リンパ腫の特定の亜型を有する患者は化学療法を回避することができる可能性がある(Abstract 7508)

Smart Start：リンパ腫の試験により、化学療法前の分子標的薬併用療法は有効であることが示された
Smart Start: Lymphoma trial finds combination targeted therapy effective prior to chemotherapy
化学療法を用いないリツキシマブ、イブルチニブ、およびレナリドミドの併用療法は、新たに診断されたnon-germinal (non-GCB) 型びまん性大細胞型リンパ腫（DLBCL）患者において非常に効果的である、と2019 ASCO Annual Meeting で発表された。第II相Smart Start 試験の結果、新たに診断されたnon-GCB DLBCL患者に対し、全ての化学療法の前にこの分子標的薬併用療法を施行した場合、全奏効率は84.6% であり、完全完解は38.5% であることが示された。本試験対象患者の90% 超は、1年後も寛解を保ったままであった。副作用は軽度であり、多くが化学療法によるものであった。
Full Text

Results of a Phase II clinical trial conducted at The University of Texas MD Anderson Cancer Center revealed that combination targeted therapy, consisting of rituximab, lenalidomide and ibrutinib (RLI), had an 84.6 percent overall response rate (ORR) and 38.5 percent complete response rate (CRR) when given prior to any chemotherapy for newly diagnosed patients with a specific type of diffuse large b-cell lymphoma (DLBCL).

The first-of-its-kind study examined a treatment regimen without chemotherapy for patients with non-germinal center (non-GCB) DLBCL, and, while confirmatory trials are needed, the findings suggest that patients who respond to targeted therapy initially may not need chemotherapy, currently the standard of care.

The results of the trial were presented in an oral presentation at the 2019 American Society of Clinical Oncology Annual Meeting by principal investigator Jason Westin, M.D., assistant professor of Lymphoma & Myeloma.

"The responses we've seen have been remarkable. More than 80 percent of our patients have responded and around 40 percent have had a complete response, showing no evidence of cancer, prior to receiving any chemotherapy," said Westin. "All patients have gone on to receive standard chemotherapy in combination with these targeted treatments per the protocol, and, so far, we've had a 100 percent response rate."

Standard treatment for large-cell lymphomas is chemotherapy, but this subtype doesn't respond as well, reaching an estimated cure rate of just 50-60 percent, explained Westin.

The clinical trial enrolled 60 patients at MD Anderson with non-GCB DLBCL and treated those patients with two cycles of RLI, followed by six cycles of RLI with chemotherapy. Westin's team designed the trial to bring new treatment options to these patients based on promising findings in the lab.

"We called the trial 'Smart Start' because we thought this was a smarter way to start therapy for these patients," said Westin. "Standard treatment for large-cell lymphoma has been largely stagnant for the better part of 40 years, despite many advances in our understanding of the disease and a host of new medications. It's exciting to see an idea that worked in the lab now beginning to yield results and show this is a potentially new way forward to fight this disease."

More than 90 percent of patients on this trial remain in remission after one year, said Westin. Additionally, side effects on the trial have been mild, with most driven by the chemotherapy treatment.

Going forward, Westin and colleagues plan to launch clinical trials to investigate whether patients who respond well to RLI treatment upfront can receive little or no chemotherapy and still attain long-term remission.

This study was supported by the Conquer Cancer Foundation, Celgene and Janssen Pharmaceuticals.