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Short-term outcomes of risk-adapted upfront docetaxel administration in patients with metastatic hormone-sensitive prostate cancer: a multicenter prospective study in Japan

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Abstract

We conducted a risk-adapted upfront docetaxel (DOC) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Here, we reported an interim analysis of the study. The study enrolled 68 patients with newly diagnosed mHSPC between 2016 and 2018. According to the presence of visceral metastasis, an EOD score ≥ 3, or prostate-specific antigen (PSA) level at 3 months of ≥ 1 ng/mL, patients were divided into low- and high-risk groups. Patients were treated with androgen deprivation therapy (ADT) with or without bicalutamide; those in the high-risk group received upfront treatment involving six cycles of DOC (70 mg/m2). Short-term treatment effect, adverse events, and quality of life (QOL) were evaluated. Fifty (73.5%) were classified in the high-risk group, and 46 (67%) received upfront ADT + DOC. In the ADT + DOC group, 43.5% (20/46) patients achieved a PSA level ≤ 0.2 ng/mL. PSA nadir and time to PSA nadir were 0.291 ng/mL and 288 days, respectively. In the ADT + DOC group, 76.1% (35/42) patients had adverse events (AEs) of grade ≥ 3. During a median follow-up of 18.5 months, 36.4% (8/22) patients in the ADT group and 43.5% (20/46) in the ADT + DOC group had CRPC. Two QOL scores including the physical status and appetite loss at 6 months significantly worsened in the ADT + DOC group but was resolved by 12 months. Upfront DOC achieved high PSA responses without long-term QOL deterioration. However, the short-term outcomes were limited. Longer follow-up is needed to determine the survival advantage.

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Acknowledgements

We would like to thank to Yoko Mitobe, Yukiko Sugiyama, Masako Nagata, and Saeko Nakamura for their assistance in performing this study.

Funding

This study was supported in part by a research grant from the MEXT/JSPS (Kakenhi, Nos. 16H02679, 19K18551, 19K16706, 19K09663). The funding bodies listed here do not have any roles in the design of the study or collection, analysis, and interpretation of data or in writing the manuscript.

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Authors and Affiliations

  1. Department of Urology, Akita University School of Medicine, 1-1-1 Hondo, Akita, 010-8543, Japan

    Yumina Muto, Shintaro Narita, Shuji Chiba, Hiromi Sato, Atsushi Koizumi & Tomonori Habuchi

  2. Department of Urology, Hirosaki University School of Medicine, Hirosaki, Japan

    Shingo Hatakeyama & Chikara Ohyama

  3. Department of Urology, Iwate Prefectural Isawa Hospital, Oshu, Japan

    Shinya Maita, Yuu Aoyama & Jiro Shimoda

  4. Department of Urology, Hiraka General Hospital, Yokote, Japan

    Kyohei Kubo & Takehiro Suzuki

  5. Department of Urology, Yuri Kumiai General Hospital, Yurihonjo, Japan

    Ryuichi Ito & Susumu Akihama

  6. Department of Urology, Omagari Kousei Medical Center, Akita, Japan

    Yoshiko Takahashi & Teruaki Kumazawa

  7. Department of Urology, Akita Red Cross Hospital, Akita, Japan

    Shuhei Takahashi & Yohei Horikawa

  8. Department of Urology, Akita City Hospital, Akita, Japan

    Kumiko Nakamura & Toshiya Ishida

  9. Department of Urology, Akita Kousei Medical Center, Akita, Japan

    Naoko Honma & Katsumi Okane

  10. Department of Urology, Yokote Municipal Hospital, Akita, Japan

    Ryoma Igarashi

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  1. Yumina Muto
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  2. Shintaro Narita
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Contributions

YM, SN: Data collection, statistical analysis, manuscript writing. SH, SM, SC, KK, YA, RI, YT, ST, KN, NH, HS, AK, RI: Data collection. KO, TI, YH, TK, SA, JS, TS: protocol development. SN: Data analysis. CO: supervision. TH: manuscript editing, supervision. All authors have read and approved the final manuscript.

Corresponding author

Correspondence to Shintaro Narita.

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Conflict of interest

SN received honoraria from Janssen Pharmaceutical K.K., Bayer AG. Dr., AstraZeneca K.K., Takeda Pharmaceutical Company Ltd., Sanofi S.A., Astellas Pharma Inc. and grants for research from Novartis Pharmaceuticals.CO received honoraria from Janssen Pharmaceutical K.K., Takeda Pharmaceutical Company Ltd., Astellas Pharma Inc., Sanofi S.A., Bayer AG. and Nippon Shinyaku, Company Ltd. TH received honoraria from Janssen Pharmaceutical K.K., Takeda Pharmaceutical Company Ltd., Astellas Pharma Inc., Daiichi Sankyo Company, Ltd., AstraZeneca K.K.,Sanofi S.A., and Bayer AG. All the other authors declare that they have no conflicts of interest associated with this research.

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Muto, Y., Narita, S., Hatakeyama, S. et al. Short-term outcomes of risk-adapted upfront docetaxel administration in patients with metastatic hormone-sensitive prostate cancer: a multicenter prospective study in Japan. Med Oncol 38, 37 (2021). https://doi.org/10.1007/s12032-021-01480-3

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