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ASCO 2019 Annual Meeting

ASCO 2019: CALGB 90203 (Alliance): Radical Prostatectomy with or without Neoadjuvant Chemohormonal Therapy in Men with Clinically Localized, High-Risk Prostate Cancer - Medical Oncologist Perspective

Chicago, IL (UroToday.com) CALGB 90203 was a large phase III randomized study where men with high-risk, clinically localized prostate cancer (stage T1 to T3a, NX, M0) who had a predictive probability of ≤60% chance of remaining free from disease recurrence were randomly assigned to radical prostatectomy (RP) or chemohormonal therapy (docetaxel and estramustine) before radical prostatectomy.1 At a late-breaking abstract at AUA 2019, data released from this study showed that neoadjuvant androgen deprivation therapy (ADT) plus docetaxel followed by RP did not increase 3-year biochemical progression-free survival (PFS) compared to RP alone in men with CLHRPC (0.87 vs 0.82; p = 0.13).2 However, the authors noted that 42% of patients received additional treatment prior to meeting the primary endpoint which made the final analysis of biochemical PFS challenging. This abstract provides additional data regarding the pathological outcomes of these patients.
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This abstract provides data on 738 men who ultimately underwent radical prostatectomy. The patient selection criteria are shown below:
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In terms of pathologic Gleason grading group (GGG), there was no significant difference between patients who received chemotherapy (CHT) and those who did not. However, there was a significant difference in pathologic T stage – those receiving CHT were more likely to be T1/T2 (41% vs 23%), and the majority of patients receiving RP alone where pT3 (75%). In terms of nodal staging, there was a trend towards increased N0 with CHT (80% vs 70%) but this was not statistically significant (p=0.05). Lastly, patients receiving CHT were more likely to have negative surgical margins than those who went straight to RP (82% vs 55%, p<0.00).

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This abstract provides evidence that patients who were treated with CHT may have more favorable pathologic outcomes at the time of RP. This benefit may translate to an increase in overall survival – at AUA, the authors noted that an overall survival (OS) treatment evaluation provided evidence that patients randomized to neoadjuvant CHT and RP had an improved OS rate relative to the RP-alone arm (HR = 0.67; 95% CI: 0.43-1.06). However, given that a substantial portion of patients in this study (42%) received additional therapy in a non-randomized fashion outside of the clinical trial, it is unknown what if any effect that may have had on OS. Also, it is unknown if chemotherapy or hormonal therapy alone is sufficient – there was evidence that neoadjuvant ADT alone can decrease tumor volume and improve the complete resection rate in patients with cT3 prostate cancer, did not appear to benefit PSA free survival.3,4 The data remains controversial regarding whether or not a neoadjuvant strategy may benefit these patients with high-risk localized prostate.

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Presented by: James Andrew Eastham, MD, FACS, Memorial Sloan Kettering Cancer Center, New York, NY

Written by: Jason Zhu, MD, Fellow, Division of Hematology and Oncology, Duke University, @TheRealJasonZhu at the 2019 ASCO Annual Meeting #ASCO19, May 31-June 4, 2019, Chicago, IL USA

References:
  1. Eastham JA, Kelly WK, Grossfeld GD, Small EJ. Cancer and Leukemia Group B (CALGB) 90203: a randomized phase 3 study of radical prostatectomy alone versus estramustine and docetaxel before radical prostatectomy for patients with high-risk localized disease. Urology 2003;62:55-62.
  2. Eastham* JA, Heller G, Halabi S, et al. LBA-12 CALGB 90203 (ALLIANCE): Radical Prostatectomy with or without neoadjuvant chemohormonal therapy in men with clinically localized, high-risk prostate cancer. The Journal of Urology 2019;201:e997-e.
  3. Powell IJ, Tangen CM, Miller GJ, et al. Neoadjuvant therapy before radical prostatectomy for clinical T3/T4 carcinoma of the prostate: 5-year followup, Phase II Southwest Oncology Group Study 9109. The Journal of Urology 2002;168:2016-9.
  4. SCOLIERI MJ, ALTMAN A, RESNICK MI. Neoadjuvant hormonal ablative therapy before radical prostatectomy: a review. Is it indicated? The Journal of Urology 2000;164:1465-72.