Comparative assessment of docetaxel for safety and efficacy between hormone-sensitive and castration-resistant metastatic prostate cancer

Mager, René; Savko, Olga; Böhm, Katharina; Thomas, Anita C; Dotzauer, Robert; Borgmann, Hendrik; Jäger, Wolfgang; Thomas, Christian; Haferkamp, Axel; Höfner, Thomas; Tsaur, Igor

doi:10.1016/j.urolonc.2019.07.005

Cited by 8 publications

(3 citation statements)

References 25 publications

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“…To our knowledge, this is the rst study that systematically reports the real world outcome of upfront docetaxel in a Scandinavian context. Other real world studies, conducted in other countries and/or ethnical groups, largely corroborate our ndings; Lavoie et al assessed the clinical effectiveness of upfront docetaxel in a Canadian setting, showing a similar outcome and safety data to ours with 12 months OS of 91% and 26% experiencing a grade 3-4 febrile neutropenia [16], and comparable outcomes were also reported in a German study [17] and in Northern American non-white populations [18] The main strengths of the present study include the truly real world setup, covering all eligible patients in a reasonably large geographical region. As there are no non-governmental healthcare providers offering cancer chemotherapy in the South East Region in Sweden, every patient that was given the therapy and met the inclusion criteria were included.…”

Section: Discussionsupporting

confidence: 91%

Real World Evaluation of Upfront Docetaxel in Metastatic Castrate Sensitive Prostate Cancer

Isaksson

Gréen

Papantoniou

et al. 2021

Preprint

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Background: Recent randomised phase III trials demonstrate survival benefit for the addition of upfront docetaxel to androgen deprivation therapy (ADT) in metastatic castrate sensitive prostate cancer (mCSPC). Following its implementation in routine care, this combined treatment strategy needs further evaluation in a real world setting.Methods: A multicentre retrospective cohort study in the South East Health care region of Sweden was conducted. All patients given upfront docetaxel for mCSPC from July 2015 until December 2017 were included. Primary endpoint was progression free survival (PFS) at 12 months and secondary endpoints were PFS at 24 months, overall survival (OS), treatment intensity, adverse events, and unplanned hospitalisations. Exploratory analyses on potentially prognostic parameters were performed.Results: 94 patients were eligible and formed the study cohort. PFS at 12 and 24 months were 75% (95% CI 66-84) and 58% (46-70). OS at 12 and 24 months were 93% (87-99) and 86% (76-96). 91% (n=86) initiated docetaxel according to the standard protocol of 75 mg/m2 every 3 weeks (6 cycles), whereas 9% (n=8) received a modified protocol of 50 mg/m2 every 2 weeks (9 cycles). The average overall dose intensity for those commencing standard treatment was 91%. Univariate cox regression analyses revealed that baseline PSA >180 vs <180 and presence vs absence of distant metastases were negative prognostic factors (HR 2.86, 95% CI 1.39-5.87, p =0.0041 and 3.36, 95% CI 1.03-10.96, p=0.045). Following multivariate analysis, the statistical significance remained for PSA (2.51, CI 1.21-5.19, p =0.013) but not for metastatic status (2.60, 95% CI 0.78-8.65, p=0.12). Febrile neutropenia was recorded in 21% (n=20) and 26% (n=24) had at least one episode of unplanned hospitalisation under and up to 30 days after the treatment course. Conclusions: The outcome and safety profile of upfront docetaxel in addition to androgen deprivation therapy in metastatic castrate sensitive prostate cancer appear similar in real world and randomised controlled populations. Further implementation of this treatment strategy is encouraged.

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Section: Discussionsupporting

confidence: 91%

Real World Evaluation of Upfront Docetaxel in Metastatic Castrate Sensitive Prostate Cancer

Isaksson

Gréen

Papantoniou

et al. 2021

Preprint

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“…Other real-world studies conducted in other countries and/or ethnic groups corroborate the results of this study. Lavoie et al [ 16 ] assessed the clinical effectiveness of upfront docetaxel in a Canadian setting, showing a similar outcome and safety data to those of this study, with 12-mo OS of 91% and 26% experiencing grade 3–4 febrile neutropenia[ 16 ], and comparable outcomes were also reported in a German study[ 17 ] and in Northern American non-white populations[ 18 ].…”

Section: Discussionsupporting

confidence: 73%

Real-world evaluation of upfront docetaxel in metastatic castration-sensitive prostate cancer

Isaksson¹,

Gréen²,

Papantoniou³

et al. 2021

WJCO

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BACKGROUND The majority of patients with newly diagnosed metastatic prostate cancer (PC) initially respond to androgen deprivation therapy (ADT) and are classified as metastatic castration-sensitive PC (mCSPC). Following months to years of ADT, the disease tends to become resistant to ADT. Recent randomized phase-III trials demonstrated a survival benefit with the addition of upfront docetaxel to ADT in mCSPC. Following its implementation in routine care, this combined treatment strategy requires more detailed evaluation in a real-world setting. AIM To assess the real-world outcome and safety of upfront docetaxel treatment in mCSPC. METHODS A multicenter retrospective cohort study in the Southeast Health Care Region of Sweden was performed. This region includes approximately 1.1 million citizens and the oncology departments of Linköping, Jönköping, and Kalmar. All patients given upfront docetaxel for mCSPC from July 2015 until December 2017 were included. The primary endpoint was progression-free survival (PFS) at 12 mo, and the secondary endpoints were PFS at 24 mo, overall survival (OS), treatment intensity, adverse events, and unplanned hospitalizations. Exploratory analyses on potential prognostic parameters were performed. RESULTS Ninety-four patients were eligible and formed the study cohort. PFS at 12 and 24 mo was 75% (95%CI: 66–84) and 58% (46–70), respectively. OS at 12 and 24 mo was 93% (87–99) and 86% (76–96). A total of 91% of patients ( n = 86) were given docetaxel according to the standard protocol of 75 mg/m 2 every 3 wk (6 cycles), while 9% ( n = 8) received a modified protocol of 50 mg/m 2 every 2 wk (9 cycles). The average overall dose intensity for those commencing standard treatment was 91%. Univariate Cox regression analyses show that baseline PSA > 180 vs < 180 and the presence of distant metastases vs locoregional lymph node metastases were only negative prognostic factors (HR 2.86, 95%CI: 1.39–5.87, P = 0.0041 and 3.36, 95%CI: 1.03–10.96, P = 0.045). Following multivariate analysis, statistical significance remained for PSA (2.51, 95%CI: 1.21–5.19, P = 0.013) but not for metastatic status (2.60, 95%CI: 0.78–8.65, P = 0.12). Febrile neutropenia was recorded in 21% ( n = 20) of patients, and 26% ( n = 24) had at least one episode of unplanned hospitalization under and up to 30 d after the treatment course. CONCLUSION Results from this study support the implementation of upfront docetaxel plus ADT as part of the standard of care treatment strategy in mCSPC.

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“…However, there are several adverse effects related to drug toxicity. The most significant effect is the occurrence of neutropenia, anemia, gastrointestinal disorders and peripheral neuropathy (Mager et al 2019). In addition, the presence of polysorbate 80 as a surfactant to solubilize the drug, which is highly lipophilic, can induce hypersensitivity reactions in patients (Engels, Mathot, and Verweij 2007).…”

Section: Introductionmentioning

confidence: 99%

EGFR-targeted immunoliposomes efficiently deliver docetaxel to prostate cancer cells

Eloy

Ruiz

Lima

et al. 2020

Colloids and Surfaces B: Biointerfaces

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Prostate cancer is the second cause of cancer death in men worldwide. Docetaxel (DTX), an antimitotic drug, is widely used for the treatment of metastatic prostate cancer patients.Taxotere ® is a commercial DTX formulation. It contains a polysorbate 80 surfactant to improve DTX aqueous solubility, which has been associated with hypersensitivity reactions in patients. Liposomes have been used as promising delivery systems for a range of hydrophobic drugs, such as DTX, offering improved drug water solubility and biocompatibility, without compromising its anticancer activity. Herein, DTX-loaded liposomes were developed using the Box-Behnken factorial design. The optimized formulation was nano-sized, homogenous in size (67.47 nm) with high DTX encapsulation efficiency (99.95%). The encapsulated DTX was in a soluble amorphous state, which was slowly released. Next, to increase the liposomes selectivity to prostate cancer cells, cetuximab, an anti-EGFR monoclonal antibody. was successfully conjugated to the surface of liposomes, without compromising cetuximab protein structure and stability. As expected, our results showed higher cellular uptake and toxicity of immunoliposomes, compared to non-targeted liposomes, in DU145 (EGFRoverxpressing) prostate cancer cells. To the best of our knowledge, this is the first report of engineering EGFR-targeted liposomes to enhance the selectivity of DTX delivery to EGFR-positive prostate cancer cells.

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Comparative assessment of docetaxel for safety and efficacy between hormone-sensitive and castration-resistant metastatic prostate cancer

Cited by 8 publications

References 25 publications

Real World Evaluation of Upfront Docetaxel in Metastatic Castrate Sensitive Prostate Cancer

Real World Evaluation of Upfront Docetaxel in Metastatic Castrate Sensitive Prostate Cancer

Real-world evaluation of upfront docetaxel in metastatic castration-sensitive prostate cancer

EGFR-targeted immunoliposomes efficiently deliver docetaxel to prostate cancer cells

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