Olaparib shows activity in prostate cancer with DNA repair gene aberrations

  • Mateo J & al.
  • Lancet Oncol
  • 2 Dec 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Olaparib shows activity against metastatic castration-resistant prostate cancer with DNA damage response (DDR) gene aberrations.

Why this matters

  • Findings, if confirmed in registration studies, would support the implementation of tumor genomic testing in clinical practice for treatment stratification in advanced disease.

Study design

  • 98 patients with progressing metastatic castration-resistant prostate cancer and with DDR gene aberrations previously treated with 1/2 taxane-based chemotherapy regimens were randomly assigned to 300 or 400 mg olaparib.
  • Funding: Cancer Research UK; AstraZeneca.

Key results

  • Median follow-up, 24.8 months.
  • In patients who received 400 vs 300 mg olaparib:
    • Confirmed composite response rate: 54.3% vs 39.1% (P=.14).
    • Radiological objective response rate: 24.2% vs 16.2%.
    • At least 50% decrease in PSA: 37.0% vs 30.2%.
    • Circulating tumor cell count conversion rate: 53.6% vs 48.1%.
    • Median radiographic PFS was 5.5 (95% CI, 4.4-8.3) vs 5.6 (95% CI, 3.7-7.7) months.
  • The most common grade 3-4 adverse events were anemia (37% vs 31%).
  • 19 serious adverse reactions were reported in 13 patients.
  • 1 treatment-related death was reported with the 300-mg dose.

Limitations

  • Open-label design.