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

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 mIU x ml(-1), or a alpha-foetoprotein level higher than 2000 mIU 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.

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 ... -  《-》

The management and survival of patients with advanced germ-cell tumours: improving outcome in intermediate and poor prognosis patients.

Bhala N ，Coleman JM ，Radstone CR ，Horsman JM ，George J ，Hancock BW ，Hatton MQ ，Coleman RE ... -  《-》

Treatment of men with metastatic non-seminomatous germ cell tumours with cyclical POMB/ACE chemotherapy.

Bower M ，Newlands ES ，Holden L ，Rustin GJ ，Begent RH ... -  《-》

Long-term results of first-line sequential high-dose etoposide, ifosfamide, and cisplatin chemotherapy plus autologous stem cell support for patients with advanced metastatic germ cell cancer: an extended phase I/II study of the German Testicular Cancer S

Schmoll HJ ，Kollmannsberger C ，Metzner B ，Hartmann JT ，Schleucher N ，Schöffski P ，Schleicher J ，Rick O ，Beyer J ，Hossfeld D ，Kanz L ，Berdel WE ，Andreesen R ，Bokemeyer C ，German Testicular Cancer Study Group ... -  《JOURNAL OF CLINICAL ONCOLOGY》

A 20% dose reduction of the original CISCA/VB regimen allows better tolerance and similar survival rate in disseminated testicular non-seminomatous germ-cell tumors: final results of a phase III randomized trial.

Fizazi K ，Do KA ，Wang X ，Finn L ，Logothetis CJ ，Amato RJ ... -  《ANNALS OF ONCOLOGY》