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Drug combo doubles progression-free survival in women with advanced breast cancer

 MD-FM Thursday October 3rd, 2013 



GENERIQUE

Carillon

 

Sarah:

MD-FM, Medical News from around the world with Peter Goodwin.

 

P1

PETER:

Hello, and with me is Sarah Maxwell. To begin with, news from the 2013 European Cancer Congress held in Amsterdam: For women with refractory or relapsing HER-2 positive breast cancer, a conjugated monoclonal antibody drug doubled progression-free survival in a randomized study with 600 patients

SARAH:

Yes, in the TH3RESA trial, the drug T-DM1 extended progression free survival from about three to six months in heavily pre-treated patients who’d failed previous agents including trastuzumab and lapatinib. They were randomised to T-DM1 or treatment of their physician’s choice. 31% of patients in the TDM1 arm had an objective response compared to just 8.6% of women on other treatments,

 

Wildiers: “In all subgroups studied, TDM-1 was better than the control arm, so it is a better drug in terms of tumor control but it also generally has a better safety profile. In many studies we see the contrary, a better progression-free survival but also higher toxicity. In this study it’s different. So I think with these results TDM-1 will be the new standard for this population.”

 

SARAH:

That was lead study author Professor Hans Wildiers, from University Hospitals Leuven in Belgium speaking to me after his presentation at the ECC.

 

PETER:

So this looks good in terms of progression free survival, but what about overall survival?

 

SARAH:

Well, the interim analysis showed trend towards increased survival, but not yet statistically significant.

 

PETER:

And how does TDM-1 work?

 

SARAH:

Well, it’s a conjugated monoclonal antibody, combining trastuzumab with a cell-killing molecule, emtansine. And for pre-treated patients failing multiple drugs there are no proven options. I asked Professor Wildiers if T-DM1 could now be considered for first line treatment

 

 

Wildiers: “That is currently being investigated in the MARIANNE Trial: It’s a first line study where TDM-1 is combined with pertuzumab even, and we are waiting for those results to see if TDM-1 also has a role in first line settings.”  

 

SARAH:

Hans Wildiers, from Belgium.



P2

PETER:

More news from ECCO. People with diabetes have an increased risk of developing and dying from certain cancers. That’s according to a meta-analysis with two million patients. It found a 23% increased risk of developing breast cancer among those with diabetes, mainly Type 2, and a 38% increased risk of dying from it, compared to patients without the disease. Diabetes also brought a 26% increased risk of developing colon cancer and a 30% increased risk of dying from that.



VIRGULE MUSICALE



P3

PETER:

For some women with menopausal symptoms hormone replacement therapy is safe and it works. But it shouldn’t be recommended for preventing chronic diseases, such as cardiovascular diseases or cancers

 

SARAH:

That’s the latest conclusion from the Women’s Health Initiative. 13-year follow-up data showed that for combined estrogens plus progestins both the risks and the benefits are less than had been hoped when this treatment first became popular. And the overall picture is complex. The results, published in JAMA, show risks and benefits were more balanced for women on estrogens alone, and HRT had now overall impact on all cause mortality. Edward Morris, from London, told MDFM that younger, healthy women shouldn’t shy away from HTR short-term to treat their symptoms

 

Morris: “Many of the features of the WHI study that attracted media attention actually put off many women of younger age groups from taking hormone replacement therapy. And if you look in depth: younger women actually have considerably fewer risks than the overall pooled population.” 

 

SARAH:

That was Dr. Edward Morris who isn’t a WHI investigator but chairs the British Menopause Society, which recently published guidelines on HRT.

 

Morris-2: “Largely, we suggest in the UK that women be reviewed at least every year, and if in the early post-menopausal years she wishes to stay on HRT then a full reapraisal should take place no later than after 5 years of being on it.”  

 

And another study, also reported in JAMA, suggests that oral estradiol appeared safer than conjugated equine estrogens in terms of venous thrombosis risk, and possibly myocardial infarction

 

Morris-3: “In Europe, actually, there are many women who take estradiol, and certainly in the UK, the trend has been away from conjugated equine estrogens towards estradiol.”

 

SARAH:

Dr Edward Morris, from London.



VIRGULE MUSICALE

 

P4

PETER:

Patients in medical and surgical intensive care units are at high-risk of the sort of long-term cognitive impairment you can see with moderate traumatic brain injury or mild Alzheimer’s disease

 

SARAH:

Yes, about half of al patients presented with serious deficits of cognitive and executive function a year after ICU discharge, according to findings published in the New England Journal of Medicine. A significant risk factor was the occurrence of delirium during hospitalization, reported in 75 per cent of patients. Lead study author, Pratik Pandharipande gave us the details

 

Pandharipande-1: “It was a linear association, so the longer the duration of delirium, the lower your scores were at 3 months and 12 months” 

 

SARAH:

Pratik Pandharipande, from Nashville, Tennessee who said this association was present regardless of age and co-existing illnesses. So, his recommendations for practitioners?

 

Pandharipande-2: “First, practitioners need to be aware that cognitive impairment does occur after critical illness and that they need to help counsel patients when they come to them with these problems and not just blow them off. Perhaps having cognitive therapy rehabilitation is something that one needs to think about and then one needs to be aware that the in-hospital factors may have some implications on these long-term cognitive impairments, and to focus on duration of delirium as one such risk factor. To reduce the duration of delirium, one can think about early mobility in patients, getting them up and exercising, even when they are critically ill and often even on the ventilator. Reduction of the sedative medications, avoiding benzodiazepines, has been associated with improvements in delirium” 

 

SARAH:

Dr. Pratik Pandharipande, from Nashville.

 

VIRGULE MUSICALE



P5

PETER:

In Denmark, an increase in the rate of lay people performing cardiopulmonary resuscitation for cardiac arrests, before the emergency medical services show up, was associated with an impressive improvement in cardiac survival rates

 

SARAH:

Yes, between 2001 and 2010, CPR performed by members of the general public more than doubled: from about 21 per cent to nearly 45 per cent, according to a study reported in JAMA. This increase coincides with national initiatives aimed at strengthening the public’s knowledge on the signs of cardiac arrest, and how to perform CPR

 

Wissenberg-1: “One strategy was to implement resuscitation training as a mandatory element in elementary schools, as well as when acquiring a driver’s licence and, overall, this was combined with a rise in voluntary first aid training to a significant proportion of the population” --16 sec

 

SARAH:

That was Dr. Mads Wissenberg from Denmark, whose team analysed data on nearly 20,000 patients who’d had out-of-hospital cardiac arrests. During the ten years studied, cardiac-arrest survival rates improved dramatically as Dr. Wissenberg explains:

 

Wissenberg: “In the same period, survival on arrival at the hospital more than doubled: from 8 percent in 2001 to 22 percent in 2010. Also, 30-day survival even tripled: from 3.5 percent to 11 percent.”

 

SARAH:

Mads Wissenberg, from the University of Copenhagen.



BREVE 1 Sur fond musical  

 

 

PETER:

Finally, in brief:

 

Exercising was more effective than drugs at reducing your risk of dying if you’ve had a stroke, according to the results of a meta-analysis, published in the British Medical Journal. A study looking at nearly 340 thousand people compared the effectiveness either exercise or drugs had on mortality among patients with four conditions: heart disease, stroke, heart failure and diabetes. The authors suggest more trials are needed to further investigate the benefits physical activity might have on mortality from different diseases.

 

And…

 

BREVE 2

 

Findings, reported in The Lancet, show the risk of death within 90 days of total hip replacement has fallen substantially over the last decade. And it could be reduced even further by four simple clinical management strategies: using a posterior surgical approach, having mechanical thrombo-prophylaxis, chemical prophylaxis with heparin, with or without aspirin, and finally, the use of spinal versus general anaesthesia.

 

That's all from MDFM for now. Sarah Maxwell and I will be back with more next week, so until then from me Peter Goodwin, goodbye!

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