A trial comparing ABVD with BEACOPP chemotherapy for advanced Hodgkin's lymphoma (EORTC 20012)

Who can enter

You can enter this trial if you

• Have stage 3 or 4 Hodgkin’s lymphoma, except for a type of Hodgkin’s called lymphocyte predominant nodular type
• Have an area of lymphoma that can be measured on a scan
• Are well enough to have chemotherapy (performance status 0, 1 or 2)
• Have satisfactory blood test results
• Are prepared to use reliable contraception while you are taking part in the trial
• Are between 18 and 60 years old

You cannot enter this trial if you

• Have had treatment for Hodgkin’s lymphoma before
• Are pregnant or breast feeding
• Have had any other cancer apart from basal cell skin cancer or carcinoma in situ of the cervix
• Have any other serious medical conditions
• Are known to have Human Immunodeficiency Virus (HIV) or Human T-Lymphotrophic Virus (HTLV1)
• Have had uncontrolled Hepatitis B infection in the past

Trial design

This is a randomised trial. There are 2 groups. The people taking part are put into treatment groups by a computer. Neither you nor your doctor can decide which group you are in.

If you are in group 1 you will have ABVD. You have chemotherapy on day 1 and day 15 out of every 28 days (4 weeks). Each 4 week period is one cycle. You have Adriamycin, vinblastine and dacarbazine as a drip through a central line into a vein. You have bleomycin either through your central line, or as in injection into a muscle (intramuscular injection). You have 8 cycles over 8 months.

If you are in group 2 you have BEACOPP. You have chemotherapy on days 1, 2, 3 and 8 out of every 22 days. Each 22 days makes up one cycle. You have etoposide, Adriamycin, cyclophosphamide and Oncovin (vincristine) through a central line into a vein. And bleomycin either through your central line or as an injection into a muscle. You also take procarbazine tablets for the first 7 days of each cycle. And prednisolone tablets for the first 14 days of each cycle.

You have 8 cycles of BEACOPP over about 6 months. For the first 4 cycles you have are a higher dose of etoposide, Adriamycin and cyclophosphamide. This is called ‘escalated BEACOPP’. For the next 4 cycles you have a lower dose of etoposide, Adriamycin and cyclophosphamide. This is called ‘baseline BEACOPP’. You have the same dose of the other 4 drugs in all 8 cycles.

Hospital visits

You will go to the hospital for some tests before you start the trial. These include

• Blood tests
• Bone marrow biopsy
• Chest X-ray
• CT scan
• Physical examination
• Lung function tests
• Heart ultrasound (echocardiogram, or echo)
• Heart trace (ECG)

You may also have a liver biopsy. You will have chemotherapy as an outpatient. You will have blood tests and a physical examination before each cycle of treatment. You will have CT scan and lung function tests after 4 cycles. And again after 6 cycles. You may have a bone marrow test and liver biopsy after 4 and 6 cycles as well. You may also have a chest X-ray, but this depends of the results of the chest X-ray you had before you started treatment.

If these tests show the treatment is working, you will have more chemotherapy, up to a total of 8 cycles. But if the tests show that your lymphoma has continued to grow despite treatment, the doctors will probably decide to stop chemotherapy. The doctors will discuss other treatment options with you, if and when this happens.

You will have a CT scan 6 months, 1 year and 2 years after you finish chemotherapy. And you will see the doctors every 3 months for 3 years, every 6 months for another 2 years, and every year after that.

Side effects

As with all treatments, both ABVD and BEACOPP have side effects. Because BEACOPP is a more intensive treatment than ABVD, the side effects are likely to be more severe.

The most common side effects of ABVD and BEACOPP are

• A drop in blood cell counts causing an increased risk of infection, bleeding problems, shortness of breath and tiredness (this is likely to be more severe with BEACOPP than with ABVD)
• Feeling or being sick
• Hair loss
• Loss of fertility

There is more information about the side effects of ABVD, and about the side effects of all the individual chemotherapy drugs used in this trial (Adriamycin), bleomycin, vinblastine, dacarbazine, etoposide, cyclophosphamide, Oncovin (vincristine) and procarbazine) on CancerHelp UK.