Featured Research

from universities, journals, and other organizations

First randomized trial of targeted cancer medicine in all tumor types

Date:
September 11, 2013
Source:
ECCO-the European CanCer Organisation
Summary:
A further step along the road to the personalization of cancer medicine, where treatment is based on the individual molecular characteristics of tumors rather than their primary site, will be presented at the 2013 European Cancer Congress.

A further step along the road to the personalisation of cancer medicine, where treatment is based on the individual molecular characteristics of tumours rather than their primary site, will be presented at the 2013 European Cancer Congress (ECC2013), which starts on Friday 27 September in Amsterdam, The Netherlands.

Related Articles


Dr Christophe Le Tourneau, Head of the Phase I Programme at the Institut Curie, Paris, France, will tell the congress that the SHIVA trial is the first randomised trial to look at patient outcomes after treatments were chosen according to the individual molecular profiles of each person's tumour. It is also the first trial to do this for all tumour types. About 40% of all those taking part in the trial have molecular abnormalities that can be targeted by existing drugs, he will say.

To date, 320 patients from seven comprehensive cancer centres across France have been included in this phase II trial, of whom 60 have been randomised. In the standard arm, the patients received the chemotherapy they would have received if they had not been participating in the trial. All patients had recurrent or metastatic cancer that was unresponsive to standard treatment for their disease.

"Our goal is to have 200 randomised patients," says Dr Le Tourneau. "Although 40% of the 320 patients have a tumour for which targeted drugs are available, some are still on the chemotherapy that was started at the time of the biopsy and therefore we will have to randomise them later. Because we are looking for an effect in different kinds of tumours, we have ruled out the inclusion of any particular type of tumour if this brings the number of randomised patients with this type to over 20% of the total. We have also allowed the inclusion of patients with rare tumours."

Preliminary results of the feasibility study, to be presented at the congress, show that this approach works, the researchers say. The ultimate goal of the phase II trial is to see whether the selection of drugs that target the specific molecular profiles of tumours will improve outcomes for patients.

Once the first 100 patients were included, the researchers looked at the feasibility of a biopsy of a metastasis, since the molecular profile of the primary tumour, if tissue is available, may not be the same as that found in a metastasis. They also investigated the quality of available tumour samples, the proportion of the patients for which the necessary analyses could be undertaken, the proportion for which a molecular abnormality can be identified and for which a targeted therapy exists, and the timeframe needed to establish the tumour profile.

"Recent advances in diagnostics have enabled us to ascertain the molecular profile of tumours in a timeframe which is compatible with good clinical care, but we needed to verify this in our study," says Dr Le Tourneau.

Unlike conventional chemotherapy, molecular targeted agents only work in the presence of their targets. Side-effects are lessened and, in principle, efficacy heightened. One of the problems to date, however, is that such drugs have principally been developed based on the primary location and histology (cellular make-up) of the tumour. This has meant that many potentially promising targeted drugs have failed in early clinical trials simply because they have not induced a response in a sufficient number of patients.

"The history of breast cancer changed beyond recognition with the discovery of the role played by the ErB2/HER2 gene, which is amplified in up to 20% of breast cancers. And we now know that trastuzumab (Herceptin), one of the most widely-used targeted cancer therapies, which targets that gene, is effective in several tumour types and not just in breast when the ERBB2/HER2 gene is amplified or even mutated," says Dr Le Tourneau. "We also know that patient outcomes in the few trials to date where the choice of treatment is based on a molecular abnormality are better than those where the treatment is not matched to the abnormality. What was missing to date is a histology-independent randomised trial comparing molecular targeted treatment with conventional therapy, and this is why I decided to set up the SHIVA trial."

Even today, the researchers say, molecularly targeted therapy for cancer patients is initially prescribed according to the location of the primary tumour. At the end of the trial, analysis of progression-free survival will show whether this practice needs to be changed.

A positive finding would imply the need to make major changes in the way cancer drugs are developed and tested in patients. But this would represent a new and difficult challenge.

"At present we have no data on the efficacy of drugs in patients with the same molecular abnormality but different tumour types, and we also suspect that a treatment effect would not depend on the presence of a single molecular abnormality, but, more likely, on several. However, we believe that it is most likely that, in future, tumour location and histology will no longer be the primary criteria for the prescription of molecularly targeted agents; rather, tumour biology will be the deciding factor," says Dr Le Tourneau. "A positive result from our trial would be an important step forward on the road to personalised medicine."

Professor Cornelis van de Velde, President of ECCO, said: "This ground-breaking randomised trial is very exciting since this is the way to individualise therapy. We have already moved from empirical to stratified treatment, and now we can offer patients personalised treatment based on the understanding of the particular molecular profiles of their tumours in order to select drugs that target a specific profile. The means to determine the individual molecular profiles of tumours will be readily available at low cost in the years to come, and the integration of biopsy-based molecular profiles with individual patient characteristics will enable precision diagnosis to be translated into precision personalised therapies. ECCO will have an important role to play in ensuring the incorporation of molecular biology genetics into clinical multidisciplinary meetings."


Story Source:

The above story is based on materials provided by ECCO-the European CanCer Organisation. Note: Materials may be edited for content and length.


Cite This Page:

ECCO-the European CanCer Organisation. "First randomized trial of targeted cancer medicine in all tumor types." ScienceDaily. ScienceDaily, 11 September 2013. <www.sciencedaily.com/releases/2013/09/130911184817.htm>.
ECCO-the European CanCer Organisation. (2013, September 11). First randomized trial of targeted cancer medicine in all tumor types. ScienceDaily. Retrieved November 26, 2014 from www.sciencedaily.com/releases/2013/09/130911184817.htm
ECCO-the European CanCer Organisation. "First randomized trial of targeted cancer medicine in all tumor types." ScienceDaily. www.sciencedaily.com/releases/2013/09/130911184817.htm (accessed November 26, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Wednesday, November 26, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Pet Dogs to Be Used in Anti-Ageing Trial

Pet Dogs to Be Used in Anti-Ageing Trial

Reuters - Innovations Video Online (Nov. 26, 2014) Researchers in the United States are preparing to discover whether a drug commonly used in human organ transplants can extend the lifespan and health quality of pet dogs. Video provided by Reuters
Powered by NewsLook.com
Today's Prostheses Are More Capable Than Ever

Today's Prostheses Are More Capable Than Ever

Newsy (Nov. 26, 2014) Advances in prosthetics are making replacement body parts stronger and more lifelike than they’ve ever been. Video provided by Newsy
Powered by NewsLook.com
From Popcorn To Vending Snacks: FDA Ups Calorie Count Rules

From Popcorn To Vending Snacks: FDA Ups Calorie Count Rules

Newsy (Nov. 25, 2014) The US FDA is announcing new calorie rules on Tuesday that will require everywhere from theaters to vending machines to include calorie counts. Video provided by Newsy
Powered by NewsLook.com
Daily Serving Of Yogurt Could Reduce Risk Of Type 2 Diabetes

Daily Serving Of Yogurt Could Reduce Risk Of Type 2 Diabetes

Newsy (Nov. 25, 2014) Need another reason to eat yogurt every day? Researchers now say it could reduce a person's risk of developing type 2 diabetes. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins