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)

P. S. Grimison, M. R. Stockler, M. Chatfield, D. B. Thomson, V. Gebski, M. Friedlander, A. L. Boland, B. Houghton, H. Gurney, M. Rosenthal, N. Singhal, G. Kichenadasse, S. S. Wong, C. R. Lewis, P. A. Vasey, G. C. 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.

LanguageEnglish
Article numbermdt369
Pages143-148
Number of pages6
JournalAnnals of Oncology
Volume25
Issue number1
DOIs
Publication statusPublished - 2014
Externally publishedYes

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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

Keywords

  • Accelerated
  • Antineoplastic combined chemotherapy
  • Dose-density
  • Germ cell tumours
  • Growth factors
  • Testicular neoplasms

Cite this

Grimison, P. S., Stockler, M. R., Chatfield, M., Thomson, D. B., Gebski, V., Friedlander, M., ... Toner, G. C. (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, 25(1), 143-148. [mdt369]. https://doi.org/10.1093/annonc/mdt369
Grimison, P. S. ; Stockler, M. R. ; Chatfield, M. ; Thomson, D. B. ; Gebski, V. ; Friedlander, M. ; Boland, A. L. ; Houghton, B. ; Gurney, H. ; Rosenthal, M. ; Singhal, N. ; Kichenadasse, G. ; Wong, S. S. ; Lewis, C. R. ; Vasey, P. A. ; Toner, G. C. / 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.
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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.",
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author = "Grimison, {P. S.} and Stockler, {M. R.} and M. Chatfield and Thomson, {D. B.} and V. Gebski and M. Friedlander and Boland, {A. L.} and B. Houghton and H. Gurney and M. Rosenthal and N. Singhal and G. Kichenadasse and Wong, {S. S.} and Lewis, {C. R.} and Vasey, {P. A.} and Toner, {G. C.}",
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Grimison, PS, Stockler, MR, Chatfield, M, Thomson, DB, Gebski, V, Friedlander, M, Boland, AL, Houghton, B, Gurney, H, Rosenthal, M, Singhal, N, Kichenadasse, G, Wong, SS, Lewis, CR, Vasey, PA & Toner, GC 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, mdt369, 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, P. S.; Stockler, M. R.; Chatfield, M.; Thomson, D. B.; Gebski, V.; Friedlander, M.; Boland, A. L.; Houghton, B.; Gurney, H.; Rosenthal, M.; Singhal, N.; Kichenadasse, G.; Wong, S. S.; Lewis, C. R.; Vasey, P. A.; Toner, G. C.

In: Annals of Oncology, Vol. 25, No. 1, mdt369, 2014, p. 143-148.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Accelerated BEP for metastatic germ cell tumours

T2 - Annals of Oncology

AU - Grimison, P. S.

AU - Stockler, M. R.

AU - Chatfield, M.

AU - Thomson, D. B.

AU - Gebski, V.

AU - Friedlander, M.

AU - Boland, A. L.

AU - Houghton, B.

AU - Gurney, H.

AU - Rosenthal, M.

AU - Singhal, N.

AU - Kichenadasse, G.

AU - Wong, S. S.

AU - Lewis, C. R.

AU - Vasey, P. A.

AU - Toner, G. C.

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.

KW - Accelerated

KW - Antineoplastic combined chemotherapy

KW - Dose-density

KW - Germ cell tumours

KW - Growth factors

KW - Testicular neoplasms

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

M1 - mdt369

ER -