!!! Pertuzumab may be approved by FDA as early as Friday !!!!

[phil]

I hope its true. Seems like approval for pertuzumab is a no-brainer. Dr. Pazdur will probably crow about it, as His FDA is feeling the heat from this weeks debut of t dm-1, the historic " smart bomb " that His Agency bungled back in 2010. He will talk, talk, talk up pert , and it is very good. He wont talk about rejecting t dm-1 ... 38 %... Embarassing. Deadly for many of us. We wont let him sweep it under the rug... AP says it " just missed the rigid cutoff for immediate approval ", couldnt bend it ? Does anyone think This FDA is capable of un-biased tx of t dm-1 ?

[Lani]

Sheila,
Am still exhausted from the conference and 7 ADDITIONAL hours of jetlag since the conference (yes, I am the scarlet pimpernel!) but could you have radiation recall dermatitis?

Google it, review your drugs and your radiation field and let me know if am just in some sleep-deprived, jet-lag induced confusion or perhaps barking up the right alley.

I have only read about it, but wouldn't it be nice if it were something other than cancer.

I read a number of scary things about your proposed radiation treatment way back when and tried to post some of it without alarming you prior to your decision on your brachial plexus treatment...some of these side effects happen late and some may perhaps be amenable to trreatment eg perhaps trental for postradiation fibrosis.

Since you are now in the realm of rare problems, perhaps it would be wise to review some of the literature. I doubt many individual oncologists or radiation oncologists even in cancer centers have a lot of experience with those with brachial plexus involvement so it might be wise to compile all of it and look for trends. You should not have trouble with the terminology I suspect as I recall you were trained as a nurse and researched and spoke up admirably about the price of herceptin.

Try to separate yourself from what you are reading in the literature-- my usual suggestion is to substitute the words chcocolate, marshmallows and whipped cream for words you don't like to read such as metastasis, overall survival, progression free survival and try to slog through the literature.

Unfortunately,they still don't really know for sure HOW radiation works against breast cancer and what makes different people react differently to radiation therapy (no doubt it is largely genetic).

If I am not just stuporous and imagining things and it might be radiation recall dermatitis, at least the problem would not be the cancer itself. Even if I am totally whacked out and delusional it couldn't hurt to review the literature on radiation to this area and the reaction to it, results from it to try to understand what might be going on.

Best of luck!

[KristinSchwick]

Love you Shelia- hang in there. Thinking of you!

Also just wondering what the FDA approval for pertuzumab will mean for most of us? Will it be for metastatic breast cancer patients? Will it be for people who have failed other her-2 therapies and what sort of other chemo agents will it be given with? And anyone know how long it could take for insurance agencies to pay for it?
Thanks

[Lauriesh]

It's going to be approved as a first line treatment for mets (those newly diagnosed with mets) in combination with Herceptin and taxotere.

Of course, a dr can prescribe it off label, but then the question will be, will the ins pay for it.

I had to fight my ins. to pay for tykerb, because I wasn't taking it with Xeloda. It will be interesting if ins. will deny covering this drug, if used outside of what it was approved for.

Laurie

[KDR]

Sheila, would a tiny specimen via biopsy help?

Phil, Go, Phil! In horseland, we used to use a twitch around the upper lip to stabilize an out of control animal...fits here, doesn't it? Sick of the stalling and cover-ups...do we have any adults in the FDA house?

Karen

[Mary Anne in TX]

Cyber hugs and hope to Sheila Girl! You gave your hair, now taxotere needs to do it's job for you! ma

[msmanuf]

Wow !! What exciting news. I haven't started Herpecin yet, called my onco to see if I would be eligible if it is approved tomorrow. Praying for everyone. I am very early stage so, hopefully I will be given the gift of Pertuzumab. I am sitting on pins and needles..like everyone else is.

Mary Jo

[chrisy]

My concern also, about if it will be covered by insurance beyond the strict label approval.

[Rolepaul]

Talk to the VP of patient affairs at your insurance company. This should be paid for if the government approves it. I will try to get to Anthem Blue Cross Blue shield to find ou.

[msmanuf]

Will this be a first or second line med?

Thanks,

Mary Jo

[msmanuf]

Hi, not sure what I am, but first line with mets does that mean it has moved somewhere else in the body? Mine hasn't moved anywhere else. Suppose to start tch tomorrow.

[msmanuf]

wooo hoooo congrats

Mary Jo

[Lani]

pertuzumab will probably not be useful as monotherapy(and thus is not a substitute for herceptin), but wil combined with herceptin (where it will be especially effective against the her2-her3 heterodimers) and even also lapatinib. It may/will probably end up being somewhat more effective when used with a taxane (although I hope not, as it would be lovely to have a purely targeted therapy only combination). Kent Osbourne and Racheal Schiff have opined that it might require an AI in the combo in ER+ her2+ cases.

Approval for a drug in the metastatic setting usually comes long before approval in the adjuvant setting as 80-90++% of those who are stage IV have historically succumbed within 10 years, whereas most of those in the earlier stages 90% or more never have a recurrence. When so many are expected to do just fine, they must weigh the safety issues in the cost/risk/benefit analysis. As an example I believe herceptin was approved for metastatic her2+ bc in the late 1990s but not for early breast cancer until late 2006 or sol

The good news was pertuzumab did not seem to be responsible for any more cardiotoxicity when added to herceptin compared to herceptin alone.

[Lani]

Sheila--

http://www.cancertreatmentreviews.co...126-X/abstract

Summary
Introduction
Radiation recall is an inflammatory skin reaction at a previously irradiated field subsequent to the administration of a variety of pharmacologic agents. Although skin has been the major site of radiation recall toxicity, instances involving other organ have been reported.

Materials and methods
Data for this review were identified by searches of Medline and Cancerlit. The search terms “radiation”, “recall”, and “toxicity” were used. References identified from within retrieved articles were also used. There was no limitation on year of publication and no abstract forms were included. Only articles published in English were taken into consideration.

Results
Idiosyncratic drug hypersensitivity phenomenon is a recent hypothesis which correlates best with the available facts at this moment. The phenomenon may occur days to years after radiotherapy has been completed. The majority of the drugs commonly used in cancer therapy have been involved in the radiation recall phenomenon. A mixed non-specific inflammatory infiltrate seems to be the common histopathologic criteria in previous published reports. Universally, corticosteroids or the use of non-steroidal anti-inflammatory agents, in conjunction with withdrawal of the offending agent, produce prompt improvement.

Conclusion
We propose to collect all future radiation recall phenomenon in a Rare Cancer Network database in order to augment our understanding of this rare reaction.

[Sheila]

Lani
Thank you for the info...I spent a good part of the day reading up on the radiation recall dermatitis...it looks very similar to what I have on the breast, and I retried on my mask today, and it appears that area was in the radiation field. I have an appointment Monday with the rad onc Dr in Chicago...I will be going with info in hand...hope I get an answer. Thank you for the valuable info...I kept wondering if it was from the radiation.....I will let you know.