Join clinical trial: of lapatinib good idea?

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Gabriel - 09 Aug 2005 00:39 GMT

As I've said in previous postings, wife has been diagnosed with what
appears to be inflammational bc with lymph system and bone metastases,
HER2 negative, hormone-sensitive. (It wasn't actually described as
inflammational, but had all the symptoms, and no lump.)

She has been asked to take part in a clinical drug trial: letrozole
definitely, and lapatinib or placebo. I'm not sure how long the trial
will last, all I know is that it will not exceed 2 years. I've appended
details of these medications. The trial may involve more tests than
would otherwise be the case, which seems a good thing.

Reading the documentation for the trial, in one place it says that
medication can be supplied beyond the end of the trial if it seems to be
beneficial; in another place it says that lapatinib cannot be supplied
beyond the end of the trial as it is not approved. Obviously we need to
clarify this with the hospital, but I would like to have a clearer idea
about the options before discussing.

I think that participating in a trial is worthwhile in either of the
following cases:

1. At worst, outcome the same as if given the best available medications
and treatment without the trial drug.

or

2. A good chance of a much enhanced outcome, with some chance of a
somewhat worse outcome.

Does anybody have any opinions or information about letrozole and
lapatinib as compared with other drugs?

Thanks,

Signature

Gabriel

Further information on drugs:

She will be on letrozole. http://www.cancer.gov/ say: "An anticancer
drug that belongs to the family of drugs called nonsteroidal aromatase
inhibitors. Letrozole is used to decrease estrogen production and
suppress the growth of estrogen-dependent tumors."

She will also be on either placebo or GW572016: "A substance that is
being studied in the treatment of cancer. It belongs to the family of
drugs called ErbB-2 and EGFR dual tyrosine kinase inhibitors. Also
called lapatinib."

*** ENDS ***

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Chris - 09 Aug 2005 02:34 GMT

Sorry, I don't have specific information on those particular drugs. I do
know that there is the idea out there that estrogen positive metastatic
cancer can be managed by manipulating hormone levels. I consult with a
researcher named Paul Goss at Mass General (he was recently in Toronto
if that helps look him up). I also know several people who had the
advantage of being diagnosed correctly initially (I was told that I was
estrogen negative for the first year) who were first managed with
anti-estrogen drugs for a good long time. For that reason, I think the
trial seems like a good treatment choice.

There are several other considerations in a clinical trial. First, what
Phase is it in. You can be more confident in Phase II and much more
confident in Phase III that what you are doing is worth doing. The other
thing to remember is that you can drop out, or you may be kicked out, if
the treatment is not appropriate and something else is needed. Your
wife's clinical care should be the priority.

Finally, I lot can happen in two years, particularly with a well done
study that is turning in good results. It may be that these medications
will be more available than you think in two years.

Good luck!

Chris

> As I've said in previous postings, wife has been diagnosed with what
> appears to be inflammational bc with lymph system and bone metastases,
[quoted text clipped - 29 lines]
>
> Thanks,

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Gabriel - 09 Aug 2005 12:43 GMT

Chris wrote, in response to my question on advisability of joining a
clinical trial:

[Much useful information snipped]

> I also know several people who had the
> advantage of being diagnosed correctly initially (I was told that I was
> estrogen negative for the first year) who were first managed with
> anti-estrogen drugs for a good long time.

Very nasty, but I'm glad you eventually got the right treatment. Every
so often a laboratory comes into the limelight for, in some cases,
simply making up results, plus the usual problems due to human
fallibility and disorganisation.

> For that reason, I think the trial seems like a good treatment choice.

The bottom line. Thanks.

> You can be ... much more
> confident in Phase III that what you are doing is worth doing.

And Tim's posting tells me that it is Phase III. I don't remember if the
documentation we were given mentions the phase, but there are certainly
figures about results so far.

> you can drop out, or you may be kicked out, if
> the treatment is not appropriate and something else is needed.

> Your wife's clinical care should be the priority.
>
> Finally, I lot can happen in two years, particularly with a well done
> study that is turning in good results. It may be that these medications
> will be more available than you think in two years.

All true

> Good luck!
>
> Chris

Thanks, we'll need it!

Best wishes,

Signature

Gabriel

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Tim Jackson - 09 Aug 2005 10:43 GMT

> As I've said in previous postings, wife has been diagnosed with what
> appears to be inflammational bc with lymph system and bone metastases,
[quoted text clipped - 29 lines]
>
> Thanks,

This is a phase III trial, the clinical trial data is at
http://www.clinicaltrials.gov/ct/gui/show/NCT00073528?order=20

The Letrozole part of the trial is standard treatment for the condition.
She would get a drug of this class whether in the trial or not.

Have you read the manufacturer's info for lapatinib, with the results of
the Phase II trial?
http://www.gsk.com/ControllerServlet?appId=4&pageId=402&newsid=564

This indicates that about 25% of patients had progression of the disease
stopped for an extended period, but for the majority it had small
benefit. There were some minor side effects, but nothing catastrophic.

So I would say that this is one of those tests that is fairly harmless
to try, and if she winds up in the active-drug arm (you probably won't
know though) then she might gain some improvement in chances.

Tim

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Gabriel - 09 Aug 2005 12:49 GMT

Many thanks to Tim Jackson, who wrote in response to my question:

[much useful detailed information snipped]

> So I would say that this is one of those tests that is fairly harmless
> to try, and if she winds up in the active-drug arm (you probably won't
> know though) then she might gain some improvement in chances.

It would appear that the usual treatment would be Letrozole only, and
the addition of lapatinib or placebo is unlikely to do harm, and may be
beneficial.

Thanks again,

Signature

Gabriel

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