Adjuvant Chemo Therapy for HER2+ Patients..

NATSGSG

Hello Members:

Sincerely hope everyone's journey towards recovey are getting better and better...as for myself, I shall be starting chemotherapy in a week's time, and has chosen to go with the Pharmac recommended 9 weeks concurrent taxane chemo + herception regimen (pre-anthracycline) because it has been proven to be effective, safe and of course of a shorter duration.

I have been doing much reading about this shorter duration, and discovered that Roche Pharmaceuticals, the Swiss Manufacturer has been doing what it can to "bury," "distort" this good news. Therefore, I am sharing this info published in Lancet for you to read so you too have more information at hand before making your final decision on adjuvant therapy. Having full information will serve you in a long way.  For example, during surgery and Sentinel Lymph Node Surgery/Dissection, of which normally between 1-4 nodes will be taken out for testing) I also signed consent for axillary clearance. Upon reading, I discovered if 1/4, or 2/4  nodes are positive, sometimes this may not require axillary clearance (based on clinical trials results). Anyway, I cancelled ALND. Glad I did even though my SLND  result was negative. What I mean to say don't easily give up your axillary if you can't help it. The point here is READ, READ, READ lots to educate yourself. Don't be passive and hand your body to your SO and MO. Yes, they hae your interests at heart. But most tends to go with the majority standard treatments...Sometimes, there are results to the contrary that our SO and MO are too busy to read.... Naturally, the final decision is yours to make. Regardless, I wish you all have a less painful, more pleasant recovery, no matter what stage of cancer you are at....

Trastuzumab: possible publication bias

The Lancet, 17 May 2008

Herceptin (trastuzumab) for early breast cancer has caught international attention. Yeet, its effectiveness may be overestimated, because important clinical trial data from nearly 1000 women has not been published.

Publication bias is of increasing concern, entrenching the use of interior treatments.  This concern now extends to adjuvant trastuzumab (Herceptin_ in women wit HER2 positive early breast cancer, because a key clinical trial has been oly selectively published. As such, patients are being givenan important treatment sequence that may be much less effective than currently thought.

Adjuvant trastuzumab can be gven in two main sequences: concurrently with or sequentially after other chemotherapy. Sequential treatment is licensed, is standard practice and is the publicly funded regimen in many countries, such as most of Europe (United Kingdom included).  Once randomized trial (out of six relevant trials) by the North Central Cancer Treatment Group (NCCTG) trial NCCTG-N9831, has studied both sequential and concurrent treatments head-to-head, together with a control or usual-care group.

However, although this three-group study has trastuzumab, it has only been partly published. Data from the 985 women given 12-month sequential trastuzumab in this study are in effect missing, despite publication of data from the 12-month concurrent and contro groups of the same trial nearly 3 years ago.

Interim resuts for all three groups of the NCCTG trial were presented orally in 2005 at the American Society of Clinical Oncology annual meeting. After 1.5 yeasr' median follow-up, sequential trastuzumab gave a comparatively small 13% relative reduction in disease evets compared with usual care -- with a reasonable chance of being no better than the control arm (harzard ratio 0.87%, 95% Cl 0.67-1.13)  Conversely, concurrent trastuzumab was significantly more effective than sequential therapy, reducig disease events by a third(0.64, 0.46-0.91).

Soon after, Romond and colleagues published the concurrent a control group results fro the NCCTG three-group study with another study of concurrent treatment )the National Surgical Adjuvent Breast and Bowel Project ((NSABP) B31 Trial) in a retrospectively approved pooled analysis. Limited efficacy data from the inidividual trials are available in the online appendix to that publication, but do not include the NCCTG sequential-group data.  These data are only available as part of the slide presentation on a confererence websitem ad have NEVER been disseminated by peer-reviewed publication.

The SELECTIVE RELEASE of data from the NCCTGstudy has far-reaching implications for women with HER2 positive early breast cancer. Without these data, sequential trastuzumab seems more effective than i probably is.  Combining the NCCTG sequential data from the conference slide show with updated results for the other trials of sequential trastuzumab (HERA, ad PACS-04) shows a treatment effect ONE-THIRD less than initially estimated...

For more info, click on link below to read the rest...

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(08)60706-0/abstract

As a cancer patient myself, I believe we must ALL take charge of what's being put in our body - too much even of a proven drug can be harmful to us in the long run. That is not what we want.

Please, please, please do not blindly follow a chemo regimen without looking into whether it's good for you in the end.

GOD BLESS !

SpecialK

Also, this Lancet citation is 7 years old.

NATSGSG

kayb, the 9 weeks of concurrent Herceptin + docetaxel treatment for HER2+ patients are attached here for your reading pleasure, along with very detail comparison studies of those 4 other very large trial results.

http://www.nejm.org/doi/full/10.1056/NEJMoa053028

http://www.pharmac.govt.nz/pdf/231205.pdf

There is currently The SOLD Study Clinical Trial conducted by The Finnish Breast Cancer Group comparing the 9 weeks concurrent treatment with the 12 months Herceptin treatment. This Trial started back in 2008 and has just completed in Nov. 2014, enrolling somewhere between 2500-3000 patients for this. The results are currently being tabulated and analyzed. If interested, please go to this site below and read through it. Am holding my breath for the results publication.

https://clinicaltrials.gov/ct2/show/NCT00593697?term=SOLD+study&rank=1

 

SpecialK , while I realize that this article from Lancet seemed "old" does not make it contents obsolete.

Publication bias creates unfair and untruth about medicine or treatments that could be harmful to us patients. I, for one, would find this extremely disturbing, for my family, my friends, my colleagues, and all others who rely on such information to make informed decision prior to any sorts of treatment or therapy. It is a basic truth that over medication, in fact, over-anything, brings more harm than good. Does this not worry you?

IN the final analysis, we make our decision based on our own knowledge, our reading, our understanding or lack of knowledge, and so will bear the consequences of such decisions.

 

SpecialK

While not questioning the veracity of the Lancet article, there is more recent discussion on the subject.  Your post exhorts patients to choose treatment after careful consideration, which I did.  I chose TCH, with 12 total months of Herceptin, because I felt it was the most effective regimen that was available at the time of my diagnosis.  That decision was based on completed trial information, NCCN recommendations, and the advice of my trusted oncologist.  I would have been more worried about under medication with node positive Her2+ cancer larger than 2cm, and until conclusive information from multiple trials showing a shorter course of Herceptin is as effective as a 12 month course, I am willing to bet that most who share my same stats would agree.