Format

Send to

Choose Destination
Blood. 2018 Jan 18;131(3):301-310. doi: 10.1182/blood-2017-07-795047. Epub 2017 Nov 17.

Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma.

Author information

1
Service des Maladies du Sang, Hôpital Claude Huriez, Lille, France.
2
Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece.
3
Mayo Clinic, Rochester, MN.
4
Frankston Hospital and Monash University, Frankston, Australia.
5
Cross Cancer Institute, Edmonton, Canada.
6
Seragnoli Institute of Hematology, Bologna University School of Medicine, Bologna, Italy.
7
Department of Hematology and Developmental Therapeutics, Hematology/Oncology and Stem Cells Transplantation Unit, National Cancer Institute, Fondazione "Pascale," Naples, Italy.
8
Department of Hematology, University of Tuebingen, Tuebingen, Germany.
9
Wilhelminenspital, Center for Oncology, Vienna, Austria.
10
Southern Alberta Cancer Research Institute, University of Calgary, Calgary, Canada.
11
Centre Hospitalier de la Côte Basque, Bayonne, France.
12
Department of Hematology, University Hospital, La Roche Sur Yon, France.
13
University Hospital Leuven, Leuven, Belgium.
14
Barts Health National Health Service Trust, London, United Kingdom.
15
Hospitais da Universidade de Coimbra, Coimbra, Portugal.
16
Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea.
17
Princess Margaret Hospital, Toronto, Canada.
18
Institut Català d'Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Badalona, Spain.
19
Hospital Dr. Peset, Valencia, Spain.
20
Queen Elizabeth II Health Sciences Centre, Halifax, Canada.
21
Kantonsspital Winterthur, Winterthur, Switzerland.
22
Peking University People's Hospital, Beijing, China.
23
Dana-Farber Cancer Institute, Boston, MA.
24
Department of Hematology, University of Nantes, Nantes, France.
25
Institut Universitaire du Cancer, Toulouse-Oncopole, France.
26
Centre Hospitalier Régional Universitaire de Nancy, Université de Lorraine, Nancy, France.
27
Hopital Saint Louis, Paris, France.
28
Blood Disease Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Tianjin, China.
29
Centre Hospitalier Universitaire Purpan/Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse, France.
30
Hôpital Saint-Antoine, Paris, France.
31
Unite de Genomique du Myelome, Centre Hospitalier Universitaire Rangueil, Toulouse, France.
32
Hôpital de la Milétrie, Centre Hospitalier Universitaire INSERM, Poitiers, France.
33
Celgene Corporation, Summit, NJ.
34
Centre Hospitalier Universitaire Hôpital Bretonneau, Tours Cedex, France; and.
35
Bordeaux Hospital University Center (Centre Hospitalier Universitaire), Bordeaux, France.

Abstract

This FIRST trial final analysis examined survival outcomes in patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM) treated with lenalidomide and low-dose dexamethasone until disease progression (Rd continuous), Rd for 72 weeks (18 cycles; Rd18), or melphalan, prednisone, and thalidomide (MPT; 72 weeks). The primary endpoint was progression-free survival (PFS; primary comparison: Rd continuous vs MPT). Overall survival (OS) was a key secondary endpoint (final analysis prespecified ≥60 months' follow-up). Patients were randomized to Rd continuous (n = 535), Rd18 (n = 541), or MPT (n = 547). At a median follow-up of 67 months, PFS was significantly longer with Rd continuous vs MPT (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.59-0.79; P < .00001) and was similarly extended vs Rd18. Median OS was 10 months longer with Rd continuous vs MPT (59.1 vs 49.1 months; HR, 0.78; 95% CI, 0.67-0.92; P = .0023), and similar with Rd18 (62.3 months). In patients achieving complete or very good partial responses, Rd continuous had an ≈30-month longer median time to next treatment vs Rd18 (69.5 vs 39.9 months). Over half of all patients who received second-line treatment were given a bortezomib-based therapy. Second-line outcomes were improved in patients receiving bortezomib after Rd continuous and Rd18 vs after MPT. No new safety concerns, including risk for secondary malignancies, were observed. Treatment with Rd continuous significantly improved survival outcomes vs MPT, supporting Rd continuous as a standard of care for patients with transplant-ineligible NDMM. This trial was registered at www.clinicaltrials.gov as #NCT00689936 and EudraCT as 2007-004823-39.

PMID:
29150421
PMCID:
PMC5774211
DOI:
10.1182/blood-2017-07-795047
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for HighWire Icon for PubMed Central
Loading ...
Support Center