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Clinical Research

Toxicity in patients receiving adjuvant docetaxel + hormonal treatment after radical radiotherapy for intermediate or high-risk prostate cancer: a preplanned safety report of the SPCG-13 trial

Prostate Cancer and Prostatic Diseases volume 15, pages 303–307 (2012)Cite this article

Subjects

Abstract

Background:

Radical radiotherapy (RT) combined with androgen deprivation therapy is currently the standard treatment for elderly patients with localized intermediate- or high-risk prostate cancer (PC). To increase the recurrence-free and overall survival, we conducted an adjuvant, randomized trial using docetaxel (T) in PC patients (Scandinavian Prostate Cancer Group trial 13).

Methods:

The inclusion criteria are the following: men >18 and ⩽75 years of age, WHO/ECOG performance status 0–1, histologically proven PC within 12 months before randomization and one of the following: T2, Gleason 7 (4+3), PSA >10; T2, Gleason 8–10, any PSA; or any T3 tumors. Neoadjuvant/adjuvant hormone therapy is mandatory for all patients. The patients were randomized to receive six cycles of T (75 mg m−2 d 1. cycle 21 d) or no docetaxel after radical RT (with a minimum tumor dose of 74 Gy). This study identifier number is NTC 006653848 (http://www.clinicaltrials.org).

Results:

In this preplanned safety analysis of 100 patients, T treatment induced grade (G) 3 adverse events (AEs) in 15 patients (30%) and G4 AEs in 30 patients (60%), mainly due to bone marrow toxicity. Neutropenia G3–4 was observed in 72% of the patients, febrile neutropenia was found in 24% of patients, neutropenic infection in 10% of patients and G3 infection without neutropenia in 4% of patients. Nonhematological G3 AEs were rare: anorexia, diarrhea, mucositis, nausea, pain (1 patient each) and fatigue (5). Other severe serious AEs related to T were pulmonary embolism and renal failure. However, only three patients discontinued T before completing the planned six cycles. No deaths had occurred. No patients in the control arm experienced G3–4 toxicities at 12 weeks after the randomization.

Conclusions:

Adjuvant docetaxel chemotherapy after radiotherapy has a higher frequency of neutropenia than previous studies on patients with metastatic disease. Otherwise, the treatment was quite well tolerated.

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Acknowledgements

We thank all the patients and investigators of the SPCG-13 trial: Sweden Ann-Sofie Fransson, Gävle, Lars Franzén, Sundsvall, Lennart Åström, Uppsala, Mihail Seke, Växjö, Marie Hjälm-Eriksson, Radiumhemmet, Stockholm, Petr Gorzov, Mälarsjukhuset, Eskilstuna, Finland Markku Leskinen, Martti Ala-Opas, Timo Marttila, Paul Nyandoto, Taina Turpeenniemi-Hujanen, Norway Jon R Iversen Ullevål, Ireland Maccon Keane, University College Hospital, Galway.

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Authors and Affiliations

  1. Department of Oncology and Radiotherapy, Tampere University Hospital, Tampere, Finland

    P-L Kellokumpu-Lehtinen

  2. Karolinska University Hospital, Stockholm, Sweden

    M Hjälm-Eriksson

  3. Umeå University Hospital, Umeå, Sweden

    C Thellenberg-Karlsson

  4. Uppsala University Hospital, Uppsala, Sweden

    L Åström

  5. Sundsvall University Hospital, Sundsvall, Sweden

    L Franzen

  6. Seinäjoki Central Hospital, Seinäjoki, Finland

    T Marttila

  7. Växjö Central Hospital, Växjö, Sweden

    M Seke

  8. 4Pharma, Turku, Finland

    M Taalikka

  9. Karlstad Central Hospital, Karlstad, Sweden

    C Ginman

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Correspondence to P-L Kellokumpu-Lehtinen.

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Competing interests

The trial is supported by Sanofi-Aventis. Dr Kellokumpu-Lehtinen and Dr Marttila has received compensation for an advisory role or lectures from Sanofi-Aventis.

Additional information

Presented at the GU-ASCO February 19–24, 2011, Orlando, FL.

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Kellokumpu-Lehtinen, PL., Hjälm-Eriksson, M., Thellenberg-Karlsson, C. et al. Toxicity in patients receiving adjuvant docetaxel + hormonal treatment after radical radiotherapy for intermediate or high-risk prostate cancer: a preplanned safety report of the SPCG-13 trial. Prostate Cancer Prostatic Dis 15, 303–307 (2012). https://doi.org/10.1038/pcan.2012.13

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