Trial to test new drug in patients with advanced cancer

Cancer Research UK launches trial to test new drug in patients with advanced cancer | Cancer Research UK

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A clinical trial to test a new cancer drug in patients with advanced solid tumours, launches in four centres across the UK, through Cancer Research UK’s Centre for Drug Development.

This early phase trial will test the safety and tolerability of the drug and establish the recommended dose for patients with a variety of cancers including advanced bowel, lung, ovarian, urothelial, pancreatic, breast, head and neck, and oesophageal cancer.

In the first part of the trial, groups of patients will receive increasing doses of the drug, called LY3143921 hydrate, to find the safest dose that best targets the cancer cells. The drug, discovered by Eli Lilly, was brought to Cancer Research UK through the charity’s Clinical Development Partnership scheme.

In the second part, larger groups of patients will receive the highest tolerated dose, so that researchers can investigate how the drug is working on the cancer cells.

The drug has not yet been tested in people but has shown promise in mice by selectively inhibiting Cdc7, a protein that helps cells to reproduce correctly.

Full story at Cancer Research UK

Patients with relapsed/refractory chronic lymphocytic leukaemia may benefit from inclusion in clinical trials irrespective of the therapy received: a case-control retrospective analsysis

Blood Cancer Journal (2015) 5, e356

Treatment for patients with chronic lymphocytic leukaemia (CLL) keeps changing at an incredible pace, perhaps more than in any other haematological malignancy. Indeed, the outlook of patients with CLL is improving with the advent of targeted therapies, including second-generation monoclonal antibodies, immune modulators, BTK inhibitors, PI3K inhibitors and BCL2 antagonists. After decades of randomized trials showing no benefit in overall survival (OS), recent trials have changed this trend and shown a true OS benefit for patients receiving novel agents. Moreover, retrospective analyses from our and other institutions have found a significant improvement in survival over the years, suggesting that new treatments are truly changing the prognosis of the disease.

Carry on reading via Blood Cancer Journal – Patients with relapsed/refractory chronic lymphocytic leukaemia may benefit from inclusion in clinical trials irrespective of the therapy received: a case-control retrospective analsysis.

Knowledge and attitudes regarding medical research studies among patients with breast cancer and gynecological diseases

BMC Cancer 2015, 15:587

Background
Medical research studies are becoming increasingly important for optimizing the prevention, diagnosis and treatment of illnesses. Participation in research studies can have many benefits for patients. In randomized and controlled clinical studies, they can receive the best possible medical care currently available. However, only a small proportion of patients nowadays are treated within the framework of medical research. The primary endpoint of this study was to discover what level of knowledge patients have about clinical studies and how they currently perceive them, in order to identify ways of optimizing the information provided about studies from the patients’ point of view.

Methods
The study included 2546 patients (breast cancer 21.6 %, gynecological cancer 8.3 %, obstetrics 32.7 %, endometriosis 7.8 %, fertility treatment 3.2 %, other benign gynecological illnesses 19.2 %, no information for 7.2 %) in the outpatient clinic (45.2 %) and in the in-patient sector (54.8 %) at the Department of Gynecology at Erlangen University Hospital and associated centers. In the single-center study, conducted between January 2011 and January 2012, the patients were asked about their level of knowledge regarding the background to medical research studies and the ways in which they are carried out and used. The patients were also asked how they perceived medical studies and how they thought study conditions might be optimized. The three-page questionnaire was included in the feedback sheet received by patients as part of the hospital’s quality management system.

Results
As a whole, the group only had moderate knowledge about clinical studies. A majority of the respondents considered that studies were valuable (91.6 %), but only a few were also willing to take part in them (58.4 %). Knowledge and willingness to participate strongly depended on age (P < 0.001), educational level (P < 0.001) and patient group (P < 0.001). Most patients would prefer to decide about participating in studies through a discussion with their outpatient physicians.

Conclusions
The information that patients have about clinical studies affects whether they participate in them. It is therefore extremely important for patients to be well informed, for their anxieties about participation to be relieved, and for the benefits of participation to be explained to them.

via BMC Cancer | Abstract | Knowledge and attitudes regarding medical research studies among patients with breast cancer and gynecological diseases.

Chemotherapy before surgery benefits patients with advanced ovarian cancer

Women with advanced ovarian cancer have fewer side effects and tend to have a better quality of life if given chemotherapy before surgery, according to a Cancer Research UK study published in The Lancet.

The CHORUS trial, conducted at the Medical Research Council Clinical Trials Unit at University College London, challenged the international standard for treating advanced ovarian cancer.

550 women with the disease took part in the trial, with 276 given the standard treatment of surgery followed by six cycles of chemotherapy, and 274 had surgery after three cycles of chemotherapy.

The Cancer Research UK funded trial found that post-surgery complications and death within 28 days of surgery was most common among women given surgery first. Women who received delayed surgery suffered fewer symptoms, a reduction in overall side effects and had a lower death rate.

Delaying surgery also reduced the amount of time the patient spent in the hospital after surgery – a benefit to both the patient and NHS resources.

The CHORUS trial is the largest surgical trial of its kind in the UK and second largest in the world. It aimed to see if this new treatment strategy was a good alternative to the traditional approach.

Reference:  Kehoe et al. Primary chemotherapy versus primary surgery for newly diagnosed advanced ovarian cancer (CHORUS): an open-label, randomised, controlled, non-inferiority trial. The Lancet.

Earlier chemotherapy extends lives of men with advanced prostate cancer

UK-led trial has found that combining a chemotherapy drug with hormone treatment extended the lives of men with advanced prostate cancer.

The drug, called docetaxel, is typically only offered if standard hormone treatment has failed. But these findings, that will be presented at the American Society of Clinical Oncology (ASCO) conference show treating patients whose cancer has already spread earlier extended survival by almost two years.

Experts say the results provide sufficient evidence to suggest that the treatment should be offered to newly diagnosed men whose disease has already spread.

In the study of 2,962 men, those who received docetaxel plus standard hormone therapy at the start of their treatment lived an average of 10 months longer than those who received only hormone treatment.

For patients whose cancer had already spread beyond the pelvis, the average increase in life expectancy was 22 months.

The results form part of the STAMPEDE trial (Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy), the largest trial of its kind for men with prostate cancer.

More detail at Cancer Research UK

‘Targeted’ ovarian cancer drug could also help certain men with prostate cancer

Olaparib was licensed in December for women with ovarian cancer and inherited BRCA mutations, but the new research suggests it could also benefit men with genomic faults within their tumours.

Researchers told the American Association of Cancer Research (AACR) conference in Philadelphia that up to 30 per cent of men with advanced prostate cancer had tumours with defects in repairing DNA — and these responded particularly well to olaparib. The men most likely to benefit could be identified by genetic testing to look for mutations in genes responsible for DNA repair — including the BRCA genes and the gene ATM.

Link to the research: Mateo et al, DNA repair defects and antitumor activity with PARP inhibition: TOPARP, a phase II trial of olaparib in metastatic castration resistant prostate cancer, AACR conference 2015

Study confirms long-term benefits of melanoma immunotherapy

A long-term follow up of people on an international clinical trial has confirmed the benefit of immunotherapy for certain patients with advanced (stage 3 or 4) melanoma. More than 18 per cent of patients were still alive five years after being treated with ipilimumab (Yervoy) in combination with a chemotherapy drug called dacarbazine. This compared to fewer than nine per cent who were treated with chemo alone. Ipilimumab is one of a new class of cancer treatments that target the immune system, and works by homing in on a molecule found on immune cells called CTLA-4.

Link to the research: Maio M. (2015). Five-Year Survival Rates for Treatment-Naive Patients With Advanced Melanoma Who Received Ipilimumab Plus Dacarbazine in a Phase III Trial Journal of Clinical Oncology