Fighting Cancer Often Involves Battling Treatment Side Effects



    
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        New study shows EMEND(R) significantly improved prevention of
    chemotherapy-induced nausea and vomiting, when added to standard therapy

    To access a multimedia version of this release, please click <a href="http://smr.newswire.ca/en/merck-frosst-canada-ltd/fighting-cancer-often-involves-battlng-treatment-side-effects">here</a>
    

    KIRKLAND, QC, June 25 /CNW Telbec/ - Presented today in Rome during the
Multinational Association of Supportive Care in Cancer (MASCC) meeting, a new
study showed that EMEND(R) (aprepitant) in combination with a standard
antiemetic regimen of ondansetron and dexamethasone significantly improved the
prevention of chemotherapy-induced nausea and vomiting (CINV) in both men and
women with various cancer types - breast, lung, colorectal and ovarian - who
received a first cycle of a broad range of moderately emetogenic
(vomit-inducing) chemotherapy. In fact, this study included the broadest range
of patients, tumour types and chemotherapy regimens to date in a clinical
trial of an NK1 (neurokinin 1) inhibitor like aprepitant.
    "These research findings are important," said Dr. David Warr, a
Toronto-based oncologist. "Before this study was carried out, the drugs to
combat nausea and vomiting had only been tested in patients who received a
couple of common chemotherapy treatments for breast cancer or high dose
cisplatin. We didn't have a clear idea of how common these problems were with
other very widely used chemotherapy programs or whether aprepitant was
necessary in addition to the usually administered antiemetics. We now have
confirmation that the nausea and vomiting are more common than what many
physicians believe and that aprepitant can significantly benefit these
patients."
    "I've been cancer free for over five years now, but when I went through
chemotherapy my best friend and ally was my chemo nurse," said Montreal
resident Jean Stutsman. "Cancer changes your life and affects everyone around
you. Our minds and bodies are involved in a fight against cancer and that
often means battling against treatment side effects too."
    "Chemotherapy induced nausea and vomiting (CINV) remains an important
issue for people dealing with cancer," states Kim Chapman, president of the
Canadian Association of Nurses in Oncology (CANO). "Key to the prevention or
management of CINV is the understanding of the patient's experience. Oncology
Nurses have the ability to consistently and in a standardized way identify a
patient's experience with CINV. People on chemotherapy need to tell their
nurse or doctor if they experience nausea and vomiting even if they currently
are taking antinausea medication so that changes can be made to get even
better control. There are many ways to manage nausea and vomiting without the
need for dose reduction or other changes to the chemotherapy."
    "This news is most welcome," said Barry Stein, cancer survivor, activist
and president of the Colorectal Cancer Association of Canada (CCAC). "Who can
forget those first few days after commencing treatment and wondering how we
will get through the side effects! EMEND(R) in combination with other
medications may go a long way to help colorectal and other cancer patients who
are undergoing chemotherapy get through their treatment so they can maximize
its benefit. When faced with the challenge of completing difficult treatments
at any stage of the disease, minimization of the side effects will also
enhance the quality of life of patients."

    More patients reported no vomiting

    The study's primary efficacy endpoint was met when significantly more
patients taking aprepitant in combination with standard therapy reported no
vomiting during the 120 hours following initiation of the first cycle of
chemotherapy compared to the control group (76.2 per cent vs. 62.1 per cent,
p(less than)0.01).
    In addition, the study's secondary efficacy endpoint was met when
significantly more patients achieved a complete response (defined as no
vomiting and no use of rescue medications) up to 120 hours post-chemotherapy
compared to the control group (68.7 per cent vs. 56.3 per cent, p(less
than)0.01).
    This randomized, double-blind, gender-stratified, parallel-group study
involved 848 male and female patients with a variety of tumour types--breast,
lung, colorectal and ovarian. Patients scheduled to receive a single dose of
moderately emetogenic chemotherapy with one or more of a broad range of agents
(carboplatin, oxaliplatin, epirubicin, idarubicin, ifosfamide, irinotecan,
daunorubicin, doxorubicin, cyclophosphamide or cytarabine) were randomized
into:

    
    - Those taking aprepitant who received an antiemetic regimen consisting
      of 125 mg aprepitant, ondansetron 8 mg twice daily and dexamethasone
      12 mg on Day 1, and aprepitant 80 mg once daily on Days 2 and 3
      (N=430).
    - Those in the control group who received the standard regimen consisting
      of ondansetron 8 mg twice daily and dexamethasone 20 mg on Day 1 and
      ondansetron 8 mg twice daily on Days 2 and 3 (N=418).
    

    Aprepitant well tolerated

    The overall incidence and types of adverse events were similar between
the two treatment groups. The number of patients with drug-related adverse
events, serious adverse events (including deaths), and adverse events
resulting in discontinuation were similar in the two treatment groups. The
most frequently reported drug-related clinical adverse events in both
treatment groups were constipation, fatigue, headache and diarrhea.

    Information about EMEND(R)

    EMEND(R) (aprepitant), Merck's neurokinin 1 (NK1) receptor antagonist,
obtained Canadian approval in October 2007 and is indicated in combination
with a 5-HT3 antagonist class of antiemetics and dexamethasone for the
prevention of acute and delayed nausea and vomiting due to highly emetogenic
cancer chemotherapy and for the prevention of nausea and vomiting in women due
to treatment with moderately emetogenic cancer chemotherapy consisting of
cyclophosphamide and anthracycline. The intravenous formulation of EMEND(R)
was approved in April 2009 as EMEND(R) IV (fosaprepitant).
    Aprepitant is believed to work through a novel mechanism, which primarily
blocks nausea and vomiting signals in the brain by targeting substance P, a
key neurotransmitter involved in the emetic pathway. By blocking the actions
of multiple signals, a combination of aprepitant with other anti-emetic
medicines works to provide more complete protection against the nausea and
vomiting caused by chemotherapy.
    Recommended dosing is 125 mg of oral aprepitant one hour prior to
chemotherapy treatment or 115 mg of fosaprepitant intravenously 30 minutes
prior to chemotherapy (day 1) and 80 mg of oral aprepitant once daily in the
morning on days 2 and 3; in addition to a corticosteroid and a 5-HT3
antagonist.

    About Merck Frosst

    At Merck Frosst, patients come first. Merck Frosst Canada Ltd. is a
research-driven pharmaceutical company discovering, developing and marketing a
broad range of innovative medicines and vaccines to improve human health.
Merck Frosst is one of the top 25 R&D investors in Canada, with an investment
of close to $110 million in 2007. More information about Merck Frosst is
available at http://www.merckfrosst.com.

    Forward-Looking Statement

    This press release contains "forward-looking statements" as that term is
defined in the Private Securities Litigation Reform Act of 1995. These
statements are based on management's current expectations and involve risks
and uncertainties, which may cause results to differ materially from those set
forth in the statements. The forward-looking statements may include statements
regarding product development, product potential or financial performance. No
forward-looking statement can be guaranteed, and actual results may differ
materially from those projected. Merck undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new information,
future events, or otherwise. Forward-looking statements in this press release
should be evaluated together with the many uncertainties that affect Merck's
business, particularly those mentioned in the cautionary statements in Item 1
of Merck's Form 10-K for the year ended Dec. 31, 2006, and in its periodic
reports on Form 10-Q and Form 8-K, which the Company incorporates by
reference.

    EMEND(R) is a trademark of Merck & Co., Inc., Used under license




For further information:

For further information: Sheila Murphy, Manager, Public Affairs, Merck
Frosst Canada Ltd., (514) 428-2748; Roch Landriault, NATIONAL Public
Relations, (514) 843-2345, rlandriault@national.ca; Stephanie Lyttle, NATIONAL
Public Relations, (514) 843-2365, slyttle@national.ca


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