Addition of Metastasis-Directed Therapy to Intermittent Hormone Therapy for Oligometastatic Prostate Cancer (EXTEND): A Multicenter, Randomized Phase II Trial - ScienceDirect
Addition
of Metastasis-Directed Therapy to Intermittent Hormone Therapy for
Oligometastatic Prostate Cancer (EXTEND): A Multicenter, Randomized
Phase II Trial
There
has been increased utilization of metastasis directed therapy (MDT) for
oligometastatic prostate cancer. Despite data demonstrating the benefit
of upfront hormone therapy (HT) and synergy between radiation and HT,
there exists no randomized trials testing their combination. As it is
accepted by most clinicians and men with prostate cancer that time off
HT holds intrinsic value, we evaluated whether the addition of
metastasis directed therapy (MDT) to intermittent HT in men with
oligometastatic prostate cancer facilities time off HT by improving PFS
and eugonad PFS.
Materials/Methods
EXTEND
(NCT03599765) is a phase II randomized basket trial for multiple solid
tumors testing whether the addition of MDT improves PFS. The primary
endpoint was pre-specified to be independently assessed and reported for
the prostate intermittent HT basket at 41 events. Men with ≤5
metastases were randomized after ≥2 months of HT to continuing HT with
or without MDT. HT consisted of a luteinizing hormone-releasing hormone
agonist/antagonist with or without a 2nd generation
androgen-receptor targeting agent (SART). The primary endpoint was
progression, defined as death or radiographic, clinical, or biochemical
progression. A planned HT break occurred 6 months after enrollment,
after which HT was withheld until progression. The study was designed to
have 80% power to detect an improvement in median PFS from 18 to 36
months, with a type I error of 0.1. Exploratory analysis included flow
cytometry and TCR sequencing from peripheral blood at baseline and 3
months follow up.
Results
Between
Sept 2018 to Nov 2020, 87 men were randomized, 43 combined therapy and
44 to HT-only. Arms were well balanced. At a median follow-up of 22.1
months (range 13.0 to 39.3 months), 41 events were observed. PFS was
improved by the receipt of MDT (median not reached vs 15.8 months for
HT-only, P<0.001; HR=0.25 [95% CI, 0.12 to 0.55]). Among secondary
endpoints, time from eugonad testosterone levels (>150 ng/dL) to
progression was improved by MDT (median not reached vs 6.1 months,
P=0.03), as was time to appearance of new lesions (2-year rate 33% vs
41%, P=0.04). Three grade 3 toxicities were observed in each arm.
Subgroup analysis identified PFS improvement with MDT in patients who
received (HR=0.24 [95% CI, 0.08 to 0.71]) or did not receive a SART
(HR=0.36 [95% CI, 0.15 to 0.83]). Flow cytometry and TCR sequencing
demonstrated increases in markers of T cell activation, proliferation,
and clonal expansion limited to the combined therapy arm.
Conclusion
EXTEND
represents the first randomized study to evaluate MDT with HT in
oligometastatic prostate cancer and demonstrated improvement in PFS and
eugonad PFS. Combination of MDT with intermittent HT may allow for both
excellent disease control while facilitating prolonged eugonad
testosterone intervals.
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