Abstract
In the mantle cell lymphoma (MCL)-002 study, lenalidomide demonstrated significantly improved median progression-free survival (PFS) compared with investigator's choice (IC) in patients with relapsed/refractory MCL. Here we present the long-term follow-up data and results of preplanned subgroup exploratory analyses from MCL-002 to evaluate the potential impact of demographic factors, baseline clinical characteristics and prior therapies on PFS. In MCL-002, patients with relapsed/refractory MCL were randomized 2:1 to receive lenalidomide (25 mg/day orally on days 1–21; 28-day cycles) or single-agent IC therapy (rituximab, gemcitabine, fludarabine, chlorambucil or cytarabine). The intent-to-treat population comprised 254 patients (lenalidomide, n = 170; IC, n = 84). Subgroup analyses of PFS favoured lenalidomide over IC across most characteristics, including risk factors, such as high MCL International Prognostic Index score, age ≥65 years, high lactate dehydrogenase (LDH), stage III/IV disease, high tumour burden, and refractoriness to last prior therapy. By multivariate Cox regression analysis, factors associated with significantly longer PFS (other than lenalidomide treatment) included normal LDH levels (P < 0·001), nonbulky disease (P = 0·045), <3 prior antilymphoma treatments (P = 0·005), and ≥6 months since last prior treatment (P = 0·032). Overall, lenalidomide improved PFS versus single-agent IC therapy in patients with relapsed/refractory MCL, irrespective of many demographic factors, disease characteristics and prior treatment history.
| Original language | English |
|---|---|
| Pages (from-to) | 224-235 |
| Number of pages | 12 |
| Journal | British Journal of Haematology |
| Volume | 180 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - Jan 1 2018 |
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Keywords
- lenalidomide
- mantle cell lymphoma
- non-Hodgkin lymphoma
ASJC Scopus subject areas
- Hematology
Cite this
Prospective subgroup analyses of the randomized MCL-002 (SPRINT) study : lenalidomide versus investigator's choice in relapsed or refractory mantle cell lymphoma. / Arcaini, Luca; Lamy, Thierry; Walewski, Jan; Belada, David; Mayer, Jiri; Radford, John; Jurczak, Wojciech; Morschhauser, Franck; Alexeeva, Julia; Rule, Simon; Cabeçadas, José; Campo, Elias; Pileri, Stefano A.; Biyukov, Tsvetan; Patturajan, Meera; Casadebaig Bravo, Marie Laure; Trnĕný, Marek; the SPRINT Trial Investigators.
In: British Journal of Haematology, Vol. 180, No. 2, 01.01.2018, p. 224-235.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Prospective subgroup analyses of the randomized MCL-002 (SPRINT) study
T2 - lenalidomide versus investigator's choice in relapsed or refractory mantle cell lymphoma
AU - Arcaini, Luca
AU - Lamy, Thierry
AU - Walewski, Jan
AU - Belada, David
AU - Mayer, Jiri
AU - Radford, John
AU - Jurczak, Wojciech
AU - Morschhauser, Franck
AU - Alexeeva, Julia
AU - Rule, Simon
AU - Cabeçadas, José
AU - Campo, Elias
AU - Pileri, Stefano A.
AU - Biyukov, Tsvetan
AU - Patturajan, Meera
AU - Casadebaig Bravo, Marie Laure
AU - Trnĕný, Marek
AU - the SPRINT Trial Investigators
PY - 2018/1/1
Y1 - 2018/1/1
N2 - In the mantle cell lymphoma (MCL)-002 study, lenalidomide demonstrated significantly improved median progression-free survival (PFS) compared with investigator's choice (IC) in patients with relapsed/refractory MCL. Here we present the long-term follow-up data and results of preplanned subgroup exploratory analyses from MCL-002 to evaluate the potential impact of demographic factors, baseline clinical characteristics and prior therapies on PFS. In MCL-002, patients with relapsed/refractory MCL were randomized 2:1 to receive lenalidomide (25 mg/day orally on days 1–21; 28-day cycles) or single-agent IC therapy (rituximab, gemcitabine, fludarabine, chlorambucil or cytarabine). The intent-to-treat population comprised 254 patients (lenalidomide, n = 170; IC, n = 84). Subgroup analyses of PFS favoured lenalidomide over IC across most characteristics, including risk factors, such as high MCL International Prognostic Index score, age ≥65 years, high lactate dehydrogenase (LDH), stage III/IV disease, high tumour burden, and refractoriness to last prior therapy. By multivariate Cox regression analysis, factors associated with significantly longer PFS (other than lenalidomide treatment) included normal LDH levels (P < 0·001), nonbulky disease (P = 0·045), <3 prior antilymphoma treatments (P = 0·005), and ≥6 months since last prior treatment (P = 0·032). Overall, lenalidomide improved PFS versus single-agent IC therapy in patients with relapsed/refractory MCL, irrespective of many demographic factors, disease characteristics and prior treatment history.
AB - In the mantle cell lymphoma (MCL)-002 study, lenalidomide demonstrated significantly improved median progression-free survival (PFS) compared with investigator's choice (IC) in patients with relapsed/refractory MCL. Here we present the long-term follow-up data and results of preplanned subgroup exploratory analyses from MCL-002 to evaluate the potential impact of demographic factors, baseline clinical characteristics and prior therapies on PFS. In MCL-002, patients with relapsed/refractory MCL were randomized 2:1 to receive lenalidomide (25 mg/day orally on days 1–21; 28-day cycles) or single-agent IC therapy (rituximab, gemcitabine, fludarabine, chlorambucil or cytarabine). The intent-to-treat population comprised 254 patients (lenalidomide, n = 170; IC, n = 84). Subgroup analyses of PFS favoured lenalidomide over IC across most characteristics, including risk factors, such as high MCL International Prognostic Index score, age ≥65 years, high lactate dehydrogenase (LDH), stage III/IV disease, high tumour burden, and refractoriness to last prior therapy. By multivariate Cox regression analysis, factors associated with significantly longer PFS (other than lenalidomide treatment) included normal LDH levels (P < 0·001), nonbulky disease (P = 0·045), <3 prior antilymphoma treatments (P = 0·005), and ≥6 months since last prior treatment (P = 0·032). Overall, lenalidomide improved PFS versus single-agent IC therapy in patients with relapsed/refractory MCL, irrespective of many demographic factors, disease characteristics and prior treatment history.
KW - lenalidomide
KW - mantle cell lymphoma
KW - non-Hodgkin lymphoma
UR - http://www.scopus.com/inward/record.url?scp=85035217950&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85035217950&partnerID=8YFLogxK
U2 - 10.1111/bjh.15025
DO - 10.1111/bjh.15025
M3 - Article
VL - 180
SP - 224
EP - 235
JO - British Journal of Haematology
JF - British Journal of Haematology
SN - 0007-1048
IS - 2
ER -