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In Europe, QoL Is Not A Cancer Footnote


The European Medicines Agency (EMA) may soon elevate the importance of quality-of-life (QoL) outcomes in the assessment of new cancer therapies.
The EMA is creating a QoL appendix that will likely be added to its standard guideline for evaluating and approving cancer drugs and therapies, according to press materials.
Thus, treatment-related fatigue, nausea, sexual dysfunction, psychological problems, and other factors will become more important than they have been in terms of a therapy's approval.
This impending development was the subject of a session at the 3rd European Organization for Treatment and Research in Cancer (EORTC) conference, entitled International Quality of Life and Clinical Trials Conference, held in Brussels, Belgium.
"There is increasing recognition that health-related QoL is an effective and relevant measure with which to evaluate and monitor therapeutic outcomes. Health-related QoL measures may complement the range of traditional objective indicators, such as survival," said Daniel O'Connor, MB ChB, PhD, in a press statement. He is from the Medicines and Healthcare Products Regulatory Agency in the United Kingdom, and moderated a session at the conference.
QoL is one of a number of measures being considered for inclusion in the EMA's appendix to its "anticancer" guideline. Clinical trial design, statistical methodology, and patient-related outcome measures are also being considered. Work on the appendix is being done by an oncology working party on behalf of EMA's Committee for Medicinal Products for Human Use. It is expected that the appendix will be released for public consultation in 2013.
Another expert added context about the use of QoL as part of drug approval. "This new guidance will be increasingly important in this new era of anticancer medicines. Some new therapies that lead to limited improvements in survival can cause extensive problems with a patient's quality of life. Conversely, new therapies can cause less toxicity than older therapies since they have become more targeted," said Andrew Bottomley, PhD, from the EORTC, in a press statement.
Patient-Reported Outcomes Also in Focus
One of the shortcomings of QoL measures is that patient-reported outcomes are seen as "soft" data and are not valued as much as investigator assessments, said another presenter at the EORTC meeting, according to press materials. However, patient-reported outcomes will be more important in the future, predicted Lesley Fallowfield, PhD, from the University of Sussex in the United Kingdom.
Thirty years ago, a systematic review of literature on breast cancer and QoL would have yielded fewer than 20 citations; now, a search would yield more than a million, said Dr. Fallowfield. "While great strides are being made in the right direction, QoL is still not high enough on the priority lists of regulators and health authorities," she said.
Most new drugs have an excellent safety profile in clinical trials, but once in the real world, adverse effects reported by patients are different, she explained.
"Tamoxifen supposedly had few side effects when first approved, but its use commonly causes hot flushes, vaginal discharge, and even mood changes in patients. Likewise, the new generation aromatase inhibitors, such as letrozole, exemestane, and anastrozole, can cause joint pain and loss of libido. We need patients to be assessing these side effects in clinical trials and take account of these findings before a drug is approved. Although no one is going to die of a hot flush (apart from embarrassment), unresolved quality-of-life side effects lead many women to discontinue taking their otherwise life-saving drugs," Dr. Fallowfield said.

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