5 june 2016

ASCO 2016
Testicular cancer: the 5-year results of GETUG 13

On Sunday 5th June at the American Society of Clinical Oncology (ASCO) annual meeting, Professor Karim Fizazi (Oncologist specialising in genitourinary tumours and Head of the Gustave Roussy Department of Medical Oncology) presented the results of 5 years of follow-up in the GETUG 13 study, In this study the patients had a very serious form of testicular cancer. This was an international, phase III, multicentre, comparative study sponsored by UNICANCER, coordinated by Professor Fizazi, and financed by INCa (National Cancer Institute) and the National Cancer League.

GETUG 13 shows that the standard protocol is not adequate for patients with severe testicular cancer and that the use of a personalised approach within a more intensive, so-called «dose-dense» protocol clearly reduces the risk of relapse or death. This represents the first advance in therapy for these patients in more than 25 years” stated Professor Fizazi.

In the GETUG 13 study, all the patients with testicular cancer of poor prognosis started on the same chemotherapy, the standard BEP protocol, combined treatment with 3 anti-cancer agents. Blood markers (hCG and AFP) were assayed 3 weeks later and further treatment depended on the results of this. If the marker levels were falling rapidly, the patient just continued on the BEP protocol. However, if the blood markers were falling slowly, the patient was randomised between two study arms: patients in the first arm continued to receive standard chemotherapy according to the BEP protocol; whereas those in the second arm were subject to an intensive, dose-dense protocol employing six chemotherapeutic drugs.

The results after 5 years of follow-up demonstrate the role of measuring the fall in blood markers in order to personalise chemotherapy in these patients with poor-prognosis testicular cancer.

Measuring the fall in biomarker values to personalise treatment

Patients treated according to the standard BEP protocol show clear differences related to the pattern of decline in blood marker levels. Those whose levels fall rapidly display a reduction of 54% in the risk of tumour progression and death in comparison with those for whom the drop is a slow one. 71% of the patients with rapid falls are alive without disease progression as against 47% of those where the falls are slow. The overall survival value is 78% in the former group against 61% in the latter one.

Intensive chemotherapy confers advantage in patients with slow falls in blood markers.

For patients with an unfavourable pattern of reduction in marker levels, 60% treated using the dose-dense protocol are alive without disease progression at 5 years compared with only 47% of those treated according to the BEP protocol. The value for reduction in the risk of tumour progression or death is 35%.

The overall survival figure is 70.4% for patients in the dose-dense arm and 60.8% for those given BEP. The reduction in risk of death is 31% when patients with an unfavourable prognosis receive dose-dense chemotherapy, but, because of the small number of patients, this does not achieve significance.

More severe side effects, such as neurotoxicity, were seen with dose-dense chemotherapy but the difference does diminish over time. There were no differences in renal or pulmonary adverse events and no greater risk of developing a second cancer.

This technique also reduces the need for recourse to aggressive salvage chemotherapy with peripheral stem cell transplant (8% of the patients treated by the dose-dense protocol compared with 17% of those in the BEP arm).

The significant findings from this study ought to lead to the general adoption of intensive, dose-dense chemotherapy as a new standard treatment for those patients with poor-prognosis testicular cancer whose blood tumour markers fall slowly (translator: on conventional therapy). The results from GETUG 13 at five years confirm and amplify those that were presented in 2013.

> Read the abstract: Mature results of the GETUG 13 phase III trial in poor-prognosis germ-cell tumors (GCT).

About GETUG 13

Sponsored by UNICANCER, the GETUG 13 study received a grant from the hospital programme of clinical research in oncology (PHRC), in the context of a call for projects from the National Cancer Institute (INCa). Since it was launched in 2003, the study has been financed by the National Cancer League and is thus registered as an orphan disease research priority.
This international study has recruited a total of 263 patients in France, the United States and Slovakia.

About cancer of the testis

Cancer of the testis is the commonest tumour in young men (mean age of 25-30 years). It affects some 2,500 men per year in France. The 5-year survival rate is 95%1. There are about one hundred poor-prognosis cases of testicular cancer per year in France. Up to 2014, patients with a poor prognosis were treated with BEP according to the standard protocol and the rate of cure was only about 50%.

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