Efficacy and safety of subcutaneous rituximab versus intravenous rituximab for first-line treatment of follicular lymphoma (SABRINA): a randomised, open-label, phase 3 trial

The Lancet Haematology

Volumn 4, Issue 6, 2017, Pages e272-e282

  Davies, Andrew ^a   Merli, Francesco ^b   Mihaljević, Biljana ^c   Mercadal, Santiago ^d   Siritanaratkul, Noppadol ^e   Solal Céligny, Philippe ^f   Boehnke, Axel ^g   Berge, Claude ^g   Genevray, Magali ^g   Zharkov, Artem ^g   Dixon, Mark ^h   Brewster, Michael ^h   Barrett, Martin ^h   MacDonald, David ⁱ  

^a UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

^b S MARIA NUOVA HOSPITAL   (Italy)

^c CLINICAL CENTER OF SERBIA   (Serbia)

^d CATALAN INSTITUTE OF ONCOLOGY   (Spain)

^e MAHIDOL UNIVERSITY   (Thailand)

^f CENTRE JEAN BERNARD   (France)

^g F HOFFMANN LA ROCHE LTD   (Switzerland)

^h ROCHE PRODUCTS LTD   (United Kingdom)

ⁱ QUEEN ELIZABETH II HEALTH SCIENCES CENTRE   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

BETA 2 MICROGLOBULIN; CD19 ANTIGEN; CYCLOPHOSPHAMIDE; DOXORUBICIN; HEMOGLOBIN; LACTATE DEHYDROGENASE; PREDNISONE; RITUXIMAB; VINCRISTINE;

ABDOMINAL PAIN; ADULT; ARTICLE; BODY SURFACE; BONE MARROW BIOPSY; CHILL; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; FEMALE; FOLLICULAR LYMPHOMA; HEMATOCRIT; HUMAN; HYPERHIDROSIS; INJECTION SITE ERYTHEMA; INJECTION SITE REACTION; LEUKOCYTE COUNT; LIFE EXPECTANCY; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; NOSE OBSTRUCTION; NUCLEAR MAGNETIC RESONANCE IMAGING; PHASE 3 CLINICAL TRIAL; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; THROAT IRRITATION; THROMBOCYTE COUNT; THROMBOCYTOPENIA; VOMITING; AGED; CLINICAL TRIAL; COMPARATIVE STUDY; INTRAVENOUS DRUG ADMINISTRATION; KAPLAN MEIER METHOD; SAFETY; SUBCUTANEOUS DRUG ADMINISTRATION;

AGED; FEMALE; HUMANS; INJECTIONS, INTRAVENOUS; INJECTIONS, SUBCUTANEOUS; KAPLAN-MEIER ESTIMATE; LYMPHOMA, FOLLICULAR; MALE; MIDDLE AGED; RITUXIMAB; SAFETY;

EID: 85018982291     PISSN: None     EISSN: 23523026     Source Type: Journal    
DOI: 10.1016/S2352-3026(17)30078-9     Document Type: Article

References (27)

1. Seiler, TM, Hiddemann, W, Advances in the management of follicular lymphoma. Curr Opin Oncol 24 (2012), 742–747.
2. Hoffmann-La Roche, F, Rituximab (MabThera) summary of product characteristics. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000165/WC500025821.pdf (accessed Aug 10, 2015).
3. Frost, GI, Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration. Expert Opin Drug Deliv 4 (2007), 427–440.
4. Shpilberg, O, Jackisch, C, Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase. Br J Cancer 109 (2013), 1556–1561.
5. De Cock, E, Kritikou, P, Sandoval, M, et al. Time savings with rituximab subcutaneous injection versus rituximab intravenous infusion: a time and motion study in eight countries. PLoS One, 11, 2016, e0157957.
6. Rummel, M, Kim, TM, Aversa, F, et al. Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol 28 (2017), 836–842.
7. Salar, A, Avivi, I, Bittner, B, et al. Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a two-stage, phase IB study. J Clin Oncol 32 (2014), 1782–1791.
8. Yin, A, Li, J, Hurst, D, Visich, J, Population pharmacokinetics (PK) and association of PK and clinical outcomes of rituximab in patients with non-Hodgkin's lymphoma. Proc Am Soc Clin Oncol, 28(suppl), 2010, e13108.
9. Tobinai, K, Igarashi, T, Itoh, K, et al., for the IDEC-C2B8 Japan Study Group. Japanese multicentre phase II and pharmacokinetic study of rituximab in relapsed or refractory patients with aggressive B-cell lymphoma. Ann Oncol 15 (2004), 821–830.
10. Jaeger, U, Fridrik, M, Zeitlinger, M, et al. Rituximab serum concentrations during immuno-chemotherapy of follicular lymphoma correlate with patient gender, bone marrow infiltration and clinical response. Haematologica 97 (2012), 1431–1438.
11. Davies, A, Merli, F, Mihaljević, B, et al. Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study. Lancet Oncol 15 (2014), 343–352.
12. 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. J Clin Oncol 15 (1997), 1110–1117.
13. Cheson, BD, Horning, SJ, Coiffier, B, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI sponsored International Working Group. J Clin Oncol, 17, 1999, 1244.
14. Cheson, BD, Pfistner, B, Juweid, ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol 25 (2007), 579–586.
15. Jager, U, Fridrik, M, Zeitlinger, M, et al. Rituximab serum concentrations during immuno-chemotherapy of follicular lymphoma correlate with patient gender, bone marrow infiltration and clinical response. Haematologica 97 (2012), 1431–1438.
16. Tobinai, K, Igarashi, T, Itoh, K, et al. Japanese multicenter phase II and pharmacokinetic study of rituximab in relapsed or refractory patients with aggressive B-cell lymphoma. Ann Oncol 15 (2004), 821–830.
17. Marcus, R, Imrie, K, Belch, A, et al. CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma. Blood 105 (2005), 1417–1423.
18. 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 advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood 106 (2005), 3725–3732.
19. Salles, G, Seymour, JF, Offner, F, et al. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet 377 (2011), 42–51.
20. Grillo-Lopez, AJ, Peripheral blood B-cell recovery in patients with non-Hodgkin's lymphoma treated with rituximab does not correlate with onset of disease progression. http://www.cancernetwork.com/review-article/peripheral-blood-b-cell-recovery-patients-non-hodgkin%E2%80%99s-lymphoma-treated-rituximab-does-not (accessed Aug 10, 2015).
21. McLaughlin, P, Grillo-López, 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 16 (1998), 2825–2833.
22. Sidner, RA, Book, BK, Agarwal, A, In vivo B-cell subset recovery after in vivo depletion with rituximab, anti-human CD20 monoclonal antibody. Hum Antibodies 13 (2004), 55–62.
23. Ismael, G, Hegg, R, Muehlbauer, S, et al. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I–III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol 13 (2012), 869–878.
24. Pivot, X, Gligorov, J, Müller, V, et al. Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study. Lancet Oncol 14 (2013), 962–970.
25. Assouline, S, Buccheri, V, Delmer, A, et al. Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial. Lancet Haematol 3 (2016), e128–e138.
26. Lugtenburg, PJ, Rueda, A, Avivi, I, et al. Subcutaneous versus intravenous rituximab in combination with CHOP for previously untreated diffuse large B-cell lymphoma: efficacy and safety results from the phase IIIb MABEASE study. Haematologica, 100(suppl 1), 2015 abstr S483.
27. Marcus, RE, Davies, AJ, Ando, K, et al. Obinutuzumab-based induction and maintenance prolongs progression-free survial (PFS) in patients with previously untreated follicular lymphoma: primary results of the randomized phase 3 GALLIUM study. Blood, 128(suppl), 2016 abstr 6.