According to the Mayo Clinic Cancer Center, lead institution for the study, the data show a “distinct survival benefit” with lower doses of the dexamethasone combined with REVLIMID. S. Vincent Rajkumar, M.D., hematologist and lead investigator of the study dr erfan rahbar reviews at the Mayo Clinic added, “This is a major advance in the treatment of cancer, and also gives researchers a new direction to explore – that more is not necessarily better when it comes to fighting the cancer.”
The data showed REVLIMID, an oral medication from Celgene, plus low-dose dexamethasone improves one year survival compared to the standard high-dose dexamethasone, 96% to 88%. Over two years the benefit continues with an 87% survival rate for low-dose dexamethasone compared to a 75% survival rate for high-dose dexamethasone. While lowering the dose of the steroid also lowers some immediate measures of response that is offset by better, long-term disease control.
“Lowering the doses of the steroid dexamethasone with REVLIMID gives us a new paradigm of treatment,” said Brian G.M. Durie, M.D., chairman and co-founder of the International Myeloma Foundation. “When we combine REVLIMID with lower dose dexamethasone, we are seeing reduced side effects so patients stay on the drug longer, and, above all, significant survival benefits. These are the outcomes that patients and physicians find most important, and take precedence over the traditional ways we have used to evaluate new therapies.”
Last April the independent committee monitoring the trial found the preliminary results so compelling that the trial was stopped and all patients in the trial were moved to lower dose dexamethasone. Because of the overwhelming positive response to REVLIMID plus low-dose dexamethasone in the ECOG study, a trial from the other large cancer cooperative, SWOG, was also stopped prematurely. This trial compared REVLIMID plus high-dose dexamethasone to dexamethasone alone. Because this SWOG trial stopped early, and because nearly half of the patients on the dexamethasone-alone-arm of the study crossed over to the REVLIMID-plus-dexamethasone-arm of the study within the first year, overall impressions regarding survival could be misleading.
According to Dr. Durie: “We do not want patients confused by statistics. In fact, the SWOG trial concluded that REVLIMID with low-dose dexamethasone is among the most active up-front combination regimens against myeloma. These results demonstrate that REVLIMID plus dexamethasone is definitely better than dexamethasone alone, and is an excellent treatment in newly diagnosed multiple myeloma.”
The International Myeloma Foundation concludes that overall findings presented at this conference about multiple myeloma in all ages, and across all categories of patients (newly diagnosed, relapsed, patients proceeding to bone marrow transplants and so on) is positive and encouraging and represents major advances in the treatment of blood cancers beginning with myeloma.