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Outcomes of older men receiving docetaxel for metastatic hormone-sensitive prostate cancer

Abstract

Background

Most men who die of prostate cancer are older than 70 years. The ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) randomized men of all ages with metastatic hormone-sensitive prostate cancer (mHSPC) to receive androgen deprivation therapy (ADT) with or without docetaxel demonstrating an overall survival (OS) benefit for docetaxel.

Methods

In a post-hoc analysis of this trial, we assessed patient characteristics and OS in patients ≥70 years (“older men”) versus <70 years (“younger men”) with Cox proportional hazards models. In addition, we compared adverse events, therapy completion rate, and subsequent treatment patterns between these two groups using Chi-squared tests.

Results

177 (22.4%) patients were ≥70 years. Docetaxel + ADT resulted in improved OS in both older and younger men (Hazard Ratio [HR] 0.45, 95%CI: 0.25–0.80 for older men; HR 0.71, 95%CI: 0.53–0.95 for younger men). This treatment benefit was seen for subgroups of older men with high volume disease (HR 0.43, 95%CI 0.23–0.79) and de novo metastatic disease (HR 0.36, 95%CI 0.19–0.69). A similar proportion of older and younger men completed six cycles of docetaxel (82.6% vs. 87.1%, p = 0.28). Rates of grade 3–5 adverse events were similar between older and younger men (36.8% vs. 26.8%, respectively, p = 0.069). The rate of any Grades 4–5 adverse events did not differ significantly between older and younger men (14.9% vs. 11.9%, respectively, p = 0.46). In the control arm, a smaller proportion of older men received subsequent cancer treatments (34.4% vs. 51.5%, p = 0.017) or subsequent docetaxel (25.6% vs. 37.6%, p = 0.035) compared to younger men.

Conclusions

Older men with mHSPC had similar OS benefit and clinical outcomes compared to younger men when receiving docetaxel + ADT. Oncologists should consider docetaxel chemotherapy as a favorable treatment option for older men with mHSPC who are fit for chemotherapy.

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Data availability

We obtained the data from CHAARTED through the National Clinical Trials Network (NCT00309985-D3 and NCT00309985-D4). Data were originally collected from clinical trial NCT00309985. The data are publicly available through the NCTN.

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Funding

NIH T32 CA092203 (DEL).

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We made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data. All were involved in drafting the article or revising it critically for important intellectual content. All provided final approval of the manuscript and agree to be accountable for all aspects of the work.

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Correspondence to Daniel E. Lage.

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Conflict of interest

RJL reports consulting role for Bayer, Janssen, Astellas, and Dendreon. JAG reports research funding from Gaido Health/BCG Digital Ventures, NCCN/AstraZeneca (Inst); royalties from Springer (Humana Press); consulting role for Concerto HealthAI. JST reports research funding from Astra Zeneca and Pfizer. CJS reports consulting role for Sanofi, Janssen, Astellas Pharma, Bayer, Genentech, AstraZeneca, Pfizer, Lilly; research funding from Janssen Biotech (Inst), Astellas Pharma (Inst), Sanofi (Inst), Bayer (Inst), Sotio (Inst), Dendreon (Inst); patents/royalties from Pathenolide (Indiana University), dimethylaminoparthenolide (Leuchemix), Exelixis: Abiraterone plus cabozantinib combination; stock ownership in Leuchemix. No other conflicts of interest were identified.

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Lage, D.E., Michaelson, M.D., Lee, R.J. et al. Outcomes of older men receiving docetaxel for metastatic hormone-sensitive prostate cancer. Prostate Cancer Prostatic Dis 24, 1181–1188 (2021). https://doi.org/10.1038/s41391-021-00389-2

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