Apalutamide data: Impact on QoL is ‘reassuring’

Apalutamide (Erleada) treatment in men with nonmetastatic castrate-resistant prostate cancer (nmCRPC) significantly improves metastasis-free survival and does so without adversely affecting health-related quality of life (HRQoL), according to analyses of data from the phase III SPARTAN trial presented at the AUA annual meeting in San Francisco.

“The primary analysis in SPARTAN showed that apalutamide prolonged median metastasis-free survival by more than 2 years compared with placebo, and additional analyses showed it had statistically significant benefits for prolonging time to symptomatic progression and time to progression after development of metastatic disease. Adverse event data showed that apalutamide was safe,” said Dr. Small, of UCSF Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.

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“Because most men with nmCRPC are asymptomatic, however, it is also important to make sure that apalutamide is not having a negative impact on functional and emotional well-being. The analyses of data from SPARTAN using two different instruments to collect patient-reported outcomes are reassuring. They show that the apalutamide-treated men had no decrement in quality of life compared with baseline or the placebo group, and the results provide confirmation that this effective therapy does not have significant side effects.”

SPARTAN enrolled 1,207 patients with nmCRPC who were on androgen deprivation therapy (ADT) and had a PSA doubling time ≤10 months. They were randomized 2:1 to apalutamide, 240 mg daily or placebo. All men continued on androgen deprivation therapy.

The Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Euro QoL Group EQ-5D-3L questionnaires were used to assess health-related quality of life and symptoms. These patient-reported outcome (PRO) instruments were completed at baseline and on the first day of treatment cycles 2-7, 9, 11, 13, and then every 4 months for the duration of treatment and again 1 year after treatment was discontinued.

The two treatment groups were well-balanced at baseline in their demographic and disease characteristics. Median treatment exposure time was 16.9 months for the apalutamide group and 11.2 months for placebo. The baseline scores for the PRO questionnaires were also similar in the two groups, and there was a high compliance rate for completion of the questionnaires, with a range of 92% to 100% at all visits.

“The baseline scores for the patients in this study were also comparable to those of the general population, showing that men with nmCRPC are generally not bothered by their disease,” Dr. Small said.

Next: HRQoL relatively stable in both groups over timeAnalyses of total and subscale scores for both instruments showed HRQoL was relatively stable in both groups over time. Between group comparisons of changes from baseline generally found no statistically significant differences.

“The items for which there were statistically significant differences favored apalutamide,” Dr. Small said.

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He also pointed out that patients in the study were blinded to treatment and to their PSA results, therefore eliminating the potential for HRQoL effects from anxiety or emotional reactions related to such knowledge.

“Considering that apalutamide improves outcomes for men with nmCRPC while maintaining HRQoL, the message for physicians who care for men with prostate cancer is that it is better to start treatment with apalutamide earlier rather than waiting until metastasis occurs,” Dr. Small told Urology Times.

Dr. Small has served as a consultant for and received honoraria from Janssen, which provided funding for the study. Several of his co-authors have a disclosure related to Janssen and/or other pharmaceutical companies.

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