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06-23-2005, 02:42 PM

hey irene~
re:abraxane + herceptin "approved" as a combination therapy...they have never been studied together & the results & findings of the off-label use has never been examined by the FDA, as far as I know.(there is a current study @msk in nyc studying abraxane/carbo/herceptin on a weekly schedule, but too early to report findings. )when i was discussing utilizing this combo, my onc did say, "these two drugs have not been studied together..." but that she didn't anticipate that there should be any reason to expect the efficacy to be any different, than the approved studies of abraxane v. taxol, as solo agents. so technically, we were using abraxane "off label".but remember,drugs & drug combos (chemotx & otherwise) are often used "off label", for many years before clinical trials are even designed &initiated.(for example-wellbutrin an antidepressant, was used off label as a smoking cessation drug, for many years before clinical trials were designed, but eventually they were & now there's Zyban.)
also, remember abraxane is PACLITAXEL suspended in albumin. taxol is PACLITAXEL suspended in cremphor...the only significant difference is the vehicle that the active ingredient of the drug, paclitaxel, is delivered. i like to think of it as the difference between say, tylenol caplets v. tylenol gel-caps- same drug, different vehicle, same response in the body.
there's no reason to suspect that herceptin would react differently to paclitaxel in albumin v. paclitaxel in cremphor...but i guess we really don't know for sure.
without direct FDA approval, there might be a complication w/insurance covering the cost of the drug...which is ASTRONOMICAL!!! I just got my bill from the hosp & it cost ~$10,000.00 yes TEN THOUSAND DOLLARS per dose!my insurance co covered it without any hesitation.(due to the hospital's negligence & misdosing of my regimen I'm filing a complaint w/risk management to address this bill.)
so, long story short...i was using the combo off label, but it you look at appropriate dosing for abraxane, i did fall under the appropriate criteria(Stage IV, taxane refractory, etc).
Hope this info is helpful. I will say it was a treat NOT having to do the pre-meds with the Abraxane...I sure do hate being back on those premeds again.
2 more cycles of TCH to go...i know NED is in reach!
Take good care...prayers, faith & courage!

06-23-2005, 02:42 PM	#2
jessica Guest Posts: n/a	hey irene~ re:abraxane + herceptin "approved" as a combination therapy...they have never been studied together & the results & findings of the off-label use has never been examined by the FDA, as far as I know.(there is a current study @msk in nyc studying abraxane/carbo/herceptin on a weekly schedule, but too early to report findings. )when i was discussing utilizing this combo, my onc did say, "these two drugs have not been studied together..." but that she didn't anticipate that there should be any reason to expect the efficacy to be any different, than the approved studies of abraxane v. taxol, as solo agents. so technically, we were using abraxane "off label".but remember,drugs & drug combos (chemotx & otherwise) are often used "off label", for many years before clinical trials are even designed &initiated.(for example-wellbutrin an antidepressant, was used off label as a smoking cessation drug, for many years before clinical trials were designed, but eventually they were & now there's Zyban.) also, remember abraxane is PACLITAXEL suspended in albumin. taxol is PACLITAXEL suspended in cremphor...the only significant difference is the vehicle that the active ingredient of the drug, paclitaxel, is delivered. i like to think of it as the difference between say, tylenol caplets v. tylenol gel-caps- same drug, different vehicle, same response in the body. there's no reason to suspect that herceptin would react differently to paclitaxel in albumin v. paclitaxel in cremphor...but i guess we really don't know for sure. without direct FDA approval, there might be a complication w/insurance covering the cost of the drug...which is ASTRONOMICAL!!! I just got my bill from the hosp & it cost ~$10,000.00 yes TEN THOUSAND DOLLARS per dose!my insurance co covered it without any hesitation.(due to the hospital's negligence & misdosing of my regimen I'm filing a complaint w/risk management to address this bill.) so, long story short...i was using the combo off label, but it you look at appropriate dosing for abraxane, i did fall under the appropriate criteria(Stage IV, taxane refractory, etc). Hope this info is helpful. I will say it was a treat NOT having to do the pre-meds with the Abraxane...I sure do hate being back on those premeds again. 2 more cycles of TCH to go...i know NED is in reach! Take good care...prayers, faith & courage!