Wall Street doesn't like the word "unprecedented"...
Dr Dave CHA quite well in the last sentence...
"A new study is reporting "unprecedented" results in the treatment of castration-resistant prostate cancer (CRPC) with the new drug cabozantinib ( Cometriq, Exelixis).
Results were published online November 19 in the Journal of Clinical Oncology.
Cabozantinib is an oral inhibitor of multiple receptor tyrosine kinases, including RET, MET, and vascular endothelial growth factor 2 (VEGFR2). It was recently approved by the US Food and Drug Administration for the treatment of medullary thyroid cancer.
Cabozantinib demonstrated "dramatic and rapid effects" on bone scan lesions in a high proportion of patients, the study authors report. These effects are "echoed in other measures of antitumor effect," they add.
Of the patients randomized to cabozantinib, 72% experienced regression in soft tissue lesions, and 68% of evaluable patients showed improvement on bone scan. In addition, there was complete resolution in 12%.
However, lead author David C. Smith, MD, professor of internal medicine and urology at the University of Michigan Medical School in Ann Arbor, said the study should not change clinical practice at this time. "Cabozantinib should not be used for CRPC outside of clinical trials at this point, but the data should prompt referrals for clinical trials such as the phase 3 trials referred to in the paper, as well as institutional trials listed on ClinicalTrial.gov," he said.
"Dosing is still being assessed and the side-effect profile requires that patients be closely monitored to limit major toxicities," Dr. Smith told Medscape Medical News. "I would not recommend off-label use AT THIS TIME (my emphasis)."
"A new study is reporting "unprecedented" results "
If true it is likely the FDA would reccomend halting the trial at some point prior to the completion and proceed to "GO". Unprecendented is hardly a term that would be used lightly by any Doctor worth his/her salt.
The list of creditable oncologists that have made similar statements is actually quite long, and growing. I just stole the following quote from Curetodaydotcom May 2011. I encourage you to Google "unprecedented bone scans" for a more complete list. You will not be disappointed.
"We saw unprecedented bone scan improvement," said the study's lead author Dr. Michael Gordon, from Pinnacle Oncology Hematology in Scottsdale, Arizona."
If memory serves me well...Drs C Higano, O Sartor, M Hussein, H Scher, J Debono and others have shared similarly profound commentary on the pronounced Cabozantinib bone phenomenon.
It's become quite a hit with the clinics - with more institutional sponsorship pending.
Don't let the shorts fool you, this drug has outstanding potential.
It's worth noting that he's starting off with a 100 mg dose. I think once more 40 mg data comes through with good efficacy but better AE profiles, we might see some official support for off-label usage.