Combining chemotherapy and hormonal therapy for patients with locally advanced prostate cancer provides longer control of prostate-specific antigen (PSA) levels than hormonal therapy alone, according to a study.
The findings of the study were published in the April issue of The
Journal of Urology, an Official Journal of the American Urological Association
(AUA). Wolters Kluwer publishes the journal as part of its Lippincott
portfolio.
"Our clinical trial is the first to show a longer time to
biochemical recurrence with chemotherapy plus standard hormone therapy for
patients with locally advanced, high-risk prostate cancer," comments
Jiahua Pan of Shanghai Jiao Tong University, People's Republic of China.
"The findings add new evidence to support the use of combined
chemohormonal therapy for a group of patients at high risk of recurrent,
progressive prostate cancer."
The randomized controlled trial included 141 men with locally
advanced prostate cancer, in which cancer has spread outside the prostate to
nearby tissues. All patients had clinical characteristics placing them at elevated
risk of distant tumor spread (metastasis) after initial treatment.
In a 2:1 ratio, patients were randomly assigned to treatment with
the chemotherapy agent docetaxel plus hormonal (androgen deprivation) therapy
or hormonal therapy alone. In both groups, these "neoadjuvant"
treatments were followed by surgery (radical prostatectomy and extended lymph
node dissection).
The study focused on biochemical progression-free survival -
control of serum PSA levels - as a sign of tumor control. Rising PSA levels are
an early sign of recurrent or progressive prostate cancer. The study also
looked at pathologic responses: whether the study treatments were effective in
shrinking the prostate cancer before surgery.
Both groups had good pathologic responses: the cancer was
"downstaged" before surgery in 65% of patients assigned to
chemohormonal therapy and 48% of with hormonal therapy only. The two groups
also had similar rates of minimal residual disease - only a small number of
cancer cells remaining after treatment.
Chemohormonal therapy had a greater effect on biochemical
progression-free survival. At three years' follow-up, 29% of patients receiving
chemotherapy plus hormonal therapy remained free of rising PSA levels, compared
to 9.5% with hormonal therapy only.
Median time to rising PSA levels was 17 months with chemohormonal
therapy versus 14 months with hormonal therapy alone. Patients receiving
chemotherapy also had a higher treatment-free survival rate: 8.5% required no
further prostate cancer treatment through five years' follow-up. The two groups
had similarly low complication and adverse event rates.
On its own, neoadjuvant hormonal therapy can improve tumor control
in locally advanced prostate cancer, but studies have shown limited effects on
patient survival. The combination of docetaxel chemotherapy and hormonal
therapy has yielded inconsistent results, likely reflecting differences between
studies.
The new study is the first to show improvement in biochemical
recurrence rate with chemohormonal therapy in this group of patients. The
results also point to possible improvements in other important outcomes.
The authors note that their study is limited by relatively short
follow-up times - making it impossible to evaluate the effects on "more
clinically significant endpoints," including overall survival and risk of
death due to prostate cancer. "Our study suggests that neoadjuvant
docetaxel-based chemotherapy could bring significant improvement for
patients," the researchers write. They emphasize, "longer follow-up
is needed for more supportive evidence."
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