R-CHOP 14 versus R-CHOP 21

Introduction

Diffuse large B cell lymphoma is a type of Non Hodgkin lymphoma. The recommended treatment for this disease is a combination of chemotherapy drugs which are commonly known as R-CHOP. The drugs which make up R-CHOP are:

• R = Rituximab
• C = Cyclophosphamide
• H = Hydroxydaunorubicin (also known as doxorubicin, daunorubicin but more commonly known as adriamycin)
• O = Oncovin (more commonly known as vincristine)
• P = Prednisolone

Who can enter this trial?

You may be asked to enter this trial if you meet the following criteria:

• You are aged over 18
• You have a confirmed diagnosis of diffuse large B-cell non-Hodgkin lymphoma
• Your blood test results are okay
• You have no serious heart conditions
• You are not pregnant
• You have not had chemotherapy in the past for this or any other disease
• If you are of child bearing age you must agree to use barrier contraception such as condoms during and after the trial for six months

How is this trial run?

This trial is known as a randomised control trial. A randomised control trial is a trial in which patients with similar disease traits are selected by a computer to be placed in different groups that are comparing different treatments. There is no way at the time for researchers to know which of the treatments is best and neither you nor your doctor get to choose which treatment you have.

In this particular trial there are two groups. Regardless of which group you are in this treatment is usually given through outpatient visits unless you need to stay in the hospital for some reason.

The first group has the standard treatment of R-CHOP 21. In this group you will have cyclophosphamide, adriamycin, vincristine and rituximab through a drip into your vein once every 3 weeks (21 days). The prednisolone is taken as a tablet once a day for five days out of the three weeks. Each period of 3 weeks is called a cycle. In total you will have 8 cycles.

The second group has the treatment of R-CHOP 14. In this group you will have cyclophosphamide, adriamycin, vincristine and rituximab through a drip into your vein once every 2 weeks (14 days). The prednisolone is taken as a tablet once a day for five days out of the two weeks. Each period of 2 weeks is called a cycle. In total you will have 6 cycles of these drugs with 2 extra doses of rituximab.

The chemotherapy drugs given in this trial can cause your blood cell count to drop which could make you more prone to infection. This is especially so if you are in the second group as you have less time than the first group for your blood cells to recover between cycles. To help support your blood cell recovery those in the second group will be given an injection of a drug called G-CSF. G-CSF encourages your blood cells to grow faster than normal. The drug is given as an injection just under the skin every day for 9 days during your 2 week cycle (if you count the day you have chemotherapy as day 1 then you will have the G-CSF on days 4-12). The chemotherapy nurses will teach you how to give this injection at home or will arrange for a district nurse to give it to you.

Regardless of which group you are in you will have a blood test before each treatment and a number of tests done after four cycles. This is to determine how well the treatment is working for you. If it is working well and you can manage the side- effects you may have up to eight cycles in the first group or six cycles in the second group. If the treatment is not working so well or the side effects are severe your doctor may stop the treatment.

Side effects

As with other treatments there are some side effects which you should know about. Your doctor or nurse can give you much more detailed information on these effects and how you might manage them.