medwireNews: The use of chemohormonal therapy (CHT) before radical prostatectomy does not significantly improve 3-year biochemical recurrence-free survival (RFS) in men with localized, high-risk prostate cancer, phase 3 trial findings suggest.
The researchers note that other survival endpoints favored neoadjuvant CHT, but nevertheless say that “the combination of neoadjuvant docetaxel with androgen-deprivation therapy [ADT] before radical prostatectomy should not be considered as a treatment option for men with clinically localized, high risk prostate cancer at this time.”
They point out, however, that follow-up is ongoing and add: “Although this longer follow-up will never change the fact that the primary end point is negative, positive clinical findings would require reconsideration of the conclusion not to use neoadjuvant CHT in this setting.”
The CALGB 90203 study included 788 men with high-risk disease, defined as a less than 60% predicted probability of being free from biochemical progression within 5 years of surgery on the 1998 Kattan nomogram or a biopsy Gleason score of 8–10. Participants were randomly assigned to receive docetaxel 75 mg/m2 every 3 weeks for six cycles and ADT for 18–24 weeks before radical prostatectomy or to surgery alone.
As reported in the Journal of Clinical Oncology, the primary endpoint of 3-year biochemical progression-free survival (PFS) did not significantly differ between the neoadjuvant group and the surgery-only group, with the probability of remaining progression-free at this timepoint being 0.89 and 0.84, respectively. And no difference was seen for 5-year biochemical PFS either.
But, over the median 6.1 years of follow-up, biochemical PFS favored the men who received neoadjuvant CHT versus those who received surgery alone, at a hazard ratio (HR) of 0.69. And the investigators note that their ability to measure biochemical PFS was “compromised” because nearly half of the study participants received additional treatment and were therefore censored from the analysis.
James Eastham (Memorial Sloan Kettering Cancer Center, New York, USA) and fellow researchers also report that other endpoints were significantly improved among men who did versus did not receive CHT, such as event-free survival (HR=0.61) which accounted for the receipt of additional treatment, as well as metastases-free survival (HR=0.70), and overall survival (HR=0.61).
Intraoperative complications were rare and comparable between treatment arms and no deaths occurred within 30 days of surgery in either treatment group. However, grade 3 postoperative bleeding and low hemoglobin levels were more common in patients who received neoadjuvant CHT (nine and seven patients, respectively) than those who did not (three and zero patients, respectively).
Of the grade 3 (26%) and 4 (19%) events that occurred during chemotherapy, neutropenia (23%), hyperglycemia (6%), fatigue (4%), and febrile neutropenia (4%) were the most common.
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