Retrospective Cohort Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Oncol. Nov 24, 2021; 12(11): 1009-1022
Published online Nov 24, 2021. doi: 10.5306/wjco.v12.i11.1009
Real-world evaluation of upfront docetaxel in metastatic castration-sensitive prostate cancer
Jenny Isaksson, Henrik Green, Dimitrios Papantoniou, Linn Pettersson, Mats Anden, Johan Rosell, Elisabeth Åvall-Lundqvist, Nils Oskar Elander
Jenny Isaksson, Elisabeth Åvall-Lundqvist, Nils Oskar Elander, Department of Oncology, Department of Biomedical and Clinical Sciences, Linköping University, Linköping 58185, Sweden
Henrik Green, Division of Drug Research, Department of Biomedical and Clinical Sciences, Linköping University, Linköping 58185, Sweden
Dimitrios Papantoniou, Linn Pettersson, Department of Oncology, Ryhov County Hospital, Jönköping 55305, Sweden
Mats Anden, Department of Oncology, Kalmar County Hospital, Kalmar 39244, Sweden
Johan Rosell, Regional Cancer Center Southeast Sweden, Linköping University, Linköping 58185, Sweden
Author contributions: Isaksson J, Green H, Åvall-Lundqvist E and Elander NO designed the study; Isaksson J acquired the patient data with the help of Papantoniou D, Pettersson L and Anden M at the respective sites; Isaksson J, Green H, Rosell J and Elander NO analyzed the data; Isaksson J, Green H and Elander NO drafted the first version of the manuscript; all authors helped develop the methodology and perform the investigation, and all read and approved the final manuscript.
Institutional review board statement: The study was conducted in accordance with the Declaration of Helsinki and was approved by the Regional Ethics Review board in Linköping, Region Östergötland, Sweden, No. 2018/139–31.
Informed consent statement: Based on the retrospective and noninterventional nature of the study and the absence of publication of individual data, the ethics board did not consider it possible or necessary to obtain written informed consent.
Conflict-of-interest statement: None of the authors have any conflicts of interest to declare.
Data sharing statement: Additional data are available at reasonable request to the corresponding author.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Corresponding author: Nils Oskar Elander, MD, PhD, Doctor, Department of Oncology, Department of Biomedical and Clinical Sciences, Linköping University, Linköping University Hospital, Linköping 58185, Sweden.
Received: March 23, 2021
Peer-review started: March 23, 2021
First decision: July 27, 2021
Revised: August 9, 2021
Accepted: October 18, 2021
Article in press: October 18, 2021
Published online: November 24, 2021
Research background

Randomized phase-III trials indicate that upfront treatment with docetaxel, in addition to androgen deprivation therapy (ADT), improves survival in metastatic castration-sensitive prostate cancer (mCSPC). Less is known about the outcome of such treatment in real-world patients treated outside the frames of a clinical trial.

Research motivation

It is important to assess the outcome and safety of upfront docetaxel and ADT combination therapy following its implementation in real-world patients with mCSPC.

Research objectives

To evaluate the outcome of docetaxel and ADT combination therapy in real-world patients with mCSPC in terms of progression-free survival (PFS), overall survival (OS), and safety.

Research methods

A multicenter retrospective noninterventional study was performed and included 94 first consecutive real-world patients with mCSPC receiving upfront docetaxel and ADT in the Southeast Health Care Region of Sweden. Univariate and multivariate regression analyses were performed to identify prognostic parameters. Adverse events and unplanned hospitalizations were thoroughly reviewed.

Research results

PFS at 12 and 24 mo was 75% and 58%, while OS was 93% and 86% concurrently points, respectively. High baseline PSA levels were associated with worse prognosis in multivariate regression analysis. Twenty-one percent of the patients experienced febrile neutropenia, and 26% had at least one episode of unplanned hospitalization.

Research conclusions

The outcome and safety of docetaxel and ADT combination therapy in mCSPC appear similar in real-world and randomized controlled trial populations. This study supports further implementation of this treatment strategy in standard of care.

Research perspectives

Future studies must identify clinically useful biomarkers and tools for tailored treatment strategies in patients with mCSPC.