Southwest Oncology Network

SWON's partner, Diplomat Specialty Pharmacy, is providing below valuable summary data from the interim results of two studies that were presented at the June 2010 American Society of Clinical Oncology (ASCO) meeting.

Lenalidomide (LEN) was shown to be an effective maintenance treatment prolonging progression free survival (PFS) in patients with multiple myeloma after autologous stem cell transplantation (ASCT).1

614 patients, under 65 years of age, with non-progressive disease after a first line ASCT (performed within the last 6 months were randomized to receive a consolidation with lenalidomide (25mg/day, 21 days/month, for 2 months) followed by a maintenance dose of LEN 10 to 15mg/day until relapse or placebo. In December 2009, the Independent and Safety Monitoring Committee recommended to unblind the trial due to the progress free survival superiority of patients randomized to daily LEN maintenance therapy compared to placebo. Daily LEN maintenance dose improved the 3 year progression free survival from randomization by 68% compared to 35% in the placebo arm. The 2-year survival was similar in both treatment arms (95%).

Revlimid® initiated at day 100-110 post-ASCT in MM patients significantly delays time to progression (TTP).2

Patients with stable disease were double-blinded randomized at day 100-110 to LEN or placebo until disease progression, after stratification by diagnostic β-2 microglobulin and prior thalidomide or lenalidomide therapy. Patients starting dose was 10mg/day, escalated to 15 mg/day after 3 months. In September 2009, the second interim analysis was performed based on 418 patients to determine the number of events defined as progression of MM or death prior to progression was 25.5 months in the placebo arm (n=208) but has not been reached yet in the LEN arm (n=210). Significant delay in time to progression was observed in patients who received LEN maintenance therapy regardless of β-2M level or prior thalidomide or lenalidomide therapy. Both groups experienced a similar adverse event profile.

The NCCN Myeloma Panel recommends single agent lenalidomide as maintenance therapy.3

Based on the evidence in the studies above as well as data from the Phase III MM-015 Study, the NCCN Myeloma Panel recommends single agent lenalidomide as maintenance therapy giving it a Category 2A status untilnstudies are completed and undergo full peer review and safety/efficacy evaluation.3 Category 2A- The recommendation is based on lower-level evidence and there is uniform NCCN consensus.3

1. Attal M, Cristini C, Marit G, et al. Lenalidomide maintenance after transplantation for myeloma. Abstract 8018 presented at: The 2010 Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2010; Chicago, IL.

2. McCarthy PL, Owzar K, Anderson KC, et al. Phase III intergroup study of lenalidomide versus placebo maintenance therapy following single autologous stem cell transplant (ASCT) for multiple myeloma (MM): CALGB 100104. Abstract 8017 presented at: The 2010 Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2010; Chicago, IL.

3. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) Multiple Myeloma (Version 3.2010). © 2010 National Comprehensive Cancer Network, Inc. Available at: NCCN.org. Accessed [June 30, 2010]. To view the most recent and complete version of the NCCN Guidelines™, go on-line to

The agreement is built around DSP's Oncology Navigator program, a series of medication & therapy management services that assist patients and healthcare professionals initiate & manage the care needed, with the mutual goals of expanding access to care, improving tolerance and adherence to oral therapies, and advancing oral cancer treatment and subsequent outcomes.

This alliance stems from our commitment to providing key strategic solutions that supplement your efforts to improve quality of patient care, while supporting your drive for better operational efficiency and cost containment. SWON serves practice administrators and oncologists as a resource for GPO contracting, group purchasing expertise, clinical & business education, coding resources, practice management forms, and networking opportunities. Current membership represents over 175 practices and nearly 300 medical oncologists across a half dozen states since 2008. The SWON mission remains as it was when SWON was formed in 2008: to help our community oncology member practices manage the largest issues and expenses in today's challenging environment.

More information about the services available through SWONRx and Diplomat will be forthcoming. At any time, you are welcome to contact me at the number below for more information. Thank you.

Bayer HealthCare Pharmaceuticals, in consultation with the U.S. Food and Drug Administration (FDA), has decided to recall Commercial Lot B13958 of Leukine® (sargramostim) liquid 500 mcg vials. We are taking this action because Lot B13958 did not meet one of the established parameters of our ongoing product stability monitoring. Bayer also alerted the FDA that, as a result of its investigation into this situation, we plan to remove Commercial Lot B12964 from the market. Even though this lot was initially within established parameters for stability monitoring, we have observed a high degree of variability in further stability test results.

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The four RACS listed below begin their work on a contingency fee basis on October 1, 2008:

California, Texas, Nevada, and Oklahoma will be added on March 1, 2009, and the other states will be added on August 1, 2009, or later.

CMS will roll out the program with an emphasis on provider education and is working towards resolving the appeals process which was an issue from the demonstration program last year.

RACs must document a targeted area they would like to review and CMS will decide if RACs can conduct the review.

CMS will limit the number of medical record requests RACs make of providers in one month, and will also limit the look-back period to October 1, 2007. Additionally, each RAC is required to hire a physician medical director and coder before they begin claims analysis.

In order to address some of the concerns of the provider community, CMS made numerous alterations to the initial RAC demonstration project. One of the changes includes the creation of a CMS review board, which will be in place to streamline the appeal process.

Review of evaluation and management services will be included in the RAC program. Documentation verifying the levels of service selected by coders will be checked.

The RACs will have a claim status Web site on which they will post all medical requests. This will allow the opportunity for everyone to be aware of the issues and vulnerabilities.

The GAO will report back on the RAC rollout.