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Testicular germ-cell tumours · Medical Oncology · Salvage chemotherapy

IT-94: conventional-dose versus high-dose salvage

After relapse following first-line chemotherapy for germ-cell tumours, does adding a single high-dose chemotherapy consolidation after conventional salvage improve survival?

Histology scope: Mixed GCT · randomized second-line study. This is not a seminoma-only efficacy estimate.

Study population
280 randomized
Evidence type
Randomized trial · mixed GCT

Reported outcomes

IT-94 compared four cycles of conventional-dose VIP/VeIP with three cycles followed by high-dose carboplatin/etoposide/cyclophosphamide and stem-cell support. Response rates were similar (about 56%); 3-year event-free survival was 35% versus 42% (P=.16), without a demonstrated significant survival benefit from the high-dose strategy.

3-y event-free survival · conventional35%
3-y event-free survival · HDCT42%
Toxic deaths · conventional3%
Toxic deaths · HDCT7%

Source-reported values only. NNT is not applicable to this single-arm or non-randomized evidence.

Interpretation and guideline context

This randomized trial did not demonstrate a statistically significant benefit for the tested single high-dose consolidation strategy and showed higher treatment-related mortality. Its HDCT schedule differs from contemporary sequential approaches such as TI-CE.

ESMO–EURACAN 2022 lists standard-dose VIP/PEI, TIP or VeIP among first-salvage options after relapse. NCCN Testicular Cancer Guidelines Insights Version 2.2025 is linked as a contemporary guideline source. Neither guideline converts mixed-histology cohorts into seminoma-specific evidence.

ESMO–EURACAN guideline ↗ · NCCN Insights v2.2025 ↗

Primary source

Pico JL, Rosti G, Kramar A, et al. A randomised trial of high-dose chemotherapy in the salvage treatment of patients failing first-line platinum chemotherapy for advanced germ cell tumours. Ann Oncol. 2005;16:1152–1159.

Original study / PubMed ↗

Evidence review date: 18 October 2026. Full clinical freshness and browser-rendered visual QA remain pending.