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
"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 randoml y 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.
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 s arcoma 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, mucou s 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).
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.
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