Multiple Myeloma- Newly Diagnosed Without Intent to ASCT

“Our results suggest that the FDA may be approving many costly, toxic drugs that do not improve overall survival, (in multiple myeloma)”

Knowledge is power for cancer patients. Especially for people diagnosed with an incurable blood cancer called multiple myeloma. Unfortunately the very studies that are supposed to give us MMers knowledge are difficult to understand and really boring to read.

I am both a long-term myeloma survivor and multiple myeloma cancer coach. I firmly believe that MMers must balance overall survival (OS) with their quality of life (QOL). Unfortunately, determining how best to accomplish OS and QOL may be difficult for you as a newly diagnosed MMer.

Further, I have lived in complete remission since 1999 by living an evidence-based, non-toxic, anti-MM lifestyle through supplementation, nutrition, bone health, lifestyle and mind-body therapies. Your oncologist will rarely, if ever, talk about the benefit of evidence-based but not FDA approved therapies. Nothing against your oncologist, but it is against the law to discuss therapies that are not approved by the FDA.

The two studies linked and excerpted below demostrate two of the most important concepts newly diagnosed MM will ever face. The first study linked below explains

overall survival (longevity)
progression-free survival (PFS)
overall response (how many patients respond)
adverse events (side effects)

These are the four MOST IMPORTANT concepts you will ever face in your decision-making about your health for the rest of your life. The “triplet” chemo cocktail of RVd is a major improvement in OS, PFS and Overall Response rate of the “doublet” chemo cocktail. Yes, the triplet may give you more side effects but in my opinion, the improvement is worth it.

The second article linked below explains how the FDA is approving drug therapies that do not necessarily show an improvement in OS or overall survival. For example, an autologous stem cell transplant, (ASCT) according to research, does NOT improve overall survival when compared with novel chemotherapy regimens. An ASCT means a lot more toxicity and financial cost yet no improvement in overall survival.

Whether you are debating treatment options, currently undergoing treatment and experiencing painful side effects, or trying to figure out how to stay in remission, I want to share what I’ve learned from 25 years of full remission from Multiple Myeloma.

Please watch the video below to learn more about the evidence-based, integrative therapies to combat treatment side effects and enhance your chemotherapy.https://youtu.be/ctekyVc9yGc

Have you been diagnosed with multiple myeloma? What stage? Any symptoms? Scroll down the page, post a question or a comment and I will reply to you ASAP.

Thank you,

David Emerson

MM Survivor
MM Cancer Coach
Director PeopleBeatingCancer

Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant

“Median progression-free survival was significantly improved in the VRd group (43 months vs 30 months in the Rd group…” This means that your disease will not progress for an average of 3-1/2 years.
“The median overall survival was also significantly improved in the VRd group (75 months vs 64 months in the Rd group,” This means that the average length of life is more than six years.
“The rates of overall response (partial response or better) were 82% (176/216) in the RVd group and 72% (153/214) in the Rd group, and 16% (34/216) and 8% (18/214) of patients who were assessable for response in these respective groups had a complete response or better.” This means that more than 80% of newly diagnosed MMer’s will respond to this treatment.

As always the the downside to a more toxic chemotherapy regimen (triplet vs. doublet) is increased side effects. More than 80% of patients experienced serious side effects and two people died from VRd.

4. “Adverse events of grade 3 or higher were reported in 198 (82%) of 241 patients in the VRd group and 169 (75%) of 226 patients in the Rd group; 55 (23%) and 22 (10%) patients discontinued induction treatment because of adverse events, respectively. There were no treatment-related deaths in the Rd group, and two in the VRd group.”

Approved But Not Proven: What’s Up With FDA, Cancer Drugs?

“In approving new cancer drugs, the US Food and Drug Administration (FDA) is now heavily relying on surrogate markers of effectiveness, such as tumor shrinkage, instead of proof that an agent improves survival, according to a new analysis.

The investigators conclude that this might be having a deleterious effect on patients, public health, and healthcare costs.

“Our results suggest that the FDA may be approving many costly, toxic drugs that do not improve overall survival,” write Chul Kim, MD, MPH, from the National Cancer Institute (NCI), and Vinay Prasad, MD, MPH, from the Knight Cancer Center at the Oregon Health and Sciences University in Portland.

Their analysis showed that 36 of 54 (67%) cancer drug approvals from 2008 to 2012 were made on the basis of surrogate markers — either tumor response rate or progression-free survival, in about equal frequency…”

Recently Diagnosed or Relapsed? Stop Looking For a Miracle Cure, and Use Evidence-Based Therapies To Enhance Your Treatment and Prolong Your Remission

Multiple Myeloma- Newly Diagnosed Without Intent to ASCT

“Our results suggest that the FDA may be approving many costly, toxic drugs that do not improve overall survival, (in multiple myeloma)”

Recommended Reading:

Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant

Approved But Not Proven: What’s Up With FDA, Cancer Drugs?

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