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Taxol Rarely Triggers Fatal Reactions

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    Posted: Jun 28 2009 at 10:27am
http://cancerfocus.org/forum/showthread.php?t=2871
 
 
 
There is some interesting information in this link I found regarding Taxol.


Edited by trip2 - Jul 04 2009 at 2:32pm
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Nancy Quote  Post ReplyReply Direct Link To This Post Posted: Jun 28 2009 at 11:19am
Pam,
 
This is very interesting as our new member just sent me this link in an email today. His name is on this article, Gregory Pawelski. Pretty scary right? Not something that the doctors or the drug companies share with us....ever!!!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote mainsailset Quote  Post ReplyReply Direct Link To This Post Posted: Jun 28 2009 at 11:45am
Well damn, now that Taxol is 'off patent' more of this will come out. And isn't this just the perfect drug, shrinks the tumor while simultaneously releasing more cells into the system. What more could Big Pharma ask of a money maker drug. I would just love the opportunity to be a blood donor to one of these CEO's
dx 7/08 TN 14x6.5x5.5 cm tumor

3 Lymph nodes involved, Taxol/Sunitab+AC, 5/09 dbl masectomy, path 2mm tumor removed, lymphs all clear, RAD 32 finished 9/11/09. 9/28 CT clear 10/18/10 CT clear
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Post Options Post Options   Thanks (0) Thanks(0)   Quote SagePatientAdvocates Quote  Post ReplyReply Direct Link To This Post Posted: Jun 28 2009 at 11:50am
Pam, thank you for posting this...I think it is essential that women take every precaution possible about this drug and if you feel very strange as the infusion starts ask them to stop it immediately..

I posted this, here, several months ago in the Welcome New Members forum-


Topic: warning about TAXOL
    Posted: 25 Apr 2009 at 7:27pm
In September 2004 my daughter embarked on a four months chemo program..2 months of AC and then 2 months of TAXOL...

Sue's sister's recent post about her sister's experience with an adverse chemo reaction(ixempra/antifungal) spurred me to write this post.

I attended all but one of my daughter's infusions and got to know the oncology nurse quite well...G-d bless her for all her kindnesses to my daughter..about a week before the transition from AC to TAXOL I asked her for the booklet that comes with PACLITAXEL(TAXOL)..you now those little booklets that you need a magnifying glass to read (I wonder if all the drug money that goes to politicians has anything to do with that?)

I asked for the booklet because at the end of the previous session my daughter went to the bathroom and I spoke to a patient in the waiting room..she told me about her experience with TAXOL.."when they started the infusion I felt like all my bones were crumbling..I have never experienced something like that in my life..My husband told me he had never heard me scream like that not even in a difficult childbirth I had..be careful with it"..so I asked for the book..

http://www.bedfordlabs.com/products/ViewProductDetails?brand=Taxol

and then click on package insert

my daughter and I had a meeting with the oncologist before the TAXOL.
I told him I read the following-

WARNINGS
Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment,
angioedema, and generalized urticaria have occurred in 2% to 4% of patients receiving paclitaxel in clinical trials. Fatal
reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphen-
hydramine, and H2antagonists. (See DOSAGE AND ADMINISTRATION.) Patients who experience severe hypersensitivi-
ty reactions to paclitaxel should not be rechallenged with the drug.

..................

To be honest I do not remember if my daughter was "pretreated". I think I was so concerned with the "fatal reactions" part that I concentrated on that. I gave the book to the oncologist and expressed my concerns and his response was "I have been doing this since this drug came out and I have never seen this problem"..."well, do you have a 'crash cart' in the infusion room?". "No, I can always call a cardiologist friend who is a couple blocks away"...at that moment, unbelievably, the oncology nurse barges into the room without knocking and tells the doctor, motioning to the hallway, "I need to talk to you, NOW"...the door is left open a crack and my daughter and I hear "the guy in rm 4 is crashing..we just gave him TAXOL"...

In any event there was a crash cart in the office when she got the TAXOL and my son-in-law came to be with her for the first couple of minutes and Thank G-d she did not have a reaction but I was petrified. I know it says 2-4% but sometimes stuff happens so for those of you about to take this drug please make sure that everything is done, as much as possible, to prepare for an emergency..We were told if there is a severe reaction to the drug you should stop the infusion immediately...also I have read that sometimes you don't know you are having an adverse cardiac reaction and sometimes it is recommended that your heart is monitored for a certain time as you are receiving the drug.

I am not recommending that this drug not be taken...just be aware there can be awful side effects...probably can be with other chemos as well..My daughter hated this drug..she had constant bone pain and severe aches and still suffers at times even four + years later. But she is almost 5 years NED so hopefully it did its thing..

all the best,

Steve

Edited by steve - Jun 28 2009 at 11:54am
I am a BRCA1+ grandson, son and father of women affected by breast/oc-my daughter inherited mutation from me, and at 36, was dx 2004 TNBC I am a volunteer patient advocate with SAGE Patient Advocates
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Post Options Post Options   Thanks (0) Thanks(0)   Quote trip2 Quote  Post ReplyReply Direct Link To This Post Posted: Jun 28 2009 at 12:01pm
Steve I remember your post.
 
I too had extreme leg bone pain w/Taxol that I still remember from 6 yrs ago.  I just laid in a heap on my bed in tears, I could not move for the pain and wanted to stop my treatments half way thru but my husband wouldn't let me.
Took Lortab which did nothing.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote gpawelski Quote  Post ReplyReply Direct Link To This Post Posted: Jun 28 2009 at 4:43pm
As in most things, it comes down to individualization. There are clearly situations where high dose therapy reliably produces cures, while low dose therapy does not. Diseases such as testicular cancer, Hodgkin's disease, childhood leukemia, etc. The problem has been the tendency to apply the lessons of these diseases to all forms of cancer.

I don't think claiming that low dose therapy is to be preferred, anymore than claiming that high dose therapy is to be preferred. If one has a highly effective drug or drug regimen, then this should be given at the optimum dose to achieve whatever it is supposed to achieve.

If what it has the capacity to achieve is to destroy the tumor cells directly, then sufficient drug should be given to achieve this goal. If the drug does not have the capacity to destroy the tumor cell, and the drug works through an effect on angiogenesis, then the drug should be given at a dose consistent with this aim.

For example, some ovarian cancer patients do have tumors which are equisitely sensitive to platinum. These patients should be treated with aggressive platinum dosing, because you have a good shot at getting a very long term survival. But giving high dose platinum to patients with intrinsically resistant disease doubtless causes more hurt than help.
 
There appears to be a number of patients who have had long-term survival after high dose therapy, but there are a number of patients whose tumors are responsive to chemotherapy who have had long-term remissions from low dose therapy, as well as a number who show no difference in survival when treated with low-dose or high-dose therapy.
 
You may want to reserve aggressive therapy for those patients who will derive more benefit than harm, while identifying the most promising treatment regimens for everyone. In patients with tumors very resistant to cytotoxic chemotherapy, the most promising treatments may be angiogenesis inhibitors, growth factor inhibitors, or more integrative medicine approaches.
 
It may be better not to give more aggressive and toxic, mutagenic and immunosuppressive combinations, but to give "targeted" single agents, or give least toxic mutagenic synergistic combinations. Although somthing may be an above-average regimen in some patients, it may not be a highly active regimen in others.
 
More emphasis should be put on matching treatment to the patient, through the use of individualized pre-testing, having more respect for minimal partial response or stable disease, when it can be achieved through use of the least toxic and mutagenic drug regimens, and reserve the use of higher dose therapy or aggressive combination chemotherapy to those patients with tumor biologies most amenable to attack and destroy by these treatments.
 
Trying to mate a notoriously heterogeneous disease into one-size-fits-all treatments is disingenuous to all who are inflicted with it. And the criticism remains: All of the clinical trials resources have gone toward driving a square peg (one-size-fits-all chemotherapy) into a round hole (notoriously heterogeneous disease).
 
Today, they are trying to "sensitize" Taxol response with other (new) and more expensive drugs. Why not utilize some other drug (or combinations) that may work much better than Taxol, instead of trying to sensitize it According to NCI's official cancer information website on "state of the art" chemotherapy for breast cancer, there is no data to support the superiority of any particular regimen.
 
Last year, an FDA advisory panel said no to Avastin for advanced breast cancer. An FDA review concluded that while Avastin appeared to lengthen the amount of time before a cancer became severe, it did not significantly lengthen the lives of patients.
 
A clinical trial was done using Avastin in combination with Taxol. Doctors were faced with a problem of whether to use Taxol and forgo Avastin, or to use some other conventional drug for initial therapy in order to use Avastin. Perhaps the problem is not in adding Avastin to Taxol for breast cancer, but in using Taxol with Avastin?
Gregory D. Pawelski
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Post Options Post Options   Thanks (0) Thanks(0)   Quote trip2 Quote  Post ReplyReply Direct Link To This Post Posted: Jun 28 2009 at 6:32pm
Hi and welcome.
 
Thank you so much for this information.  Food for thought, much appreciated.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote sibu Quote  Post ReplyReply Direct Link To This Post Posted: Jun 28 2009 at 7:59pm
Mainy,

Can you (or anyone else) please expand on your comment in the post about Taxol coming "off patent" and what the ramifications of that are?

Is more information on a drug's side effects made public when something comes off patent?

Please explain.

Thanks,

Donna
Donna, age 42
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Chemo 6 X TAC 6/07, rads 10/07
Hyst./Recon. 12/07
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Post Options Post Options   Thanks (0) Thanks(0)   Quote dmwolf Quote  Post ReplyReply Direct Link To This Post Posted: Jun 28 2009 at 8:06pm
Hey, Gregory.  Thanks for such a thoughtful commentary.  Out of curiosity, what is your line of work?  Are you an MD and/or bio researcher of some type?  What brings you to us here at TNBC?
Thx,
Denise
DX 2/08@43 stg II IDC; gr2,0 nodes. Neoadj chemo, first ACx2 (fail) then CarboTaxotereX6(better). Lump, Rads done 11/08; Clodronate. False alarm queen: PetCT lung & TM marker. NED. PBM w/recon 9/10.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote SapphireSkies Quote  Post ReplyReply Direct Link To This Post Posted: Jun 29 2009 at 4:03am

Although this information is good to have, I find it very scary. I have one more A/C treatment scheduled, then they are switching me to Taxol. Everything I've read about Taxol seems negative. As if the pain and possible permanent neuropathy associated with it isn't bad enough, now it may cause more cancer and it's not patented anymore? And the drug itself can cause death?? Scary. Now I don't want to take it...but what other choice do I have being triple negative? Someone I know who is also triple neg. will be getting Taxotore -(spelling?) instead of Taxol...does anyone know the difference between the two drugs?

I read an article with Melissa Etheridge that I found interesting. She had like one dose of Taxol, and it affected her so badly that she stopped taking it. She is still cancer-free today, as far as I know. Does that mean anything??
This is just scary.... what to do?
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Post Options Post Options   Thanks (0) Thanks(0)   Quote gpawelski Quote  Post ReplyReply Direct Link To This Post Posted: Jun 29 2009 at 5:16am
Mainy
 
Dr. David Graham, a Food and Drug Administration (FDA) employee, appeared before a Senate Finance Committee in 2006 and announced that the FDA was incapable of protecting us from unsafe drugs. He said there is an inherent structural problem that exists within the FDA. People who approve the drugs are also the ones who oversee the post marketing regulation of the drug. The people who approve a drug when they see that there is a safety problem with it are very reluctant to do anything about it because it will reflect badly on them. They continue to let the damage occur.
 
The organizational structure within the FDA and the Center for Drug Evaluation Research (CDER) is geared towards the review and approval of new drugs. When a serious safety issue arises at post marketing, the immediate reaction is almost always one of denial, rejection and heat. They approved the drugs, so there can't possibly be anything wrong with it. This is an inherent conflict of interest.
 
The basic criterion for approval of a new drug is that its benefits outweigh its associated risks. So benefits must be considered in light of the drug's toxicity and potential safety problems. The FDA weighs the tradeoff between safety and access.
 
Denise
 
I was a spouse/caregiver to a cancer patient. I became intensely interested in cancer by virtue of working through, enduring and surviving my wife's illness. I've gotten a street education by virtue of voluminous reading and hundreds of hours of past and ongoing personal communication with noted authorities in the field.
 
As a cancer patient advocate, I've been interested in and studied the aspects of cell function analysis (harken back to my college days studying biology) for a number of years, like anyone would have an interest in molecular science or biological science. My point with respect to cell function analysis is to educate patients and others that such science and technology exists, and might be very valuable.
 
I get nothing out of my endeavors except the satisfaction of knowing that I've helped to increase the knowledge of informed consent. I get no pay, no lectureships, no junkets, not even any free meals. To paraphrase Martin Luther King, Jr., "a scientific communication should be judged on the quality of its content and only secondarily, or not at all, on the qualifications of its author (I have no prefix to my name).
 
SapphireSkies
 
It's always going to be a case of what works best for you, after you performed extensive research and study. Your life depends on all the information you can muster. This is called informed consent. You must be aware of all possible "problems" as well as the "benefits." In addition, the physician "informing" a patient needs to spend enough time to make sure that the patient understands well enough that the "consent" is truly "informed."
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Post Options Post Options   Thanks (0) Thanks(0)   Quote gerriesue Quote  Post ReplyReply Direct Link To This Post Posted: Jun 30 2009 at 7:06am
Hi, Interesting reading! I was given Taxotere and had a severe reaction on my second dose. I was pre-treated with a variety of drugs as is usual. However, ten minutes into the infusion started seeing stars, and having trouble breathing, nausea and severe back/kidney pain.    My chemo nurse was right on top of things and administered the drugs necessary to control the reaction. It was pretty scary and people were moving quickly all around me.   I was then (several weeks later) switched to Abraxane. Evidently, the solvent, cremespore is the thing that most people react to in the Taxol/taxene drug and abraxane does not have that in it. The solvent in abraxane is human albumin. I asked why they didn't just give Abraxane to begin with and was told iit is very expensive and usually used primarily for metastatic disease. I went on to have three rounds of that with no reaction, except for the neuropathy that over 70% of people get with this type of drug.
57 yrs. old at DX Oct. 2008 Stage 1, Grade 3, TNB, 1.7 cm tumor,Negative nodes TX partial masectomy, 4 rounds A/C, 4 rounds Abraxane
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Post Options Post Options   Thanks (0) Thanks(0)   Quote alene Quote  Post ReplyReply Direct Link To This Post Posted: Jun 30 2009 at 8:29am
Taxotere...
what a nightmare...
 
The burning the burning the burning...
My face and upper chest/neck were on fire....It was like a chemical burn from the inside out...I couldn't be in any light...not outside...even lamps inside the house...made the burn worse...So I lived in darkness and wore veils when I had to ride in the car to an appointment.
 
My skin hardened...blistered  (huge blisters) and crusted over...I had to use silvadene all over my face and neck...used mountains of different cremes to try and soothe the burn.Mixed up concoctions of silvadene, skin cremes and baby sunscreen (so it wouldn't burn my eyes)...Looked like monster...
 
Got thrush 3 times...Sores up my nose...down my throat
 
Then there was of course the neuropathy....nose, around my mouth, feet and hands.
 
I was on dose dense...so every week I was worse..The nurses got so worried they complained to the doctor that my reactions were too severe...They made me take a break...then we tried again...same thing...
 
When I started having troubles breathing...My throat was swelling..the onc just stopped  the drug.  I cried and beg them to let me continue.  But they said they were worried it was going to kill me.
 
They told me...initially that taxotere had a 16% of curing me...that it was my best chance...so that's why I wanted to try to stick with it.
 
So they moved me to Red Devil...for more fun...
 
So I don't know about taxol..but my personal experience with taxotere was pretty awful...
 
 
 
 
 


Edited by alene - Jun 30 2009 at 8:35am
DX 5/21/2008 TN 8cm TAC
Mast 12/08
Extensive Residual Lymphatic Invasion
Inop node clavicle
68 Rads
Stage IIIc
Recur 11/09 Her2+
Surgery 68 RADS
4/10 Biopsy Skin Mets TN
28 RADS
Stage IV
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Post Options Post Options   Thanks (0) Thanks(0)   Quote minniemouse Quote  Post ReplyReply Direct Link To This Post Posted: Jun 30 2009 at 8:33am
gerriesue,
I have case history similar to yours. Developed breathing difficulties after second cytoxan/taxotere dose (though not as serious as yours or as quickly). My onc switched me to cytoxan/adriamycin for final two doses. (He was skeptical that Abraxane is being pushed by its makers as a miracle drug for many types of cancer at many stages, when most of research so far relates to its effect on metastic disease. ) I'm stage 1, grade 1.
 
I shared his concerns, but here I am about to get my final treatment and I'm a little concerned -- have I gotten all the meds I need to fight this cancer?
I realize there is no magic cure for TN, but I hate the not-knowing.
 
minnie
 
dx 02/09 @62;lumpectomy 3/24/09; 1.5cm; node neg; stg I/gr I; BRCA 1/2 neg
2 rnds Taxotere/Cytoxan; 2 rnds A/C (after lung react to tax); 33 rads.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote alene Quote  Post ReplyReply Direct Link To This Post Posted: Jun 30 2009 at 8:41am
Well I'm not a doctor...but my personal research...leads me to believe that you have really good stats...and a good prognosis...even though your TN.
 
You were node negative...This is HUGE...You  caught it early...tumour size small...Good   The tumour grade...is low for recurrance...Grade 1...This is really really good..You're not BRCA positive...Good and double good.
 
Adriamycin...has a life time limit...so getting 2 rounds...I think will allow you to save it...as a tool in case you should need it in the future.
 
It seems to me...that you got aggressive treatment...and with your stats...I just bet...you're going to be a big success story..
 
Lots of love
Alene
DX 5/21/2008 TN 8cm TAC
Mast 12/08
Extensive Residual Lymphatic Invasion
Inop node clavicle
68 Rads
Stage IIIc
Recur 11/09 Her2+
Surgery 68 RADS
4/10 Biopsy Skin Mets TN
28 RADS
Stage IV
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Post Options Post Options   Thanks (0) Thanks(0)   Quote minniemouse Quote  Post ReplyReply Direct Link To This Post Posted: Jun 30 2009 at 8:46am
Thanks Arlene!!! I needed those words of encouragement!
 
minnie
dx 02/09 @62;lumpectomy 3/24/09; 1.5cm; node neg; stg I/gr I; BRCA 1/2 neg
2 rnds Taxotere/Cytoxan; 2 rnds A/C (after lung react to tax); 33 rads.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote dmwolf Quote  Post ReplyReply Direct Link To This Post Posted: Jun 30 2009 at 9:03am
Just a word to the newbies who might read this and get scared.  Most people do just fine on Taxol/taxotere.  I was in the majority with this, having no problems with allergy (I didn't even need the steroids, which I quickly dropped because they made me depressed).  I also didn't end up with neuropathy or any other lasting damage to any part of my body that I can discern.  It will probably be ok for you too.
-Denise
DX 2/08@43 stg II IDC; gr2,0 nodes. Neoadj chemo, first ACx2 (fail) then CarboTaxotereX6(better). Lump, Rads done 11/08; Clodronate. False alarm queen: PetCT lung & TM marker. NED. PBM w/recon 9/10.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote gerriesue Quote  Post ReplyReply Direct Link To This Post Posted: Jun 30 2009 at 9:53am
I'm glad you wrote that Denise, and I know you are right. Most people do not get this reaction. My oncologist said she has given many treatments of Taxol/taxotere and had not seen this type of reaction ( similar to mine) except once before.
57 yrs. old at DX Oct. 2008 Stage 1, Grade 3, TNB, 1.7 cm tumor,Negative nodes TX partial masectomy, 4 rounds A/C, 4 rounds Abraxane
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Post Options Post Options   Thanks (0) Thanks(0)   Quote minniemouse Quote  Post ReplyReply Direct Link To This Post Posted: Jun 30 2009 at 12:34pm
Same here. My onc said my reaction to taxotere was an "extremely rare" reaction.
 
minnie
dx 02/09 @62;lumpectomy 3/24/09; 1.5cm; node neg; stg I/gr I; BRCA 1/2 neg
2 rnds Taxotere/Cytoxan; 2 rnds A/C (after lung react to tax); 33 rads.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote alene Quote  Post ReplyReply Direct Link To This Post Posted: Jun 30 2009 at 2:41pm
Thank you Denise
 
Listen to Denise all you newbees
 
My reaction to taxotere was rare...
 
The good news is...
 
I lived through it...I'm still here...and able to tell about it... I have no permanent scarring...
 
All that's left are "fond memories of travails gone bye"
 
Alene
DX 5/21/2008 TN 8cm TAC
Mast 12/08
Extensive Residual Lymphatic Invasion
Inop node clavicle
68 Rads
Stage IIIc
Recur 11/09 Her2+
Surgery 68 RADS
4/10 Biopsy Skin Mets TN
28 RADS
Stage IV
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