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Avastin (aka Bevacizumab) - Miracle Drug or Colossal Flop?

I swear I'm going to be able to go to medical school after I get done with this (well, assuming that I can get over the nausea that the sight of blood gives me - I should be a dream patient, huh?). Anyway, my heads a bit swimming, and I have to head out in a few moments and I'm hungry, and I've put on weight since the diagnosis, so my pants are tight and well, heck, I'm just going to post some links and notes here during the day, as I have time, and publish later.

Articles:

Costly Cancer Drug Offers Hope, but Also a Dilemma
F.D.A. Extends Avastin’s Use to Breast Cancer
Panel Recommends Against Avastin for Breast Cancer
In Second Trial, Avastin Is Found Effective in Treating Breast Cancer

Back home now.

There's tons more out there but that's what I've read so far. The doctor also sent over a 19-page document describing the trial and all the nasty side effects, possibilities, etc. I came up with a list of questions to ask him and some notes:

Notes

  • I have a 20% chance of getting a placebo
  • a 40% chance of being in ArmB which coincides with my normal treatment and getting the new drug
  • I have a 40% chance of being in Armc which requires extended care
  • If I'm in ArmC (40%chance), I will still need to go to the doctor for Bevacizumab once every three weeks (10 cycles) for an additional 30 weeks
  • I can stop the study at any time

Questions

  • I'm Stage 2A, why am I high risk (the trial is for patients with lymph node positive and high risk lymph node negative breast cancer patients)? Is it because of the grade 3 tumor? Basically, why am I a good candidate for the study? What is my risk of recurrence (I haven't asked that question yet; I'm afraid to)?
  • In previous trials, the "studies showed improved results in patients whose breast cancer recurred." What were those improved results? And can you apply those statistics to me since we're not dealing with a recurrence but a prevention of recurrence?
  • How many of the five other candidates from our local hospital have already been selected? Is it possible to talk to them or any other participants?
  • I thought my second round of paclitaxel was every other week for 8 weeks, 4 cycles but the info on the study says once a week for 12 weeks, which is it?
  • If I'm in the study, and in ArmC, does that mean I have to keep the port in for an additional 30 weeks?
  • I was pre-eclampsia at the end of my first pregnancy. Does that make me pre-disposed to high blood pressure as a side effect of Avastin?
  • Why am I on a dose dense schedule (one dose, every other week - 4 cycles, repeated twice), as opposed to the classical schedule (one dose every third week)
  • What is my drop dead date for deciding
  • So far, there have been 1,136 participants. Have their been any indications of side effects more frequent than others? More harmful than others? Has anyone finished yet? Any indication of results?
  • How will this improve my outcome versus the standard care for breast cancer?
  • What experience do you have with this clinical trial? Other trials?
  • What will be involved in the long term follow-up?

That's it so far. Honestly, right now I'm leaning away from doing this. Unless my chances for recurrence are high and this substantially lowers them, I just don't think the benefits will outweigh the extra burdens (i.e., side effects and potential side effects) that I will have to deal with.

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Other Thinks (4)

Oh Kim, this all sounds so overwhelming! It sounds like you are thinking it through rationally though and are being quite thorough. Great questions.

Donna:

Kim, when I was being treated for breast cancer, I participated in a blind study for an anti-nausea drug while I was going through chemo. I never had a moment of nausea, so I (and my doctor) believe I got the real thing, and not the placebo.

What you're having to decide, however, is completely different. The best of luck with your decision. Has your oncologist offered her/his opinion?

Wow that made my head spin. Hope you get some good answer from the doctor that will help you make the decision.

Kim [TypeKey Profile Page]:

Donna, I think if I had that opportunity, I might take it too - the nauseau part is something I'm so hoping to avoid. Thanks for the comment.

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This page contains a single entry from the blog posted on November 19, 2008 10:08 AM.

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