New England Journal of Medicine Publishes MINDACT Trial Results Proving the Clinical Utility of MammaPrint® in Assisting Physicians to Identify Early-Stage Breast Cancer Patients who can Safely Forgo Chemotherapy
46% of patients identified as high risk for recurrence according to clinical-pathological factors as described in the publication, and who therefore would be usual candidates for adjuvant chemotherapy, were reclassified as Low Risk by MammaPrint® and MINDACT shows could possibly forgo chemotherapy (Source) (1)
MammaPrint could change clinical practice by providing critical prognostic information to aid in assessing patients’ risk for distant metastasis and potentially sparing over one hundred thousand women annually, with early-stage breast cancer worldwide from unnecessary toxicities and side effects from chemotherapy and creating considerable cost savings. (2)
As demonstrated in the MINDACT trial, MammaPrint is now the only FDA-cleared breast cancer prognostic test with the highest level of evidence (1A) for its clinical utility to aid correctly identifying Low Risk patients. (Ibid)
We have known for years that millions of Americans have gotten advised to treat their cancer with conventional therapies when in fact these cancers would have gone away by themselves. (See DOSSIER) These so called “indolent” cancers have been shown to be without malignancy consequence for prostate, breast and thyroid cancers (See Dossier)
A few years later, thanks to this MINDACT clinical trial, we have more evidence that breast cancer patients have been still receiving chemotherapy treatments they didn’t need. Thanks to a genetic test called MammaPrint, which determined that nearly half the women slated for chemotherapy based on standard clinical recommendations didn’t need it.
After surgery to remove their tumors, early-stage breast cancer patients (0-3 positive nodes) with a MammaPrint score recommending against chemotherapy had a 95% survival rate, said co-researcher Laura van ‘t Veer, the test’s inventor.
“That’s very high, and we showed that it doesn’t differ between those who are treated and those who are not treated by chemotherapy,” said van ‘t Veer, leader of the breast oncology program at the University of California, San Francisco Diller Family Cancer Center.
The MINDACT phase 3 clinical trial involved nearly 6,700 women at 111 medical centers in nine countries. It “represents what we in medicine call the highest level of evidence (level 1A),” AACR President Dr. Jose Baselga said.
“This study is telling us in a very clear way we can spare many women chemotherapy,” said Baselga, chief medical officer of Memorial Hospital at Memorial Sloan Kettering Cancer Center, in New York City.
The MammaPrint test looks at the inner biology of the cancer (versus what pathologists look at, size, grade and spread) via a panel of 70 genes within the tumor itself to assess its aggressiveness and the odds it will come back without chemotherapy.
MammaPrint reduced chemotherapy prescriptions by 46% among the more than 3,300 patients in the trial categorized as having a high risk of breast cancer recurrence based on common clinical and pathological criteria, the researchers said.
Further, just over 2,700 patients who had a low MammaPrint risk score but a high clinical risk score wound up with a 94.7 percent five-year survival rate, whether they got chemo or not, the researchers said.
“If we can select those patients that don’t need chemotherapy, unneeded treatment can be avoided and we will be one step closer to making sure treatment for breast cancer is tailored to the individual,” said Dr. Stephanie Bernik, chief of surgical oncology at Lenox Hill Hospital in New York City.
Still, this finding does not mean the Era of no Chemo has arrived, chemo will still make women infertile, with brain fog and heart attacks as its purported design is to shrink tumors, tumors that can be shrunk holistically for the vast majority of them. But there is no big money in holistic oncology At least there’s some progress, we can help save young women with small hormone-responsive tumors who now, asy the conventional experts, may not need chemotherapy. But what about the others cancer patients ? The conventional system still says that chemo will “benefit” them. But benefit is not a reversal with no debilitating side effects. It just means that the tumor should shrink. But since when is there are correlation between tumor shrinkage and post 5 years survivability ?
The See the ACR Institute’s analysis of MammaPrint, see the Test area. It is now covered by Medicare and is reimbursed by most large health insurers in the United States. It costs around 4,000 dollars, money which could be used to buy organic Mediterranean and-or vegan produce that would help clear both cancer and senescent cells.
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(1). Cardoso F, van’t Veer LJ, Bogaerts J et al. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med 2016; 375: 717-29.
(2). Based on applying MINDACT risk data to: American Cancer Society. Global Cancer Facts & Figures 3rd Edition. Atlanta: American Cancer Society; 2015. (online) and American Cancer Society. Breast Cancer Facts & Figures 2015-2016. Atlanta: American Cancer Society, Inc. 2015. See also Hudis CA, Dickler, M. Increasing Precision in Adjuvant Therapy for Breast Cancer. N Engl J Med 2016; 375: 790-91. And Sparano JA, Gray RJ, Makower DF, et al. Prospective validation of a 21-gene expression assay in breast cancer. N Engl J Med 2015; 373: 2005-14. And Gluz O, Nitz, U. A., Matthias, C, et al. West German Study Group Phase III Plan B Trial: First Prospective Outcome Data for the 21-Gene Recurrence Score Assay and Concordance of Prognostic Markers by Central and Local Pathology Assessment. J Clin Oncol 2016; 34(20):2341-9
Disclaimer About MammaPrint
MammaPrint is a FDA-cleared in vitro diagnostic test, performed in a single laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis. The MammaPrint result is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. MammaPrint is not intended for diagnosis, or to predict or detect response to therapy, or to help select the optimal therapy for patients. Results should be taken in the context of other relevant clinical-pathological factors and standard practice of medicine.