Quality of life for cancer patients highlighted at ESMO

There is an insatiable demand for news of new drugs which promise to prolong the lives of cancer patients, or even produce a cure.

But these are relatively few and far between, meanwhile researchers are making major advances to help alleviate the frequently severe symptoms of cancer, or cancer treatment such as chemotherapy.

Four new studies were presented today at the ESMO cancer congress in Madrid which promise to significantly improve the quality of life for a range of different cancer patients.

Chairing the press briefing, Giuseppe Curigliano, MD, PhD, co-chair of the Division of Medical Oncology at European Institute of Oncology in Milan said the studies ‘provide something different’ to drugs which produce breakthroughs in overall survival. He added: “We often neglect the quality of life of patients.”

Weight loss and appetite problems

One of the worst side-effects commonly seen in cancer patients is a rapid loss of weight and appetite, a condition called cancer anorexia-cachexia.

A new drug called anamorelin was highlighted as an exciting potential breakthrough for the condition.

The drug is being developed by Swiss pharma company Helsinn, and investigators have presented Phase 3 results for the drug in patients with non-small cell lung cancer (NSCLC).

Anamorelin works by increasing levels of ghrelin, a peptide which regulates body weight, lean body mass, appetite and metabolism.

Two 12 week studies of the drug showed it helped patients increase lean body mass (LBM, a measure of body weight with body fat factored out) compared with a loss of LBM for those on placebo. In the strongest study, there was a 1.1 kg LBM increase compared to a loss of 0.44 kg in those on placebo. This trend was mirrored in overall weight, suggesting that the drug could help patients maintain a better quality of life and a good appetite, despite having advanced lung cancer.

Jennifer Temel, MD, Clinical Director of Thoracic Oncology at Massachusetts General Hospital Cancer Center and a Principal Investigator in the ROMANA 1 and ROMANA 2 trials, commented: “These data show that anamorelin represents a new option in the treatment of anorexia-cachexia syndrome in patients with advanced non-small cell lung cancer in which patients frequently experience poor quality of life due to symptoms such as cachexia, loss of appetite and fatigue. The ROMANA data clearly demonstrates that anamorelin increased lean body mass and improved symptoms related to anorexia and cachexia.”

However it wasn’t all good news – the trial had two primary endpoints: increasing lean body mass and improving handgrip strength, but the study showed no improvement in the latter. This is a disappointment, as the weakness caused by the condition means patients are reliant on carers to help with everyday tasks.

The drug was found to be generally well tolerated, although a small number of patients (less than 3 per cent) suffered adverse events, including some who developed hypoglycaemia and diabetes.

Further studies looking at whether the effects of the drug could help patients live longer are underway, with results expected shortly.

Chemotherapy-induced nausea

Another problem is the nausea and vomiting commonly seen in patients as a result of chemotherapy.

There are a number of existing treatments for chemotherapy-induced nausea and vomiting (CINV) but Tesaro’s new treatment rolapitant could be a step forward in the therapy area.

Phase 3 trials of the drug in patients receiving cisplatin-based chemotherapy showed the drug significantly reduced CINV in the acute, delayed and overall phases following chemotherapy compared to placebo.

Rolapitant is a neurokinin-1 (NK-1) receptor antagonist, an oral treatment which alleviates the nausea symptoms for five days.

The drug was submitted to the FDA on 8 September, and would be Tesaro’s first product on the market if approved.

The drug’s oral formulation and efficacy could make it a major new product, as most patients are currently given anti-emetics intravenously.

Improving quality of life in patients with head and neck cancer

Many new cancer treatments are first being tested in the most advanced and hard-to-treat cancers. Early results often lack evidence of extended overall survival (OS) which is clearly the ultimate goal.  However, overall survival can’t be the sole target: new treatments which can improve progression free survival and time without symptoms are important too, as these are very important quality of life measures for patients with a terminal illness.

Boehringer Ingelheim has a new drug in development to treat head and neck cancer, afatinib. New Phase 3 trial results in patients with recurrent or metastatic squamous cell carcinoma showed a modest improvement in progression free survival (2.6 months compared to 1.7 for methotrexate) and didn’t show an increase in overall survival.

Despite these limitations, the results suggested the drug could offer patients significantly better quality of life compared to methotrexate treatment.

Investigators say patients taking the drug reported fewer problems with swallowing and pain and other health problems, compared to those taking methotrexate.

“The improvement in progression-free survival was associated with a significant delayed worsening of symptoms (such as pain, swallowing and global health status) versus chemotherapy. Patients treated with afatinib had less pain over time than patients treated with methotrexate. “These are important outcomes for patients with these conditions,” notes study author Dr Jean-Pascal Machiels, a medical oncologist at Institut Roi Albert II, Cliniques Universitaires St. Luc, in Brussels, Belgium.

Boehringer will hope to produce stronger efficacy data when treating the condition at an earlier stage, otherwise the commercial viability of the drug might be questionable.

This is a problem for all drugs aiming to alleviate symptoms and improve quality of life. The rush of new cancer treatments onto the market means the cost of new cancer treatment is increasing rapidly, and treatments considered to have ‘marginal benefits’ are unlikely to be taken up widely.

Chemotherapy in pregnancy

Another very significant study presented on Saturday looked at the long term effects on children born to women who had been pregnant whilst on chemotherapy. The case control study conducted by Dr Frederic Amant looked at the mental development of 38 children, and found no problems caused by treatment

It shows that chemotherapy during pregnancy can be considered safe for mental development and cardiac functioning of the child, the authors say. This is because the placenta is able to block the majority of chemotherapy molecules reaching the unborn child.

Fears about the effects of chemotherapy on unborn children can sometimes lead to women being advised to abort their pregnancies, or for babies to be delivered prematurely, but the study concluded this was not necessary.

“When chemotherapy is administered after the first trimester of pregnancy, we cannot discern any problems in the children,” says lead author Dr Frederic Amant, KU Leuven and University Hospitals Leuven in Belgium. “Fear about the risks of chemotherapy administration should not be a reason to terminate a pregnancy, delay cancer treatment for the mother, or to deliver a baby prematurely.”

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