Caveat Emptor: Treatment duration for for HER2+ patients

nat_hu

Hello Members:

Hope everyone's journey towards recovering 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 before you make your final decision. Having all information on hand 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, this may not require axillary clearance (based on clinical trials results). Anyway, I cancelled ALND. Glad I did though it was not required since result was negative. What I mean to say don't easily give up on the nodes in your axillary if you could. Naturally, the finaly decision is yours to make. May you have a less painful, more pleasant recovery, no matter what stage of cancer you are at....

Trastuzumab: possible publication bias

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Scott Metcalfe

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• Pharmaceutical Management Agency (PHARMAC), Wellington 6143, New Zealand

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Carl Burgess

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• Department of Medicine, University of Otago Wellington School of Medicine and Health Sciences, Wellington, New Zealand

Scott Metcalfe,

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Scott Metcalfe

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• Pharmaceutical Management Agency (PHARMAC), Wellington 6143, New Zealand

 Carl Burgess , George Laking,

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George Laking

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• Department of Medical Oncology, Regional Cancer and Blood Service, Auckland District Health Board, Auckland, New Zealand

Jackie Evan,

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Jackie Evans

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• Pharmaceutical Management Agency (PHARMAC), Wellington 6143, New Zealand

Susan Wells,

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Susan Wells

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• Section of Epidemiology and Biostatistics, School of Population Health, University of Auckland, Auckland, New Zealand

Steffan Crausaz

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Steffan Crausaz

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• Pharmaceutical Management Agency (PHARMAC), Wellington 6143, New Zealand

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...

 

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 do not blindly follow a chemo regimen without looking into whether it's good for you.

agness70

Good luck with your

Good luck with your treatment. I'm not sure what Pharmac is, or the protocol you are describing.

I completed treatment earlier this year of 18 weeks neoadjuvant TCHP for HER2+/HR- breast cancer that was locally advanced at stage 3B. I continued with adjuvant Herceptin for a total of 16 doses -- because at that point my body had enough. My lumpectomy and SND (I requested less surgery up front, otherwise they wanted to do full ALND).

I agree that there is a lot they don't know are are likely overtreating most patients. By clinical observation by my MO, and also based on observation by my doctor of Chinese Medicine, after three rounds of TCHP my tumor had dissolved. When I had surgery three months later all that was found was scar tissue. I endured radiation therapy due to the lack of information about the durability of the response -- plus based on prior, similar protocols, I fit the description of the patient likely to have a recurrence - younger, HER2+ with nodal involvement.

Of course allopathic oncology treatment doesn't heal the body, it just focuses on irradicating malignant cell lines. In order to heal you will need to seek support elsewhere, through nutrition, exercise, etc. From my observations, HER2+ breast cancer is particularly associated with nutritional deficiencies -- you will want to get your copper, zinc, iron (ferritin), magnesium (RBC magnesium), and D3 levels checked and then may want to evaluate your dietary and lifestyle habits to see where your nutritional needs aren't being met.

Best wishes,

A