Non-Hodgkin’s lymphoma stages

To help guide therapy after a non-Hodgkin’s lymphoma diagnosis, the stage of the cancer is determined using the Ann Arbor staging system. The Ann Arbor staging system classifies non-Hodgkin’s lymphoma into four main stages:

STAGE I indicates that the cancer is present in only a single lymph node and its surrounding area. This staging designation often has no presence of symptoms.

STAGE II indicates that the cancer is present in two or more lymph node groups, both located either above or below the diaphragm, which is the muscle lining under the lungs.

STAGE III indicates that the cancer is present both above and below the diaphragm.

STAGE IV indicates that the cancer is present in one or more organs, as well as the lymph node system.

The Ann Arbor staging system also utilizes modifiers to more accurately describe the cancer. These modifiers appear as letters immediately following the stage number.

A or B: Patients without signs of fever, night sweats and weight loss are classified with an “A.” Patients with these symptoms are classified with a “B.”

E: If the cancer involves an organ outside of the lymph system, it is designated by the addition of an “E” after its stage number.

X: If the largest tumor is greater than 10 cm in size, the letter “X” is used.

S: If the cancer has spread to the spleen, an “S” modifier is given.

Non-Hodgkin’s treatment assessment

After a treatment course is completed, your doctor will perform tests to assess your response to the non-Hodgkin’s lymphoma treatment. Based on the findings, your doctor will describe your response using one of the four following categories:

Complete Response (CR): no sign of the cancer can be detected.

Partial Response (PR): the cancer remains, but has diminished.

Stable Response (SD): no significant change has occurred.

Progressive Response (PD): the cancer continues to spread or grow.

Indications and Usage

ZEVALIN^® (ibritumomab tiuxetan) injection for intravenous use is a combination of two prescription medications. It is given with two treatments of rituximab and one treatment of Yttrium-90 (Y-90) ZEVALIN. Rituximab is used to reduce the amount of B-cells in your blood and Y-90 ZEVALIN is given to treat your non-Hodgkin’s lymphoma (NHL).

The ZEVALIN therapeutic regimen is used to treat patients with:

• Recurring, low-grade or follicular B-cell NHL, after other anticancer drugs are no longer working.
• Newly diagnosed follicular NHL following a response to initial anticancer therapy.

What Is the Most Important Safety Information I Should Know About ZEVALIN Treatment?

The following section provides an overview of the most important safety information you should know about ZEVALIN, including side effects. Not all of the safety information about ZEVALIN treatment is included here. For complete safety information, please see the enclosed full prescribing information for ZEVALIN. Additional information may also be found on this Web site or by speaking with your health care provider. Because ZEVALIN treatment includes the use of rituximab, please see the rituximab medication guide (www.rituxan.com).

Additional Safety Information:

• Leukemia and Myelodysplastic Syndrome (MDS):  Among 204 Patients who received Y-90 ZEVALIN, following anticancer therapy, 2 patients (1%) were diagnosed with Acute Myelogenous Leukemia (a type of cancer of the blood, AML) within 3 years of receiving ZEVALIN treatment. MDS (another type of cancer in the bone marrow) and/or AML were reported in 5.2% (11/211) of patients with recurring non-Hodgkin’s lymphoma (NHL) in clinical studies, and 1.5% (8/535) of all patients included in the expanded-access trial, with median follow-up of 6.5 and 4.4 years, respectively. Among the 19 reported cases, the median time to diagnosis of MDS or AML was 1.9 years following the ZEVALIN therapy; however, the total incidence continues to increase.

• ZEVALIN therapy may cause harm to an unborn baby, please tell your doctor if you are pregnant or plan to become pregnant.
• ZEVALIN may leak from your vein or infusion site. Your doctor will monitor you during treatment and will stop the infusion and switch to another vein, if this occurs during treatment.
• Do not get a vaccine that contains live virus for at least 12 months following ZEVALIN treatment.
• Your doctor will need to monitor your blood weekly to watch for dropping blood counts and platelet counts.
• Your doctor will discuss precautions with you to minimize radiation exposure.
• Creutzfeldt-Jakob Disease (CJD): CJD is a form of brain damage that leads to rapid decrease of mental function and movement. The ZEVALIN therapeutic regimen contains a protein made from human blood. Based on effective donor screening and product manufacturing processes, ZEVALIN carries a very low risk for transmission of viral diseases. The risk for getting CJD is also very low. No cases of transmission of viral diseases or CJD have ever been identified.
• Impairment of Fertility: There is a risk that ZEVALIN therapy will affect the male and female reproductive organs. Use birth control during treatment and for up to 12 months following ZEVALIN therapy.
• Nursing: Patients should be advised to discontinue nursing during and after ZEVALIN treatment.

Adverse Reactions (Side Effects):

• The most common adverse reactions of ZEVALIN are: decreases in blood counts, tiredness, abdominal (stomach) pain, nausea (upset stomach), inflammation of the nose and upper throat, weakness, diarrhea, cough, and fever. Common adverse reactions (≥40%) in clinical trials were: low neutrophil count (a type of white blood cell), decrease in number of white blood cells, decrease in platelets, decrease in red blood cells or hemoglobin, infection, lack of body strength and energy, muscles and bones symptoms, and stomach and intestinal symptoms.
• The most serious adverse reactions of ZEVALIN are prolonged and severe reduction in the number of blood counts and secondary cancers.
• When administered following initial anticancer therapy, grade 3/4 adverse reactions of ZEVALIN include prolonged and severe decrease in blood counts (decrease in platelets [51%], decrease in neutrophils [41%], decrease in white blood cells [36%], decrease in lymphocytes [18%], and decrease in red blood cells or hemoglobin [5%]), and secondary cancers. Reductions in blood cells were more severe and more prolonged among eleven (5%) patients who received ZEVALIN after first-line fludarabine or a fludarabine-containing anticancer regimen as compared to patients receiving non–fludarabine-containing regimens. Grade 3/4 infections occurred in 8% of ZEVALIN-treated patients and in 2% of controls and included neutropenic sepsis (fever and infection due to decrease in the number of neutrophils [1%]), bronchitis, catheter sepsis (bacterial infection in the blood related to catheter), diverticulitis (inflammation in the intestines), shingles or blistering skin rash caused from herpes virus reactivation, flu, lower air passage infection, sinusitis (swelling of the sinuses), and upper air passage infection.
• Grade 3/4 adverse reactions of ZEVALIN in recurring NHL patients include prolonged and severe reduction of blood cells (decrease in platelets [63%], decrease in neutrophils [60%], decrease in red blood cells or hemoglobin [17%], and ecchymosis (small blue or purple patch on the skin or mucous membrane [<1%])) and secondary cancers. Serious infections occurred in 3% of patients (urinary tract infection, febrile neutropenia, sepsis, pneumonia, cellulitis (type of skin infection), colitis (swelling of the large intestine), diarrhea, osteomyelitis (bone infection), and upper-air passage infection). Life-threatening infections were reported in 2% of patients (sepsis, empyema (collection of pus), pneumonia, febrile neutropenia, fever, and biliary stent-associated cholangitis (bile duct infection)).

Please click here to see the full Prescribing Information, including BOXED WARNINGS, for ZEVALIN. Because ZEVALIN treatment includes the use of rituximab, please see the rituximab medication guide (www.rituxan.com).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.