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Alert Number 117

FRC, Kicked Up Another Notch!

Date: August 9, 2005

A couple of readers wrote to me, asking about the FCR + M (fludarabine, cyclophosphamide, Rituxan + mitoxantrone) combination that is presently undergoing clinical trial at M. D. Anderson, and recruiting patients as we speak. I do not know if this trial is recruiting patients at other centers as well.

We are all familiar with the FCR combination pioneered at M. D. Anderson: high percentage of CRs (“Complete Responses”) as well as a gratifyingly high percentage of pcr negative responses (meaning no CLL cell could be detected even with our most sensitive testing methods). Unfortunately, there have also been some concerns expressed by other CLL experts that the combination may be quite immunosuppressive as well. While majority of the patients who got CR and the coveted pcr negative responses continue to be in good health, it has also been noted that some of them have relapsed after a year or two. Only time will tell how this combination of two powerful chemotherapy agents (F and C) with the monoclonal antibody drug Rituxan will play out in the long term.

It appears that M. D. Anderson has chosen to add another well known chemotherapy drug to the FRC arsenal with the introduction of mitoxantrone, catchy name of the combination is FCM-R. No doubt the addition of mitoxantrone will increase CLL cell kill, it is a powerful chemotherapy drug with a long history. I expect we will see even higher CR rates with this combination, compared to plain vanilla FRC combo. Unfortunately, mitoxantrone also has a well established reputation for immune suppression, which will also no doubt add to the existing issues with FRC. Once again, only time will tell how this game plan will play out. We owe the patients who volunteer for this clinical trial a debt of gratitude, their generosity will make it easier for the rest of us to make good therapy choices down the road.

I looked up mitoxantrone and below are some quotes from the American Cancer Society website. Chicken pox, shingles, etc., are specifically mentioned, as well as heart, kidney and liver function - but I wonder how this combination would work in terms of CMV reactivation, the nemesis of Campath therapy. As with all immune suppressive therapies, I urge you to be careful about sun exposure during and after therapy. Skin cancer in CLL patients can be a lot more aggressive, and that odd patch on your face you have been neglecting can be squamous cell or basal cell carcinoma, waiting to take off during a period when your immune system is not working well.

I will keep an eye out for this clinical trial, let you know if I find anything else about it. In the meantime, if you are participating in this trial, do tell. It helps when we all share our information, anonymously if that is your wish. We promise total confidentiality.

Be well,



ACS Link: Cancer Drug Guide Mitoxantrone


Trade Name: Novantrone

  • Mitoxantrone belongs to a general group of chemotherapy drugs known as antibiotics. It is an FDA approved drug for treating various cancers.
  • Mitoxantrone is given by a shot in the vein over 5 to 20 minutes, daily for 3 days, or once every 3 weeks. You will get a mild antinausea medicine before the mitoxantrone. The dose and how often you get the medicine depends upon your size, your blood counts, how well your liver is working, and the type of cancer being treated.
  • Before taking this drug, tell your doctor if you have any of the following medical problems: chickenpox or exposure to chickenpox, gout, heart disease, congestive heart failure, shingles, kidney stones, liver disease.


  • While you are being treated with mitoxantrone, and after you stop treatment, do not have any immunizations (vaccinations) without your doctor’s okay. Try to avoid contact with people who have recently taken the oral polio vaccine. Check with your doctor about this.
  • Mitoxantrone can injure the heart muscle when large total doses are given. Your doctor will test your heart function before you receive your first treatment, and then during the treatment. This way, any damage can be found early.
  • Mitoxantrone can decrease your white blood cell count, especially 9 to 10 days after the drug is given. This can increase your risk of getting an infection. Report fever of 100.5°F or higher, or signs of infection such as pain in passing your urine, or coughing, and bringing up sputum.
  • Mitoxantrone can decrease your platelet count. This can increase your risk of bleeding. DO NOT take any aspirin or aspirin–containing medicines. Report unusual bruising, or bleeding such as nosebleeds, bleeding gums when you brush your teeth, or black, tarry stools.
  • Mitoxantrone can cause an allergic reaction with itching, dizziness, flushed appearances, and rash. You will be watched closely by your doctor or nurse.


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