Evaluating the long-term effectiveness and safety of nivolumab and AVD chemotherapy combination in patients with early-stage unfavorable classical Hodgkin lymphoma.

This study reported the long-term safety and effectiveness of nivolumab (Opdivo; N) + AVD (doxorubicin, vinblastine, and dacarbazine) chemotherapy combinations in patients with early-stage unfavorable classical Hodgkin lymphoma (cHL). The data showed that the N+AVD combination is safe and highly effective over the long term for these patients.

Classical Hodgkin lymphoma (cHL) is a cancer of white blood cells. Most patients with cHL respond to first-line chemotherapy regimens. The most commonly used frontline chemotherapy regimen for cHL is AVD (doxorubicin, vinblastine, dacarbazine).

Nivolumab is an immunotherapy that helps the immune system detect and find cancer cells. Some cancer cells have on their surface proteins, such as PD-L1 that binds to PD-1 protein which helps them avoid detection from the immune system. Nivolumab blocks the PD-1 protein, and this inhibition triggers the immune system to attack tumor cells and kills them.

N + AVD regimen was shown to have high complete remission rates and improved 1-year survival without cancer worsening rates in patients with early-stage cHL. However, it is not known if this combination continues to give better treatment results over the long term in patients with early-stage unfavorable cHL.

This study involved 109 patients with early-stage unfavorable cHL. Patients were randomly assigned into two groups. Group 1 included 55 patients who received 4 cycles of N+AVD. Group 2 included 54 patients who received sequential treatment with 4 doses of N, 2 cycles of N+AVD, and 2 cycles of AVD. All patients received 30-Gy of involved-site radiotherapy. The average follow-up time was 41 months.

After 3 years, 100% of the patients were alive in both groups. After 3 years, 100% of the patients in group 1 were alive without cancer worsening compared to 98% of the patients in group 2.

The most common side effect was hypothyroidism (low thyroid function) which occurred in 15% of the patients. Among them, 87% were female.

Patient-reported quality of life improved over time. No secondary cancers were reported in either group.

This study concluded that the N+AVD combination was safe and highly effective in patients with early-stage unfavorable cHL over the long term.

This study was funded by Bristol Myers Squibb, the manufacturer of nivolumab.