1540-1545.
9. 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: 1290-1297.
10. Hudis C. Dose-dense chemotherapy for breast cancer: The story so far. Br J Cancer 2000; 82: 1897-1899.
11. Norton L, Simon R. Tumor size, sensitivity to therapy, and design of treatment schedules. Cancer Treat Rep. 1977; 58: 1735-1739.
12. Oken MM Creech RH, Tormey DC et al. Toxicity and response criteria of the Estern Cooperative Oncology Group. Am J Clin Oncol 1982; 5: 569-573.
13. 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.
14. Fisher RI, Longo DL, DeVita VT Jr et al. Long-term follow-up of ProMACE-CytaBOM in non-Hodgkin's lymphomas. Ann Oncol 1991; 2 (Suppl 1): 33-35.
15. Federico M, Clò V, Brugiatelli M et al. Efficacy of two different ProMACE-CytaBOM derived regimens in advanced aggressive non-Hodgkin's lymphoma. Final report of a multicenter trial conducted by GISL. Haematologica 1998: 83: 800-811.
16. Gobbi PG, Ghirardelli ML, Avanzini P et al. A variant of ProMACE-CytaBOM chemotherapy for non-Hodgkin's lymphoma with threefold higher drug dose size but identical cumulative dose intensity. A pilot study of the Italian Lymphoma Study Group (GISL). Haematologica 2000; 85: 263-268.
17. De Vita VT Jr, Hubbard SM, Longo DL. The chemotherapy of lymphomas: looking back, moving forward - the Richard and Hinda Rosenthal Foundation award lecture. Cancer Res 1987; 47: 5810-5824.
18. Cheson BD, Horning SJ, Coiffier B et al. Report of an International Workshop to standardize response criteria for non-Hodgkin's lymphomas. J Clin Oncol 1999; 17: 1244-1253.
19. Dixon DO, Mc Laughlin P, Hagemeister FB et al. Reporting outcomes in Hodgkin's disease and lymphoma. J Clin Oncol 1987; 5: 1670-1673.
20. Makuch R, Simon R. Sample size requirements for evaluating a conservative therapy. Cancer Treat Rep 1978; 62: 1037-1040.
21. Reiss JL, Tytun A, Ury HK. A simple approximation for calculating sample sizes for comparing independent proportions. Biometrics 1980; 36: 343-346.
22. Silingardi V, Federico M, Cavanna L et al. ProMECE-CytaBOM vs. MACOP-B in advanced aggressive non-Hodgkin's lymphoma: Long-term results of a multicenter study of the Italian Lymphoma Study Group (GISL) Leuk Lymphoma 1995; 17: 313-320.
23. Federico M, Gobbi PG, Brugiatelli M et al. Treatment of aggressive non-Hodgkin's lymphomas according to prognostic factors. Lessons from the GISL LA03 study. Haematologica 2000: 85 (suppl. 7): 12 (Abstr.).
24. Gottlieb JA, Gutterman JU, McCredie KB et al. Chemotherapy of malignant lymphoma with adriamycin. Cancer Res 1973; 33: 3024-3028.
25. Coiffier B. Increasing chemotherapy intensity in aggressive lymphomas: A renewal? J Clin Oncol 2003; 13: 2457-2459.
26. Blayney DW, McGuire BW, Cruickshank SE, Johnson DH. Increasing chemotherapy dose density and intensity: Phase I trials in non-small cell lung cancer and non-Hodgkin's lymphoma. Oncologist 2005; 10: 138-149.
27. 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.
28. 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.
29. Pfreundschuh M, Trümper L, Kloess M et al. 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 tdal of the DSHNHL. Blood 2004; 104: 626-33.
30. Pfreundschuh M, Trümper 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.
31. Norton L. Implications of kinetic heterogeneity in clinical oncology. Semin Oncol 1985; 12: 231-235.