Original Research Lenalidomide-dexamethasone versus observation in high-risk smoldering myeloma after 12 years of median follow-up time: A randomized, open-label study*

被引：30

作者：

Mateos, Maria-Victoria ^{[1
]}

Hernandez, Miguel-Teodoro ^{[2
]}

Salvador, Carlos ^{[3
]}

de la Rubia, Javier ^{[4
]}

de Arriba, Felipe ^{[5
]}

Lopez-Corral, Lucia ^{[1
]}

Rosinol, Laura ^{[6
]}

Paiva, Bruno ^{[7
]}

Palomera, Luis ^{[8
]}

Bargay, Joan ^{[9
]}

Oriol, Albert ^{[10
]}

Prosper, Felipe ^{[7
]}

Lopez, Javier ^{[11
]}

Arguinano, Jose-Maria ^{[12
]}

Blade, Joan ^{[6
]}

Lahuerta, Juan-Jose ^{[13
]}

San-Miguel, Jesus ^{[7
]}

机构：

[1] Univ Salamanca, Consejo Super Invest Cient, CIBERONC,Hosp Univ Salamanca, Inst Biol Mol & Celular Canc,Inst Invest Biomecl, Salamanca, Spain

[2] Hosp Univ Canarias, Tenerife, Spain

[3] Hosp Miguel Servet, Zaragoza, Spain

[4] Univ Catolica Valencia, Hosp Univ La Fe, Escuela Med & Odontol, CIBERONC CB16 12 00284, Valencia 00284, Spain

[5] Hosp Morales Messeguer, Murcia, Spain

[6] Hosp Clin Barcelona, IDIBAPS, Barcelona, Spain

[7] Clin Univ Navarra, CCUN, CIMA, IDISNA,CIBERONC, Pamplona, Spain

[8] Hosp Lozano Blesa, Zaragoza, Spain

[9] Hosp Univ Son LLatzer, Inst Invest Sanitaria Illes Balears IdISBa, Palma De Mallorca, Spain

[10] Hosp Badalona Germans Trias & Pujol, Badalona, Spain

[11] Hosp Ramon & Cajal, Madrid, Spain

[12] Complejo Hosp Navarra, Pamplona, Spain

[13] Hosp 12 Octubre, Madrid, Spain

来源：

EUROPEAN JOURNAL OF CANCER | 2022年 / 174卷

关键词：

Smoldering multiple; Drug therapy; Lenalidomide; myeloma; Dexamethasone; Followup study; MULTIPLE-MYELOMA; MONOCLONAL GAMMOPATHIES; PLUS DEXAMETHASONE; CRITERIA;

D O I：

10.1016/j.ejca.2022.07.030

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

SMM randomized to treatment or observation. Treatment consisted of nine 4-week induction cycles (lenalidomide [Rd], 25 mg on days 1-21 plus dexamethasone, 20 mg on days 1-4 and 12-15), followed by maintenance (R, 10 mg on days 1-21) for up to 2 years. The primary endpoint was time to progression (TTP) to myeloma based on per protocol population. Secondary end-points were overall survival (OS), response rate, and safety. An update of the trial after a long-term follow-up is presented here. This trial was registered with ClinicalTrials.gov (NCT00480363). Findings: After a median follow-up time of 12.5 years (range: 10.4-13.6), the median TTP to MM was 2.1 years in the observation arm and 9.5 years in the Rd arm (HR: 0.28, 95% CI: 0.18 -0.44, p < 0.0001). The median OS was 8.5 years in the abstention arm and not reached in the Rd group (HR: 0.57, 95% CI: 0.34-0.95, p = 0.032). Patients who progressed received optimized treatments according to the standards of care, and the OS from progression was comparable in both arms (p = 0.96). Interpretation: This analysis confirms that early treatment with Rd for high-risk SMM translates into a sustained benefit in both TTP and OS. Funding: Pethema (Spanish Program for the Treatment of Hematologic Diseases), Spain. 2022 Elsevier Ltd. All rights reserved.

引用

页码：243 / 250

页数：8

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