Successive EORTC trials have registered continuous progress in the development of treatment strategies for Hodgkin’s lymphoma. These trials have not only improved treatment efficacy, but have also identified clinical and biological parameters that could be used to adapt the treatment strategy.
The greatly improved outcomes resulting from the earlier trials meant that subsequent trials could focus on reducing (late) treatment toxicity while maintaining excellent disease control. Restricting radiotherapy to the involved node, for example, was developed for patients with early stage Hodgkin’s lymphoma, and mounting evidence of late effects following radiotherapy instigated efforts to further reduce radiation doses.
The EORTC 20101 – 23101 H11 trial will investigate the benefit of very early FDG-PET/CT (18F fluorodeoxyglucose – positron emission tomography / computed tomography) response adapted therapy for patients with advanced Hodgkin’s Lymphoma. The H11 trial posits that patients who might be cured with ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine) chemotherapy could be selected very early on the basis of a negative FDG-PET/CT scan after just one cycle of ABVD. Patients with a positive FDG-PET/CT scan could have their treatment changed to the more intensive BEACOPPesc (bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone escalated regimen) treatment after just one ABVD cycle. This would be early enough to avoid compromising the possible superior effectiveness of the BEACOPPesc treatment for these patients.
Patients in the experimental arm will begin treatment with ABVD. If they have a negative FDG-PET/CT scan after one cycle of ABVD, they will continue with ABVD. If the FDG-PET/CT scan is positive, they will be switched to BEACOPPesc treatment. Patients in the standard arm will be treated with BEACOPPesc throughout. The objective is to show that this ABVD response adapted therapy for patients with advanced stage Hodgkin’s lymphoma has non-inferior efficacy compared with the standard BEACOPPesc regimen.
Dr. Martin Hutchings of the Rigshospitalet, Copenhagen and Coordinator of this study says “We believe this trial is an important and necessary part of our efforts to make the treatment of advanced Hodgkin’s lymphoma more and more tailored to the individual patient. The EORTC Lymphoma Group and our partners groups are very pleased to be able to offer our patients inclusion in this trial”.
EORTC trial 20101 – 23101 plans to accrue 600 patients and will be conducted in 24 sites in seven countries: Belgium, The Netherlands, France, Poland, Croatia, Portugal, and Denmark. The EORTC is the Sponsor in all participating countries, and the trial is coordinated by the EORTC Lymphoma Group in collaboration with the EORTC Imaging Group and the Polish Lymphoma Research Group. It is an entirely academic trial supported by the EORTC Academic Fund and a private donation.
For more information concerning EORTC trial 20101 – 23101 please contact: www.eortc.org/contact
John Bean, MA PhD
EORTC, Medical Science Writer