Safety and efficacy of obinutuzumab in Chinese patients with B-cell lymphomas: a secondary analysis of the GERSHWIN trial

Cancer Communications
Yan QinYuankai Shi

Abstract

Patients with relapsed/refractory B-cell lymphomas have limited treatment options. GERSHWIN is an open-label, single-arm, phase Ib study of obinutuzumab monotherapy in Chinese patients with histologically documented CD20+ relapsed/refractory chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), or follicular lymphoma (FL). The primary outcome measure of pharmacokinetics has been previously reported. We now present data on the secondary endpoint measures (e.g., safety, and efficacy and pharmacodynamics). Patients received 1000 mg obinutuzumab intravenously on days 1, 8, and 15 of cycle 1 (CLL patients; first dose split over 2 days), and on day 1 of cycles 2-8. Each cycle lasted for 21 days; the treatment period was 24 weeks. All subjects receiving at least one dose of obinutuzumab were included in the analysis of safety, efficacy, as well as pharmacodynamics. A total of 48 patients (> 18 years of age) were enrolled (CLL: 12; DLBCL: 23; FL: 13). The subjects received a median of two lines of anticancer treatment prior to the enrollment. Thirty-five patients (72.9%) had at least one adverse event (AE). The most frequent AE was infusion-related reactions (15 patients; 31.3%), followed by pyrexia (11 patients; 2...Continue Reading

References

Aug 15, 1998·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·P McLaughlinB K Dallaire
Nov 24, 1999·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·B D ChesonG P Canellos
May 2, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·John D HainsworthUNKNOWN Minnie Pearl Cancer Research Network
Aug 9, 2008·The New England Journal of Medicine·Bruce D Cheson, John P Leonard
Jul 10, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Gilles A SallesGuillaume Cartron
Jul 10, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Franck Andre MorschhauserGilles Andre Salles
Jan 10, 2014·The New England Journal of Medicine·Valentin GoedeMichael Hallek
Jul 21, 2015·Cancer Treatment Reviews·Tim IllidgeGuillaume Cartron
Aug 19, 2015·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Laurie H SehnOliver W Press
Jan 11, 2017·British Journal of Clinical Pharmacology·John ZhaiJun Shi

❮ Previous
Next ❯

Citations

Oct 9, 2019·Cancer Biomarkers : Section a of Disease Markers·Zhenhai JingQing Hong
Sep 29, 2020·Recent Patents on Anti-cancer Drug Discovery·Romeo G Mihăilă

❮ Previous
Next ❯

Clinical Trials Mentioned

NCT01680991

Software Mentioned

GAUGUIN
GERSHWIN

Related Concepts

Related Feeds

B-Cell Leukemia (Keystone)

B-cell leukemia includes various types of lymphoid leukemia that affect B cells. Here is the latest research on B-cell leukemia.

B-Cell Lymphoma

B-cell lymphomas include lymphomas that affect B cells. This subtype of cancer accounts for over 80% of non-Hodgkin lymphomas in the US. Here is the latest research.