Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial

Autor: Martin Goerner, Markus Munder, Martin Hoffmann, Katja Weisel, Peter Brossart, Elias K. Mai, Anja Seckinger, Hans Salwender, Bernhard Rabold, Dirk Hose, Thomas Hielscher, Igor Wolfgang Blau, Uta Bertsch, Steffen Luntz, Ahmet H. Elmaagacli, Stefanie Huhn, Nicola Giesen, Hartmut Goldschmidt, Jens Hillengass, Marc S. Raab, Christina Kunz, Christof Scheid, Anna Jauch, Maximilian Merz, Diana Tichy, Barbara Hügle-Dörr, Hans-Walter Lindemann, Mathias Hänel, Helga Bernhard, Jan Dürig, Stephan Fuhrmann
Přispěvatelé: Hematology, Basic (bio-) Medical Sciences
Rok vydání: 2020
Předmět:
Male
0301 basic medicine
Melphalan
Oncology
Cancer Research
Medizin
Dexamethasone
Cyclophosphamide/administration & dosage
Bortezomib
0302 clinical medicine
Antineoplastic Combined Chemotherapy Protocols
Lenalidomide/administration & dosage
Medicine
Hematopoietic Stem Cell Transplantation/mortality
Prospective Studies
Lenalidomide
Multiple myeloma
education.field_of_study
Maintenance Chemotherapy/mortality
Remission Induction
Hazard ratio
Hematopoietic Stem Cell Transplantation
Hematology
Prognosis
Combined Modality Therapy
Thalidomide
Survival Rate
030220 oncology & carcinogenesis
Female
Multiple Myeloma
medicine.drug
Dexamethasone/administration & dosage
Melphalan/administration & dosage
medicine.medical_specialty
Population
Transplantation
Autologous
Maintenance Chemotherapy
03 medical and health sciences
Internal medicine
Internal Medicine
Humans
education
Cyclophosphamide
Survival rate
Aged
Thalidomide/administration & dosage
business.industry
Consolidation Chemotherapy/mortality
medicine.disease
Multiple Myeloma/pathology
Consolidation Chemotherapy
Transplantation
030104 developmental biology
Bortezomib/administration & dosage
Antineoplastic Combined Chemotherapy Protocols/therapeutic use
business
Follow-Up Studies
Zdroj: Leukemia. 34:1853-1865
ISSN: 1476-5551
0887-6924
DOI: 10.1038/s41375-020-0724-1
Popis: The MM5 trial aimed at demonstrating a progression-free survival (PFS) difference in continued vs. response-adapted (in case of complete response, CR) lenalidomide (LEN) maintenance therapy (MT) in newly diagnosed, transplant-eligible multiple myeloma (MM). Patients were equally randomized to receive induction therapy with PAd (bortezomib/doxorubicin/dexamethasone) or VCD (bortezomib/cyclophosphamide/dexamethasone), high-dose melphalan and autologous blood stem cell transplantation, and LEN consolidation, followed by either LEN MT for a fixed duration of 2 years (LEN-2Y) or until achievement of CR (LEN-CR, intention-to-treat population n = 502): arms A1:PAd + LEN-2Y (n = 125), B1:PAd + LEN-CR (n = 126), A2:VCD + LEN-2Y (n = 126), B2:VCD + LEN-CR (n = 125). In the LEN-CR group (B1 + B2), n = 88/17.5% patients did not start or discontinued LEN MT due to CR. There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms. On pooled LEN MT strategies, OS (hazard ratio, hazard ratio [HR] = 1.42, p = 0.03) but not PFS (HR = 1.15, p = 0.20) was shorter in LEN-CR (B1 + B2) vs. LEN-2Y (A1 + A2) groups. PFS was shortened on landmark analyses from the start of LEN MT in patients being in CR in the LEN-CR group (LEN-CR vs. LEN-2Y, HR = 1.84, p = 0.02). OS from first progression was shortened in the LEN-CR vs. LEN-2Y group (HR = 1.60, p = 0.01). LEN MT should be applied beyond CR for at least 2 years.
Databáze: OpenAIRE
Externí odkaz: