Featured Research

from universities, journals, and other organizations

Cancer drug labels missing key information about patients' symptoms

Date:
July 4, 2013
Source:
University of North Carolina School of Medicine
Summary:
For patients facing treatment for cancer, it is essential to understand how their symptoms will be affected. Symptoms like pain, fatigue, or nausea can result from the cancer, or from treatment side effects. The best way to collect this information is from patients themselves in research studies. But almost no drug labels in the U.S. include this information. As a result, incomplete information is available to patients and clinicians to help with treatment decisions.

"As an oncologist, when I sit with patients to discuss starting a new chemotherapy, their first questions are often 'How will it make me feel?' and 'How did patients like me feel with this treatment?'" said Dr. Ethan Basch, MD, director of Cancer Outcomes Research at the University of North Carolina.

In the July 10th issue of The New England Journal of Medicine, Dr. Basch calls for pharmaceutical manufacturers to collect rigorous information on how drugs impact symptoms and quality of life starting early in drug development, and for the U.S. Food and Drug Administration (FDA) to include this information in drug labels.

"As patients live longer with cancer, they must increasingly choose among agents with varying efficacy-toxicity balances. And as approved drugs continue to yield only tiny median survival benefits, patients understandably want to know how their peers felt during and after a treatment," said Dr. Basch.

In 2011, the FDA approved 15 new anti-cancer drugs, but only one of them, ruxolitinib, included symptom information in the label -- reporting that multiple symptoms improve substantially when patients take the drug. This was actually the first cancer therapy in more than a decade to include symptom information in its label. Cancer labels stand in contrast to non-cancer labels, which describe symptoms about 25 percent of the time.

Research has shown that patients who experience worse symptoms and quality of life face a worse prognosis and are more likely not to follow treatment guidelines or may stop treatment altogether. The FDA has taken several steps to include the patient perspective in drug development, issuing guidance, collaborating with industry to develop standardized tools, and requesting funds from Congress to support these efforts.

Dr. Basch argues that the culture of pharmaceutical development must shift to include direct patient input during the earliest stages of research. For patients, physicians and insurers to have a true picture of a treatment's impact, they must have access to reliable data on how a drug will impact symptoms and daily quality of life, in addition to information about tumor response and survival.

"Ideally, moving forward, whenever representatives of a pharmaceutical company and a regulatory agency sit down to discuss a product-development program, they will ask the same question my patients ask of me: "How does this product make people feel?" said Dr. Basch.

Dr. Basch is the director of Cancer Outcomes Research at the UNC Lineberger Comprehensive Cancer Center. He serves as a federally appointed member of the Methodology Committee of the Patient-Centered Outcomes Research Institute (PCORI), a member of the National Cancer Institute's Board of Scientific Advisors, a member of the Board of Directors of the International Society for Quality of Life Research (ISOQOL), Co-Chair of the Health Outcomes Committee of the Alliance for Clinical Trials in Oncology, and a member of the Board of Scientific Advisors of the National Cancer Institute. He leads an ongoing NCI initiative to develop a patient-reported adverse event monitoring system for use in clinical research (the "PRO-CTCAE"), and is study chair for multiple trials employing patient-reported endpoints.


Story Source:

The above story is based on materials provided by University of North Carolina School of Medicine. Note: Materials may be edited for content and length.


Journal Reference:

  1. Ethan Basch. Toward Patient-Centered Drug Development in Oncology. New England Journal of Medicine, 2013; 130703140022001 DOI: 10.1056/NEJMp1114649

Cite This Page:

University of North Carolina School of Medicine. "Cancer drug labels missing key information about patients' symptoms." ScienceDaily. ScienceDaily, 4 July 2013. <www.sciencedaily.com/releases/2013/07/130704094351.htm>.
University of North Carolina School of Medicine. (2013, July 4). Cancer drug labels missing key information about patients' symptoms. ScienceDaily. Retrieved July 31, 2014 from www.sciencedaily.com/releases/2013/07/130704094351.htm
University of North Carolina School of Medicine. "Cancer drug labels missing key information about patients' symptoms." ScienceDaily. www.sciencedaily.com/releases/2013/07/130704094351.htm (accessed July 31, 2014).

Share This




More Health & Medicine News

Thursday, July 31, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Health Insurers' Profits Slide

Health Insurers' Profits Slide

Reuters - Business Video Online (July 30, 2014) Obamacare-related costs were said to be behind the profit plunge at Wellpoint and Humana, but Wellpoint sees the new exchanges boosting its earnings for the full year. Fred Katayama reports. Video provided by Reuters
Powered by NewsLook.com
Concern Grows Over Worsening Ebola Crisis

Concern Grows Over Worsening Ebola Crisis

AFP (July 30, 2014) Pan-African airline ASKY has suspended all flights to and from the capitals of Liberia and Sierra Leone amid the worsening Ebola health crisis, which has so far caused 672 deaths in Guinea, Liberia and Sierra Leone. Duration: 00:43 Video provided by AFP
Powered by NewsLook.com
At Least 20 Chikungunya Cases in New Jersey

At Least 20 Chikungunya Cases in New Jersey

AP (July 30, 2014) At least 20 New Jersey residents have tested positive for chikungunya, a mosquito-borne virus that has spread through the Caribbean. (July 30) Video provided by AP
Powered by NewsLook.com
Xtreme Eating: Your Daily Caloric Intake All On One Plate

Xtreme Eating: Your Daily Caloric Intake All On One Plate

Newsy (July 30, 2014) The Center for Science in the Public Interest released its 2014 list of single meals with whopping calorie counts. 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:
from the past week

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