Indolent lymphoma - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main iNHL page for regimens that include active anticancer treatment.
Last updated on 2024-12-02:2 regimens on this page
2 variants on this page
=Early disease, consolidation=
==Observation==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Kelsey et al. 1994 	1974-1981 	Randomized (C)	Chlorambucil	Did not meet primary endpoint of OS
Yahalom et al. 1993	1980-1988 	Randomized (C)	CHOP x 6 	Seems to have shorter RFS
No further treatment.
====Preceding treatment====
*Definitive Radiation therapy
===References===
#Yahalom J, Varsos G, Fuks Z, Myers J, Clarkson BD, Straus DJ. Adjuvant cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy after radiation therapy in stage I low-grade and intermediate-grade non-Hodgkin lymphoma: results of a prospective randomized study. Cancer. 1993 Apr 1;71(7):2342-50. link to original article EuroPMC
#Kelsey SM, Newland AC, Hudson GV, Jelliffe AM. A British National Lymphoma Investigation randomised trial of single agent chlorambucil plus radiotherapy versus radiotherapy alone in low grade, localised non-Hodgkins lymphoma. Med Oncol. 1994;11(1):19-25. link to original article EuroPMC
=Consolidation after first-line therapy=
==Observation==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Hagenbeek et al. 1998 	1985-1992 	Phase 3 (C)	Interferon alfa 	Might have shorter TTP
Fisher et al. 2000 (SWOG S8809) 	1988-1994 	Phase 3 (C)	Interferon alfa 	Did not meet co-primary endpoints of PFS/OS
Hochster et al. 2009 (ECOG E1496)	Not reported 	Phase 3 (C)	Rituximab 	Shorter PFS
Rule et al. 2022 (MabCute) 	Not reported 	Phase 3 (C)	SC Rituximab indefinitely	Did not meet primary endpoint of PFS
No further treatment after induction therapy.
====Preceding treatment====
*ECOG E1496: First-line CVP x 6 to 8
*MabCute: SC rituximab maintenance x 2 y
===References===
#Hagenbeek A, Carde P, Meerwaldt JH, Somers R, Thomas J, De Bock R, Raemaekers JM, van Hoof A, De Wolf-Peeters C, van Glabbeke M; EORTC Lymphoma Cooperative Group. Maintenance of remission with human recombinant interferon alfa-2a in patients with stages III and IV low-grade malignant non-Hodgkin's lymphoma. J Clin Oncol. 1998 Jan;16(1):41-7. link to original article EuroPMC
#SWOG S8809: Fisher RI, Dana BW, LeBlanc M, Kjeldsberg C, Forman JD, Unger JM, Balcerzak SP, Gaynor ER, Roy V, Miller T. Interferon alpha consolidation after intensive chemotherapy does not prolong the progression-free survival of patients with low-grade non-Hodgkin's lymphoma: results of the Southwest Oncology Group randomized phase III study 8809. J Clin Oncol. 2000 May;18(10):2010-6. link to original article EuroPMC
#ECOG E1496: Hochster H, Weller E, Gascoyne RD, Habermann TM, Gordon LI, Ryan T, Zhang L, Colocci N, Frankel S, Horning SJ. Maintenance rituximab after cyclophosphamide, vincristine, and prednisone prolongs progression-free survival in advanced indolent lymphoma: results of the randomized phase III ECOG1496 Study. J Clin Oncol. 2009 Apr 1;27(10):1607-14. Epub 2009 Mar 2. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC NCT00003204
##Update: Barta SK, Li H, Hochster HS, Hong F, Weller E, Gascoyne RD, Habermann TM, Gordon LI, Colocci N, Bengtson EM, Horning SJ, Kahl BS. Randomized phase 3 study in low-grade lymphoma comparing maintenance anti-CD20 antibody with observation after induction therapy: A trial of the ECOG-ACRIN Cancer Research Group (E1496). Cancer. 2016 Oct;122(19):2996-3004. Epub 2016 Jun 28. link to original article link to PMC article EuroPMC
#MabCute: Rule S, Barreto WG, Briones J, Carella AM, Casasnovas O, Pocock C, Wendtner CM, Zaja F, Robson S, MacGregor L, Tschopp RR, Nick S, Dreyling M. Efficacy and safety assessment of prolonged maintenance with subcutaneous rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma: results of the phase III MabCute study. Haematologica. 2022 Feb 1;107(2):500-509. link to original article link to PMC article EuroPMC NCT01461928
Category:Indolent lymphoma regimens
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