We are international
Donate
• IMF TV TEXT SIZE   
webcasts from medical meetings    back

ASCO 2013: Dr. Palumbo - Second primary malignancies (SPM) in newly diagnosed myeloma (MM) patients treated with lenalidomide (Len): Meta-analysis of 6,383 individual patient data (IPD).

Antonio Palumbio, MD
University Of Turin
Turin, Italy

06.04.13

Abstract Number: 
8517

Citation: 
J Clin Oncol 31, 2013 (suppl; abstr 8517)

Author(s): 
Antonio Palumbo, Sara Bringhen, Vincent Rajkumar, Giulia Lupparelli, Saad Zafar Usmani, Anders Waage, Alessandra Larocca, Bronno van der Holt, Pellegrino Musto, Andrea Evangelista, Sonja Zweegman, Meletios A. Dimopoulos, Roman Hajek, Michele Cavo, Sagar Lonial, Giovannino Ciccone, Mario Boccadoro, Bart Barlogie, Pieter Sonneveld, Philip L. McCarthy; Division of Hematology, University of Turin, Turin, Italy; Myeloma Unit, Division of Hematology, University of Torino, Torino, Italy; Mayo Clinic, Rochester, MN; Myeloma Institute for Research and Therapy, Little Rock, AR; St. Olav's Hospital/NTNU, Trondheim, Norway; Erasmus MC, Rotterdam, Netherlands; Department of Onco-Hematology, IRCCS-CROB, Referral Cancer Center of Basilicata, Rionero in Vulture, Italy; Cancer Epidemiology Unit, CeRMS and CPO Piemonte, Città della Salute e della Scienza, University of Torino, Torino, Italy; VU University Medical Center, Amsterdam, Netherlands; Department of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece; School of Medicine, University of Ostrava; Institute of clinical haematology, University Hospital Ostrava, Ostrava, Czech Republic; Bologna University School of Medicine, Seràgnoli Institute of Hematology, Bologna, Italy; Emory University School of Medicine, Atlanta, GA; Roswell Park Cancer Institute, Buffalo, NY

ABSTRACT: 

Background: An increased risk of SPM in MM pts treated with len has been reported. We performed an IPD metanalysis to estimate the incidence of SPM according to len exposure. 

Methods: Randomized studies of MM, from PubMed and ASCO/IMW/ASH (after 2000), that met the following criteria, were included: randomization to treatment with len (len-trials); randomization to treatment including new drug but not len (no-len-trials); available SPM data. Primary aim was to estimate cumulative incidence of SPMs by len exposure, corrected for death (competing event). 

Results: Data from 6,383 pts (3,218 from 8 len-trials, 3,165 from 10 no-len-trials) were analyzed. Median age was 69 years. During follow-up (median=30 mos) 420 (6.6%) SPMs were reported: 188 (2.9%) hematologic and 232 (3.6%) solid cancers. Solid tumors occurred with similar incidence in all groups. Incidence of hematologic SPM was significantly higher in patients receiving len (3.2 vs 1.1, p=0.04), but risk is limited to patients treated with melphalan+len (4.1, 95%CI: 2.4-5.8) with no excess in other combinations (len without melphalan: 1.2, 0.0-2.6; melphalan without len: 1.1, 0.0-2.7) (p=0.003). The cumulative incidence of death for any cause was much higher than the risk of SPM. 

Conclusions: The risk of hematologic SPMs was higher in pts receiving melphalan+len. The benefit/risk profile of len treatment remains positive. Cumulative incidence (%) of SPMs and death (95%CI).


 related articles
ASCO 2013: Dr. Anderson - Overview of the 2013 Annual Meeting of the American Society of Clinical Oncology
ASCO 2013: Dr. Jagannath - Data on New Novel Agents
ASCO 2013: Dr. Kumar - Emerging Trends for Multiple Myeloma Patient Survival
ASCO 2013: Dr. Lonial - Overview of New Novel Agents Presented at ASCO 2013
ASCO 2013: Dr. Richardson - Current Front Line Treatments
ASCO 2013: Dr. Usmani - Total therapy 5 (TT5) for newly diagnosed high-risk multiple myeloma (HRMM): Comparison with predecessor trials total therapy 3a and 3b (TT3 a/b).
ASCO 2013: Dr. Lonial - Phase (Ph) I/II study of elotuzumab (Elo) plus lenalidomide/dexamethasone (Len/dex) in relapsed/refractory multiple myeloma (RR MM): Updated Ph II results and Ph I/II long-term safety.
ASCO 2013: Dr. Nooka- Early versus delayed autologous stem cell transplant (ASCT) in patients receiving induction therapy with lenalidomide, bortezomib, and dexamethasone (RVD) for newly diagnosed multiple myeloma (MM).
ASCO 2013: Dr. Richardson - MM-005: A phase I trial of pomalidomide, bortezomib, and low-dose dexamethasone (PVD) in relapsed and/or refractory multiple myeloma (RRMM).
ASCO 2013: Dr. Weisel - MM-003: A phase III, multicenter, randomized, open-label study of pomalidomide (POM) plus low-dose dexamethasone (LoDEX) versus high-dose dexamethasone (HiDEX) in relapsed/refractory multiple myeloma (RRMM).
ASCO 2013: Dr. Jakubowiak - Treatment outcome with the combination of carfilzomib, lenalidomide, and low-dose dexamethasone (CRd) for newly diagnosed multiple myeloma (NDMM) after extended follow-up.
ASCO 2013: Dr. Palumbo - Melphalan/prednisone/lenalidomide (MPR) versus high-dose melphalan and autologous transplantation (MEL200) plus lenalidomide maintenance or no maintenance in newly diagnosed multiple myeloma (MM) patients.
ASCO 2013: Dr. Palumbo - Second primary malignancies (SPM) in newly diagnosed myeloma (MM) patients treated with lenalidomide (Len): Meta-analysis of 6,383 individual patient data (IPD).
ASCO 2013: Dr. Jagannath - Pomalidomide (POM) with or without low-dose dexamethasone (LoDEX) in patients (Pts) with relapsed and refractory multiple myeloma (RRMM): MM-002 phase II age subgroup analysis.
ASCO 2013: Dr. Usmani - Retrospective analysis of cardiovascular (CV) events following compassionate use of carfilzomib (CFZ) in patients (Pts) with relapsed and refractory multiple myeloma (RRMM).
ASCO 2013: Dr. Usmani - Total therapy 5 (TT5) for newly diagnosed high-risk multiple myeloma (HRMM): Comparison with predecessor trials total therapy 3a and 3b (TT3 a/b).
ASCO 2013: Dr. Nooka- Early versus delayed autologous stem cell transplant (ASCT) in patients receiving induction therapy with lenalidomide, bortezomib, and dexamethasone (RVD) for newly diagnosed multiple myeloma (MM).
ASCO 2013: Dr. Richardson - MM-005: A phase I trial of pomalidomide, bortezomib, and low-dose dexamethasone (PVD) in relapsed and/or refractory multiple myeloma (RRMM).
ASCO 2013: Dr. Jakubowiak - Treatment outcome with the combination of carfilzomib, lenalidomide, and low-dose dexamethasone (CRd) for newly diagnosed multiple myeloma (NDMM) after extended follow-up.
ASCO 2013: Dr. Kumar- Weekly MLN9708, an investigational oral proteasome inhibitor (PI), in relapsed/refractory multiple myeloma (MM): Results from a phase I study after full enrollment.
ASCO 2013: Dr. Richardson - Clinical response by baseline characteristics in patients (pts) with relapsed and bortezomib (BTZ)-refractory multiple myeloma treated with panobinostat (PAN), BTZ, and dexamethasone (DEX; PANORAMA 2).
ASCO 2013: Dr. Ghobrial - Phase I study of TH-302, an investigational hypoxia-targeted drug, and dex in patients with RRMM
ASCO 2013: Dr. Lokhorst - Phase I/II dose-escalation study of daratumumab in patients with relapsed or refractory multiple myeloma.
ASCO 2013: Dr. Lonial - Phase (Ph) I/II study of elotuzumab (Elo) plus lenalidomide/dexamethasone (Len/dex) in relapsed/refractory multiple myeloma (RR MM): Updated Ph II results and Ph I/II long-term safety.
ASCO 2013: Dr. Richardson - Clinical response by baseline characteristics in patients (pts) with relapsed and bortezomib (BTZ)-refractory multiple myeloma treated with panobinostat (PAN), BTZ, and dexamethasone (DEX; PANORAMA 2).
ASCO 2013: Dr. Usmani - Total therapy 5 (TT5) for newly diagnosed high-risk multiple myeloma (HRMM): Comparison with predecessor trials total therapy 3a and 3b (TT3 a/b).
ASCO 2013: Dr. Nooka- Early versus delayed autologous stem cell transplant (ASCT) in patients receiving induction therapy with lenalidomide, bortezomib, and dexamethasone (RVD) for newly diagnosed multiple myeloma (MM).
ASCO 2013: Dr. Palumbo - Melphalan/prednisone/lenalidomide (MPR) versus high-dose melphalan and autologous transplantation (MEL200) plus lenalidomide maintenance or no maintenance in newly diagnosed multiple myeloma (MM) patients.
ASCO 2013: Dr. Raje - Evaluating results from the multiple myeloma subset of patients treated with denosumab or zoledronic acid (ZA) in a randomized phase III study.
ASCO 2013: Dr. Pandey - Beneficial effect of complete response and type of therapy in multiple myeloma.


You might also be interested in:

Overviews
ASCO 2013: Dr. Anderson - Overview of the 2013 Annual Meeting of the American Society of Clinical Oncology

Ken Anderson, MD
Dana Farber Cancer Institute
Boston, Massachusetts, USA


ASCO 2013: Dr. Jagannath - Data on New Novel Agents

Sundar Jagannath, MD
Mount Sinai Medical Center
New York, New York, USA


ASCO 2013: Dr. Kumar - Emerging Trends for Multiple Myeloma Patient Survival

Shaji Kumar, MD
Mayo Clinic
Rochester, Minnesota, USA


ASCO 2013: Dr. Lonial - Overview of New Novel Agents Presented at ASCO 2013

Sagar Lonial, MD
Emory University School of Medicine
Atlanta, Georgia, USA


ASCO 2013: Dr. Richardson - Current Front Line Treatments

Paul Richardson, MD
Dana-Farber Cancer Institute
Boston, Massachusetts, USA


Immunomodulatory Agents
ASCO 2013: Dr. Usmani - Total therapy 5 (TT5) for newly diagnosed high-risk multiple myeloma (HRMM): Comparison with predecessor trials total therapy 3a and 3b (TT3 a/b).

Saad Usmani, MD, FACP
Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences
Little Rock, Arkansa, USA


ASCO 2013: Dr. Lonial - Phase (Ph) I/II study of elotuzumab (Elo) plus lenalidomide/dexamethasone (Len/dex) in relapsed/refractory multiple myeloma (RR MM): Updated Ph II results and Ph I/II long-term safety.

Sagar Lonial, MD
Emory University School of Medicine
Atlanta, Georgia, USA


ASCO 2013: Dr. Nooka- Early versus delayed autologous stem cell transplant (ASCT) in patients receiving induction therapy with lenalidomide, bortezomib, and dexamethasone (RVD) for newly diagnosed multiple myeloma (MM).

Ajay Nooka, MD, MPH, FACP
Winship Cancer Institute of Emory University
Atlanta, Georgia, USA


ASCO 2013: Dr. Richardson - MM-005: A phase I trial of pomalidomide, bortezomib, and low-dose dexamethasone (PVD) in relapsed and/or refractory multiple myeloma (RRMM).

Paul Richardson, MD
Dana-Farber Cancer Institute
Boston, Massachusetts, USA


ASCO 2013: Dr. Weisel - MM-003: A phase III, multicenter, randomized, open-label study of pomalidomide (POM) plus low-dose dexamethasone (LoDEX) versus high-dose dexamethasone (HiDEX) in relapsed/refractory multiple myeloma (RRMM).

Katja Weisel, MD
University Hospital Tuebingen
Tuebingen, Germany


ASCO 2013: Dr. Jakubowiak - Treatment outcome with the combination of carfilzomib, lenalidomide, and low-dose dexamethasone (CRd) for newly diagnosed multiple myeloma (NDMM) after extended follow-up.

Andrzej Jakubowiak, MD
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, USA


ASCO 2013: Dr. Palumbo - Melphalan/prednisone/lenalidomide (MPR) versus high-dose melphalan and autologous transplantation (MEL200) plus lenalidomide maintenance or no maintenance in newly diagnosed multiple myeloma (MM) patients.

Antonio Palumbio, MD
University Of Turin
Turin, Italy


ASCO 2013: Dr. Palumbo - Second primary malignancies (SPM) in newly diagnosed myeloma (MM) patients treated with lenalidomide (Len): Meta-analysis of 6,383 individual patient data (IPD).

Antonio Palumbio, MD
University Of Turin
Turin, Italy


ASCO 2013: Dr. Jagannath - Pomalidomide (POM) with or without low-dose dexamethasone (LoDEX) in patients (Pts) with relapsed and refractory multiple myeloma (RRMM): MM-002 phase II age subgroup analysis.

Sundar Jagannath, MD
Mount Sinai Medical Center
New York, New York, USA


Proteasome Inhibitors
ASCO 2013: Dr. Usmani - Retrospective analysis of cardiovascular (CV) events following compassionate use of carfilzomib (CFZ) in patients (Pts) with relapsed and refractory multiple myeloma (RRMM).

Saad Usmani, MD, FACP
Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences
Little Rock, Arkansa, USA


ASCO 2013: Dr. Usmani - Total therapy 5 (TT5) for newly diagnosed high-risk multiple myeloma (HRMM): Comparison with predecessor trials total therapy 3a and 3b (TT3 a/b).

Saad Usmani, MD, FACP
Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences
Little Rock, Arkansa, USA


ASCO 2013: Dr. Nooka- Early versus delayed autologous stem cell transplant (ASCT) in patients receiving induction therapy with lenalidomide, bortezomib, and dexamethasone (RVD) for newly diagnosed multiple myeloma (MM).

Ajay Nooka, MD, MPH, FACP
Winship Cancer Institute of Emory University
Atlanta, Georgia, USA


ASCO 2013: Dr. Richardson - MM-005: A phase I trial of pomalidomide, bortezomib, and low-dose dexamethasone (PVD) in relapsed and/or refractory multiple myeloma (RRMM).

Paul Richardson, MD
Dana-Farber Cancer Institute
Boston, Massachusetts, USA


ASCO 2013: Dr. Jakubowiak - Treatment outcome with the combination of carfilzomib, lenalidomide, and low-dose dexamethasone (CRd) for newly diagnosed multiple myeloma (NDMM) after extended follow-up.

Andrzej Jakubowiak, MD
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, USA


ASCO 2013: Dr. Kumar- Weekly MLN9708, an investigational oral proteasome inhibitor (PI), in relapsed/refractory multiple myeloma (MM): Results from a phase I study after full enrollment.

Shaji Kumar, MD
Mayo Clinic
Rochester, Minnesota, USA


ASCO 2013: Dr. Richardson - Clinical response by baseline characteristics in patients (pts) with relapsed and bortezomib (BTZ)-refractory multiple myeloma treated with panobinostat (PAN), BTZ, and dexamethasone (DEX; PANORAMA 2).

Paul Richardson, MD
Dana-Farber Cancer Institute
Boston, Massachusetts, USA


Other Novel Agents
ASCO 2013: Dr. Ghobrial - Phase I study of TH-302, an investigational hypoxia-targeted drug, and dex in patients with RRMM

Irene M. Ghobrial, MD
Dana-Farber Cancer Institute
Boston, MA


ASCO 2013: Dr. Lokhorst - Phase I/II dose-escalation study of daratumumab in patients with relapsed or refractory multiple myeloma.

Henk M. Lokhorst, MD
University Medical Center Utrecht
Utrecht, Netherlands
Member, IMF Board of Scientific Advisors


ASCO 2013: Dr. Lonial - Phase (Ph) I/II study of elotuzumab (Elo) plus lenalidomide/dexamethasone (Len/dex) in relapsed/refractory multiple myeloma (RR MM): Updated Ph II results and Ph I/II long-term safety.

Sagar Lonial, MD
Emory University School of Medicine
Atlanta, Georgia, USA


ASCO 2013: Dr. Richardson - Clinical response by baseline characteristics in patients (pts) with relapsed and bortezomib (BTZ)-refractory multiple myeloma treated with panobinostat (PAN), BTZ, and dexamethasone (DEX; PANORAMA 2).

Paul Richardson, MD
Dana-Farber Cancer Institute
Boston, Massachusetts, USA


Transplant
ASCO 2013: Dr. Usmani - Total therapy 5 (TT5) for newly diagnosed high-risk multiple myeloma (HRMM): Comparison with predecessor trials total therapy 3a and 3b (TT3 a/b).

Saad Usmani, MD, FACP
Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences
Little Rock, Arkansa, USA


ASCO 2013: Dr. Nooka- Early versus delayed autologous stem cell transplant (ASCT) in patients receiving induction therapy with lenalidomide, bortezomib, and dexamethasone (RVD) for newly diagnosed multiple myeloma (MM).

Ajay Nooka, MD, MPH, FACP
Winship Cancer Institute of Emory University
Atlanta, Georgia, USA


ASCO 2013: Dr. Palumbo - Melphalan/prednisone/lenalidomide (MPR) versus high-dose melphalan and autologous transplantation (MEL200) plus lenalidomide maintenance or no maintenance in newly diagnosed multiple myeloma (MM) patients.

Antonio Palumbio, MD
University Of Turin
Turin, Italy


Others
ASCO 2013: Dr. Raje - Evaluating results from the multiple myeloma subset of patients treated with denosumab or zoledronic acid (ZA) in a randomized phase III study.

Noopur Raje, MD
Massachusetts General Hospital
Boston, Massachusetts, USA


ASCO 2013: Dr. Pandey - Beneficial effect of complete response and type of therapy in multiple myeloma.

Shivlal Pandey, MD
Mayo Clinic
Rochester, Minnesota, USA