Efficacy and safety of obinutuzumab in patients with previously untreated follicular lymphoma: a subgroup analysis of patients enrolled in Japan in the randomized phase III GALLIUM trial

Ken Ohmachi, Kensei Tobinai, Tomohiro Kinoshita, Takayuki Ishikawa, Kiyohiko Hatake, Satoshi Ichikawa, Ken Ohmine, Yuri Kamitsuji, Ilseung Choi, Takaaki Chou, Kunihiro Tsukasaki, Kyoya Kumagai, Masafumi Taniwaki, Toshiki Uchida, Yoshitaka Kikukawa, Kohmei Kubo, Keichiro Mihara, Norifumi Tsukamoto, Koji Izutsu, Isao YoshidaFumihiro Ishida, Noriko Usui, Shinsuke Iida, Tohru Murayama, Eisuke Ueda, Hiroshi Kuriki, Kiyoshi Ando

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3 Citations (Scopus)

Abstract

GALLIUM is a global phase III study that demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with obinutuzumab plus chemotherapy (G-chemo) versus rituximab plus chemotherapy (R-chemo) in previously untreated patients with follicular lymphoma (FL). In this single-country subgroup analysis, we explored patterns of efficacy and safety in patients enrolled in the GALLIUM study in Japan (Japanese subgroup). Patients were randomized to open-label induction treatment with G-chemo or R-chemo. Responders received maintenance monotherapy with their randomized antibody for up to 2 years. The primary endpoint was investigator-assessed PFS. Overall, 123 patients with FL were randomized in the Japanese subgroup (G-chemo, n = 65; R-chemo, n = 58). The majority of patients received cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy (82.9 vs 33.1% in the global GALLIUM FL population). PFS at 3 years was 89.9% (G-chemo) vs. 74.7% (R-chemo); hazard ratio 0.42; 95% confidence interval 0.15, 1.15; P = 0.08. Higher rates of grade 3–5 adverse events (96.9 vs. 89.7%) and serious adverse events (35.4 vs. 22.4%) were observed with G-chemo vs R-chemo, respectively. Neutropenia was frequent in the Japanese subgroup (92.3% G-chemo; 79.3% R-chemo). Overall, the results in the Japanese subgroup were consistent with those in the global GALLIUM population.

Original languageEnglish
Pages (from-to)499-509
Number of pages11
JournalInternational Journal of Hematology
Volume108
Issue number5
DOIs
Publication statusPublished - 01-11-2018

All Science Journal Classification (ASJC) codes

  • Hematology

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    Ohmachi, K., Tobinai, K., Kinoshita, T., Ishikawa, T., Hatake, K., Ichikawa, S., Ohmine, K., Kamitsuji, Y., Choi, I., Chou, T., Tsukasaki, K., Kumagai, K., Taniwaki, M., Uchida, T., Kikukawa, Y., Kubo, K., Mihara, K., Tsukamoto, N., Izutsu, K., ... Ando, K. (2018). Efficacy and safety of obinutuzumab in patients with previously untreated follicular lymphoma: a subgroup analysis of patients enrolled in Japan in the randomized phase III GALLIUM trial. International Journal of Hematology, 108(5), 499-509. https://doi.org/10.1007/s12185-018-2497-0