for those with brain mets or leptomeningeal mets
 

a new review paper from Dana Farber's Nancy Lin rehashes what has been tried and what is new and upcoming.

On L-M mets it states:

From an investigational standpoint, given that HER2 amplification appears to be retained in patients with HER2-positive primary tumours and leptomeningeal involvement, intrathecal trastuzumab is the subject of two ongoing prospective trials in France and in the United States (www.clinicaltrials.gov; NCT01373710, NCT01325207) [86]. A number of case reports have been published in the medical literature, although on close review, in many cases, patients received multiple concurrent therapies, making isolation of the true effect of intrathecal trastuzumab a challenge [87–89]. At present, off-label use of intrathecal trastuzumab is not recommended, given that the commercial drug supply is not formulated for intrathecal use [90]. Newer anti-HER2 agents, such as pertuzumab or TDM1, which have demonstrated activity against extracranial metastases, could also be of interest in patients with leptomeningeal disease when given intrathecally. However, these would need to be studied carefully for both safety and efficacy and, as of now, would not be recommended for off-label use in this setting [91–93].

Since she has just reviewed how little effect one can expect with other treatments of leptomeningeal mets these pious "is not recommended" and "would not be recommended"
may not go a long way with patients/their caregivers and oncologist really just trying to help them. Wouldn't it be better just not to publish those in a review than put in black and white words which preclude any but the most brave oncologists from offering the drugs,especially as those patients often don't feel well enough to travel for the trials and the number of patients with LM mets at any one or two or three institutions is such that trials may take decades?

Just bringing up for discussion what is the role for informed consent and off-label use outside clinical trials in conditions that are relatively rare and imminently lethal with no other good treatment options.

I usually do not get "political" but sometimes I wish these words would not get used. It keeps insurance for paying for things they might otherwise be obliged to under state or federal law (off label use), frightens oncologist who might otherwise just be willing to try treatments on the basis of previously reported good results, hinders progress in finding solutions for these hard to treat mets and erases hope from those who need it as another door is shut in their face. I can of course, see the other point of view--first do not harm, not wanting to get sued for practicing less than the standard of care, etc--

Can any of you devise a better way to solve this dilemma?

Re: for those with brain mets or leptomeningeal mets
 

I agree, Lani. Those words should not be used

I think the dilemma is created by a "cya" situation. "Standard of care" is a safe harbor to avoid malpractice liability. I am in favor of keeping good, careful physicians out of trouble, so I'm not criticizing them for wanting to stay in their safe harbors. But as you said, with the lack of better alternatives and imminent death if nothing is done, I would think one could devise a close-to-bulletproof informed consent. The patient was dying. He/she knew that and chose to try this. The patient died. No harm done.

I practiced law before heading off to seminary in 2008. My practice was mostly transactional, but I drafted some waivers and releases in my time. It should work.

Re: for those with brain mets or leptomeningeal mets
 

Crazy ness, with limited options out there, and most surgical options, for me not an option. Or being told will just see what happens when the next "SPOT" shows up. It took over a year to get my It Herceptin started, since basically failing radiation to my thoracic spinal canal on the nerve tumours. When 1 of the 2 cofounding Doctors of the large group practice, says yes and took 3-4 months trying to make it work and see if we could do in a sterile procedure room at the hospital across the street from the office. Of course they said no eventually, so they decided we are doing it at the Office. they have given other drugs IT before including methotrexate, just not the Herceptin. Ironwood Cancer and Research Centers here in Arizona is who takes care of me. I did not have to sign anything, have had other DR's, offer support and train staff in the procedure. Frying your brain with WBR, and the side effects from that "regular" procedure has had more side effects and COST to treat them, then being part of an off label patient to add to all the other published random IT Herceptin tx off label. Hey my insurance company is paying for a vial a week to use no preservative, and they get a huge break from the drug company. So me getting IT Herceptin versus being paralyzed and having to have all that goes along with that, versus a treatment center, and a world renown Neurosurgeon practice, who is willing to participate. they should play nice with their 2 cents of advise!!! This is America and freedom of what we subject ourselves to to save our lives is our choice. to me is almost like being part of a "clinical trial" it is either going to work or not, there may be some side effects, but what happens in an official trial as well? FLIP of the Coin, Phase 1 could really mess you up. Or like herceptin original trials, save the Lives and change this beast into a Chronic chase rather than the Death sentence I was originally given in Jan of 2006. I have worked through most of the cancer years, and am still able to contribute to society, by volunteering, advocating for others and raising my children with my husband. Sorry this probably is totally a rant now, off topic. As I have told a few insurance people, other health care providers for myself and others. Do Not Make Me Come Down There And Stand on Your DESK!! Get it done, or get me your supervisor!!
As always LANI thank you for your dedication to help us with posting the latest.

Peace and prayers to all of those who have walked the path before me and their families. Yet gave their battle history to us whom followed, to be able to get "out of the box treatment" to save and extend the time and quality of life for me and those whom are affected the the big "C" word and the future impact of this disease.

Darita

Re: for those with brain mets or leptomeningeal mets
 

And by the the way it is the Dr and Medical staffs own personal decision whether to participate or in the "off label" drug procedure.
Darita

Re: for those with brain mets or leptomeningeal mets
 

Darita!
Such fire! You go girl!
Well said!

Amy and Lani...
I couldn't agree more.
Denise