What long-term responses and serious harms were reported with MVC treatment for newly diagnosed or relapsed Hodgkin’s disease?

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Advanced-stage or relapsed/refractory Hodgkin’s disease (HD) has a poor prognosis despite aggressive chemotherapy and high-dose therapy with autologous support. This single-arm Phase II study evaluated MVC in 67 patients: 23 newly diagnosed and 45 with relapsed/refractory disease, with one patient treated twice. MVC consisted of mitoxantrone 8 mg/m²/day intravenously on days 1–3, vinblastine on days 1 and 22 (the abstract prints the dose as “8m/m2/day”), and CCNU 100 mg/m² on day 1, repeated every 6–8 weeks. The regimen was designed to combine the most effective chemotherapy agents from previous regimens for poor-prognosis HD while removing marginally active agents associated with unnecessary toxicities.

Median age at treatment was 35 years, with a range of 16–71; there were 42 males and 25 females. The 23 previously untreated (PU) patients had stage II (7), III (7), or IV (9) disease. Their subtypes were nodular sclerosis (21), mixed cellularity (1), and lymphocyte depletion (1). Among the 45 previously treated patients, the abstract lists first relapse in 20, second relapse in 13, and third relapse in 12. Prior treatment was chemotherapy alone in 17, radiotherapy alone in 4, and combined-modality treatment in 24. There were 39 relapsed and 6 treatment-refractory patients.

At diagnosis, the relapsed/refractory (R/R) group had stage II (11), III (10), IV (22), or unknown-stage (2) disease. Subtypes were nodular sclerosis (34), mixed cellularity (3), anaplastic large cell (1), lymphocyte predominant (1), lymphocyte depleted (2), and unknown (4).

All newly diagnosed patients responded, giving an overall response (OR) rate of 100%. Median response duration was 57.2 months and median survival was 108.1 months. Eleven complete responses were ongoing at 39+ to 189+ months.

Among previously treated patients, 41 responded to MVC, an OR rate of 91%. Median response duration was 11 months and median survival was 82.1 months.

Grade 3 and 4 treatment-related toxicities included neutropenia (89%), thrombocytopenia (73%), infection (40%), and bleeding (20%). Two deaths (2.9%) were related to granulocytopenia and infection. At a median follow-up of 16 years, three secondary myeloid leukemias had occurred: two in the newly diagnosed group and one in the R/R group.

The abstract’s response table also reports complete response (CR) and partial response (PR) rates: 83% and 17% in PU patients, and 44% and 47% in R/R patients. For PU patients, the table lists OR 100%, overall median response duration 57.2 months, overall survival 108 months, median CR duration not reached, and median survival among complete responders 186 months. For R/R patients, it lists OR 91%, overall median response duration 11 months, overall survival 82 months, median CR duration 15 months, and median survival among complete responders 168 months. The table defines NR as “not reached” and gives a range of 8.2–189+ months in that footnote.

The authors concluded that MVC was very active in both newly diagnosed and relapsed/refractory HD, with high response rates and survival that compared favorably with reported results of high-dose therapy with stem-cell transplantation. This was a single-arm study, not a direct comparison with transplantation. They described the toxicities as significant but manageable.