The National Comprehensive Cancer Network (NCCN) establishes guidelines for myeloma treatments. Doctors use these guidelines to understand the various treatment options that are available and approved for patients. Eight new options were updated in the guidelines for 2016. To help make sense of it all, here are key take-aways according to a recently published article in Targeted Oncology:
In newly diagnosed patients, primary therapy now includes lenalidomide plus dexamethasone in combination with bortezomib (preferred) or the oral proteasome inhibitor, ixazomib. Here's more information on the newly-approved drug ixazomib:
Additionally, the “active” myeloma category was expanded through an adjustment in the diagnostic criteria, to make more patients eligible for therapy. “In the guidelines this year, the criteria for treatment of multiple myeloma have changed,” said Kenneth Anderson, director of the Multiple Myeloma Center at Dana-Farber Cancer Institute. “Previously, treatment has demanded abnormalities in calcium, renal function, anemia, and bone disease [the so-called CRAB features]. However, that is no longer true.” Even without CRAB features, if patients have the following, they can be diagnosed with "active myeloma" and qualify for treatment:
The new guidelines have a revised International Staging System (ISS) that incorporates cytogenetics for the first time in order to define prognosis following treatment. Stringent measures of complete response (CR) were included, with a molecular complete response now defined as <1 myeloma cell per 1 million normal cells by sequencing or immunophenotypic CR by multicolor flow cytometry, the most sensitive of which can detect <1 myeloma per 1 million normal cells.
In bone marrow transplant candidates, primary treatment options in the most recent guideline include a proteasome inhibitor plus lenalidomide and dexamethasone. The recommendation for the use of triplet combination therapy in newly diagnosed multiple myeloma is based on synergies in activity in preclinical models and in the clinic, said Anderson. The three primary proteasome inhibitors available include bortezomib, carfilzomib, and the oral agent ixazomib, which was most recently introduced. These agents have shown varying levels of success in the frontline setting but based on results from the Phase III SWOG S0777 trial, a triplet (bortezmib, len, dex) was clearly better than the doublet of len/dex alone.
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Ixazomib has also been explored as an upfront therapy, with a phase III currently ongoing. In a phase II study, induction therapy with the all-oral regimen of ixazomib plus lenalidomide/dexamethasone produced a 90% response rate, including a 59% very good partial response or better. Following induction, ixazomib was continued as single agent maintenance therapy. In the maintenance arm, 11 patients experienced a complete response with continuous ixazomib (52%), 4 of which were stringent complete responses (19%). Overall, 33% of patients had an improvement in their response during maintenance treatment. The recommendation to use triplet therapy upfront applies to transplant candidates and very fit non-transplant candidates. Following induction regardless of transplant, maintenance therapy “is a standard of practice in multiple myeloma,” Anderson said. Preferred maintenance regimens in the new guideline are bortezomib, lenalidomide, and thalidomide. Progression free survival is approximately doubled with the use of lenalidomide maintenance post-transplant. In North America, maintenance until progression is recommended. Subcutaneous bortezomib every other week as maintenance has also conferred a progression free and 5-year overall survival advantage versus no maintenance, whether or not the patient undergoes transplant.
A number of the preferred regimens listed in the new guideline for pretreated patients included triplet combinations, specifically those that build upon lenalidomide and dexamethasone, which are recommended alone or in combination with carfilzomib, elotuzuumab, ixazomib, cyclophosphamide, or panobinostat. Additionally, the latest guideline elevated the combination of pomalidomide and low-dose dexamethasone to category 1 regimen for patients with relapsed/refractory multiple myeloma.
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“It’s been a truly remarkable year in multiple myeloma, we’ve had 16 new FDA approved treatments in the last 12 years and last year alone we had 7 new FDA approved treatments, so the 2016 version of the NCCN guidelines is completely revised,” concluded Anderson.
To read the article in its entirety, click here.
about the author
Lizzy Smith was diagnosed with myeloma in 2012 at age 44. Within days, she left her job, ended her marriage, moved, and entered treatment. "To the extent I'm able, I want to prove that despite life's biggest challenges, it is possible to survive and come out stronger than ever," she says.
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