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Apalutamide equally beneficial in Asians with nmCRPC

Elvira Manzano
05 Dec 2018
Prof Paul Mainwaring

Apalutamide, added to standard treatment with androgen deprivation therapy (ADT), provides comparable clinical benefits among Asian vs non-Asian patients with nonmetastatic castration-resistant prostate cancer (nmCRPC), according to a subset analysis of the phase III SPARTAN study.  

Similar with outcomes in non-Asian patients, treatment with apalutamide reduced the risk for distant metastasis (new bone or soft tissue lesions or enlarged lymph nodes outside the pelvis) or death due to any cause by 71 percent (hazard ratio [HR], 0.29; p<0.001) in Asian patients. [ESMO Asia 2018, abstract MOS-2130]

“SPARTAN showed that Asians or non-Asians, there was a hazard ratio benefit,” said lead investigator Prof Paul Mainwaring from the Centre for Personalized Nanomedicine, University of Queensland, Brisbane, Australia.  “The high-risk baseline characteristic in Asian patients didn’t affect the benefit of this drug. On top of that, we’ve got a tolerable safety profile that we’re happy to use it in the clinic.”

The Asian patients (9.8 percent of the total SPARTAN population) were from Japan, Taiwan, and South Korea. Most baseline characteristics were similar between Asians and non-Asians. But what was important was that Asian men had a higher proportion of N1 disease and Gleason score was >7. Median time from diagnosis to treatment and median treatment duration were shorter for Asian men. Rates of treatment discontinuation and adverse events were higher.

“These are patients at a very high risk … But the good point was that the benefit of adding apalutamide to ADT over placebo plus ADT was stunning at an HR of <0.3. This was a real revolution and change in the natural history of the disease,” commented Mainwaring. “Imagine if we could give this therapy earlier into these men diagnosed to have a high-risk disease and a PSA doubling time of ≤10 months but no evidence of metastatic disease.”

Looking at the subgroup analysis, the benefits were consistent regardless of patients’ age, number of prior hormone therapy, baseline PSA, ECOG status, bone sparing agent used, and locoregional disease.

In terms of safety, there were no significant differences in treatment-emergent adverse events (TEAEs) between groups, except for skin rash (38 percent in Asians vs 22 percent in non-Asians), which was higher particularly in Japanese men.

“When we looked into that, what we found was that the Asian men who got rash stopped treatment,” revealed Mainwaring. “What we normally do is stop the medication, wait until the rash is about grade 0 or 1, and then recommend a full dose, or if rash is still a concern, go for a reduced dose.”

By changing and understanding the evolution of new medications that are coming into the clinic, and with symptom management algorithms, we can assure that patients are getting the benefits, said Mainwaring. “Men who had a reduction in dose actually derived the same benefits.”

Results of the SPARTAN trial, reported early this year, showed that apalutamide plus ADT reduced the risk for distant metastasis or death by 72 percent (HR, 0.28, 95 percent confidence interval [CI], 0.23–0.35; p<0.0001) vs placebo. Median metastasis-free survival (MFS) was 40.5 months for apalutamide vs 16.2 months for placebo, for a difference of 24.3 months. [N Engl J Med 2018;378:1408-1418]

Based on SPARTAN findings, apalutamide was subsequently approved for nmCRPC in the US as a second-generation ADT. However, calls for apalutamide to be a new standard of care in the setting of nmCRPC were tempered by concerns about higher AEs vs placebo.

However, in an analysis of apalutamide’s effects on health-related quality of life (HRQoL), HRQoL was maintained following initiation of apalutamide whereas it deteriorated from baseline in those randomized to ADT plus placebo. [Lancet Oncol 2018;19:1404-1416].

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Most Read Articles
29 Jul 2020
Adjunctive perampanel appears to be safe and effective for long-term treatment of patients with tonic‐clonic seizures, according to a posthoc analysis.
11 Aug 2020
During the Allergic Rhinitis (AR) Boot Camp held in conjunction with the Bayer Pharmacist Congress 2020, Professor Dr Baharudin Abdullah discussed the management of AR in the primary care setting and the importance of using patient profiles to guide the choice of antihistamines.
Elaine Soliven, 18 Sep 2020
Adding mepolizumab to standard of care treatment significantly reduces nasal polyp size and obstruction in adults with chronic rhinosinusitis with nasal polyps (CRSwNP), according to the SYNAPSE* study presented at ERS 2020.
Jairia Dela Cruz, 18 Feb 2020
Administering daily oral doses of adjunctive perampanel is safe and well tolerated in the treatment of young and older children with focal seizures or generalized tonic‐clonic seizures, in addition to yielding about 40–70 percent reduction in seizure frequency, according to data from the open-label 311 Core Study.