Rituximab versus a watch-and-wait approach in patients with advanced-stage, asymptomatic, non-bulky follicular lymphoma: An open-label randomised phase 3 trial

The Lancet Oncology

Volumn 15, Issue 4, 2014, Pages 424-435

  Ardeshna, Kirit M ^a   Qian, Wendi ^b   Smith, Paul ^d   Braganca, Nivette ^d   Lowry, Lisa ^d   Patrick, Pip ^d   Warden, June ^e   Stevens, Lindsey ^d   Pocock, Christopher F E ^f   Miall, Fiona ^g   Cunningham, David ^h   Davies, John ⁱ   Jack, Andrew ^j   Stephens, Richard ^k   Walewski, Jan ^l   Ferhanoglu, Burhan ^m   Bradstock, Ken ⁿ   Linch, David C ^c  

^a UNIVERSITY COLLEGE HOSPITAL   (United Kingdom)

^b MRC BIOSTATISTICS UNIT   (United Kingdom)

^c UNIVERSITY COLLEGE LONDON   (United Kingdom)

^d IMPERIAL CANCER RESEARCH FUND   (United Kingdom)

^e UNIVERSITY OF MANCHESTER   (United Kingdom)

^f EAST KENT HOSPITALS UNIVERSITY NHS FOUNDATION TRUST   (United Kingdom)

^g LEICESTER ROYAL INFIRMARY   (United Kingdom)

^h ROYAL MARSDEN HOSPITAL   (United Kingdom)

ⁱ WESTERN GENERAL HOSPITAL   (United Kingdom)

^j ST JAMES S INSTITUTE OF ONCOLOGY   (United Kingdom)

^k MRC CLINICAL TRIALS UNIT   (United Kingdom)

^l INSTITUTE OF ONCOLOGY   (Poland)

^m ISTANBUL UNIVERSITY   (Turkey)

ⁿ UNIVERSITY OF SYDNEY   (Australia)

more..

Author keywords

[No Author keywords available]

Indexed keywords

RITUXIMAB;

ADULT; ADVANCED CANCER; AGED; ALLERGIC REACTION; ARTICLE; CANCER CHEMOTHERAPY; CANCER GRADING; CANCER STAGING; CLINICAL EFFECTIVENESS; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG USE; FEMALE; FOLLICULAR LYMPHOMA; FOLLOW UP; HUMAN; INFECTION; MAINTENANCE CHEMOTHERAPY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUTROPENIA; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SEPSIS; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT PLANNING; TUMOR VOLUME; VERY ELDERLY; WATCHFUL WAITING;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; ANTINEOPLASTIC AGENTS; ASYMPTOMATIC DISEASES; AUSTRALIA; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; EUROPE; FEMALE; HUMANS; INTENTION TO TREAT ANALYSIS; KAPLAN-MEIER ESTIMATE; LYMPHOMA, FOLLICULAR; MALE; MIDDLE AGED; NEOPLASM GRADING; NEOPLASM STAGING; NEW ZEALAND; PATIENT SELECTION; PROPORTIONAL HAZARDS MODELS; QUALITY OF LIFE; RISK FACTORS; TIME FACTORS; TREATMENT OUTCOME; WATCHFUL WAITING;

EID: 84897406150     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(14)70027-0     Document Type: Article

References (18)

1. Portlock CS, Rosenberg SA No initial therapy for stage III and IV non-Hodgkin's lymphomas of favorable histologic types. Ann Intern Med 1979, 90:10-13.
2. Horning SJ, Rosenberg SA The natural history of initially untreated low-grade non-Hodgkin's lymphomas. N Engl J Med 1984, 311:1471-1475.
3. Ardeshna KM, Smith P, Norton A, et al. Long-term effect of a watch and wait policy versus immediate systemic treatment for asymptomatic advanced-stage non-Hodgkin lymphoma: a randomised controlled trial. Lancet 2003, 362:516-522.
4. Brice P, Bastion Y, Lepage E, et al. Comparison in low-tumor-burden follicular lymphomas between an initial no-treatment policy, prednimustine, or interferon alfa: a randomized study from the Groupe d'Etude des Lymphomes Folliculaires. Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol 1997, 15:1110-1117.
5. Young RC, Longo DL, Glatstein E, Ihde DC, Jaffe ES, DeVita VT The treatment of indolent lymphomas: watchful waiting v aggressive combined modality treatment. Semin Hematol 1988, 25(2 suppl 2):11-16.
6. Colombat P, Brousse N, Salles G, et al. Rituximab induction immunotherapy for first-line low-tumor-burden follicular lymphoma: survival analyses with 7-year follow-up. Ann Oncol 2012, 23:2380-2385.
7. Colombat P, Salles G, Brousse N, et al. Rituximab (anti-CD20 monoclonal antibody) as single first-line therapy for patients with follicular lymphoma with a low tumor burden: clinical and molecular evaluation. Blood 2001, 97:101-106.
8. 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.
9. Ghielmini M, Schmitz SF, Cogliatti SB, et al. Prolonged treatment with rituximab in patients with follicular lymphoma significantly increases event-free survival and response duration compared with the standard weekly × 4 schedule. Blood 2004, 103:4416-4423.
10. Martinelli G, Schmitz SF, Utiger U, et al. Long-term follow-up of patients with follicular lymphoma receiving single-agent rituximab at two different schedules in trial SAKK 35/98. J Clin Oncol 2010, 28:4480-4484.
11. Solal-Celigny P, Roy P, Colombat P, et al. Follicular lymphoma international prognostic index. Blood 2004, 104:1258-1265.
12. Kahl BS, Hong F, Williams ME, et al. Results of Eastern Cooperative Oncology Group Protocol E4402 (RESORT): a randomized phase III study comparing two different rituximab dosing strategies for low tumor burden follicular lymphoma. Blood 2011, 118:LBA 9. (abstr).
13. Crawford JR, Henry JD, Crombie C, Taylor EP Normative data for the HADS from a large non-clinical sample. Br J Clin Psychol 2001, 40:429-434.
14. Sinha R, Byrtek M, DeJoubner N, et al. Examining the outcomes of watchful waiting among US patients with advanced stage follicular lymphoma. Blood 2011, 118:775.
15. Montoto S, Davies AJ, Matthews J, et al. Risk and clinical implications of transformation of follicular lymphoma to diffuse large B-cell lymphoma. J Clin Oncol 2007, 25:2426-2433.
16. Al-Tourah AJ, Gill KK, Chhanabhai M, et al. Population-based analysis of incidence and outcome of transformed non-Hodgkin's lymphoma. J Clin Oncol 2008, 26:5165-5169.
17. Gisselbrecht C, Schmitz N, Mounier N, et al. Rituximab maintenance therapy after autologous stem-cell transplantation in patients with relapsed CD20+ diffuse large B-cell lymphoma: final analysis of the collaborative trial in relapsed aggressive lymphoma. J Clin Oncol 2012, 30:4462-4469.
18. Muller C, Murawski N, Wiesen MH, et al. The role of sex and weight on rituximab clearance and serum elimination half-life in elderly patients with DLBCL. Blood 2012, 119:3276-3284.