Premium
Frontline bortezomib and rituximab for the treatment of newly diagnosed high tumour burden indolent non‐Hodgkin lymphoma: a multicentre phase II study
Author(s) -
Evens Andrew M.,
Smith Mitchell R.,
Lossos Izidore S.,
Helenowski Irene,
Millenson Michael,
Winter Jane N.,
Rosen Steve T.,
Gordon Leo I.
Publication year - 2014
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.12915
Subject(s) - medicine , rituximab , bortezomib , follicular lymphoma , regimen , lymphoma , phases of clinical research , gastroenterology , surgery , salvage therapy , international prognostic index , oncology , chemotherapy , multiple myeloma
Summary There is a lack of published data examining non‐cytotoxic options for the frontline treatment of patients with high‐tumour burden ( HTB ) indolent non‐Hodgkin lymphoma ( iNHL ). We completed a multicentre phase II study for patients with untreated HTB iNHL ( NCT 00369707) consisting of three induction cycles of weekly bortezomib and rituximab followed by an abbreviated consolidation. Forty‐two patients were treated and all were evaluable; the most common histology was follicular lymphoma ( FL ) ( n = 33, 79%). Patient characteristics included median age 62 years (40–86); 38% bulky disease; 19% malignant effusions; 91% advanced‐stage disease; and median FL International Prognostic Index ( FLIPI ) score was 3. Therapy was well tolerated with few grade 3/4 toxicities including minimal neurotoxicity. On intent‐to‐treat, the overall response rate ( ORR ) at end of therapy was 70% with a complete remission ( CR ) rate of 40% ( FL : ORR 76%, CR 44%). With 50‐month median follow‐up, 4‐year progression‐free survival ( PFS ) was 44% with 4‐year overall survival ( OS ) of 87% ( FL : 44% and 97%, respectively). Four‐year PFS for FLIPI 0–2 vs. 3–5 was 60% vs. 26% respectively ( P = 0·02), with corresponding OS rates of 92% and 81% respectively ( P = 0·16). Collectively, bortezomib/rituximab is a non‐cytotoxic therapeutic regimen that was well tolerated and resulted in long‐term survival rates approximating prior rituximab/cytotoxic chemotherapy series for untreated HTB FL .