Clinical Trial Reveals Revlimid (Lenalidomide) Combination with Other Chemotherapy Drugs Fails as Prostate Cancer Therapy

October 4, 2012 by  
Filed under Prostate Cancer News

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At new and large international trial has shown that Revlimid addition to other chemotherapy regimen did not yield any positive result.

In other words, the mortality rate of patients with castration-resistant prostate cancer treated with the combo soared. This has result has cancel out early studies that revealed the  Revlimid could help reduce mortality with combined with other regimen.

Details of this new study have been published online. Here are details on the findings:

Adding lenalidomide (Revlimid) to the chemotherapy regimen led to greater toxicity and worse survival in patients with untreated castration-resistant prostate cancer (CRPC), results of a large international trial showed.

Men randomized to a regimen of lenalidomide, docetaxel, and prednisone, had a 53% increased mortality hazard, a 32% greater hazard for progression, and significantly higher rates of neutropenia, febrile neutropenia, and multiple non-hematologic adverse events.

Investigators found no outcomes that favored lenalidomide over a docetaxel-prednisone-placebo combination, Daniel Petrylak, MD, of Yale Cancer Center, reported here at the European Society for Medical Oncology meeting.

Lenalidomide’s poor performance “may be attributed to shorter treatment duration, lower dose intensity of docetaxel, and earlier treatment discontinuation,” Petrylak said.

“Further analysis of the data is underway to help elucidate the observed results in the lenalidomide arm,” he said.

Lenalidomide has antiangiogenic and immunomodulatory properties that suggested therapeutic potential in CRPC. In phase I/II clinical trials, lenalidomide demonstrated activity and tolerability when used as a single agent or in combination with docetaxel and prednisone, said Petrylak.

The promising early results provided the basis for a multicenter, randomized phase III clinical trial of lenalidomide in combination with docetaxel and prednisone as first-line therapy for metastatic CRPC.

Investigators randomized patients to lenalidomide 25 mg/d, docetaxel 75 mg/m2 on day 1, and prednisone 5 mg BID, or to placebo and the same two drugs at the same doses. Treatment continued on 21-day cycles until disease progression, and follow-up continued for 5 years after discontinuation of treatment.

The primary endpoint was overall survival (OS), and key secondary endpoints were progression-free survival (PFS), overall response rate, and safety.

The final analysis included 1,059 patients. Treatment groups did not differ significantly with respect to baseline characteristics.

Data analysis showed a median OS of 77 weeks in the lenalidomide arm, whereas the median had yet to be reached in the placebo group (HR 1.53, P=0.0017). Median PFS was 45 weeks with lenalidomide and 46 weeks with placebo (HR 1.32, P=0.0187).

Comparisons of other response outcomes showed no difference between treatment groups:

50% PSA decline: 58.7% with lenalidomide versus 58% with placebo

30% PSA decline: 67.2% versus 67.1%

Complete response: 0.9% versus 1.5%

Partial response: 21.2% versus 22.8%

Stable disease: 53.8% versus 59.7%

Progressive disease: 8.8% versus 5.9%

Overall response rate: 22.1% versus 24.3%

Patients in the lenalidomide group completed fewer therapy cycles (six versus eight), required more dose reductions for lenalidomide and docetaxel, and received a lower average cumulative dose of study drug and docetaxel. Click here for the complete report.

Although this new findings would still be further analyzed, they already provides researchers and experts what to work on.

The trial has been comprehensive and extended; hence it still reveals the likely flaws of the early studies.

This is why it is so important to review and evaluate details of any research findings. As stated above, this report should be further analyzed for more elucidation.

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