{"entity":{"id":"eortc-h10","kind":"trial","name":"EORTC/LYSA/FIL H10","aka":["H10","EORTC H10","Early positron emission tomography response-adapted treatment in early Hodgkin lymphoma"],"tldr":"In early Hodgkin lymphoma, people whose scan was still positive after two rounds did much better on more intensive chemotherapy, and people whose scan was clear still needed their radiotherapy.","summary":"H10 tested both directions of scan-adapted treatment at once, in people with stage I and II Hodgkin lymphoma classified by the European Organisation for Research and Treatment of Cancer criteria as favourable or unfavourable. The standard arm was ABVD followed by involved-node radiotherapy irrespective of the scan. In the experimental arm, a negative scan after two cycles meant ABVD alone, tested for non-inferiority; a positive scan meant switching to two cycles of escalated BEACOPP with involved-node radiotherapy, tested for superiority.\n\nOf 1,950 randomly assigned patients, 1,925 had an early scan and 361 (18.8 per cent) were positive. In those scan-positive patients, intensification worked: five-year progression-free survival rose from 77.4 per cent with ABVD and radiotherapy to 90.6 per cent with escalated BEACOPP and radiotherapy (hazard ratio 0.42, 95 per cent confidence interval 0.23 to 0.74, p = 0.002). In the scan-negative patients, non-inferiority of ABVD alone could not be demonstrated in either group: in the favourable group five-year progression-free survival was 99.0 per cent with combined treatment against 87.1 per cent without (hazard ratio 15.8, 3.8 to 66.1), and in the unfavourable group 92.1 against 89.6 per cent (hazard ratio 1.45, 0.8 to 2.5).\n\nThe 99.0 per cent figure in the favourable group is the most striking number in early Hodgkin lymphoma and sets the bar any radiotherapy-sparing strategy has to clear. Together with HD16 and RAPID it establishes that an interim scan identifies who needs more treatment far better than it identifies who needs less.","status":"mixed","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT00433433","url":"https://clinicaltrials.gov/study/NCT00433433"},{"label":"Journal of Clinical Oncology 2017","url":"https://doi.org/10.1200/JCO.2016.68.6394"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["early-stage-classical-hodgkin-lymphoma","hodgkin-lymphoma"],"sections":["radiation","chemotherapy","imaging"],"technologies":["pet-ct","radiotherapy","imrt-igrt"],"targets":[],"drugs":["doxorubicin","bleomycin","vinblastine","dacarbazine","etoposide","cyclophosphamide","vincristine","procarbazine","prednisone"],"companies":[],"institutions":[],"pathways":[],"terms":["deauville-score","abvd-beacopp","non-inferiority"],"trials":["hd16","hd10","rathl"],"people":[],"bottlenecks":["b-survivorship","b-toxicity-qol"],"keyPapers":["paper-eortc-h10-pet-adapted-early-hodgkin-jco-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00433433","phase":"3","setting":"Stage I and II Hodgkin lymphoma: standard ABVD with involved-node radiotherapy against treatment adapted to the scan after two cycles, intensifying for a positive scan and dropping radiotherapy for a negative one","sponsor":"European Organisation for Research and Treatment of Cancer","result":"Switching a positive interim scan to escalated BEACOPP raised five-year progression-free survival from 77.4 to 90.6 per cent; omitting radiotherapy after a negative scan was not non-inferior in either risk group.","started":"2006-10","startedType":"actual","yearReported":2017,"enrolled":1925,"enrolledBasis":"analysed","enrolledNote":"1,950 patients were randomly assigned and 1,925 had an early scan, of whom 361 (18.8 per cent) were positive.","outcomes":[{"endpoint":"Progression-free survival at 5 years, scan-positive patients","primary":true,"unit":"%","arms":[{"name":"Escalated BEACOPP with involved-node radiotherapy","value":90.6},{"name":"ABVD with involved-node radiotherapy","value":77.4}],"hr":0.42,"ci":[0.23,0.74],"p":"0.002","source":"https://doi.org/10.1200/JCO.2016.68.6394"},{"endpoint":"Progression-free survival at 5 years, scan-negative favourable group","unit":"%","arms":[{"name":"ABVD with involved-node radiotherapy","value":99},{"name":"ABVD alone","value":87.1}],"hr":15.8,"ci":[3.8,66.1]},{"endpoint":"Progression-free survival at 5 years, scan-negative unfavourable group","unit":"%","arms":[{"name":"ABVD with involved-node radiotherapy","value":92.1},{"name":"ABVD alone","value":89.6}],"hr":1.45,"ci":[0.8,2.5]}],"replication":"The scan-negative finding matches HD16 and the United Kingdom RAPID trial; the scan-positive intensification finding matches RATHL in advanced disease."},"route":"/trials/eortc-h10/","neighbours":{"cancer":[{"id":"early-stage-classical-hodgkin-lymphoma","kind":"cancer","name":"Early-stage classical Hodgkin lymphoma (stage I to II)","route":"/cancers/early-stage-classical-hodgkin-lymphoma/"},{"id":"hodgkin-lymphoma","kind":"cancer","name":"Hodgkin lymphoma","route":"/cancers/hodgkin-lymphoma/"}],"section":[{"id":"chemotherapy","kind":"section","name":"Chemotherapy","route":"/fronts/chemotherapy/"},{"id":"imaging","kind":"section","name":"Imaging","route":"/fronts/imaging/"},{"id":"radiation","kind":"section","name":"Radiation Therapy","route":"/fronts/radiation/"}],"technology":[{"id":"imrt-igrt","kind":"technology","name":"IMRT / IGRT (modern external beam)","route":"/technologies/imrt-igrt/"},{"id":"pet-ct","kind":"technology","name":"PET/CT","route":"/technologies/pet-ct/"}],"term":[{"id":"abvd-beacopp","kind":"term","name":"ABVD, BEACOPP and BrECADD (Hodgkin lymphoma regimens)","route":"/terms/abvd-beacopp/"},{"id":"deauville-score","kind":"term","name":"Deauville five-point scale","route":"/terms/deauville-score/"},{"id":"non-inferiority","kind":"term","name":"Non-inferiority trial","route":"/terms/non-inferiority/"},{"id":"radiotherapy","kind":"term","name":"Radiotherapy","route":"/terms/radiotherapy/"}],"drug":[{"id":"bleomycin","kind":"drug","name":"Bleomycin","route":"/drugs/bleomycin/"},{"id":"cyclophosphamide","kind":"drug","name":"Cyclophosphamide","route":"/drugs/cyclophosphamide/"},{"id":"dacarbazine","kind":"drug","name":"Dacarbazine","route":"/drugs/dacarbazine/"},{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"},{"id":"etoposide","kind":"drug","name":"Etoposide","route":"/drugs/etoposide/"},{"id":"prednisone","kind":"drug","name":"Prednisone","route":"/drugs/prednisone/"},{"id":"procarbazine","kind":"drug","name":"Procarbazine","route":"/drugs/procarbazine/"},{"id":"vinblastine","kind":"drug","name":"Vinblastine","route":"/drugs/vinblastine/"},{"id":"vincristine","kind":"drug","name":"Vincristine","route":"/drugs/vincristine/"}],"trial":[{"id":"hd10","kind":"trial","name":"GHSG HD10","route":"/trials/hd10/"},{"id":"hd16","kind":"trial","name":"GHSG HD16","route":"/trials/hd16/"},{"id":"radar-hodgkin","kind":"trial","name":"RADAR","route":"/trials/radar-hodgkin/"},{"id":"rathl","kind":"trial","name":"RATHL","route":"/trials/rathl/"}],"bottleneck":[{"id":"b-survivorship","kind":"bottleneck","name":"Survivorship and late effects are neglected","route":"/bottlenecks/b-survivorship/"},{"id":"b-toxicity-qol","kind":"bottleneck","name":"Toxicity and quality of life are undervalued","route":"/bottlenecks/b-toxicity-qol/"}],"paper":[{"id":"paper-eortc-h10-pet-adapted-early-hodgkin-jco-2017","kind":"paper","name":"Early positron emission tomography response-adapted treatment in stage I and II Hodgkin lymphoma: final results of the randomized EORTC/LYSA/FIL H10 trial","route":"/key-papers/paper-eortc-h10-pet-adapted-early-hodgkin-jco-2017/"}],"roadmap":[{"id":"lymphoma-roadmap","kind":"roadmap","name":"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","route":"/roadmaps/lymphoma-roadmap/"}],"idea":[{"id":"lymphoma-ev-radiotherapy-free-early-hodgkin","kind":"idea","name":"A radiotherapy-free cure for early Hodgkin lymphoma that actually holds","route":"/ideas/lymphoma-ev-radiotherapy-free-early-hodgkin/"}]}}