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The only randomised trial ever run exclusively in the virus-driven T-cell leukaemia found an intensive Japanese regimen better than standard chemotherapy, at the cost of much more severe low blood counts.
Adult T-cell leukaemia/lymphoma is caused by human T-lymphotropic virus type 1, a virus endemic in southwestern Japan, where Hinuma's seroepidemiology found antibodies in 26 per cent of healthy adults, and in a small number of other regions. JCOG9801 is the only randomised controlled trial conducted exclusively in the disease. 118 previously untreated patients with aggressive disease were assigned to six courses of VCAP-AMP-VECP, a Japanese three-part regimen, every four weeks, or to eight courses of CHOP every two weeks. Both arms used granulocyte colony-stimulating factor support and intrathecal prophylaxis.
The complete response rate was higher with VCAP-AMP-VECP, 40 against 25 per cent (p = 0.020). One-year progression-free survival was 28 against 16 per cent (p = 0.100, two-sided p = 0.200) and three-year overall survival 24 against 13 per cent (p = 0.085, two-sided p = 0.169), so the time-to-event endpoints did not reach significance. Grade 4 neutropenia occurred in 98 against 83 per cent, grade 4 thrombocytopenia in 74 against 17 per cent and grade 3 or 4 infection in 32 against 15 per cent, with three toxic deaths in the intensive arm.
The trial is quoted as establishing VCAP-AMP-VECP as the Japanese standard, and the survival numbers are the honest reason the field has kept looking: three-year overall survival of 24 per cent is what the best available chemotherapy achieved. Allogeneic transplantation, mogamulizumab and interferon with zidovudine in the leukaemic subtypes are the routes that followed. The disease has no cancer record of its own in OnCo yet; it is attached here to peripheral T-cell lymphoma.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
118 analysed.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Complete response rateprimary | VCAP-AMP-VECP | - | 40% | - | 0.020 | link |
| Biweekly CHOP | - | 25% | ||||
| Overall survival at 3 years | VCAP-AMP-VECP | - | 24% | - | 0.085 one-sided, 0.169 two-sided | - |
| Biweekly CHOP | - | 13% |
The Japanese standard regimen for aggressive adult T-cell leukaemia/lymphoma rests on this trial. Three-year overall survival of 24 per cent with the better arm is the plainest statement of how much room remains, and is why allogeneic transplantation, mogamulizumab and antiviral approaches have all been pursued since.
The seroepidemiology that tied a virus to a cancer across a population rather than in one patient. It is the reason blood donations are screened for human T-lymphotropic virus type 1 in Japan and elsewhere, and the reason breastfeeding advice is part of cancer prevention in endemic regions.
The first human retrovirus, and the start of the line of work that identified HIV three years later. For lymphoma it means that adult T-cell leukaemia/lymphoma has a known, transmissible, preventable cause, and that screening blood donors and advising on breastfeeding in endemic areas are cancer prevention measures.
Shares ECHELON-2, Complete response, Randomised evidence for the T-cell lymphomas, including the ones that are not in Europe or North America, Etoposide and the tag lymphoma-evidence.
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Shares Prednisone, Trials enrol too few, too slowly, Vincristine, Rare and paediatric cancers without markets and the tag lymphoma-evidence.
Shares Prednisone, Vincristine, Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma), Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting and the tag lymphoma-evidence.
Shares Prednisone, Vincristine, Etoposide, Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting and the tag lymphoma-evidence.
Shares Prednisone, Vincristine, Etoposide, Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting and the tag lymphoma-evidence.
Shares Prednisone, Vincristine, Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting, Cyclophosphamide and the tag lymphoma-evidence.
Shares Prednisone, Trials enrol too few, too slowly, Vincristine, Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting and the tag lymphoma-evidence.