2018-10-11T16:29:00
(BPT) – Jennifer Hoodless was in the prime of her life (37) when she was diagnosed with Stage 3 classical Hodgkin lymphoma, a cancer that can affect younger people. A schoolteacher, wife, and mother of five young children who prided herself on living a healthy life, Jennifer was shocked when she learned of her disease.
“My Stage 3 diagnosis came out of nowhere,” Jennifer noted. “Our family lived a very active life and the idea that cancer could strike any one of us came as a true shock.” Jennifer’s diagnosis occurred in her early adulthood, which is not just the time when Hodgkin lymphoma is most common, but also a time in many people’s lives when they are managing daily stresses, such as college and new families, in addition to new challenges of coping with the diagnosis and subsequent treatment.
Hodgkin lymphoma starts in lymphocytes, which are white blood cells that comprise a large part of the body’s lymphatic system — a part of the immune system that helps fight infections and diseases. According to the American Cancer Society, an estimated 8,500 cases of Hodgkin lymphoma will be diagnosed in the United States this year, with approximately 1,050 of those cases resulting in death. Hodgkin lymphoma can affect people of all ages, and while it is most common in early adulthood, the risk of developing Hodgkin lymphoma also rises again later in life (after age 55).
Until recently, treatment for newly diagnosed Stage 3 or 4 Hodgkin lymphoma patients hadn’t changed in more than 40 years. In March 2018, ADCETRIS® (brentuximab vedotin) for injection was approved by the U.S. Food and Drug Administration for adults with previously untreated Stage 3 or 4 classical Hodgkin lymphoma in combination with chemotherapy. Stage 3 and Stage 4 classical Hodgkin lymphoma is also called advanced stage Hodgkin lymphoma; this means that the cancer is more widespread throughout the body and may be present in organs outside the lymphatic system.
ADCETRIS represents important progress in treatment options for people like Jennifer. After noticing enlarged lymph nodes in her abdomen and on her neck, Jennifer was referred to Joseph M. Connors, M.D., FRCPC, Clinical Director, Center for Lymphoid Cancer at BC Cancer in Vancouver, Canada, who told her she was a candidate for a clinical trial testing ADCETRIS in combination with chemotherapy in patients with newly diagnosed advanced stage classical Hodgkin lymphoma. The clinical trial, called ECHELON-1, evaluated a combination of ADCETRIS and three chemotherapies, adriamycin, vinblastine, and dacarbazine (AVD), against a standard chemotherapy regimen of adriamycin, bleomycin, vinblastine and dacarbazine (ABVD).
“When I enrolled in this clinical trial, I was scared but determined to beat my cancer,” said Jennifer. “I persevered through side effects and I am thankful to be in remission now and back to work, with a thriving family and lots to look forward to.”
Historically, newly diagnosed patients with Hodgkin lymphoma have been treated with a chemotherapy regimen that includes bleomycin, an agent that can cause unpredictable and sometimes fatal lung toxicity. While ADCETRIS in combination with chemotherapy is bleomycin-free, there are side effects including possible lung toxicity, low numbers of red blood cells, low numbers of white blood cells, tingling or numbness in the hands or feet, constipation, vomiting, diarrhea, fever, weight loss, mouth sores, and abdominal pain. Please read the Important Safety Information, including BOXED WARNING, below.
“ADCETRIS in combination with chemotherapy marks an important advance in treatment for newly diagnosed advanced-stage classical Hodgkin lymphoma patients who are often young and have their whole lives ahead of them,” said Dr. Connors. “As an oncologist, it is exciting to see a treatment that fills an unmet need and can help improve patient prognosis.”
ADCETRIS Indication
ADCETRIS® (brentuximab vedotin) for injection is approved for the treatment of:
- Previously untreated Stage 3/4 classical Hodgkin lymphoma (cHL): Adult patients with previously untreated Stage 3/4 cHL in combination with chemotherapy
IMPORTANT SAFETY INFORMATION
What is the most important serious safety information I should know about ADCETRIS?
- PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): Patients who are treated with ADCETRIS can have a rare, serious infection of the brain called PML. It can cause death. Symptoms started at different times after starting ADCETRIS treatment, some within 3 months after the first dose. Other possible causes of PML are prior treatments or diseases that weakened the patient’s immune system.
- ADCETRIS should not be taken with bleomycin because of possible side effects in the lungs.
What are the other possible serious side effects of ADCETRIS?
- Nerve damage: Peripheral neuropathy (nerve damage) that mostly involves numbness or tingling in the hands or feet (sensory) and/or weakness in the arms or legs (motor). Symptoms increase with more doses. Your doctor may change or stop your ADCETRIS dose depending on the severity of your symptoms.
- Allergic and infusion reactions: Allergic reactions, including severe forms, during infusion or up to 24 hours after administration of ADCETRIS. Patients who had a reaction with earlier doses should receive premedication with later doses, which may include acetaminophen, an antihistamine, and a corticosteroid.
- Blood problems: Serious cases, including deaths, of fever with a low number of white blood cells have occurred with ADCETRIS. ADCETRIS may also cause a low number of white blood cells lasting a week or more, with or without fever. A low number of platelets (which help the blood clot) or red blood cells has also occurred with ADCETRIS.
Your doctor will give you a medicine called growth factor with your first dose if you are receiving ADCETRIS in combination with chemotherapy to treat Stage 3 or 4 cHL. Growth factor is meant to prevent you from having a low number of white blood cells.
Your blood counts will be checked before each dose, more often if necessary. You will be monitored for fever. If your white blood cell count is too low, your doctor may delay your next infusion, lower your dose, stop your ADCETRIS therapy, or give you growth factor with future doses of ADCETRIS.
- Infections: Serious infections, including deaths, that occur when your immune system is weakened, such as pneumonia, bacteremia, and sepsis or septic shock.
- Tumor lysis syndrome (TLS): You will be closely monitored for TLS if you have a tumor that grows quickly or have many tumor cells throughout your body.
- Patients with severe kidney disease may have more side effects and deaths compared to patients with normal kidney function and should avoid use of ADCETRIS.
- Patients with moderate or severe liver disease may have more side effects and deaths compared to patients with normal liver function and should avoid use of ADCETRIS.
- Liver injury: Serious liver problems, including deaths, have been reported after the first dose of ADCETRIS and after ADCETRIS was stopped and restarted. Your liver function will be monitored. Having liver problems, raised liver enzymes, and some medicines may increase the risk. Your doctor may delay your next infusion, lower your dose, or stop your ADCETRIS therapy if you have liver problems.
- Lung problems: Serious lung problems, including deaths, have been reported. If you have symptoms, your doctor may hold your ADCETRIS therapy until they improve.
- Skin problems: Rare but serious skin conditions, including deaths, called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). If either occurs, your doctor will stop ADCETRIS and treat you for symptoms.
- Gastrointestinal (GI) problems: Serious problems, including deaths, related to the pancreas, stomach, intestine, and colon have been reported. Lymphoma that involves the stomach or intestine may increase the risk of GI perforation (hole in the stomach or intestine).
- Fetal harm: ADCETRIS can harm a fetus (unborn baby). Women should not become pregnant while taking ADCETRIS and for at least 6 months after the last dose of ADCETRIS.
What were the most common side effects in the study?
In the 662 patients treated with ADCETRIS + chemotherapy, the most common side effects were low numbers of red blood cells, low numbers of white blood cells, tingling or numbness in the hands or feet, constipation, vomiting, diarrhea, fever, weight loss, mouth sores, and abdominal pain.
What should I tell my doctor before I start treatment with ADCETRIS?
- Tell your doctor about all of your medical conditions. ADCETRIS should be avoided if you have severe kidney disease or moderate or severe liver disease.
- Tell your doctor about any medicine you are taking (including over-the-counter drugs, vitamins, and herbal supplements) because it is possible for ADCETRIS to interact with certain types of drugs.
- Tell your doctor if you are pregnant or plan to become pregnant. You should not take ADCETRIS while pregnant or breastfeeding.
- Women should use effective birth control while taking ADCETRIS and for at least 6 months after the final dose of ADCETRIS.
- Men with female partners should use effective birth control while taking ADCETRIS and for at least 6 months after the final dose of ADCETRIS.
Contact your doctor if you experience any of the following:
- Symptoms of nerve damage: Tingling, burning, or numbness in the hands or feet. Changes in sense of touch or trouble moving the hands or feet.
- Symptoms of infection: Fever of 100.5°F or higher, chills, cough, or pain upon urination.
- Symptoms of infusion reaction: Fever, chills, rash, or breathing problems within 24 hours of infusion.
- Symptoms of liver injury: Fatigue, anorexia, upper stomach pain, dark urine, yellowing of the skin and eyes (jaundice).
- Symptoms of PML: Changes in mood or usual behavior. Confusion, thinking problems, or loss of memory. Changes in vision, speech, or walking. Decreased strength or weakness on one side of the body.
- Symptoms of lung problems: New or worsening cough or shortness of breath.
- Symptoms of acute pancreatitis: Severe abdominal pain.
- Symptoms of GI problems: Severe stomach pain, chills, fever, nausea, vomiting, or diarrhea.
- Pregnancy: Pregnant or breastfeeding women should not receive ADCETRIS. ADCETRIS can harm a fetus (unborn baby).
- Any other side effects that are bothersome or do not go away.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/Safety/MedWatch/ or call 1-800-FDA-1088.
Please click here for full Prescribing Information, including BOXED WARNING.
