DOXIL—Choosing a Treatment Option

DOXIL (doxorubicin HCl liposome injection)

You Have Options
Although 60% to 80% of patients respond to initial treatment, ovarian cancer commonly returns. This is referred to as recurrent ovarian cancer. How you and your doctor evaluate your treatment options will depend on whether you have platinum-refractory, platinum-resistant or platinum-sensitive ovarian cancer.

Platinum-Refractory Ovarian Cancer
Platinum-refractory ovarian cancer is defined as disease that progresses during treatment. Approximately 20% to 40% of patients do not respond to initial treatment.

Platinum-Resistant Ovarian Cancer
If ovarian cancer recurs within 6 months of completing primary chemotherapy with a platinum-based medication, the cancer is considered “platinum-resistant.” But “platinum-resistant ” does not mean “treatment resistant.” There are still effective therapy options available.

Platinum-Sensitive Ovarian Cancer
If ovarian cancer recurs more than 6 months after completing primary therapy with a platinum-based medication, the cancer is considered platinum-sensitive. If you have platinum-sensitive ovarian cancer, it is important that you work with your doctor to evaluate these issues when considering treatment options.

Treating Recurrent Ovarian Cancer
Many doctors now look at recurrent ovarian cancer as a chronic disease. This means that you may have repeated cycles of illness, treatment and recovery. While a complete cure may not be possible, in many cases recurrent ovarian cancer can be effectively treated or stabilized for an extended period of time. The period of time when the symptoms of the disease subside is called remission. Some women may cycle through this process several times, receiving chemotherapy on and off over a long period of time.

If you have recurrent ovarian cancer, it is important that you work with your doctor to evaluate these issues when considering treatment options.

Questions or Topics to Discuss with Your Doctor

Current symptoms and disease volume

What is the extent of the disease?
Are you currently experiencing symptoms, such as abdominal discomfort or pain, nausea or a loss of appetite, that impact the way you want to live your life?

Efficacy of available treatment options

What treatment options are available?
What is the clinical data to support the efficacy of each treatment option?

Side effects and tolerability

What side effects were the most difficult for you in your previous chemotherapy?
What are the side effect profiles of each treatment?
What side effects would you most hope to avoid or reduce?

Time to recurrence

How well did your previous therapy work?
What was the time interval before the recurrence?

Your health status and history

What other health issues should be taken into consideration? For example, is your
immune system currently compromised?

Schedule and ease of administration of therapy

How frequently can you travel to a clinic or doctor’s office for infusions?
How long will infusions last?
Is intravenous (IV) access a problem for you?

Social and life style issues

What is most important to you to maintain your current life style?
Are there special events such as a wedding or another celebration that you want to work your treatment around?

Download a copy of these questions

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