GETUG 13: personalised chemotherapy based on tumour marker decline in poor-prognosis germ cell tumours
Men with poor-prognosis testicular cancer whose tumour markers fell too slowly after one cycle of BEP did better when their chemotherapy was intensified, with fewer needing high-dose salvage treatment.
Overview
Phase 3 multicentre randomised trial: of 263 patients with poor-prognosis non-seminomatous germ cell tumours, 203 with an unfavourable marker decline after one BEP cycle were randomised to continue BEP (98) or switch to dose-dense chemotherapy (105); 51 with a favourable decline continued BEP.
Three-year progression-free survival was 59 percent with dose-dense chemotherapy against 48 percent with BEP (hazard ratio 0.66, p 0.05) and 70 percent in the favourable group. More grade 3 to 4 neurotoxicity and haematotoxicity occurred with intensification, with no difference in toxic deaths; salvage high-dose chemotherapy was needed in 6 against 16 percent.
- Three-year progression-free survival 59 percent (95% CI 49 to 68) versus 48 percent (38 to 59); hazard ratio 0.66 (0.44 to 1.00), p 0.05.
- Favourable marker decline group: three-year progression-free survival 70 percent (57 to 81).
- Salvage high-dose chemotherapy 6 versus 16 percent; grade 3 to 4 neurotoxicity 7 versus 1 percent.
Early tumour marker decline should guide treatment intensification in poor-prognosis germ cell tumours, which is now standard in expert centres.
- Borderline statistical significance; the dose-dense regimen is complex and toxic and belongs in high-volume centres.
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