How may I benefit from ADCETRIS?
ECHELON-1 study design
ECHELON-1 was a large, international clinical study of 1334 people that compared the effectiveness and safety of ADCETRIS plus AVD with ABVD chemotherapy in patients with previously untreated Stage 3 and 4 classical Hodgkin lymphoma.
- 664 people were assigned to receive ADCETRIS plus AVD chemotherapy every 2 weeks for up to 12 doses
- 670 people were assigned to receive ABVD chemotherapy every 2 weeks for up to 6 cycles
Researchers reviewed the modified progression-free survival results (primary endpoint) at approximately 2 years and the overall survival results (secondary endpoint) at around 6 years.
Overall survival results
At 6 years of follow up, the overall survival results for patients treated with ADCETRIS plus AVD were significantly higher than those treated with ABVD chemotherapy alone.
Median overall survival was not reached, because more than half of patients in either treatment group were still alive.
Modified progression-free survival
At 2 years of follow up, the modified progression-free survival for patients treated with ADCETRIS plus AVD was higher than those treated with ABVD chemotherapy alone.
No significant difference in overall survival was observed at 2 years.
The most important serious safety information
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): Patients treated with ADCETRIS can have a rare, serious brain infection called PML that can lead to death. Tell your doctor immediately if you have mood or behavior changes, confusion, problems in thinking or loss of memory, changes in vision, speech, or walking, or decreased strength or weakness on one side of the body. PML may also be caused by prior treatments or diseases that weakened your immune system.
Do not take ADCETRIS if you are receiving bleomycin due to pulmonary toxicity (serious
lung problems).
Adcetris can cause other serious side effects including nerve damage, allergic and infusion reactions, blood problems, serious infections, tumor lysis syndrome (TLS), serious side effects for patients with severe kidney or moderate to severe liver disease, liver problems, lung problems, serious skin problems, gastrointestinal problems, high blood sugar (hypoglycemia) and fetal harm. Some of these cases resulted in death. Please see Important Safety Information below or Important Facts about ADCETRIS to learn more.
Most common side effects while taking ADCETRIS plus AVD
In people treated with ADCETRIS plus AVD, the most common side effects that occurred in ≥20% of study patients were low red blood cell count (98%), low white blood cell count (91%), nerve damage (peripheral sensory neuropathy; PN) (65%), constipation (42%), vomiting (33%), diarrhea (27%), fever (27%), weight loss (22%), stomach pain (21%), and sores or swelling in the mouth (21%).
The most common serious side effects were significantly low numbers of white blood cells with a fever (17%), fever (7%), low numbers of white blood cells (3%), and pneumonia (3%).
For more information on serious side effects and other side effects, please see the Important Safety Information at the bottom of this page and read the Important Facts about ADCETRIS, including BOXED WARNING.
Tell your doctor about any side effect concerns you have
Your doctor should prescribe granulocyte colony-stimulating factor (G-CSF) along with your ADCETRIS treatment right at the start. G-CSF is a medication that may help reduce the chance of neutropenia (low white blood cell count).
Don’t stop, change, or delay your ADCETRIS plus AVD treatment unless directed by your doctor. Your doctor may take additional steps to help manage side effects, including:
- Reducing your ADCETRIS dosage, or delaying your next dose, until symptoms improve
- Stopping ADCETRIS completely if side effects are severe or do not improve
For more information about understanding side effects, download a copy of the ADCETRIS side effects guide
Learn more about what you can expect before starting ADCETRIS treatment.
Glossary
ABVD: A combination of 4 chemotherapies—Adriamycin, bleomycin, vinblastine, and dacarbazine.
AVD: A combination of 3 chemotherapies—Adriamycin, vinblastine, and dacarbazine.
G-CSF: Granulocyte colony-stimulating factor, a medication that can help boost white blood cell count.
Median: The middle number in a list of numbers.
Modified progression-free survival: The length of time during and after treatment a patient lives without cancer progression, death, or receiving another cancer treatment.
Neutropenia: Having low levels of a type of white blood cell called neutrophils that help your immune system. You could have a higher chance of getting an infection.
Overall survival: The length of time that patients remain alive after enrolling in a study.
Peripheral neuropathy: Nerve damage that can cause numbness or tingling in the hands or feet (sensory) and/or weakness in the arms or legs (motor).