ER-Negative: the good news and the bad

ER-Negative: the good news and the bad

ER-Negative: the good news and the bad A report in the Journal of the American Medical Association today found that changes in chemotherapy developed in U.S. trials over the course of the 1990s reduced the risk of recurrence in ER-negative women receiving the newest treatments by 55 per cent over the course of the 1990s.

Or, as the conclusion notes: ‘Among patients with node-positive tumors, ER-negative breast cancer, biweekly doxorubicin/cyclophosphamide plus paclitaxel lowers the rate of recurrence and death by more than 50% in comparison with low-dose cyclophosphamide, doxorubicin, and fluorouracil as used in the first study.’

The bad news? The UK seems to be rather behind the U.S. here, with less use of taxanes and greater reliance on three-weekly schedules rather than two-weekly schedules (which require jabs to keep the blood counts up).

For the synopsis, see:

It does seem like cancer treatments suffer a bit from ‘not invented here syndrome.’ For example, the herceptin licencing applications for Europe and the U.S. actually cite completely different studies, with the European ones covering HERA and the U.S. ones citing the big U.S. trials. When I tried to talk to my oncologist about the U.S.-based herceptin trials once, he just blanked, whereas he knows the European trials backwards and forwards.

Anybody have any ideas on this?

Concerns about cardiac function??? The differences in the licence applications in the EU and in the US worries me. My concern is that ,here a licence will be granted for use as per HERA (sequential use) ?? because of concerns re cardiac function. Making the assumption a licence is granted (and it will be) and that NICE approve use (more of a question mark in my mind about that one from health economics and general funding issues) I’m not trying however to suggest that cardiac function is not an issue, it certainly is and one of the risk/benefits that need to be weighed up for us on a case by case basis.

-Dr Piccart (one of HERA investigators ) said in a recent “expert interview” that because the trials had different approaches and complimentary design it was possible to suggest what is the best strategy (based on indivudual risk/benefit evaluations). The example she gave were

1/ A woman of 60+ years, Who has Oestrogen positive disease, and a limited number of nodes involved as well as known cardiac risk factors - HERA style regime

2/ Younger woman - more aggressive tumor etc. etc. No cardiac issues, Here the doxorubicin/cyclophosphamide then paclitaxel/herceptinapproach of the American trials may be clinically more appropriate.

3/ For the same younger woman if cardiac risk issues were present. Perhaps to use the more novel carboplatin/docetaxel/trastuzumab

So she thinks all treatment regimes currently studied should be used in individualising therapy. Not just the study she is involved in.

It does worry me that with the system we have that a “decision” re treatment plan will be made and thats it , and if its as per HERA, thats what you will get. This as in all things associated with BC is that one size certainly doesn’t fit all. It is also all very well having the “backing” of an organisation such as MHRA, NICE etc , but such an organisation needs to ensure that all available data is used for such decisions (not the blinkered view we appear to have now) and that such decisions once made are reviewed regularly and rapidly to ensure that the “guidelines” designed to support us all are based on all available current evidence - this is a fast changing field.

Not letting Pharmaceutical companies off the hook here - they need to support licence applications with all data - given the prior publicity of this issue - the studies are all well know so I wonder how the licencing authorities will handle dealing with data they know of that is missing .

For the record - my Herceptin was combined with chemo - if I had the misfortune to be diagnosed tomorrow this is certainly how I would wish to be managed again (large cancers, lots of nodes).

I was lucky enough to have private insurance and my onc recommended this regime but 3 weekly eg AC x 4 Taxol x 4 probably because of the poor prognostic features of my cancer. This wasn’t available on the NHS in this area as they had not approved its use for primary BC only for advanced.
I surfed the internet and found some data re the improved results for a 2 weekly regime and sent off the details to my oncologist. He agreed to it and luckily my insurance company agreed to fund the additional cost of the injections. I am ER+ so the improvement in survival may not be as great but are still significant. It just shows that it’s worth doing some research to make sure we get the best treatment available.

bi-weekly cycles good for all? I also found doing my own research reallyy paid dividends. If I hadn’t mentioned the use of Taxol/Taxotere to my onco myself - I don’t think I would’ve had it. I’ve ended up with 4xFEC + 4xT (on three weekly cycles … just had the first Taxotere). I also read about the improvements shown with bi-weekly cycles, but a little too late to renegotiate with my onco. It does seem to make common sense to me, boosting the immune system between cycles really ought to help the body get a head start on any remaining cancer. A healthy immune system is key to the battle against cancer, everyone has the odd cancer cell from time to time in their body , one of the jobs of the immune system is to weed them out.

Has anyone ever seen a clinical trail that compared 2-weekly cycles with 3-weekly cycles (same chemo) but both using boosters? That would be interesting.

Post code lottery Need to sort out the Post Code Lottery that currently exists for the Taxanes (can’t be prescribed on the NHS in my area)

When treatments change Best practice in treatments is changing all the time, and yes it is hard to look back and realise that maybe we could have got better treatment. Sometimes though I think we just have to accept that maybe we got the best that was avaiable or known at that time. Sometimes too what was thought to be best turns out later not to have been…here I am thinking of the horrible stem cell transfusion high dose chemo that was being used for aggressive primary breast cancer in the late 1990s (Linda McCartney had it, as did Kate Carr…anyone who knows her book). It is now considered that this regime was not better than standard chemos for preventing recurrence, and so isn’t used for breast cancer.

For myself I’m glad I had a sharp onc. and private medical insurance in Oct 2003 so that yes I got AC plus taxotere (though I believe I’d have got the tax on the NHS here in East London). I didn’t get the 2 weekly cycles though so congrats to those who’ve argued for and got this.

I agree with slp that there is a really shameful postcode lottery about use of taxanes for primary breast cancer with poor prognostic features …every bit as important as the postcode lottery on herceptin…someone needs to take up the campaigning mantel on this one too.