DOXIL—About Ovarian Cancer

DOXIL (doxorubicin HCl liposome injection)

You Are Not Alone
The American Cancer Society estimates that more than 22,000 women will be diagnosed with ovarian cancer in 2005, accounting for 3% of all cancers in women. Unfortunately, approximately 70% of ovarian cancer cases are diagnosed in later stages when the disease is more difficult to treat.

Initial Treatment
Surgery is the usual initial treatment for women diagnosed with ovarian cancer. Typically, the ovaries, the fallopian tubes, the uterus, and the cervix are removed. Often, the surgeon also removes the omentum (the thin tissue covering the stomach and large intestine) and lymph nodes (small organs located along the channels of the lymphatic system) in the abdomen. If the cancer has spread, the surgeon removes as much of the cancer as possible in a procedure called tumor debulking. Tumor debulking reduces the amount of cancer that will have to be treated later with chemotherapy or radiation therapy.

Surgery is typically followed by platinum-based chemotherapy to destroy any cancerous cells that may remain in the body after surgery to control tumor growth or to relieve symptoms of the disease.

If Cancer Persists or Recurs
Approximately 10% to 15% of patients with advanced stage ovarian cancer achieve and maintain a complete response following treatment. However, in the vast majority of patients (85% to 90%), the disease persists or recurs and a patient generally undergoes a progression of treatments.

The length of time between your initial diagnosis of ovarian cancer and the recurrence of the disease impacts the treatment decision. Typically, if the cancer returns in less than 6 months after initial treatment, doctors will choose a different chemotherapy drug than the one you previously received. However, if the cancer does not return until after 6 months have passed, you may be given the same chemotherapy you initially received or you may receive a new drug. Your physician will discuss your treatment options with you.

The largest clinical study ever conducted in recurrent ovarian cancer has shown that DOXIL is an effective chemotherapy agent for ovarian cancer that has progressed or recurred after platinum-based chemotherapy treatment.

RELATED RESOURCES

FREQUENTLY ASKED QUESTIONS

GLOSSARY

Indications:

DOXIL is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after prior platinum-based therapy.

Important Safety Information
BOXED WARNINGS: Cardiotoxicity, infusion reaction, myelosuppression, liver impairment, substitution

The use of DOXIL may lead to cardiac toxicity. Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose of doxorubicin HCl approaches 550mg/m²

— Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dose.

— Cardiac toxicity may also occur at lower cumulative doses (400 mg/m²) in patients with prior mediastinal irradiation or who are receiving concurrent cyclophosphamide therapy

Acute infusion-related reactions including, but not limited to, flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and/or hypotension have occurred in up to 10% of patients treated with DOXIL. In most patients, these reactions have resolved within several hours to a day once the infusion is terminated. In some patients, reactions resolved with slowing of the infusion rate

— Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have occurred. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use

— The initial rate of infusion should be 1mg/min to minimize the risk of infusion reactions.

Severe myelosuppression may occur.

DOXIL dosage should be reduced in patients with impaired hepatic function.

Accidental substitution has resulted in severe side effects. Do not substitute for doxorubicin HCl on a mg per mg basis.

Contraindiction

Patients with a history of hypersensitivity reactions to a conventional doxorubicin formulation or the components of DOXIL
Nursing mothers

Additional Safety Information

Cardiac function should be carefully monitored.

	— Congestive heart failure or cardiomyopathy may occur after discontinuation of anthracycline therapy
	— For patients with a history of cardiovascular disease, or if the results of cardiac monitoring indicate possible cardiac injury, the benefit of therapy must be weighed against the risk of myocardial injury

Myelosuppression may occur; frequently monitor complete blood count (including platelet count), at least prior to each dose of DOXIL

	— In patients with recurrent ovarian cancer, hematologic toxicity (based on platelet count or absolute neutrophil count) may require dose reduction or delay in administration of DOXIL
	— Persistent severe myelosuppression may result in superinfection, neutropenic fever, or hemorrhage
	— Sepsis occurring during neutropenia has resulted in discontinuation of treatment and in rare cases of death

DOXIL may potentiate the toxicity of other anticancer therapies, especially hematologic toxicities, when used in combination with other therapies that suppress bone marrow
Hand-foot syndrome (HFS) may occur during therapy with DOXIL

	— Based on HFS toxicity grade, dose reduction, delay in administration, or discontinuation of DOXIL may be required
	— HFS was generally observed after 2 to 3 cycles of treatment, but may occur earlier
	The reaction was mild in most patients, resolving in 1 to 2 weeks
	The reaction can be severe and debilitating in some patients, resulting in discontinuation of therapy

DOXIL is an irritant, not a vesicant; ; use precautions to avoid extravasation
DOXIL can cause fetal harm when used during pregnancy
Recall reaction has occurred with DOXIL administration after radiotherapy
DOXIL may interact with drugs known to interact with the conventional formulation of doxorubicin HCl
In patients with recurrent ovarian cancer, the most common all-grade adverse reactions (ARs) ≥ 20% (DOXIL vs topotecan, respectively) included: asthenia (40% vs 51%), fever (21% vs 31%), nausea (46% vs 63%), stomatitis (41% vs 15%), vomiting (33% vs 44%), diarrhea (21% vs 35%), anorexia (20% vs 22%), dyspnea (15% vs 23%), HFS (51% vs 1%), and rash (29% vs 12%)

	— In addition, 19% vs 52.3% reported alopecia (all grades)
	— Grade 3/4 hematologic ARs reported in ≥ 5% (DOXIL vs topotecan, respectively) were neutropenia (12% vs 76%) and anemia (6% vs 29%)

Please see accompanying full Prescribing Information, including Boxed WARNINGS