Novel Agent Significantly Improves Survival in Men with Advanced Prostate Cancer

Great news for patients with advanced prostate cancer.  A new investigational agent, abiraterone acetate, was shown to significantly improved survival in men with metastatic castration-resistant prostate cancer. 

Abiraterone acetate is an investigational agent being developed by Ortho Biotech.  It acts by blocking CYP17 and potently inhibits persistent androgen synthesis from adrenal and intratumoral sources. 

In the study, investigators randomly assigned 1,195 patients with castration-resistant metastatic prostate cancer and who had been previously treated with docetaxel to 1 of 2 study groups: abiraterone 1000 mg plus prednisone 5 mg twice daily (n = 797) or placebo plus prednisone (n = 398). 

Patients who received abiraterone acetate plus prednisone had a median overall survival of 14.8 months, compared with 10.9 months for patients assigned to receive corticosteroid prednisone plus placebo. 

The most commonly observed adverse effects in the abiraterone group were fluid retention (30.5% vs 22.3%) and hypokalemia (17.1% vs 8.4%).  Grade 3/4 hypokalemia (3.8% vs 0.8%) and grade 3/4 hypertension (1.3% vs 0.3%) were infrequent. 

While 3.9 months may not seem like much in the history of prostate cancer, only 4 drugs have ever shown a survival benefit.  Furthermore, it is an oral that does not have the toxicity of chemotherapy.  

It is anticipated that this new drug will change the way doctors treat advanced prostate cancer in the future. 

Source: 35th European Society for Medical Oncology Congress: Abstract LBA5. Presented October 11, 2010.

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New Chemotherapy, Cabazitaxel (Jevtana), for Advanced Prostate Cancer

A new chemotherapy, Cabazitaxel (Jevtana) has been approved in the United States to treat men who have advanced hormone-refractory prostate cancer and have failed docetaxel.

The approval was based on the results of the phase 3 TROPIC clinical study, which involved 755 advanced hormone-refractory prostate cancer patients who were randomized to receive either cabazitaxel or mitoxantrone, both in combination with prednisone.  Furthermore, all this patients must have failed docetaxel before enrollment.

The results indicated that cabazitaxel was able to significantly improve the median overall survival when compared with mitoxantrone (15.1 months with cabazitaxel and 12.7 months with mitoxantrone (P < .0001).

The tumor response rate was also higher in the cabazitaxel group than the mitoxantrone group (14.4% versus 4.4% respectively, P = .0005).

The most common adverse reactions were neutropenia, anemia, leukopenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysguesia, cough, arthralgia, and alopecia.

To monitor the occurrence of neutropenia, frequent blood cell counts should be performed.  Also, patients with neutrophil counts of 1500 cells/mm3 or less should not be given cabazitaxel.

This certainly is good news for patients with hormone and chemotherapy refractory prostate cancer patients.  There is another drug to extend their life span.

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Source: http://en.sanofi-aventis.com/press/press.asp

Psoriasis Is Associated With an Increased Risk of Cancer

If you have psoriasis, you might have an increased risk of cancer, including melanoma, prostate cancer and non-Hodgkin’s lymphoma, according to a new research presented at the 68th annual meeting of the American Academy of Dermatology (AAD 2010). 

The researchers evaluated the incidence of psoriasis and cancers in 37,159 patients and 111,473 controls from a large insurance claims database.

Their analysis found that patients with psoriasis had a 56% higher risk for any type of cancer, 76% higher risk for melanoma, 12% higher risk for breast cancer, 75% higher risk for non-Hodgkin’s disease, 87% higher risk for lymphoma and 22% higher risk for prostate cancer.

The results might not be too surprising since patients with psoriasis are known to have defected immune system and defected immune system is associated with cancer. 

However, the results of this study indicated that patients who have psoriasis will need to monitor not only their skin symptoms, but also for their overall health, co morbidities, and well-being.

Presented at the 68th annual meeting of the American Academy of Dermatology (AAD 2010). 

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New Drug Offer Hope to Patients with Late Stage Prostate Cancer

At present, metastatic and hormonal-refractory prostate cancer patients who have failed 1st line chemotherapy will be given mitoxantrone plus prednisone as the salvage therapy.  However, mitoxantrone plus prednisone is not very effective in controlling metastatic prostate cancer.  Now, a new drug developed by sanofi-aventis might offer hope to patients who have failed 1^st line chemotherapy (docetaxel plus prednisone).

The new drug called cabazitaxel was investigated in the TROPIC trial that included 755 advanced prostate cancer patients who have failed 1^st line docetaxel chemotherapy.  Half of the patients in the trial received combination of cabazitaxel and prednisone while the other half received mitoxantrone and prednisone.

After one year of treatment, men in the cabazitaxel arm had an overall median survival of 15.1 months, compared to 12.7 months among men in the mitoxantrone arm.  Cabazitaxel was also associated with a 30 percent reduced risk of dying.

Like other chemotherapies, cabazitaxel was associated with side-effects such as low white blood cells (81.7%), low white blood cells with fever (7.5%), diarrhea (6.2%) and infections (10.2%).

This drug has not been approved by FDA, but is under the fast track approval process.  To participate in clinical trials, you may visit www.clinicaltrials.gov for details.

http://en.sanofi-aventis.com/binaries/20100304_Asco_GU_en_tcm28-27547.pdf

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