Caelyx Delays Time to Disease Progression as Maintenance Therapy in Patients with Metastatic Breast Cancer
CHICAGO - June 3, 2007 - Schering-Plough Corp. announced results
from a Phase III study that showed maintenance chemotherapy with
Caelyx (pegylated liposomal doxorubicin hydrochloride)
significantly prolonged time to progression (TTP) in patients with
metastatic breast cancer with infrequent and manageable clinical
toxicity after first-line chemotherapy. These data were presented
today at the 43rd Annual Meeting of the American Society of
Clinical Oncology.
"While standard chemotherapy has proven effective for patients with
metastatic breast cancer, their response is short-lived and the
time to progression is brief," said Emilio Alba, M.D., professor at
Hospital U. Virgen de la Victoria, in Malaga, Spain and lead
investigator for the
study. "The results from this study showed a significantly
improved time to progression (13.2 months) in patients treated with
CAELYX versus the observational arm (10.2 months)."
The Spanish Cooperative Group, Grupo Espanol de Investigacion en
Cancer de Mama (GEICAM) conducted the multi-center, Phase III study
at seven different sites throughout Spain.
Of the 288 patients with metastatic breast cancer registered for
the trial, 155 subjects who had responded to initial therapy or had
stable disease were randomized either to receive CAELYX or to
observation. Patients receiving therapy were given a regimen of
CAELYX at 40 mg/m2 once every four weeks for 6 cycles of therapy.
Patients in the CAELYX arm experienced a median improvement in time
to progression of three months (13.2 months versus the
observational arm of 10.2 months; p=0.0005).
The patients in the study had a median age of 57, and had adequate
bone marrow, renal, hepatic and cardiac function. These patients
had experienced either complete response, partial response or had
stable disease. Patients received induction chemotherapy with three
cycles of
anthracycline followed by three cycles of taxane, and were then
randomly assigned to either the CAELYX or the observation arm. The
incidence of nausea/vomiting and alopecia were low and manageable;
21 percent of patients experienced grade 1 or 2 nausea/vomiting and
29 percent experienced alopecia. Importantly, neither clinically
relevant left ventricular ejection fraction (decrease heart
function) nor clinical congestive heart failure was observed.
"The study results are promising and suggest the potential value of
CAELYX in the management of metastatic breast cancer," said Robert
J. Spiegel, M.D., chief medical officer and senior vice president,
Schering-Plough Research Institute. "Further evaluation is
indicated to
confirm that CAELYX is effective and safe for select metastatic
breast cancer patients who are at increased cardiac risk."
The current approved dosage of CAELYX in metastatic breast
cancer is 50 mg/m2, every 4 weeks. To manage certain adverse
events, such as palmar-plantar erythrodysesthesia (PPE), the dose
may be reduced.
Metastatic Breast Cancer
Metastatic breast cancer (MBC) is the most advanced stage of
breast cancer (stage IV), in which cancer cells have spread past
the breast and axillary (underarm) lymph nodes to other areas of
the body where they continue to grow and multiply. Breast cancer
has the potential to spread to almost any region of the body. The
most common region breast cancer spreads to is bone, followed by
lung and liver.
About CAELYX
CAELYX is a long-circulating pegylated liposomal formulation of
doxorubicin hydrochloride, a widely used cytotoxic agent.
CAELYX is approved in the European Union (EU) as monotherapy for
metastatic breast cancer in patients who are increased cardiac
risk. CAELYX is also approved in the EU for the treatment of
advanced ovarian cancer in women who have failed first-line,
platinum-based therapy and for the treatment of AIDS-related
Kaposi's sarcoma in patients with low CD4 counts (<200 CD4
lymphocytes/mm3) and extensive mucocutaneous or visceral
disease.
Schering-Plough Corp. has exclusive ex-U.S. marketing rights to
CAELYX,
except in Japan and Israel, through a distribution agreement with
ALZA, a wholly owned subsidiary of Johnson & Johnson of New
Brunswick, N.J., USA. The product is marketed in the United States
under the trade name DOXIL® by Ortho Biotech Products,
L.P.
Important Safety Information from the U.S. label for DOXIL
Myocardial damage may lead to congestive heart failure and may be
encountered as the total cumulative dose of doxorubicin HCl
approaches 550 mg/m2. The use of DOXIL may lead to cardiac
toxicity. Prior use of other anthracyclines or anthracenediones
should be included in calculations of total cumulative dosage.
Cardiac toxicity may also occur at lower cumulative doses in
patients with prior mediastinal irradiation or who are receiving
concurrent cyclophosphamide therapy. DOXIL should be administered
to patients with a history of cardiovascular disease only when the
potential benefit outweighs the risk. Cardiac function should be
carefully monitored in patients treated with DOXIL. Acute
infusion-related reactions have occurred in up to 10% of patients
treated with DOXIL. Serious and sometimes life-threatening or fatal
allergic/anaphylactoid-like infusion reactions have been
reported.
Medications to treat such reactions, as well as emergency
equipment, should be available for immediate use. Severe
myelosuppression may occur. Dosage should be reduced in patients
with impaired hepatic function. Accidental substitution of DOXIL
for doxorubicin HCl has
resulted in severe side effects. DO NOT SUBSTITUTE. Use of DOXIL
should be limited to physicians experienced in the use of cancer
chemotherapeutic agents. The most common side effects
reported with DOXIL therapy included asthenia (weakness), abdominal
pain, fever, pain, mucous membrane disorder, back pain, infection,
headache, nausea, stomatitis (mouth sores), vomiting, constipation,
diarrhea, anorexia, dyspepsia (indigestion), intestinal
obstruction, peripheral edema (foot, leg, and/or ankle swelling),
paresthesia (sensation of tingling, pricking, or numbness of the
skin), pharyngitis (sore throat), dyspnea (shortness of breath),
hand-foot syndrome (a skin irritation, typically occurring on the
hands and feet), rash, and alopecia (hair loss).
About Schering-Plough
Schering-Plough Corporation is a global science-based health
care company with leading prescription, consumer and animal health
products. Through internal research and collaborations with
partners, Schering-Plough discovers, develops, manufactures and
markets advanced
drug therapies to meet important medical needs. Schering-Plough's
vision is to earn the trust of the physicians, patients and
customers served by its more than 33,500 people around the world.
The company's Web site is www.scheringplough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press
release
includes certain "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995, including the
potential market and prospects for CAELYX. Forward-looking
statements relate to expectations or forecasts of future events.
Actual results may vary materially from the forward-looking
statements, and there are no guarantees about the performance of
Schering-Plough stock or Schering-Plough's business.
Schering-Plough does not assume the obligation to update any
forward-looking statement. Many factors could cause actual results
to differ from Schering- Plough's forward-looking statements,
including uncertainties in the regulatory process, market
acceptance of CAELYX, manufacturing issues, current and future
branded and generic competition, timing of trade buying, and
difficulties in product development, among other
uncertainties. For further details about these and other
factors that may impact the forward-looking statements, see
Schering- Plough's Securities and Exchange Commission filings,
including item Part II, 1A. Risk Factors in the company's first
quarter 2007 10-Q.
Schering-Plough Corporation
2000 Galloping Hill Road
Kenilworth, New Jersey 07033-0530
Media Contact: Cathy Cantone
(908) 298-3944
Onsite at ASCO: (908) 327-3013
Investors: Alex Kelly
(908) 298-7436
Posted: June 2007
