Promising results have been seen in a trial of a new treatment regime for intravascular large B-cell lymphoma (IVLBCL), Japanese researchers have reported.
A team from Nagoya University in Japan, led by Dr Kazuyuki Shimada, aimed to develop a safe treatment protocol which also reduces the high risk of central nervous system (CNS) relapse associated with the condition.
A previous retrospective analysis of IVLBCL patients’ treatment suggested that standard chemotherapy together with rituximab may be more promising than standard treatment alone.
The team carried out a multicentre, single-arm, Phase 2 trial of their combination, which involved 38 patients aged 20 to 79 years with newly diagnosed IVLBCL without CNS involvement. The regimen tested in these patients was based upon R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone), with additional methotrexate and intrathecal chemotherapy aimed at preventing CNS relapse.
Median follow-up was nearly four years. After two years, 76% of patients had survived without disease progression, and two-year overall survival was 92%. CNS relapse occurred in only one person (3% of patients). Side effects were rare and manageable.
Full details appeared in The Lancet Oncology in April this year.
Dr Shimada said: “We considered that rituximab-containing chemotherapies combined with treatment for the secondary central nervous system problems could lead to further improvement in the clinical outcome.
“To the best of our knowledge, this is the first ‘prospective’ trial of any treatment in patients with intravascular large B-cell lymphoma. It appears that the proposed treatment protocol might be effective in patients without apparent central nervous system involvement at the time of diagnosis.”
He concludes: “The results of our trial provide a safe and effective treatment option that can function as a historic control for future prospective trials.”
Source: Shimada K, Yamaguchi M, Atsuta Y, Matsue K, Sato K, Kusumoto S, Nagai H, Takizawa J, Fukuhara N, Nagafuji K, Miyazaki K, Ohtsuka E, Okamoto M, Sugita Y, Uchida T, Kayukawa S, Wake A, Ennishi D, Kondo Y, Izumi T, Kin Y, Tsukasaki K, Hashimoto D, Yuge M, Yanagisawa A, Kuwatsuka Y, Shimada S, Masaki Y, Niitsu N, Kiyoi H, Suzuki R, Tokunaga T, Nakamura S, Kinoshita T (2020) “Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone combined with high-dose methotrexate plus intrathecal chemotherapy for newly diagnosed intravascular large B-cell lymphoma (PRIMEUR-IVL): a multicentre, single-arm, phase 2 trial.” The Lancet Oncology, doi: 10.1016/S1470-2045(20)30059-0
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