title: Clinical efficacy and safety in relapsed/refractory mantle cell lymphoma: a systematic literature review.
abstract: A systematic literature review was performed to collect and review information on the clinical efficacy and safety of treatments for relapsed/refractory (R/R) mantle cell lymphoma (MCL), with a meta-analysis, if possible. PubMed, Embase, and the Cochrane Library were searched for studies published in English from January 1, 1997, to August 2, 2012. Conference proceedings, bibliographic reference lists of included articles, recent reviews, and ClinicalTrials.gov were searched for phase II to IV studies displaying results. Studies were included if they reported on patients with R/R MCL who were ineligible to receive high-dose chemotherapy with stem cell transplant. Studies of patients with several non-Hodgkin lymphoma subtypes were only included if they reported MCL outcomes separately. We identified 59 studies in R/R MCL. Forty distinct treatment regimens were evaluated. Thirty studies included more than 15 patients with R/R MCL. Six studies were comparative (including 5 randomized controlled trials [RCTs]); 53 were single-arm. There were no common treatments among the RCTs; therefore, a meta-analysis was not feasible. Thirty-one of 59 studies reported baseline data for patients with R/R MCL. Of the 30 studies with > 15 patients with R/R MCL, 30 reported overall response rate data, 14 reported progression-free survival (PFS), and 12 reported overall survival (OS). The small number of RCTs in R/R MCL precludes identifying an optimal treatment. Small sample sizes, infrequent reporting of OS and PFS, and limited information on patient characteristics made a comparison of results difficult. High-quality comparative studies of novel therapies that have the potential to demonstrate OS advantages in R/R MCL are needed.
authors: RTI Health Solutions, The Pavillion, Towers Business Park, Manchester, United Kingdom. Electronic address: anjue@rti.org.
authors: Annete
authors: A
authors: Njue
authors: RTI Health Solutions, Research Triangle Park, NC.
authors: Ann
authors: A
authors: Colosia
authors: Global Evidence and Value Development, Sanofi, Cambridge, MA.
authors: Peter C
authors: PC
authors: Trask
authors: Global Evidence and Value Development, Sanofi, Chilly-Mazarin, France.
authors: Robert
authors: R
authors: Olivares
authors: RTI Health Solutions, The Pavillion, Towers Business Park, Manchester, United Kingdom.
authors: Shahnaz
authors: S
authors: Khan
authors: Global Evidence and Value Development, Sanofi, Chilly-Mazarin, France.
authors: Adeline
authors: A
authors: Abbe
authors: RTI Health Solutions, Waltham, MA.
authors: Rachel
authors: R
authors: Police
authors: RTI Health Solutions, The Pavillion, Towers Business Park, Manchester, United Kingdom.
authors: Jianmin
authors: J
authors: Wang
authors: Oncology Research and Development, Sanofi, Cambridge, MA.
authors: Rodrigo
authors: R
authors: Ruiz-Soto
authors: RTI Health Solutions, Waltham, MA.
authors: James A
authors: JA
authors: Kaye
authors: The Ohio State University, Columbus, OH.
authors: Farrukh
authors: F
authors: Awan
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents
keywords: Chemotherapy; MCL treatment