Intensifying standard chemotherapy, known as escalated eBEACOPP, with the anti-CD20 antibody Rituxan (rituximab) showed no added benefit to progression-free survival in patients with advanced-stage Hodgkin’s lymphoma (HL), according to updated results of the HD18 trial (NCT00515554).
German researchers presented their study, “Ebeacopp with or without rituximab in interim-pet-positive advanced-stage hodgkin lymphoma: updated results of the international, randomized phase 3 ghsg hd18 trial,”at the European Hematology Association Annual Congress, held June 22-25 in Madrid.
An intensive chemotherapy regimen with six to eight cycles of eBEACOPP – a mixture of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone – was shown to be effective in patients with advanced-stage HL.
Coupling positron emission tomography (PET), an imaging technique that assesses tissue and organ metabolic responses, after two cycles of eBEACOPP can guide clinicians in choosing the best treatments as well as making better predictions of patient’s outcomes.
Researchers at Cologne’s University Hospital hypothesized that intensifying standard chemotherapy (eight cycles of eBEACOPP) by adding Rituxan would improve progression-free survival in PET-2 positive patients.
They performed a clinical study (NCT00515554) on patients with newly diagnosed, advanced-stage HL who still had signs of cancer in their PET scans after two cycles of chemo. Patients were initially randomized to receive six additional cycles of eBEACOPP or eBEACOPP plus Rituxan (R-eBEACOPP), totaling eight cycles of chemo.
Later, the standard treatment was changed from eight to six cycles, after the HD15 trial showed that treatment with six cycles of eBEACOPP followed by PET-guided radiotherapy was more effective and less toxic than eight cycles of the same chemo regimen.
Between May 2008 and June 2011, researchers recruited 434 patients with positive PET-2 and randomly assigned them to eBEACOPP or R-eBEACOPP. Then, after June 2011, 506 PET2-positive patients were assigned to standard treatment with six cycles of eBEACOPP.
Participants were followed for a median of 5.5 years. Among patients initially treated with eight cycles of eBEACOPP, the estimated five-year progression-free survival was 89.7 percent for those on eBEACOPP and 88.1 percent for those on R-eBEACOPP. After five years, 96.4 percent of patients in the first group were still alive, as were 93.9 percent of patients in the second.
Among patients recruited after June 2011 and who received six cycles of eBEACOPP, 98 percent were still alive and 92 percent were disease-free three years after enrollment.
These findings show that adding Rituxan to eBEACOPP does not improve the progression-free survival of patients with advanced-stage HL. Researchers also observed that progression-free survival was comparable between PET2-positive and PET-2-unselected patients treated with eBEACOPP, which supports the efficacy of standard therapy for advanced-stage HL, independently of PET.