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Lenalidomide versus...
Lenalidomide versus lenalidomide plus dexamethasone prolonged treatment after second-line lenalidomide plus dexamethasone induction in multiple myeloma
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- Lund, Johan (author)
- Karolinska Univ Hosp, Sweden
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- Gruber, Astrid (author)
- Karolinska Univ Hosp, Sweden
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- Lauri, Birgitta (author)
- Sunderby Hosp, Sweden
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- Duru, Adil Doganay (author)
- Karolinska Univ Hosp, Sweden; NSU, FL USA
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- Blimark, Cecilie (author)
- Sahlgrens Univ Hosp, Sweden
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- Swedin, Agneta (author)
- Skane Univ Hosp, Sweden
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- Hansson, Markus (author)
- Skane Univ Hosp, Sweden
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- Forsberg, Karin (author)
- Norrland Univ Hosp, Sweden
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- Ahlberg, Lucia, 1959- (author)
- Region Östergötland, Hematologiska kliniken US
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- Carlsson, Conny (author)
- Hallands Hosp, Sweden
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- Waage, Anders (author)
- Norwegian Univ Sci and Technol, Norway
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- Gimsing, Peter (author)
- Rigshosp, Denmark
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- Vangsted, Annette Juul (author)
- Rigshosp, Denmark; Zealand Univ, Denmark
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- Frolund, Ulf (author)
- Zealand Univ, Denmark
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- Holmberg, Erik (author)
- Inst Clin Sci, Sweden
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- Gahrton, Gösta (author)
- Karolinska Institutet,Karolinska Univ Hosp, Sweden
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- Alici, Evren (author)
- Karolinska Institutet,Karolinska Univ Hosp, Sweden
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- Hardling, Mats (author)
- Uddevalla Cent Hosp, Sweden
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- Mellqvist, Ulf-Henrik (author)
- Sahlgrens Univ Hosp, Sweden
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- Nahi, Hareth (author)
- Karolinska Institutet,Karolinska Univ Hosp, Sweden
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(creator_code:org_t)
- 2018-04-19
- 2018
- English.
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In: Cancer Medicine. - : WILEY. - 2045-7634. ; 7:6, s. 2256-2268
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Abstract
Subject headings
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- Lenalidomide (Len) plus dexamethasone (Dex) is approved for the treatment of relapsed or refractory multiple myeloma (RRMM). It is possible that single-agent Len may be effective as prolonged treatment regimen in RRMM once patients demonstrate an initial response to Len+Dex induction. Patients with RRMM who responded to first-line Len+Dex in an observational study (NCT01430546) received up to 24 cycles of either Len (25mg/day) or Len+Dex (25mg/day and 40mg/week) as prolonged treatment in a subsequent phase 2 clinical trial (NCT01450215). In the observational study (N = 133), median time to response was 1.7 (range 0.6-9.6) months. A complete response to all treatments received in both studies was observed in 11% of patients; very good partial response and partial response rates were 31% and 38%, respectively. Corresponding response rates in the subgroup of patients who did not enter the phase 2 trial (n = 71) were 3%, 18%, and 39%, respectively. Rates of disease progression at 2years in the phase 2 trial were 47% versus 31% for Len versus Len+Dex (P = 0.14). After 36months median follow-up in surviving patients, median time to progression was not reached with Len+Dex and was 24.9months (95% confidence interval 12.5-not calculable, P amp;lt; 0.001) with Len. Three-year OS among the total observational study population was 61% (95% CI, 52-69%). The corresponding rate among patients who entered the phase 2 clinical trial was 73% (95% CI, 60-83%) and was significantly lower among those patients who achieved PR but did not proceed into the phase 2 trial (55%; P = 0.01). In the phase 2 trial, OS was 73% in both treatment arms (P = 0.70). Neutropenia and thrombocytopenia were more common with prolonged (phase 2 trial) versus short-term (observational study) Len administration but remained manageable. Prolonged treatment with Len with or without Dex provides sustained, clinically relevant responses and demonstrates an acceptable safety profile.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Keyword
- Clinical Trial; Lenalidomide; Multiple Myeloma
Publication and Content Type
- ref (subject category)
- art (subject category)
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To the university's database
- By the author/editor
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Lund, Johan
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Gruber, Astrid
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Lauri, Birgitta
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Duru, Adil Dogan ...
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Blimark, Cecilie
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Swedin, Agneta
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Hansson, Markus
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Forsberg, Karin
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Ahlberg, Lucia, ...
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Carlsson, Conny
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Waage, Anders
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Gimsing, Peter
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Vangsted, Annett ...
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Frolund, Ulf
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Holmberg, Erik
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Gahrton, Gösta
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Alici, Evren
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Hardling, Mats
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Mellqvist, Ulf-H ...
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Nahi, Hareth
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
- Articles in the publication
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Cancer Medicine
- By the university
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Linköping University
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Karolinska Institutet