AN ORAL APPROACH AGAINST STAGE 3 AND FOUR MELANOMA- PHENOMENAL RESULTS

FOR METASTATIC OR STAGE THREE MELANOMA:  THIS WAS WRITTEN HERE AND THE BLOG AS THERE IS PATEINT WHO HAS FRIENDED ME WHO HAS A DAD ( SHE HAS DISCLOSED ALL THIS ALREADY ON FACEBOOK) WITH METASTATIC MELANOMA. THE BEST RESULTS THAT WERE BELIEVABLE- STRONG STUDY- WERE WITH DOUBLET MONOCLONAL ANTIBODY THERAPY

THIS NEW THERAPY EXPLAINED GENERALLY BELOW IS A WHOLE DIFFERENT ORAL APPROACH WITH SUPERB RESULTS – MIGHT THERE BE TWO THERAPIES FOR THIS KILLER THAT PATIENTS COULD TAKE, TAKE TOGETHER, IN SEQUENCE,  OR  WHEN FAILING ONE- ALL OF THIS RESEARCH WILL CERTAINLY BE DONE . THIS IS PROFOUNDLY EXCITING

JUST RELEASED AND PUBLISHED IN THE LANCET – BRITISH AND RESPECTED— A TRIAL WHICH MIGHT NOT REQUIRE HAVING TISSUE TO ASSESS FOR CERTAIN MARKERS AS THERE IS COMMERCIALLY AVAILABLE ASSAYS OF BLOOD AND IN SOME CASES URINE TO DETECT CIRCULATING TUMOR CELLS OR THEIR DNA AND ASSESS IF THEY HAVE A SPECIAL MUTANT BRAF STATUS. ( A WORKHORSE ENGINE IN THE CANCER CELL) BOTH OF THE DRUGS ARE ORAL AND ARE NOT MONOCLONAL ANTIBODIES OR IMMUNE THERAPY PER SE, THIS IS MOLECULAR TARGETING AT A TUMORS ACHILLEES HEEL AND HAS INCREDIBLE RESULTS- FOR THOSE PATIENTS PROSPECTIVELY FOUND TO HAVE THE APPROPRIATE BIOCHEMICAL PERSONALITY, SO TO SPEAK. THOSE DRUGS ARE NOT ( FROM A UNIVERSITY OR md Anderson ) HARD TO GET–

HERE IS THE STUDY AND YOU CAN READ ABOUT WHAT BRAF IS AND MEK IS-

Dabrafenib Plus Trametinib Improves Overall Survival vs Dabrafenib in BRAF V600–Mutant Melanoma

YOU HAVE MORE HOPE AND OPTIONS. WHAT IF MD ANDERSON STARTS HIM AND HE IS FOLLOWED LOCALY FOR INSTANCE AND SHOWS UP Q 3 MONTHS OR SO AT MD AND SO ON- ASSUMING YOU CAN NOT GET IT LOCALLY

ONE COULD WELL START THE NEXT STUDY OF ORAL FIRST CONTINUE UNTIL PROGRESSION IN BRAF MUTANT PATIENTS AND THEN CROSS OVER TO ANTIBODIES OR VICE VERSA- THERE IS NOT MUCH SCIENCE IN THE WAY OF THAT AND THE ANTIBODIES MAY WELL BE BOTH fda ( INSURANCE) APPROVED BY THEN

HE COULD WELL GET THE DRUGS RIGHT NEAR HOME. CHECK OUT CANCER.ORG AND NCI TO SEE IF THEY HAVE STARTED THE OBVIOUS NEXT STEP

SEE WHO IS WILLING TO GO THE ORAL LANCET ROUTE AND DECIDE BETWEEN TWO GREAT CHOICES- DIFFERING TOXICITIES::::: DR RYAN

By Matthew Stenger

Key Points:

•Dabrafenib plus trametinib significantly prolonged overall survival vs dabrafenib alone in patients with BRAF V600-mutant melanoma
•Significant improvement in progression-free survival was maintained in the current analysis.

Overall survival results of a phase III COMBI-d trial reported in The Lancet by Long et al showed that the combination of the BRAF inhibitor dabrafenib (Tafinlar) with the MEK inhibitor trametinib (Mekinist) resulted in significantly prolonged overall survival vs dabrafenib alone in patients with BRAF V600–mutant melanoma. The primary analysis of the trial had shown that the combination significantly prolonged progression-free survival.

Study Details

In this double-blind trial, 423 previously untreated patients from 14 countries with BRAF Val600Lys/Glu mutation–positive unresectable stage IIIC or stage IV melanoma were randomly assigned between May 2012 and November 2012 to receive oral dabrafenib at 150 mg twice daily and oral trametinib at 2 mg once daily (n = 211) or dabrafenib and placebo (n = 212). The primary endpoint was progression-free survival; overall survival was a secondary endpoint.

Improved Overall Survival

At the final data cutoff (January 2015), after 222 patients had died, median overall survival was 25.1 months (95% confidence interval [CI] = 19.2 months to not reached) in the combination group vs 18.7 months (95% CI = 15.2–23.7 months) in the dabrafenib group (hazard ratio [HR] = 0.71, P = .0107). Overall survival was 74% vs 68% at 1 year and 51% vs 42% at 2 years. Consistent benefit of the combination was observed across all subgroups.

At the current analysis, median progression-free survival was 11.0 months (95% CI = 8.0–13.9 months) in the combination group and 8.8 months (95% CI = 5.9–9.3 months) in the dabrafenib group (HR = 0.67, P = .0004, unadjusted for multiple testing).

Adverse Events

Treatment-related adverse events of any grade occurred in 87% of the combination group and 90% of the dabrafenib group, with the most common in the combination group being pyrexia (52% vs 25%) and the most common in the dabrafenib group being hyperkeratosis (33% vs 6%). Treatment-related grade 3 or 4 adverse events occurred in 32% vs 31% of patients. Cutaneous squamous cell carcinoma occurred in 3% vs 9%.

The investigators concluded: “The improvement in overall survival establishes the combination of dabrafenib and trametinib as the standard targeted treatment for BRAF Val600 mutation–positive melanoma. Studies assessing dabrafenib and trametinib in combination with immunotherapies are ongoing.”

Georgina V. Long, MD, of The University of Sydney, is the corresponding author for The Lancet article.

The study was funded by GlaxoSmithKline. For full disclosures of the study authors, visit http://www.thelancet.com

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