Navigation Links
Lower risk of serious side-effects in trials of new targeted drugs

Patients in early clinical trials of new-style targeted cancer therapies appear to have a much lower risk of the most serious side-effects than with traditional chemotherapy, according to a new analysis.

Researchers at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust analysed data from 36 Phase I trials run by the organisations' joint Drug Development Unit.

The study, published today in August's Annals of Oncology, found the overall risk to patients of suffering a life-threatening side-effect was around seven times less than for traditional cytotoxic agents*.

Most new cancer drugs developed over recent years are targeted agents, which attack the specific genetic or molecular faults driving cancer growth, rather than one-size-fits-all chemotherapeutics, which kill all rapidly dividing cells.

Recent studies have shown that patient response rates in Phase I trials of new-generation targeted drugs are approximately two-fold higher than for old-style drugs. But until now, the risk of side-effects to patients taking part in early stage trials of new-style drugs has been unclear.

Senior author Dr Rhoda Molife, a medical oncologist and senior investigator in Phase I clinical trials in the Drug Development Unit of The Institute of Cancer Research and The Royal Marsden, said: "Our study found that the risk of developing a serious side-effect in a Phase I trial of a targeted drug was relatively low, compared with previous analyses of similar trials of old-style chemotherapies.

"The theory behind targeted drugs is that they should affect only cancer cells that have a specific fault and spare healthy cells, which we hoped would lead to higher rates of efficacy and lower rates of side-effects. It's very pleasing that our study seems to back this up, at least in the context of Phase I trials."

"Importantly, we also identified characteristics that put patients at higher risk of these toxicities, including if they were sicker when joining the trial. This will help doctors make the right choices about who should be given new drugs in early stage clinical trials."

Scientists retrospectively analysed data from 687 patients treated at the Drug Development Unit of The Institute of Cancer Research and The Royal Marsden between January 2005 and December 2009. They had a range of cancer types, with gastrointestinal, gynaecological and sarcoma the most common.

The Drug Development Unit of The Institute of Cancer Research and The Royal Marsden is supported by the National Institute for Health Research Biomedical Research Centre for Cancer, and also receives funding from Cancer Research UK and the Experimental Cancer Medicine Centre network.

For targeted drugs, the most common toxicities were gastrointestinal such as loss of appetite, diarrhoea and vomiting and fatigue, while side-effects for cytotoxic drugs are generally haematological or cardiovascular in nature

Patients were more likely to suffer side-effects if they were given a higher dose than that which the trial later found to be optimal, or if they were sicker when they joined the trial. The findings should help guide researchers in selecting patients for trials and improving trial design.

Professor Alan Ashworth, Chief Executive of The Institute of Cancer Research, said: "The discovery of targeted therapies is revolutionising the way we treat cancer, and is a key focus of our research here at The Institute of Cancer Research. Many of these drugs have individually transformed the care of certain cancers, but the strength of this study is that it helps confirm the validity of the overall approach."


Contact: ICR Science Communications Manager Jane Bunce
Institute of Cancer Research

Related medicine news :

1. Lower GI problems plague many with rheumatoid arthritis, Mayo Clinic study finds
2. Tree nut consumption associated with lower body weight and lower prevalence of health risks
3. Diagnostic yield of colonoscopy for melena after nondiagnostic upper endoscopy is lower than previously reported
4. Everyday Activities Might Lower Alzheimers Risk
5. Modest alcohol consumption lowers risk and severity of liver disease
6. Lower Risk for Bowel Obstruction With Less Invasive Surgery: Study
7. CAM therapy combined with conventional medical care may improve treatment of lower back pain
8. Blood pressure drugs linked with lower PTSD symptoms
9. Lower-Dose Radioiodine Effective Against Thyroid Cancer
10. Eating More Foods Rich in Omega-3s May Lower Alzheimers Risk: Study
11. Presence of fetal cells in women lowers risk of breast cancer but raises risk of colon cancer
Post Your Comments:
(Date:11/24/2015)... , ... November 24, 2015 , ... In an ... restrictions and variables that determine which patients are or are not eligible for bariatric ... have a BMI over 40, are more than 100 pounds overweight, or have a ...
(Date:11/24/2015)... UT (PRWEB) , ... November 24, 2015 , ... It ... Magazine. For a business, it is critical that the first impression be positive and ... they are not likely to buy anything or want to return. They will also ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... ... gather to share their knowledge and experiences at a live taping of the ... Ruesch Center for the Cure of Gastrointestinal Cancers 2015 Symposium at Georgetown University ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... Aided by ... today announced an innovative study designed to yield insights into how to detect and ... of biomarkers for pancreatic cancer from small, non-coding RNA molecules (ncRNA), genetic material that ...
(Date:11/24/2015)... ... November 24, 2015 , ... Sir Grout of Baltimore is ... certification. The award recognizes good companies for excellence in service and a commitment ... and hard surface restoration company earned this recognition after a thorough review by ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... November 24, 2015 F1000Workspace - ... - since it was launched just six months ago. ... and authoring platform for scientists - since it was launched ... have been loaded on to F1000Workspace - a ... since it was launched just six months ago. ...
(Date:11/24/2015)... YORK , Nov. 24, 2015 iRhythm Technologies, ... advancing cardiac care, today announced that it will participate in the ... Hotel in New York, NY . ... present on Tuesday December 1, 2015 at 8:50am ET. ... . --> . ...
(Date:11/24/2015)... uptake of recently approved and pipeline premium products for Type 1 Diabetes ... says GBI Research . --> The ... Mellitus (T1DM), will be a key driver of market growth to 2021, ... The uptake of recently approved and pipeline premium products for Type 1 ... 2021, says GBI Research . Type ...
Breaking Medicine Technology: