Bexxar® (tositumomab, iodine I 131 tositumomab) is a promising new treatment for B-cell non-hodgkin's lymphoma. Bexxar consists of a murine monoclonal antibody (anti B1), radiolabeled with the beta-emitting radionuclide, Iodine131. The antibody has some tumoricidal activity alone, but primarily it's used to target CD20-positive cells (which are expressed on 95% of malignant B lymphocytes), and to deliver lethal radiation to the tumor site. Clinical results from investigational trials of Bexxar show that complete remissions can be achieved in newly diagnosed patients, as well as in end-stage patients who have exhausted all other options.

---

Bruce's Bexxar Experience

In December 2000, Bruce received a therapeutic dose of Bexxar at New England Medical Center in Boston, MA. Below is an outline of Bruce's experience with it. To read in more detail about his Bexxar experience, or to follow his progress, please visit his Recent Updates page.

11/29/00

• Bruce started taking potassium iodide (SSKI). This is to try to prevent uptake of iodine in the thyroid gland. He had to take this 3 times a day, for 3 weeks.
• We left for Boston and our nine day stay at the Neely House.

11/30/00

• In the morning, Bruce reported to the Infusion Center at NEMC (New England Medical Center). First he was given Tylenol and Benadryl, and then he received unlabeled Anti-B1 intravenously. His blood pressure dropped slightly while getting the infusion, but he had no other side-effects.
• In the afternoon, he received a tracer dose of Bexxar intravenously in the Nuclear Medicine Department at NEMC.
• After receiving the tracer dose, he had a whole-body gamma scan done. This was an easy test, for which there was no preparation required, as there is with CT scans, etc..

12/04/00

• Bruce had a whole-body gamma scan done. It only took about 10 minutes.

12/06/00

• Bruce had a whole-body gamma scan done. It only took about 10 minutes.

12/08/00

• In the morning, Bruce reported to the Infusion Center. First he was given Tylenol and Benadryl, and then he received unlabeled Anti-B1 intravenously. Again, a slight lowering of his blood pressure was the only side-effect he experienced.
• In the afternoon, he received the therapeutic dose of Bexxar intravenously. The Bexxar was in a large syringe, and the syringe was inside a lead box, which was on a table. Through a hole in the lead box, the syringe was hooked up to Bruce's IV line. Throughout the infusion a technician had a meter, with which he kept scanning the box, the IV line, and Bruce. In the beginning, the box was the only thing that was radioactive. By the end of the infusion, only Bruce made the needle swing wildly. The infusion only took about an hour, and Bruce had no reaction at all while receiving it. Other than laughter and chatter that is! The nuclear medicine technicians at NEMC delighted us with their humor, and with their willingness to answer our many questions.
• The nuclear medicine technicians gave us a list of the safety precautions Bruce would have to take, and then they escorted us to the door and sent us home for Bruce's "at home" isolation period.

12/09/00

• Bruce still felt fine, with no side-effects.
• Still no evidence of a response.

12/10/00

• Bruce's entire neck ached, and the chest pains he had prior to getting Bexxar worsened (his neck and chest were the location of his enlarged lymph nodes).
• He had a severe headache.
• He felt nauseous.
• His throat felt tight.
• He had an all-over "strange" feeling.
• He was running a low-grade fever.
• Although the house temperature remained the same throughout the day, in the morning he felt hot, and in the evening he felt so cold that he was shivering.
• Still no evidence of a response.

12/15/00

• We discovered that Bruce had an itchy rash all over his upper back, but we think it might have been there for a couple of days. The rash consisted mainly of small, red, raised spots, but a few of them looked almost like chicken pox blisters after they've broken.
• Bruce's neck was bright red, like he had a severe sunburn.
• Bruce was still having all the other symptoms he had on the 10th, but each day they were gradually lessening a little in intensity.
• Still no evidence of a response.

12/16/00

• The rash spread to include Bruce's lower back (as well as his upper back), his forearms, and his chest.
• The lymph nodes in his neck ACHED, and his chest pains were worse.
• His headache, nausea, and fever were gone.
• Still no evidence of a response.

12/17/00

• During the night of the 16th, Bruce woke up several times with drenching nightsweats.
• The rash on his chest, forearms and lower back was fading, and all the red spots on his upper back had changed to that "popped chicken pox" look.
• His neck was still red, but much less so than it was on the 16th.
• He still had chest tightness, but no longer any pain.
• Still no evidence of a response.

12/18/00

• During the night of the 17th, Bruce woke up only once with nightsweats.
• The rash was pretty much gone from his chest and lower back, completely gone from his forearms, and the rash on his upper back consisted mainly of just tiny scabs.
• His neck was no longer red.
• There was evidence that the Bexxar was working! Some of the lymph nodes in his neck felt softer and smaller, and a few of the smallest enlarged lymph nodes were gone!

12/19/00

• The lymph nodes in Bruce's neck were even smaller, and the largest one he had (the one that was too entangled with vital nerves and muscles for the surgeon to remove when he did the biopsy), was completely gone.

12/22/00

• When Bruce woke up in the morning, the last remaining enlarged lymph node in his neck was gone.
• His chest pressure had eased considerably, and he was breathing easier than he had in months.
• He had an appointment with his regular oncologist. His oncologist couldn't feel any enlarged lymph nodes anywhere.
• Although CT scans hadn't been done to know what was happening with the enlarged lymph nodes in his chest, Bruce's oncologist said he believed Bruce was in (or was very near to being in) a complete remission! This was only two (2) weeks after Bruce received the therapeutic dose of Bexxar!

12/29/00

• Bruce's WBC (white blood count) had dropped by nearly half, and his platelets had fallen by more than half. A drop in blood counts is the most common side-effect experienced with Bexxar. Although only a "moderate" drop in blood counts is usually experienced, Bruce was expected to have a "severe" drop, due to all the prior chemo he's had. The nadir (low point) usually happens around 6 weeks after having Bexxar.

1/05/01

• Bruce's white blood count, red blood count, hematocrit, hemoglobin, and platelets were all down some more, although not low enough for him to need transfusions.

1/12/01

• All of Bruce's blood counts fell some more, and his ANC (absolute neutrophil count) had dropped considerably. They contemplated admitting him to the hospital (because of his low neutrophil count), but they decided to let him come home, as long as he promised to be very careful and to call them immediately if he developed a fever, bleeding, bruising, etc..

1/19/01

• Bruce's platelets were up slightly, but most everything else was down slightly. Very slightly however!

1/26/01

• Bruce's RBC had fallen some more, his WBC was about the same as the last time, and his platelets had gone up slightly.

1/29/01

• Bruce had CT scans done.

1/31/01

• We got the results of Bruce's CT scans. As we had suspected they would, two weeks after he received the therapeutic dose of Bexxar, they showed no evidence of disease. He's in a complete remission!

12/08/01

• One year after receiving Bexxar, Bruce is still in a complete remission!

12/08/02

• Two years after receiving Bexxar, Bruce is still in a complete remission!

6/30/03

• Bexxar has finally been approved by the FDA!

1/08/04

• Three years after receiving Bexxar, it appears that Bruce has relapsed.

2/09/05

• Despite Bruce's relapse, a year later he's still in "Watch and Wait". According to one lymphoma specialist that Bruce saw for a 2nd opinion, it's not uncommon for lymphoma to be non-aggressive like this when one relapses after having received Bexxar. Yet another great thing to be said about Bexxar!

12/08/05

• It was 5 years ago that Bruce had Bexxar. Five years later, he still hasn't needed any further treatment for his Non-Hodgkin's Lymphoma!

12/08/06

• Six years after receiving Bexxar, Bruce still hasn't needed any further treatment for his Non-Hodgkin's Lymphoma! Have I mentioned how much I love Bexxar? :)
  Read the most recent updates about Bruce's condition.

---

Thank You!

Bruce and I would like to thank everyone who was involved in the development of Bexxar. We would also like to express our deepest gratitude to everyone who participated in helping Bruce to get Bexxar!

We'd also like to extend a special thank you to Dr. Mark Kaminski. In addition to the role you played in the invention of Bexxar, you took the time to personally answer an email I sent you in 1997, even though Bruce wasn't your patient and you had never met us. During a bleak time in our lives, when Bruce was not doing well at all, you encouraged us to never give up. Thank you for being an incredible humanitarian, as well as a brilliant doctor and scientist!

---

Bexxar Links

Bexxar for Non-Hodgkin's Lymphoma - Bexxar Web Site

Newly Approved Therapy Successfully Targets Non-Hodgkin's Lymphoma - Dec. 2003

Re-Treatment with Tositumomab and Iodine I 131 Tositumomab (the BEXXAR Therapeutic Regimen) in Patients with Non-Hodgkins Lymphoma (NHL) with a Previous Response to the BEXXAR Therapeutic Regimen - Dec. 2003

Medicare will cover treatment with Bexxar, a life-saving cancer drug invented at U-M - Sept. 2003

Analysis of Long-Term Response Population From BEXXAR Clinical Trials Presented at ASCO - May 2003

Bexxar vs. Zevalin - From Lymphomation

Information Sheet Tositumomab (Bexxar) - From CancerBACUP

Bexxar...Tositumomab and Iodine I 131 Tositumomab - From RxList

Bexxar: Chronicle of a Cancer Treatment

Bexxar® may Improve Survival in Autologous Stem Cell Transplants for Follicular Lymphoma

Bexxar Halts Progression Of Non-Hodgkin's Lymphoma, Study Shows

Tumor-absorbed-dose estimates versus response in tositumomab therapy of previously untreated patients with follicular non-Hodgkin's lymphoma: preliminary report. - From PUB MED Aug. 2000

Radioimmunotherapy with iodine (131)I tositumomab for relapsed or refractory B-cell non-Hodgkin lymphoma: updated results and long-term follow-up of the University of Michigan experience. - From PUB MED Aug. 2000

Radioactive Antibodies Highly Effective Against Non-Hodgkin's Lymphoma - May 2000

Harvesting Stem Cells for Transplant in Non-Hodgkin’s Lymphoma Patients Is Still Possible After Treatment with Bexxar, Weill Cornell Physician Reports to ASCO on Study That Allays Concern with a New Monoclonal Antibody - May 2000

Multicenter phase II study of iodine-131 tositumomab for chemotherapy-relapsed/refractory low-grade and transformed low-grade B-cell non-Hodgkin's lymphomas. - From PUB MED March 2000

Bexxar™ (Tisitumoab, Iodine I 131 Tositumoab) Can Be Safely Administered In Relapsed Low-Grade or Transformed Low-Grade Non-Hodgkin's Lymphoma (NHL) Patients After Prior Treatment with Rituximab: Initial Experience From Expanded Access Study. - American Society of Hematology Dec. 1999