{"entity":{"id":"hd16","kind":"trial","name":"GHSG HD16","aka":["HD16","Positron emission tomography-guided omission of radiotherapy in early Hodgkin lymphoma"],"tldr":"Trying to spare people radiotherapy by using a clear scan after two rounds of chemotherapy cost them about seven in a hundred in disease control, so the radiotherapy stayed.","summary":"Radiotherapy in early Hodgkin lymphoma is the main cause of the second cancers and heart disease that the Dutch late-effects cohorts measured decades later, so omitting it in people who respond quickly has been the field's most wanted de-escalation. HD16 tested it directly. 1,150 patients aged 18 to 75 with newly diagnosed early-stage favourable Hodgkin lymphoma were randomised to standard combined-modality treatment of two cycles of ABVD with 20 Gy of involved-field radiotherapy, or to a positron emission tomography-guided arm in which the radiotherapy was omitted after a negative scan.\n\nAmong the 628 patients with a negative scan treated per protocol, five-year progression-free survival was 93.4 per cent (95 per cent confidence interval 90.4 to 96.5) with combined-modality treatment and 86.1 per cent (81.4 to 90.9) with chemotherapy alone, a difference of 7.3 points (1.6 to 13.0) and a hazard ratio of 1.78 (1.02 to 3.12). Five-year overall survival was 98.1 and 98.4 per cent. Among the 693 patients assigned to combined-modality treatment, a positive scan after two cycles predicted worse progression-free survival, 88.4 against 93.2 per cent (p = 0.047), and the gap widened to 93.1 against 80.9 per cent (p = 0.0011) when the more common liver threshold of Deauville score 4 was used.\n\nThe trial is a clear negative for the de-escalation it tested and a clear positive for the prognostic value of the interim scan. It is also the reason that the current attempts to drop radiotherapy, such as RADAR, change the chemotherapy as well rather than relying on the scan alone.","status":"negative","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT00736320","url":"https://clinicaltrials.gov/study/NCT00736320"},{"label":"Journal of Clinical Oncology 2019","url":"https://doi.org/10.1200/JCO.19.00964"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["early-stage-classical-hodgkin-lymphoma","hodgkin-lymphoma"],"sections":["radiation","chemotherapy","imaging"],"technologies":["radiotherapy","pet-ct"],"targets":[],"drugs":["doxorubicin","bleomycin","vinblastine","dacarbazine"],"companies":["ghsg"],"institutions":[],"pathways":[],"terms":["deauville-score","abvd-beacopp"],"trials":["hd10","eortc-h10","radar-hodgkin"],"people":["peter-borchmann","andreas-engert"],"bottlenecks":["b-negative-results","b-survivorship","b-toxicity-qol"],"keyPapers":["paper-ghsg-hd16-pet-guided-early-favourable-hodgkin-jco-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00736320","phase":"3","setting":"Early-stage favourable Hodgkin lymphoma: two cycles of ABVD with 20 Gy involved-field radiotherapy against the same chemotherapy with radiotherapy omitted if the scan after two cycles is negative","sponsor":"University of Cologne (German Hodgkin Study Group)","result":"Omitting radiotherapy after a negative interim scan cost 7.3 percentage points of five-year progression-free survival (86.1 against 93.4 per cent), with identical overall survival.","started":"2009-11","yearReported":2019,"enrolled":1150,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 5 years, scan-negative patients","primary":true,"unit":"%","arms":[{"name":"Chemotherapy with radiotherapy","value":93.4,"note":"95 per cent confidence interval 90.4 to 96.5"},{"name":"Chemotherapy alone","value":86.1,"note":"81.4 to 90.9"}],"hr":1.78,"ci":[1.02,3.12],"source":"https://doi.org/10.1200/JCO.19.00964"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Chemotherapy with radiotherapy","value":98.1},{"name":"Chemotherapy alone","value":98.4}]}],"replication":"The same direction as the scan-negative comparison in EORTC H10 and the United Kingdom RAPID trial: omitting radiotherapy costs tumour control."},"route":"/trials/hd16/","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/"}],"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":"radiotherapy","kind":"term","name":"Radiotherapy","route":"/terms/radiotherapy/"}],"technology":[{"id":"pet-ct","kind":"technology","name":"PET/CT","route":"/technologies/pet-ct/"}],"drug":[{"id":"bleomycin","kind":"drug","name":"Bleomycin","route":"/drugs/bleomycin/"},{"id":"dacarbazine","kind":"drug","name":"Dacarbazine","route":"/drugs/dacarbazine/"},{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"},{"id":"vinblastine","kind":"drug","name":"Vinblastine","route":"/drugs/vinblastine/"}],"company":[{"id":"ghsg","kind":"company","name":"German Hodgkin Study Group","route":"/companies/ghsg/"}],"trial":[{"id":"eortc-h10","kind":"trial","name":"EORTC/LYSA/FIL H10","route":"/trials/eortc-h10/"},{"id":"hd10","kind":"trial","name":"GHSG HD10","route":"/trials/hd10/"},{"id":"radar-hodgkin","kind":"trial","name":"RADAR","route":"/trials/radar-hodgkin/"}],"person":[{"id":"andreas-engert","kind":"person","name":"Andreas Engert","route":"/people/andreas-engert/"},{"id":"peter-borchmann","kind":"person","name":"Peter Borchmann","route":"/people/peter-borchmann/"}],"bottleneck":[{"id":"b-negative-results","kind":"bottleneck","name":"Failures are hidden","route":"/bottlenecks/b-negative-results/"},{"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-van-nimwegen-cardiovascular-disease-after-hodgkin-jama-intern-med-2015","kind":"paper","name":"Cardiovascular disease after Hodgkin lymphoma treatment: 40-year disease risk","route":"/key-papers/paper-van-nimwegen-cardiovascular-disease-after-hodgkin-jama-intern-med-2015/"},{"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/"},{"id":"paper-ghsg-hd16-pet-guided-early-favourable-hodgkin-jco-2019","kind":"paper","name":"Positron emission tomography-guided treatment in early-stage favorable Hodgkin lymphoma: final results of the international, randomized phase III HD16 trial by the German Hodgkin Study Group","route":"/key-papers/paper-ghsg-hd16-pet-guided-early-favourable-hodgkin-jco-2019/"},{"id":"paper-schaapveld-second-cancer-risk-40-years-hodgkin-nejm-2015","kind":"paper","name":"Second cancer risk up to 40 years after treatment for Hodgkin's lymphoma","route":"/key-papers/paper-schaapveld-second-cancer-risk-40-years-hodgkin-nejm-2015/"}],"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/"}]}}