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. 2019 May 3;19(1):30.
doi: 10.1186/s12894-019-0463-7.

A retrospective feasibility study of biweekly docetaxel in patients with high-risk metastatic castration-naïve prostate cancer

Sang Eun Yoon  1 , Youjin Kim  1 , Jangho Cho  1 , Minyong Kang  2 , Hyun Hwan Sung  2 , Hwang Gyun Jeon  2 , Byoung Chang Jeong  2 , Seong Il Seo  2 , Seong Soo Jeon  2 , Hyun Moo Lee  2 , Han Yong Choi  2   3 , Su Jin Lee  1 , Se Hoon Park  4
Affiliations

A retrospective feasibility study of biweekly docetaxel in patients with high-risk metastatic castration-naïve prostate cancer

Sang Eun Yoon et al. BMC Urol. .

Abstract

Background: Results from randomized phase III trials have shown that thrice-weekly docetaxel added to androgen-deprivation therapy (ADT) has a significant impact on the survival of patients with metastatic castration-naïve prostate cancer (mCNPC) and established early chemotherapy as part of the standard of care for high-risk disease. Controversy remains, however, because some patients experience critical toxicities related to docetaxel. The purpose of the current study was to evaluate the feasibility and adverse events of biweekly-administered docetaxel in patients with previously-untreated, high-risk mCNPC.

Methods: The study included 35 consecutive patients with high-risk mCNPC who received ADT plus docetaxel 40 mg/m2. Oral prednisone 5 mg twice daily was also given. Treatment was repeated every two weeks for up to 12 cycles or until disease progression or unacceptable toxicity occurred. High-risk was defined as bone metastases beyond axial skeleton and/or visceral disease.

Results: The included patients' median age was 68 years (range: 31-86 years) and 17 (49%) had visceral metastases. Biweekly docetaxel was generally well-tolerated; the most commonly observed adverse events, considering those of all grades, included alopecia (74%), nail changes (42%), and constipation (31%). Hematologic adverse events were infrequent, and no patient received hematopoietic growth factors. One patient died after the fourth cycle due to respiratory failure, which occurred as a complication of pneumonia. Among the 35 patients, 28 completed the planned 12 cycles of biweekly docetaxel. Prostate-specific antigen response (> 50% decrease from baseline) was recorded in 33 patients (94%), and the radiologic response rate was 49%. Median progression-free survival was 13.6 months (95% confidence interval: 6.7-20.4).

Conclusion: ADT plus biweekly-administered docetaxel appeared to be tolerated and effective in patients with high-risk mCNPC.

Keywords: Biweekly; Castration-naïve prostate cancer; Docetaxel.

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Conflict of interest statement

Ethics approval and consent to participate

This research is strictly retrospective and involving the collection of existing data and records. This study was approved by the Institutional Review Board of Samsung Medical Center (Seoul, Korea; IRB_2017–01-005) and written informed consent was provided by all patients prior to starting chemotherapy, according to our institutional standards.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Kaplan–Meier curve for PFS (solid line) and OS (dotted line)
See this image and copyright information in PMC

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