Clinical Trial Reports

by Stanton R. Mehr
Published: Monday, Jun 07, 2010
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Clinical Trial Reports

Phase III

Does Finasteride Prevent Prostate Cancer?

Finasteride has been used for many years in the treatment of benign prostatic hyperplasia (BPH) to improve the symptoms associated with enlarged prostate. However, it was not known if finasteride simply improved symptoms or actually helped prevent prostate cancer. Researchers from the Prostate Cancer Prevention Trial (PCPT) sought to determine the answer to this question, and found some encouraging results.

In this phase III trial, clinicians from the University of Texas Health Science Center, San Antonio, utilized a logistic regression model to evaluate men in the PCPT placebo group. In order to predict prostate cancer during the study’s subsequent seven years, prostate cancer risk at entry was assessed. No one was included if their prostate-specific antigen (PSA) level exceeded 3.0 ng/mL. The extent that finasteride may affect prostate cancer prevention was evaluated across risk and PSA strata.

Participants in each risk quintile experienced a significant reduction of prostate cancer risk with finasteride treatment. The risk of prostate cancer was cut by at least 28% (Figure) (P ≤ .05). Although the benefit of finasteride use did not appear to trend with increasing or decreasing overall risk, there did seem to be some association with baseline PSA level. For example, the odds ratio increased (smaller treatment effect of finasteride) from 0.60 for those with PSA levels below 0.7 ng/mL to 0.69 for men with PSA concentrations from 1.8 to 3.0 ng/mL. However, the treatment effect still continued to be statistically significant, even at the highest PSA concentration (P < .001).

Likelihood of Cancer Decreased With Finasteride Use,

Regardless of Prostate Cancer Risk

Risk Quintile*

Odds Ratio











* Highest risk is 5.

The risk of prostate cancer was significantly reduced by finasteride treatment, the researchers concluded, regardless of the level of this risk. That suggests, they added, that finasteride has both treatment and preventive effects, and all men should be made aware of the agent’s potential to reduce prostate cancer risk when they have PSA screenings.

Thompson IM, Tangen CM, Parnes HL, et al: Does the level of prostate cancer risk affect cancer prevention with finasteride? Urology 2008;71:854-857.

Phase III

Lapatinib Plus Trastuzumab for Patients With Progressing Metastatic HER-2–Positive Breast Cancer

Approximately 25% to 30% of patients with breast cancer are HER-2 positive, and this is a particularly aggressive form. Results from a first-ever randomized, multicenter, open-label phase III trial demonstrated that the combination of two targeted agents, lapatinib plus trastuzumab produced positive outcomes for women with HER-2 breast cancer.

The study group comprised 296 subjects with HER-2 positive breast cancer whose disease had progressed with the use of prior trastuzumab treatment. They were randomized to receive either treatment with lapatinib 1,000 mg/day plus trastuzumab 2 mg/kg weekly after a 4 mg/kg loading dose, or lapatinib 1,500 mg/day alone. All of the participants had previously received anthracycline and taxane therapy, and a median of six prior chemotherapy regimens.

The Figure shows that progression-free survival and clinical benefit rate at 24 weeks were significantly improved with the combination therapy, although the absolute difference in terms of time was limited. The researchers pointed out that response rate and overall survival were not different between groups. Generally, both treatment regimens were well tolerated although grades 1 and 2 diarrhea occurred more frequently in the combination therapy group (53% vs. 41%, P = .03). Symptomatic decreases in left ventricular ejection fraction were noted in the two patients in the combination group and in one in the monotherapy group. One patient receiving combination therapy died as a result of cardiac toxicity.

Progression-Free Survival Improved With Lapatnib + Trastuzumab

Treatment In HER2 + Metastatic Breast Cancer

  Lapatinib +

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