Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: The BRIGHT study

Blood

Volumn 123, Issue 19, 2014, Pages 2944-2952

  Flinn, Ian W ^a   Van Der Jagt, Richard ^b   Kahl, Brad S ^c   Wood, Peter ^d   Hawkins, Tim E ^e   MacDonald, David ^f   Hertzberg, Mark ^g   Kwan, Yiu Lam ^h   Simpson, David ⁱ   Craig, Michael ^j   Kolibaba, Kathryn ^k,l   Issa, Samar ^m   Clementi, Regina ⁿ   Hallman, Doreen M ⁿ   Munteanu, Mihaela ⁿ   Chen, Ling ⁿ   Burke, John M ^k,o  

^a SARAH CANNON RESEARCH INSTITUTE   (United States)

^b UNIVERSITY OF OTTAWA   (Canada)

^c UNIVERSITY OF WISCONSIN   (United States)

^d PRINCESS ALEXANDRA HOSPITAL   (Australia)

^e AUCKLAND CITY HOSPITAL   (New Zealand)

^f DALHOUSIE UNIVERSITY   (Canada)

^g WESTMEAD HOSPITAL   (Australia)

^h Department of Geriatric Medicine   (Australia)

ⁱ NORTH SHORE HOSPITAL   (New Zealand)

^j WEST VIRGINIA UNIVERSITY   (United States)

^k The US Oncology Network McKesson Specialty Health   (United States)

^l Vancouver Cancer Center   (United States)

^m MIDDLEMORE HOSPITAL   (New Zealand)

ⁿ Teva Branded Pharmaceutical Products RandD Inc ^*  (United States)

^o ROCKY MOUNTAIN CANCER CENTERS   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BENDAMUSTINE; COLONY STIMULATING FACTOR; CORTICOSTEROID; CYCLOPHOSPHAMIDE; DOXORUBICIN; HEMOGLOBIN; PREDNISONE; RITUXIMAB; VINCRISTINE; ANTINEOPLASTIC AGENT; CHLORMETHINE DERIVATIVE; MONOCLONAL ANTIBODY;

ABDOMINAL PAIN; ADULT; AGED; ALOPECIA; ANXIETY DISORDER; ARTHRALGIA; ARTICLE; BACKACHE; CANCER COMBINATION CHEMOTHERAPY; CANCER MORTALITY; CHEMOTHERAPY INDUCED EMESIS; CHILL; COMPARATIVE STUDY; CONSTIPATION; CONTROLLED STUDY; COUGHING; DECREASED APPETITE; DIARRHEA; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; DYSGEUSIA; DYSPEPSIA; DYSPNEA; EDEMA; FAINTNESS; FATIGUE; FEMALE; HEADACHE; HUMAN; HYPERGLYCEMIA; INFECTION; INFUSION RELATED REACTION; INSOMNIA; LEUKOCYTE COUNT; LOW DRUG DOSE; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MANTLE CELL LYMPHOMA; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL PAIN; MYALGIA; NAUSEA; NEUTROPENIA; NEUTROPHIL COUNT; NONHODGKIN LYMPHOMA; OPEN STUDY; OPPORTUNISTIC INFECTION; PARESTHESIA; PERIPHERAL NEUROPATHY; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; SENSORY NEUROPATHY; SIDE EFFECT; SINGLE BLIND PROCEDURE; THROMBOCYTE COUNT; THROMBOCYTOPENIA; TREATMENT RESPONSE; CHEMICALLY INDUCED; CLINICAL TRIAL; DRUG ADMINISTRATION; LYMPHOMA, MANTLE-CELL; LYMPHOMA, NON-HODGKIN; MIDDLE AGED; PHASE 3 CLINICAL TRIAL; TREATMENT OUTCOME; VERY ELDERLY; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ALOPECIA; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYCLOPHOSPHAMIDE; DOXORUBICIN; DRUG ADMINISTRATION SCHEDULE; FATIGUE; FEMALE; HUMANS; LYMPHOMA, MANTLE-CELL; LYMPHOMA, NON-HODGKIN; MALE; MIDDLE AGED; NAUSEA; NITROGEN MUSTARD COMPOUNDS; PARESTHESIA; PERIPHERAL NERVOUS SYSTEM DISEASES; PREDNISONE; TREATMENT OUTCOME; VINCRISTINE; VOMITING;

EID: 84900423736     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2013-11-531327     Document Type: Article

References (17)

1. Hiddemann W, Kneba M, Dreyling M, et al. Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advancedstage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2005;106 (12): 3725-3732. (Pubitemid 41742196)
2. Marcus R, Imrie K, Belch A, et al. CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma. Blood. 2005;105 (4):1417-1423. (Pubitemid 40223656)
3. Knauf WU, Lissichkov T, Aldaoud A, et al. Phase III randomized study of bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukemia. J Clin Oncol. 2009;27 (26):4378-4384.
4. Kahl BS, Bartlett NL, Leonard JP, et al. Bendamustine is effective therapy in patients with rituximab-refractory, indolent B-cell non-Hodgkin lymphoma: results from a Multicenter Study. Cancer. 2010;116 (1): 106-114.
5. Robinson KS, Williams ME, van der Jagt RH, et al. Phase II multicenter study of bendamustine plus rituximab in patients with relapsed indolent B-cell and mantle cell non-Hodgkin's lymphoma. J Clin Oncol. 2008; 26 (27):4473-4479.
6. Rummel MJ, Niederle N, Maschmeyer G, et al; Study group indolent Lymphomas (StiL). Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. Lancet. 2013;381 (9873): 1203-1210.
7. Cheson BD, Pfistner B, Juweid ME, et al; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25 (5): 579-586. (Pubitemid 350002966)
8. US Food and Drug Administration. FDA draft guidance for industry: non-inferiority clinical trials. Silver Spring, MD: FDA; March 2010. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM202140.pdf. Accessed March 12, 2013.
9. Friedberg JW, Taylor MD, Cerhan JR, et al. Follicular lymphoma in the United States: first report of the national LymphoCare study. J Clin Oncol. 2009;27 (8):1202-1208.
10. Van der Jagt R, Laneuville P, Macdonald D, Stewart D, Christofides A, Sehn LH. A Canadian perspective on bendamustine for the treatment of chronic lymphocytic leukemia and non- Hodgkin lymphoma. Curr Oncol. 2012;19 (3): 160-168.
11. Alberta Health Services. Lymphoma. Clinical practice guideline LYHE-002. Edmonton, AB, Canada: Alberta Health Services; April 2013.
12. World Health Organisation. Handbook for Reporting Results of Cancer Treatment. Geneva, Switzerland: World Health Organization; 1979.
13. Friedberg JW, Cohen P, Chen L, et al. Bendamustine in patients with rituximabrefractory indolent and transformed non- Hodgkin's lymphoma: results from a phase II multicenter, single-agent study. J Clin Oncol. 2008;26 (2):204-210.
14. Data on file. Frazer, PA: Teva Branded Pharmaceutical Products R&D, Inc.
15. Press OW, Palanca-Wessels MC. Selection of first-line therapy for advanced follicular lymphoma. J Clin Oncol. 2013;31 (12): 1496-1498.
16. Federico M, Luminari S, Dondi A, et al. R-CVP versus R-CHOP versus R-FM for the initial treatment of patients with advanced-stage follicular lymphoma: results of the FOLL05 trial conducted by the Fondazione Italiana Linfomi. J Clin Oncol. 2013;31 (12):1506-1513.
17. Cheson BD, Friedberg JW, Kahl BS, Van der Jagt RH, Tremmel L. Bendamustine produces durable responses with an acceptable safety profile in patients with rituximab-refractory indolent non- Hodgkin lymphoma. Clin Lymphoma Myeloma Leuk. 2010;10 (6):452-457.