Treatment Related Side Effects of Chemotherapy with TAXOTERE (Docetaxel) in Men with Prostate Cancer

In May 2004, the US Food and Drug Administration (FDA) approved Taxotere (docetaxel), a chemotherapy drug given by intravenous infusion, in combination with prednisone (a steroid), for the treatment of patients with advanced metastatic prostate cancer.

Taxotere is the first drug approved for hormone refractory prostate cancer that has shown a survival benefit.

The safety and efficacy of Taxotere were established in a randomized, multi-center global clinical trial (TAX 327 ) with over 1,000 patients. In this trial, chemotherapy with taxotere and prednisone was compared to mitoxantrone and prednisone in men with metastatic, hormone-refractory prostate cancer.

Taxotere, in combination with prednisone, given every three weeks showed a median survival advantage of approximately 2.5 months over the control group in the trial.

Medical oncologists can tailor the dose and schedule of this drug to the needs of the individual patient. Some patients do well on the 3 weekly dose regimen. Other patients do well on a weekly regimen at lower dose (below)

The most commonly reported adverse events (side effects) were nausea, hair loss (alopecia), and bone marrow suppression (low blood counts). Also observed were fluid retention and peripheral neuropathy (tingling sensations in hands and feet).

The following chart of all reported side effects data is based on the experience of just 332 patients, who were treated with TAXOTERE 75 mg/m2 every 3 weeks in combination with prednisone 5 mg orally twice daily.

Because these patients took the Taxotere in a clinical trial designed to measure side effects (as well as survival advantage) they did not receive a full range of supportive medications. PSA Rising editor lists some available supportive medications and ways of coping with some side effects.

Ask your medical oncologist and your insurance company (or Medicare) about which supportive meds will be available to you and covered by insurance if you are bothered by side effects like anemia and fatigue, low white cell counts (neutropenia) or nausea.

TAXOTERE 75 mg/m2 every 3 weeks
+ prednisone 5 mg twice daily
Number of men in trial = 332

Side effect

Any Grade

Severe
(Grade 3/4)

Anemia Low hemoglobin (red cell) count. If severe may cause fatigue. Can be treated with Procrit®, Aranesp®, or blood transfusion.

66.5

4.9

Neutropenia - low neutrophil (white blood cell) count. Makes you more vulnerable to infection. May lead to treatment interruption until counts recover. Can be treated with Neupogen® or Neulasta®.

40.9

32.0

Thrombocytopenia - low platelets (the cells that form blood clots that stop bleeding). May cause purple blotches on skin especially at site of injections. Chemo will be interrupted (delayed) if platelets fall below a certain level. Severe drop (not common in this trial) may bring on a medical emergency (bleeding) requiring hospitalization and platelet transfusion.

3.4

0.6

Febrile neutropenia - fever and a significant reduction in white blood cells. Any temperature over 100.5 F (Fahrenheit) or 37.5 C (Celsius) should be reported to the medical oncologist without delay and you should go to the ER (Urgent Care) for work up and antibiotics.

2.7

N/A

Infection

32.2

5.7

Epistaxis (nosebleed)

5.7

0.3

Allergic Reactions, Hypersensitivity reactions see below

8.4

0.6

Fluid Retention*

24.4

0.6

Peripheral Edema*- Fluid retention and swelling in feet, ankles, legs or arms

18.1

0.3

Weight Gain*

7.5

0.3

Neuropathy Sensory- Nerve damage causing tingling or pain, usually in feet or hands

30.4

1.8

Neuropathy Motor - Weakness but no tingling, pain or numbness. Cramps or muscle twitching may be present.

7.2

1.5

Rash/ Flaking skin

6.0

0.3

Alopecia - Hair loss

65.1

N/A

Nail Damage -- keeping finger tips and toes in ice water during the chemo may help. See "Frozen Glove Reduces Skin and Nail Damage from Docetaxel Chemotherapy" (NCI)

29.5

0.0

Nausea

41.0

2.7

Diarrhea

31.6

2.1

Stomatitis/Pharyngitis - mouth sores

19.6

0.9

Taste Disturbance may be a metallic taste

18.4

0.0

Vomiting

16.9

1.5

Anorexia - weight loss from lack of interest in food

16.6

1.2

Cough

12.3

0.0

Dyspnea shortness of breath

15.1

2.7

Impaired cardiac left ventricular function

9.6

0.3

Fatigue

53.3

4.5

Arthralgia joint pain

8.1

0.6

Myalgia aches and pains, muscle pain

14.5

0.3

Irritated, teary eyes
use artificial tears during and after each treatment to flush the Taxotere from the surface of the eye to prevent this problem.

If it persists, tearing can be relieved by a tiny silicone tube inserted in the irritated tear ducts. If you are taking Taxotere and your eyes tear too much, tell your cancer doctor and get checked by an eye doctor who has experience placing these tubes.

9.9

0.6

Allergy, Hypersensitivity Reaction

This is rare, but it is an emergency. Your oncology nurses should watch you closely for hypersensitivity reaction, especially during the first and second infusions. If a family member or friend accompanies you, ask the doctor and nurse to describe to both of you what to watch out for.

Hypersensitivity reactions may be signaled by very rapid onset of itching/ flushing, redness / rash of facial skin, palms of hands and/or reddening and itching of whites of eyes (erythema).

Blood pressure may fall rapidly (hypotension) and/or you may feel bronchospasm (inability to breath).

According to the manufacturer, this allergic reaction occurred in 2.2% of 92 patients premedicated with 3-day corticosteroids. Hypersensitivity reactions severe enough to force a halt to TAXOTERE infusion were reported in 5 out of 1260 patients with various tumor types who did not receive premedication, but in 0/92 patients premedicated with 3-day corticosteroids."Patients with a history of severe hypersensitivity reactions should not be rechallenged with TAXOTERE." See warning information, aventis.us.com.

Related ARTICLES:

Cancer and Chemotherapy Fatigue

"What a difference it would have made if my fatigue had been acknowledged! .... What a comfort there would have been ... in knowing that my exhaustion was being monitored." Maureen Gilbert.

Practical Aspects of Weekly Docetaxel Administration Schedules John D. Hainsworth The Sarah Cannon Cancer Center, Nashville, Tennessee, USA The Oncologist, September 2004

"Weekly dosing of docetaxel has been investigated in an effort to reduce toxicity and has been identified as a safe and effective regimen in clinical trials."

Cancer, Chemotherapy, Anemia and Fatigue: What's the Connection? If you have cancer, you may assume feeling tired is part of the disease. However, feeling unusually tired may be due to anemia, a common side effect of your cancer and many chemotherapy treatments. anemiainstitite.org (Canada)

High-Risk Localized Prostate Cancer: Integrating Chemotherapy William K. Oh The Oncologist, October 2005

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This page made and last UPDATED by J. Strax, December 10, 2005.

Information on this web site is not intended as medical advice nor to be taken as such. Consult qualified physicians specializing in the treatment of prostate cancer. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained on this web site.

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