Could BEACOPP Regimen Work Without Bleomycin, Vincristine?

July 7, 2015

Advanced Hodgkin lymphoma patients who discontinue their treatment with bleomycin and vincristine as part of a BEACOPP regimen did not experience an effect on survival.

Patients with advanced Hodgkin lymphoma who discontinue their treatment with bleomycin and vincristine as part of a BEACOPP regimen due to adverse events did not experience an effect on progression-free or overall survival, according to the results of a study published in the Journal of Clinical Oncology.

“Our analysis shows that discontinuation of bleomycin or vincristine was safe in the setting of the HD12 and HD15 trials; however, the reasons for this lack of effect on progression-free and overall survival remain unclear,” wrote study researchers Heinz Haverkamp, of the University Hospital of Cologne, Germany.

According to the study, the role of bleomycin and vincristine as part of the BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) regimen is unclear, and both drugs can cause significant toxicity leading to discontinuation.

In the HD12 and HD15 trials, Haverkamp and colleagues analyzed the characteristics and outcomes of patients who discontinued these drugs. The analysis included 3,309 patients with Hodgkin lymphoma. The researchers found that discontinuation of bleomycin and vincristine was “frequent.” Bleomycin was discontinued in 17.6% of patients and vincristine in 32.6%.

They found that discontinuation of the drugs was more common in patients aged 50 years or older (P = .015) and that more women discontinued vincristine (P = .001)

There was a median follow-up of 59 months for progression-free survival (PFS) and 67 months for overall survival (OS). Data showed no significant difference in either of these survival outcomes for patients who received 4 or less or greater than 4 cycles of bleomycin (5-year PFS difference, 1.7%; 95% CI, 4.2%–7.6%; 5-year OS difference, 1.5%; 95% CI, 2.6%–5.5%). Similarly, results showed no difference in survival for patients receiving 3 or less or more than 3 cycles of vincristine (5-year PFS difference, 1.3%; 95% CI, 5.6%–3.1%; 5-year OS difference, 0.1%; 95% CI, 3.1%–2.9%).

“Because the current standard for patients with advanced Hodgkin lymphoma treated with BEACOPP is 6 cycles of BEACOPP escalated, according to the final results of the HD15 trial, we also restricted our analysis to this subgroup of patients,” the researchers wrote. Even with the limitation of smaller patient numbers, the results were similar for survival regardless of the number of cycles for bleomycin and vincristine.

“As a consequence of our analysis, bleomycin and vincristine were replaced by the anti-CD30 antibody drug conjugate brentuximab vedotin in the prospective phase II targeted BEACOPP trial for advanced Hodgkin lymphoma,” the researchers wrote. “First interim results suggest favorable efficacy and tolerability of two modified BEACOPP regimens without bleomycin and vincristine as compared with conventional BEACOPP escalated.”