International Journal of Hematology

DOI: 10.1007/s12185-018-2497-0 Pages: 499-509

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

1. Tokai University, School of Medicine

2. National Cancer Center Hospital

3. Aichi Cancer Center

4. Kobe City Medical Center General Hospital

5. The Cancer Institute Hospital

6. Tohoku University Graduate School of Medicine

7. Jichi Medical University

8. Matsushita Memorial Hospital

9. National Hospital Organization Kyushu Cancer Center

10. Niigata Cancer Center Hospital

11. National Cancer Center Hospital East

12. Chiba Cancer Center

13. Kyoto Prefectural University of Medicine

14. Japanese Red Cross Nagoya Daini Hospital

15. Kumamoto University Graduate School of Medicine

16. Aomori Prefectural Central Hospital

17. Hiroshima University Hospital

18. Gunma University Graduate School of Medicine

19. Toranomon Hospital

20. National Hospital Organization Shikoku Cancer Center

21. Shinshu University School of Medicine

22. The Jikei University School of Medicine

23. Nagoya City University Graduate School of Medical Sciences

24. Hyogo Cancer Center

25. Chugai Pharmaceutical Co., Ltd.

Correspondence to:
Ken Ohmachi
Tel: +81-463-93-1121
Email: 8jmmd004@is.icc.u-tokai.ac.jp

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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.

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