Navigation Links
Aflibercept in colorectal cancer: Indication of minor added benefit
Date:7/11/2013

The drug aflibercept (trade name: Zaltrap) has been approved in Germany since February 2013 in combination with a certain chemotherapy for adults with metastatic colorectal cancer in whom chemotherapy with oxaliplatin could not stop the disease from progressing. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG) the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether this new drug offers an added benefit over the current standard therapy. According to this, considerable advantages in respect of overall survival are accompanied by major potential harm in the form of side effects. Overall, there is therefore an indication of a minor added benefit of aflibercept.

Aflibercept complements chemotherapy

Aflibercept in combination with a chemotherapy consisting of irinotecan/5-fluorouracil/folinic acid (FOLFIRI) was compared with FOLFIRI alone. The approval study (VELOUR), which compared the treatment "aflibercept plus FOLFIRI" with the treatment "placebo plus FOLFIRI", was available for the benefit assessment. This was a randomized and double-blind study, i.e. the patients were assigned randomly to one of the two treatment groups, and neither the patients nor the doctors knew whether aflibercept with FOLFIRI or FOLFIRI alone was used.

A total of 178 centres in Europe, America, Australia, New Zealand, South Africa and Korea took part in this multinational study: The participants were 1226 adults with adenocarcinoma of the colon or rectum who had recurrence after failure of a chemotherapy containing the drug oxaliplatin.

Overall survival: indication of considerable added benefit

Half of the patients who received FOLFIRI chemotherapy alone had died after 12 months. Half of the patients who received aflibercept in combination with FOLFIRI chemotherapy had died after 13 to 14 months. This means that life expectancy increased by 1 to 2 months on average (median). For overall survival, this led to an indication of an added benefit with the extent "considerable" for the combination of aflibercept with FOLFIRI in comparison with FOLFIRI alone.

The manufacturer's dossier did not provide any results, or any results that could be used, on symptoms and complaints (morbidity) and health-related quality of life. Hence an added benefit of aflibercept in comparison with the appropriate comparator therapy for these outcome categories is not proven.

Side effects: indications of greater harm

Serious events and severe adverse events (e.g. infection, diseases of organs, metabolism, blood and lymph system) as well as treatment discontinuations due to severe adverse events were more frequent during the treatment with aflibercept than during the treatment with FOLFIRI alone in all age groups.

In summary, there is an indication of greater harm with major extent from the treatment with aflibercept plus FOLFIRI in comparison with FOLFIRI alone for several outcomes of the category side effects.

Overall, indication of minor added benefit

Overall, positive effects of aflibercept are accompanied by negative effects with the same certainty of results: the indication of a considerable added benefit in mortality (overall survival) has to be weighed up against the indications of greater harm with major extent regarding side effects. IQWiG therefore downgrades the extent of the added benefit of aflibercept in comparison with the appropriate comparator therapy from "considerable" to "minor".

IQWiG published a first assessment of aflibercept (trade name: Eylea) on 15th March 2013. This dealt with a different therapeutic indication, however, namely the "treatment of wet age-related macular degeneration (AMD)".

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.


'/>"/>

Contact: IQWiG
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

Related medicine news :

1. Aflibercept in AMD: No proof of added benefit
2. Researchers uncover a viable way for colorectal cancer patients to overcome drug resistance
3. Study says screening accounts for much of black/white disparity in colorectal cancer
4. Blacks and Hispanics at higher risk for precancerous colorectal polyps
5. Geisel researchers sift through junk to find colorectal cancer clues
6. Blood pressure drugs dont protect against colorectal cancer
7. NIH study finds sigmoidoscopy reduces colorectal cancer rates
8. Colonoscopy screening markedly reduces colorectal cancer incidence and death
9. Surgical patient safety program lowers SSIs by one-third following colorectal operations
10. A recipe for increased colorectal cancer screening rates
11. Gene mutation identifies colorectal cancer patients who live longer with aspirin therapy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network ... advocate for action towards gender equality at their inaugural Summit in New York City ... and reached a social audience of over 3 million. To watch the Mobilize Women ...
(Date:10/13/2017)... ... , ... “The Journey: From the Mountains to the Mission Field”: the story ... the Philippines. “The Journey: From the Mountains to the Mission Field” is the creation ... has taught all ages and currently teaches a class of ladies at her church, ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... products to meet the demand of today’s consumer and regulatory authorities worldwide. From ... probiotic experts and tested to meet the highest standard. , These products ...
(Date:10/12/2017)... ... October 12, 2017 , ... Dr. Parsa Mohebi, the Los ... article to the newly revamped Cosmetic Town journal section, featuring articles ... procedure known as Follicular Unit Extraction (FUE). , Dr. Mohebi says ...
(Date:10/12/2017)... ... October 12, 2017 , ... Health Literacy Innovations ... literacy software tool, and the Cancer Patient Education Network (CPEN), an independent professional ... announce a new strategic alliance. , As CPEN’s strategic partner, HLI will ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... YORK , Sept. 27, 2017  DarioHealth Corp. (NASDAQ: DRIO), a ... today announced that its MyDario product is expected to appear on The ... when The Dr. Oz Show airs in your area: http://www.doctoroz.com/page/where-watch-dr-oz-show ... The nine-time Emmy award-winning, The Dr. Oz ... The ...
(Date:9/23/2017)... Sept. 22, 2017 Janssen Biotech, Inc. (Janssen) ... letter from the U.S. Food and Drug Administration (FDA) ... sirukumab for the treatment of moderately to severely active ... clinical data are needed to further evaluate the safety ... active RA. ...
(Date:9/19/2017)... ANN ARBOR, Mich. , Sept. 19, 2017 HistoSonics, Inc., a venture-backed medical ... the precise destruction of targeted tissues, announced three leadership team developments today:   ... Josh Stopek, PhD ... ... Veteran medical device executive ...
Breaking Medicine Technology: