Alternating dose-dense chemotherapy in patients with high volume disseminated non-seminomatous germ cell tumours

K. Fizazi, D. M. Prow, K. A. Do, X. Wang, L. Finn, J. Kim, D. Daliani, C. N. Papandreou, S. M. Tu, R. E. Millikan, L. C. Pagliaro, C. J. Logothetis, R. J. Amato

Research output: Contribution to journalArticle

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Abstract

Only about half of patients with a poor-prognosis non-seminomatous germ-cell tumours can achieve a cure. The aim of this phase II study was to assess the efficacy and toxicity of a dose-dense alternating chemotherapy regimen in this subset of patients. High volume non-seminomatous germ-cell tumours was defined as follows: at least two sites of non pulmonary metastases, an extragonadal primary tumour, a serum human chorionic gonadotropin level higher than 10 000 mlU ml-1, of a alpha-foetoprotein level higher than 2000 mlU ml-1. Patients who fulfilled these criteria were treated with the so-called BOP-CISCA-POMB-ACE regimen (bleomycin, vincristine, and cisplatin; cisplatin, cyclophosphamide, and doxorubicin; cisplatin, vincristine, methotrexate, and bleomycin; etoposide, dactinomycin, and cyclophosphamide) plus granulocyte colony-stimulating factor. A total of 58 patients were enrolled. Patients were retrospectively classified according to the International Germ-Cell Cancer Consensus Group classification; 38 patients (66%) had poor-prognosis disease and 19 patients (33%) had intermediate-prognosis. Patients received a median of 2.5 courses (range 0.25 to five courses) of the BOP-CISCA-POMB-ACE regimen. Forty-two patients (72.4%) had a complete response to therapy. With a median follow-up time of 31 months, the 3-year progression-free survival rate was 71% (95% confidence interval, 60 to 84%) and the 3-year overall survival rate was 73% (95% confidence interval: 62 to 86%). The 3-year PFS rates were 83% (95% confidence interval: 68 to 100%) in the intermediate-prognosis group and 65% (95% confidence interval: 51 to 82%) in the poor-prognosis group. Early side effects included mainly grade 4 haematologic toxicity (neutropaenia in 79% of patients, thrombocytopaenia in 69%, anaemia in 22%), grade 4 stomatitis (19%), and four early deaths (7% of patients), at least partially related to toxicity. The dose-dense BOP-CISCA-POMB-ACE regimen is highly active in patients with non-seminomatous germ-cell tumours classified as intermediate-prognosis or poor-prognosis according to the International Germ-Cell Cancer Consensus Group. Because outcomes with this regimen compare favourably with outcome after standard therapy, dose-dense chemotherapy should be further investigated in this subset of patients.

Original languageEnglish (US)
Pages (from-to)1555-1560
Number of pages6
JournalBritish Journal of Cancer
Volume86
Issue number10
DOIs
StatePublished - May 20 2002
Externally publishedYes

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Drug Therapy
Confidence Intervals
Cisplatin
Germ Cell and Embryonal Neoplasms
Bleomycin
Vincristine
Nonseminomatous germ cell tumor
Cyclophosphamide
Survival Rate
Stomatitis
alpha-Fetoproteins
Dactinomycin
Granulocyte Colony-Stimulating Factor
Etoposide
Chorionic Gonadotropin
Methotrexate
Doxorubicin
Disease-Free Survival
Anemia
Neoplasm Metastasis

Keywords

  • Chemotherapy
  • Dose-dense chemotherapy
  • Germ-cell tumours
  • International Germ-Cell Cancer Consensus Group
  • Non-seminomatous germ cell-tumours

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Alternating dose-dense chemotherapy in patients with high volume disseminated non-seminomatous germ cell tumours. / Fizazi, K.; Prow, D. M.; Do, K. A.; Wang, X.; Finn, L.; Kim, J.; Daliani, D.; Papandreou, C. N.; Tu, S. M.; Millikan, R. E.; Pagliaro, L. C.; Logothetis, C. J.; Amato, R. J.

In: British Journal of Cancer, Vol. 86, No. 10, 20.05.2002, p. 1555-1560.

Research output: Contribution to journalArticle

Fizazi, K, Prow, DM, Do, KA, Wang, X, Finn, L, Kim, J, Daliani, D, Papandreou, CN, Tu, SM, Millikan, RE, Pagliaro, LC, Logothetis, CJ & Amato, RJ 2002, 'Alternating dose-dense chemotherapy in patients with high volume disseminated non-seminomatous germ cell tumours', British Journal of Cancer, vol. 86, no. 10, pp. 1555-1560. https://doi.org/10.1038/sj.bjc.6600272
Fizazi, K. ; Prow, D. M. ; Do, K. A. ; Wang, X. ; Finn, L. ; Kim, J. ; Daliani, D. ; Papandreou, C. N. ; Tu, S. M. ; Millikan, R. E. ; Pagliaro, L. C. ; Logothetis, C. J. ; Amato, R. J. / Alternating dose-dense chemotherapy in patients with high volume disseminated non-seminomatous germ cell tumours. In: British Journal of Cancer. 2002 ; Vol. 86, No. 10. pp. 1555-1560.
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AU - Finn, L.

AU - Kim, J.

AU - Daliani, D.

AU - Papandreou, C. N.

AU - Tu, S. M.

AU - Millikan, R. E.

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N2 - Only about half of patients with a poor-prognosis non-seminomatous germ-cell tumours can achieve a cure. The aim of this phase II study was to assess the efficacy and toxicity of a dose-dense alternating chemotherapy regimen in this subset of patients. High volume non-seminomatous germ-cell tumours was defined as follows: at least two sites of non pulmonary metastases, an extragonadal primary tumour, a serum human chorionic gonadotropin level higher than 10 000 mlU ml-1, of a alpha-foetoprotein level higher than 2000 mlU ml-1. Patients who fulfilled these criteria were treated with the so-called BOP-CISCA-POMB-ACE regimen (bleomycin, vincristine, and cisplatin; cisplatin, cyclophosphamide, and doxorubicin; cisplatin, vincristine, methotrexate, and bleomycin; etoposide, dactinomycin, and cyclophosphamide) plus granulocyte colony-stimulating factor. A total of 58 patients were enrolled. Patients were retrospectively classified according to the International Germ-Cell Cancer Consensus Group classification; 38 patients (66%) had poor-prognosis disease and 19 patients (33%) had intermediate-prognosis. Patients received a median of 2.5 courses (range 0.25 to five courses) of the BOP-CISCA-POMB-ACE regimen. Forty-two patients (72.4%) had a complete response to therapy. With a median follow-up time of 31 months, the 3-year progression-free survival rate was 71% (95% confidence interval, 60 to 84%) and the 3-year overall survival rate was 73% (95% confidence interval: 62 to 86%). The 3-year PFS rates were 83% (95% confidence interval: 68 to 100%) in the intermediate-prognosis group and 65% (95% confidence interval: 51 to 82%) in the poor-prognosis group. Early side effects included mainly grade 4 haematologic toxicity (neutropaenia in 79% of patients, thrombocytopaenia in 69%, anaemia in 22%), grade 4 stomatitis (19%), and four early deaths (7% of patients), at least partially related to toxicity. The dose-dense BOP-CISCA-POMB-ACE regimen is highly active in patients with non-seminomatous germ-cell tumours classified as intermediate-prognosis or poor-prognosis according to the International Germ-Cell Cancer Consensus Group. Because outcomes with this regimen compare favourably with outcome after standard therapy, dose-dense chemotherapy should be further investigated in this subset of patients.

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