ASH Clinical News February 2016 | Page 72

Drawing First Blood We invite two experts to debate controversial topics in hematology and health care Optimal Timing of Transplant in Myeloma Shaji Kumar, MD Ola Landgren, MD Disclaimer: The following positions were assigned to the participants and do not necessarily reflect ASH opinions, the participants’ opinions, or what they do in daily practice. Agree? Disagree? We want to hear from you! Send your thoughts and opinions on this controversial issue to ashclinicalnews@ hematology.org. 70 ASH Clinical News New therapeutic options for the treatment of multiple myeloma are capable of achieving sustained and deep remissions, calling into question the role of upfront stem cell transplantation. ASH Clinical News has invited Shaji Kumar, MD, and Ola Landgren, MD, to debate the question: “What is the optimal timing for hematopoietic cell transplantation in patients with multiple myeloma – early or delayed?” Dr. Kumar will be arguing on the “early”a side, and Dr. Landgren will be arguing on the “delayed” side. Dr. Kumar is professor of medicine at Mayo Clinic College of Medicine in Rochester, Minnesota. Dr. Landgren is professor of medicine and chief of myeloma service at Memorial Sloan Kettering Cancer Center in New York City, New York. Shaji Kumar, MD: For more than two decades, autologous hematopoietic cell transplantation (AHCT) has been used for the treatment of myeloma, based on studies that demonstrated that the combination of high-dose chemotherapy and AHCT enhanced response rates and improved survival – particularly in younger patients with the disease – compared with conventional therapy alone.1 Over the past 10 to 15 years, new agents in new therapeutic classes have become available and have been shown to improve patient outcomes; yet, randomized trials have consistently demonstrated that patients do benefit from receiving AHCT.2 I think the majority of hematologists would agree that AHCT is capable of producing durable disease control and improving the survival outcomes in multiple myeloma. Treatment with novel drug combination can demonstrate comparable levels of response, but complements the role of transplant. Ola Landgren, MD: Yes, one can’t argue that certain patients benefit from AHCT, but does it benefit every single patient? Every patient is unique and the myeloma disease biology varies across patients. Beyond these facts, the myeloma treatment landscape and our possibilities to assess treatment response have changed dramatically the past few years. As you mentioned, Dr. Kumar, there has been an influx of new drugs as alternatives to transplantation. Since 2012, when the U.S. Food and Drug Administration approved carfilzomib, there have been five new agents approved either as monotherapy or as part of a multiple-drug regimen for the treatment of multiple myeloma. Three of these agents (elotuzumab, ixazomib, and daratumumab) were approved in the month of November 2015 alone. The pipeline we have ahead of us also promises more options in the near future. With all of these new configurations of drugs, the response to treatment and the duration of the response continues to grow, raising the question of whether the addition of high-dose melphalan will remain the standard of care for every patient. In simple language: Does highdose melphalan followed by AHCT add progression-free and overall survival in patients who already have obtained a deep response following modern combination therapy? This question becomes increasingly more important as the proportion of newly diagnosed multiple myeloma pa- tients who obtain MRD 10-6 negativity after modern effective combination therapy already is reaching 50 to 60 percent.3 Dr. Kumar: The initial randomized trials looking at this clinical question found that AHCT was effective consolidation therapy after the initial treatment of myeloma, but these trials were conducted when available therapies (such as doxorubicin, cyclophosphamide, vincristine, and melphalan) were simply not as effective,1,4 and three to four cycles of treatment failed to produce deep responses in the vast majority of patients. If no further measures were taken, these patients would inevitably relapse. In these trials, AHCT served as consolidation therapy and allowed patients to achieve much deeper responses, which then translated into a longer relapse-free survival and overall survival than what was achieved in non-transplant cohorts. Even with new, more effective therapies for the initial treatment of myeloma, “Transplant should be considered in the context of all available treatment options, not as the default, ‘go-to’ option.” —OLA LANDGREN, MD recent clinical trials have shown a benefit with transplantation, in terms of progression-free survival. The question we now have to answer is whether transplant should be performed early or late, after the initial treatment has stopped working. We will have to wait for future clinical trials to infor m us about the advantages and disadvantages of early versus delayed transplant, as well as which subgroups of patients would benefit most from transplant – either early or delayed. February 2016