R2 vs R-CHOP

橙色雨丝

Celgene and LYSARC Provide Update on Phase III ‘RELEVANCE' Study of REVLIMID® in Combination with Rituximab (R²) for the Treatment of Previously Untreated Patients with Follicular Lymphoma

Celgene Corporation (NASDAQ:CELG) and the Lymphoma Study Association(LYSA) today announced that the Lymphoma Academic Research Organisation (LYSARC) reported results from a phase III, randomized, open-label, international clinical study (RELEVANCE).

This investigational study evaluated REVLIMID plus rituximab (R2) followed by R2 maintenance compared to the standard of care with rituximab plus chemotherapy (R-CHOP, R-bendamustine or R-CVP) followed by rituximab maintenance in patients with previously untreated follicular lymphoma.

The R2 treatment arm did not achieve superiority in the co-primary endpoints of complete response or unconfirmed complete response (CR/CRu) at 120 weeks and progression-free survival (PFS) during the pre-planned analysis (final analysis of CR/CRu and interim analysis of PFS). Neither arm was superior for either of the co-primary endpoints. The safety findings were consistent with the known profiles of the regimens investigated. Additional analyses are ongoing and planned.

"This is the first Phase III trial to evaluate a chemotherapy-free regimen to the established standard of care in patients with previously untreated follicular lymphoma and represents a landmark study in this disease setting," said Prof. Gilles Salles, President of the Lymphoma Study Association (LYSA). "We look forward to further analyzing and presenting these important data at a future medical congress.""We thank the patients, their families, the Co-Primary Investigators, Franck Morchhauser MD1, PhD, and Nathan Fowler, MD2 and the investigators for participating in the RELEVANCE trial," said Jay Backstrom, M.D., Chief Medical Officer and Head of Global Regulatory Affairs for Celgene. "We remain committed to advancing our broad pipeline of novel therapies to establish new standards of care for patients with lymphoma."

1 Professor of Haematology Centre Hospitalier Régional Universitaire de Lille, Lille France

2Associate Professor, Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX

REVLIMID is not approved for use in follicular lymphoma.

橙色雨丝

这两天关于滤泡性淋巴瘤分别传出来两个消息，一个是新基公司的RELEVANCE研究，另一个是与罗氏公司有关的PRIMA研究，有喜有忧。
RELEVANCE是用R2（来那度胺+美罗华）来比较R-CHOP或R-CVP或BR，是一项优效性研究，即如果不能证明R2在CR率和PFS上优于化疗，就算是失败了。这项全球性多中心的III期临床试验一共入组了一千位患者，一旦成功意义非常重大，会是首次在淋巴瘤治疗上证明非化疗方案优于化疗方案，不过却失败了。其实业界对此已经有所预期，因为一直没有传出过什么消息，大家都觉得坏消息的可能性大，果不其然。不过用R2做初治方案的病友也不必担心，因为试验也未证明R-CHOP/R-CVP/BR一定比R2好，因为具体的试验数据没有出来。还有待进一步分析。只是根据新基公司的新闻稿，口气比较悲观，虽然试验并未结束，已经在感谢主要研究者和参加试验的所有患者了，看起来最终结果已成定局。

PRIMA研究主要是用来证明美罗华维持的必要性的，现在给出的是一个十年后的update，结论是R-CHOP加上美罗华维持到第十年的时候一半的患者仍未复发。这个结果使专家们的口气非常upbeat，甚至反问道：should we really continue to say that follicular lymphoma is an incurable disease?” （我们真的还能够继续说滤泡性淋巴瘤是一个不可治愈的疾病吗？！

xueyafeng051

至少也能说明R2不比R-chop差。
副作用方面，应该优于rchop

橙色雨丝

10-year updated PRIMA study results for FL patients receiving rituximab maintenance – ASH 2017 Oral Abstract #486

The 59th Annual Meeting & Exposition of the American Society of Hematology(ASH) took place in Atlanta, GA, on December 9–12, 2017. On Sunday December 10th, abstract #486 was presented during this session titled “Long Term Follow-up of the PRIMA Study: Half of Patients Receiving Rituximab Maintenance Remain Progression Free at 10 Years” by Gilles Andre Salles, Hospices Civils de Lyon - Université de Lyon, Pierre-Bénite, France and colleagues.

The Primary RItuximab and MAintenance (PRIMA) study aimed to evaluate the benefit of rituximab (R) maintenance in patients with follicular lymphoma (FL) after response to a first line R-chemotherapy induction. This study was based on previous evidence suggesting that rituximab maintenance provides significant clinical benefit to FL patients. The ASH oral presentation provided the 10-year updated results of the PRIMA trial. This article is based on data presented at the live session, which may supersede information in the pre-published ASH Abstract.

Study Highlights

        •        Patients with FL were randomized firstly to an R-chemotherapy induction regime and then randomized to either observation or to receive R-maintenance (375 mg/m2) every 8 weeks for 2 years

        •        A total of 607 patients were available for follow-up with a median of 9.7 years

        •        Median progression-free survival (PFS): 4.1 observation vs 5 years R-maintenance (P < 0.0001; HR=0.61, 95% CI, 0.52–0.73)

        •        10-year estimated disease-free progression: 35% observation vs 51% R-maintenance

        •        R-maintenance was shown to be favorable across all major sub-groups including age, FLIPI Index and response to induction

        •        Time-to-next-treatment median time was not reached for the R-maintenance group vs 6 years with observation (P < 0.001; HR=0.66, 95% CI 0.55–0.78)

        •        The overall survival (OS) was not significantly different between the two arms: 80% R-maintenance vs 80% observation (P = 0.795; HR=1.04, 95% CI 0.77–1.40)

        •        No new safety signals emerged from this study

The 10-year updated results showed that R-maintenance after induction immunochemotherapy had enduring PFS benefit compared with observation. Although the OS survival was not significantly different between the two groups, patients with high tumor burden had an 80% chance of survival at ten years. Gillies Salles concluded that “with more than half of the patients responding to rituximab chemo and having received rituximab maintenance with a free-of-disease recurrence at 10 years, should we really continue to say that follicular lymphoma is an incurable disease?”

c76de

雨丝老师麻烦能看看我刚发的帖子吗？我不知道为啥好像@的不对，谢谢

icelakefish

赞！！谢谢雨丝分享！！

13381272202

雨丝大哥，有没有关于BR方案后美罗华维持的数据啊？

将军

这个实验美罗华要一直维持10年吗 没有别的一些说明了吗 肺功能能受的了吗

风雨豪情

学习了，谢谢分享

橙色雨丝

将军 发表于 2017-12-22 18:25
这个实验美罗华要一直维持10年吗 没有别的一些说明了吗 肺功能能受的了吗
...

维持治疗两年，跟踪随访了9.7年。

r81881

橙色雨丝 发表于 2017-12-22 18:34
维持治疗两年，跟踪随访了9.7年。

想请教一下，复发的概率与初始治疗时的分期有关吗？我们是滤泡低级别，在犹豫是立即治疗，还是观察等待一段时间

peipei2007610

最后一句话真是鼓舞人心，也坚定了我结疗后美罗华维持

橙色雨丝

13381272202 发表于 2017-12-22 18:24
雨丝大哥，有没有关于BR方案后美罗华维持的数据啊？

根据德国的StiL NHL 7-2008 trial (MAINTAIN)，套细胞在BR后美罗华维持不能提高PFS和OS，滤泡的结论不明确。

13381272202

感谢您的回复，我们是滤泡1-2型/4期.

橙色雨丝

r81881 发表于 2017-12-22 18:37
想请教一下，复发的概率与初始治疗时的分期有关吗？我们是滤泡低级别，在犹豫是立即治疗，还是观察等待一 ...

理论上说是有关的。

将军

橙色雨丝 发表于 2017-12-22 18:34
维持治疗两年，跟踪随访了9.7年。

您可回复了我一下 以前给您发过好多 都没有回复 您看看我这个情况 有什么建议吗 治疗和观察

Robinson

xueyafeng051 发表于 2017-12-22 19:10
至少也能说明R2不比R-chop差。
副作用方面，应该优于rchop

但是价格是那四种化疗药的几百倍。

二黑哥

谢谢雨丝

妈妈平安就是福

欧耶！

明天定会更好

大受鼓舞！虽然我们家病人才六疗完成.主治说他们滤泡一般都是做满8个chop具体情况七疗再说吧