Accelerated BEP for metastatic germ cell tumours

a multicenter phase II trial by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)

Peter Grimison, Martin Stockler, Mark Chatfield, D Thomson, V Gebski, M Friedlander, A Boland, Baerin Houghton, H Gurney, M Rosenthal, N Singhal, G Kichenadasse, S Wong, C Lewis, P Vasey, Guy Toner

    Research output: Contribution to journalArticleResearchpeer-review

    Abstract

    Background: This Australian single-arm, multicenter, phase II trial evaluated feasibility, tolerability and activity of accelerated bleomycin, etoposide and cisplatin (BEP) as first-line chemotherapy for metastatic germ cell tumours.

    Patients and methods:
    Patients were planned to receive cisplatin 20 mg/m2 and etoposide 100 mg/m2 days 1-5, and pegfilgrastim 6 mg day 6, all repeated every 2 weeks for four cycles (three cycles for good prognosis). Bleomycin was given at 30 000 IU weekly to a total of 12 doses (9 doses for good prognosis). Primary end point was feasibility, defined as the proportion of patients able to complete the etoposide and cisplatin components of BEP and be eligible to receive a fourth cycle of BEP by day 50.

    Results: Twelve poor, 16 intermediate and 15 good prognosis (n = 43) eligible patients were enrolled. Two patients aged >40 years were ineligible and excluded from analyses. The regimen was feasible in 86%, not feasible in 7% and not assessable in 7% of patients. Most common grade 3/4 adverse events were non-neutropenic infection (16%) and febrile neutropenia (12%). Complete response (CR) to chemotherapy and surgery was achieved in 33% poor-prognosis, 81% intermediate-prognosis and 100% good-prognosis patients. At median follow-up of 27 months (range 6-42), the 2-year progression-free survival was 50% for poor-prognosis, 94% for intermediate-prognosis and 92% for good-prognosis patients.

    Conclusion: Accelerated BEP is feasible and tolerable. Efficacy data appear to be promising. This trial and a similar UK study provide the rationale for a randomised trial comparing accelerated versus standard BEP.
    Original languageEnglish
    Pages (from-to)143-148
    Number of pages6
    JournalAnnals of Oncology
    Volume25
    Issue number1
    DOIs
    Publication statusPublished - 2014

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    Urogenital Neoplasms
    Germ Cell and Embryonal Neoplasms
    Bleomycin
    Etoposide
    New Zealand
    Cisplatin
    Prostatic Neoplasms
    Drug Therapy
    Febrile Neutropenia
    Disease-Free Survival

    Cite this

    Grimison, Peter ; Stockler, Martin ; Chatfield, Mark ; Thomson, D ; Gebski, V ; Friedlander, M ; Boland, A ; Houghton, Baerin ; Gurney, H ; Rosenthal, M ; Singhal, N ; Kichenadasse, G ; Wong, S ; Lewis, C ; Vasey, P ; Toner, Guy. / Accelerated BEP for metastatic germ cell tumours : a multicenter phase II trial by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). In: Annals of Oncology. 2014 ; Vol. 25, No. 1. pp. 143-148.
    @article{bf55eceac97e43bfae50a0108bc7dcfb,
    title = "Accelerated BEP for metastatic germ cell tumours: a multicenter phase II trial by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)",
    abstract = "Background: This Australian single-arm, multicenter, phase II trial evaluated feasibility, tolerability and activity of accelerated bleomycin, etoposide and cisplatin (BEP) as first-line chemotherapy for metastatic germ cell tumours.Patients and methods: Patients were planned to receive cisplatin 20 mg/m2 and etoposide 100 mg/m2 days 1-5, and pegfilgrastim 6 mg day 6, all repeated every 2 weeks for four cycles (three cycles for good prognosis). Bleomycin was given at 30 000 IU weekly to a total of 12 doses (9 doses for good prognosis). Primary end point was feasibility, defined as the proportion of patients able to complete the etoposide and cisplatin components of BEP and be eligible to receive a fourth cycle of BEP by day 50. Results: Twelve poor, 16 intermediate and 15 good prognosis (n = 43) eligible patients were enrolled. Two patients aged >40 years were ineligible and excluded from analyses. The regimen was feasible in 86{\%}, not feasible in 7{\%} and not assessable in 7{\%} of patients. Most common grade 3/4 adverse events were non-neutropenic infection (16{\%}) and febrile neutropenia (12{\%}). Complete response (CR) to chemotherapy and surgery was achieved in 33{\%} poor-prognosis, 81{\%} intermediate-prognosis and 100{\%} good-prognosis patients. At median follow-up of 27 months (range 6-42), the 2-year progression-free survival was 50{\%} for poor-prognosis, 94{\%} for intermediate-prognosis and 92{\%} for good-prognosis patients.Conclusion: Accelerated BEP is feasible and tolerable. Efficacy data appear to be promising. This trial and a similar UK study provide the rationale for a randomised trial comparing accelerated versus standard BEP.",
    author = "Peter Grimison and Martin Stockler and Mark Chatfield and D Thomson and V Gebski and M Friedlander and A Boland and Baerin Houghton and H Gurney and M Rosenthal and N Singhal and G Kichenadasse and S Wong and C Lewis and P Vasey and Guy Toner",
    year = "2014",
    doi = "10.1093/annonc/mdt369",
    language = "English",
    volume = "25",
    pages = "143--148",
    journal = "Annals of Oncology",
    issn = "0923-7534",
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    Grimison, P, Stockler, M, Chatfield, M, Thomson, D, Gebski, V, Friedlander, M, Boland, A, Houghton, B, Gurney, H, Rosenthal, M, Singhal, N, Kichenadasse, G, Wong, S, Lewis, C, Vasey, P & Toner, G 2014, 'Accelerated BEP for metastatic germ cell tumours: a multicenter phase II trial by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)', Annals of Oncology, vol. 25, no. 1, pp. 143-148. https://doi.org/10.1093/annonc/mdt369

    Accelerated BEP for metastatic germ cell tumours : a multicenter phase II trial by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). / Grimison, Peter; Stockler, Martin; Chatfield, Mark; Thomson, D; Gebski, V; Friedlander, M; Boland, A; Houghton, Baerin; Gurney, H; Rosenthal, M; Singhal, N; Kichenadasse, G; Wong, S; Lewis, C; Vasey, P; Toner, Guy.

    In: Annals of Oncology, Vol. 25, No. 1, 2014, p. 143-148.

    Research output: Contribution to journalArticleResearchpeer-review

    TY - JOUR

    T1 - Accelerated BEP for metastatic germ cell tumours

    T2 - a multicenter phase II trial by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)

    AU - Grimison, Peter

    AU - Stockler, Martin

    AU - Chatfield, Mark

    AU - Thomson, D

    AU - Gebski, V

    AU - Friedlander, M

    AU - Boland, A

    AU - Houghton, Baerin

    AU - Gurney, H

    AU - Rosenthal, M

    AU - Singhal, N

    AU - Kichenadasse, G

    AU - Wong, S

    AU - Lewis, C

    AU - Vasey, P

    AU - Toner, Guy

    PY - 2014

    Y1 - 2014

    N2 - Background: This Australian single-arm, multicenter, phase II trial evaluated feasibility, tolerability and activity of accelerated bleomycin, etoposide and cisplatin (BEP) as first-line chemotherapy for metastatic germ cell tumours.Patients and methods: Patients were planned to receive cisplatin 20 mg/m2 and etoposide 100 mg/m2 days 1-5, and pegfilgrastim 6 mg day 6, all repeated every 2 weeks for four cycles (three cycles for good prognosis). Bleomycin was given at 30 000 IU weekly to a total of 12 doses (9 doses for good prognosis). Primary end point was feasibility, defined as the proportion of patients able to complete the etoposide and cisplatin components of BEP and be eligible to receive a fourth cycle of BEP by day 50. Results: Twelve poor, 16 intermediate and 15 good prognosis (n = 43) eligible patients were enrolled. Two patients aged >40 years were ineligible and excluded from analyses. The regimen was feasible in 86%, not feasible in 7% and not assessable in 7% of patients. Most common grade 3/4 adverse events were non-neutropenic infection (16%) and febrile neutropenia (12%). Complete response (CR) to chemotherapy and surgery was achieved in 33% poor-prognosis, 81% intermediate-prognosis and 100% good-prognosis patients. At median follow-up of 27 months (range 6-42), the 2-year progression-free survival was 50% for poor-prognosis, 94% for intermediate-prognosis and 92% for good-prognosis patients.Conclusion: Accelerated BEP is feasible and tolerable. Efficacy data appear to be promising. This trial and a similar UK study provide the rationale for a randomised trial comparing accelerated versus standard BEP.

    AB - Background: This Australian single-arm, multicenter, phase II trial evaluated feasibility, tolerability and activity of accelerated bleomycin, etoposide and cisplatin (BEP) as first-line chemotherapy for metastatic germ cell tumours.Patients and methods: Patients were planned to receive cisplatin 20 mg/m2 and etoposide 100 mg/m2 days 1-5, and pegfilgrastim 6 mg day 6, all repeated every 2 weeks for four cycles (three cycles for good prognosis). Bleomycin was given at 30 000 IU weekly to a total of 12 doses (9 doses for good prognosis). Primary end point was feasibility, defined as the proportion of patients able to complete the etoposide and cisplatin components of BEP and be eligible to receive a fourth cycle of BEP by day 50. Results: Twelve poor, 16 intermediate and 15 good prognosis (n = 43) eligible patients were enrolled. Two patients aged >40 years were ineligible and excluded from analyses. The regimen was feasible in 86%, not feasible in 7% and not assessable in 7% of patients. Most common grade 3/4 adverse events were non-neutropenic infection (16%) and febrile neutropenia (12%). Complete response (CR) to chemotherapy and surgery was achieved in 33% poor-prognosis, 81% intermediate-prognosis and 100% good-prognosis patients. At median follow-up of 27 months (range 6-42), the 2-year progression-free survival was 50% for poor-prognosis, 94% for intermediate-prognosis and 92% for good-prognosis patients.Conclusion: Accelerated BEP is feasible and tolerable. Efficacy data appear to be promising. This trial and a similar UK study provide the rationale for a randomised trial comparing accelerated versus standard BEP.

    UR - http://www.scopus.com/inward/record.url?scp=84905367678&partnerID=8YFLogxK

    U2 - 10.1093/annonc/mdt369

    DO - 10.1093/annonc/mdt369

    M3 - Article

    VL - 25

    SP - 143

    EP - 148

    JO - Annals of Oncology

    JF - Annals of Oncology

    SN - 0923-7534

    IS - 1

    ER -