A multi-center retrospective analysis of patients with relapsed/refractory follicular lymphoma after third-line chemotherapy

Fuji, Shigeo; Tada, Yasuyuki; Nozaki, Kengo; Saito, Hideaki; Ozawa, Takayuki; Kida, Toru; Kosugi, Satoru; Sugahara, Hiroyuki; Ikeda, Hirokazu; Hashimoto, Koji; Karasuno, Takahiro; Ueda, Shuji; Ishikawa, Jun; Shibayama, Hirohiko

doi:10.1007/s00277-020-04126-y

Cited by 5 publications

(16 citation statements)

References 25 publications

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“…The general alignment of results from SCHOLAR-5, conducted in the US and Europe, to those from the literature (US, 5,6 Europe, 23 and Japan 21 ), suggest that OS and PFS results in r/r FL patients are similar across these regions. In addition, the inverse relationship between length of overall survival and number of LoTs (i.e., shorter survival at higher LoTs) in SCHOLAR-5 is consistent with the trends documented in previously reported cohort studies.…”

Section: Discussionsupporting

confidence: 62%

“…SCHOLAR-5 can be contextualized with respect to five recently published r/r FL patient cohorts; however, direct comparisons between patient cohorts can be challenging and should be interpreted with caution. Three cohorts were published prior to SCHOLAR-5, including singlecenter cohorts from the US (Batlevi et al, 2020) and Japan (Fuji et al, 2020) and a large multicenter cohort from the US (Link et al, 2019). 5,6,21 Two additional multicenter cohort studies were conducted at approximately the same time as SCHOLAR-5, namely the ReCORD-FL and LEO CReWE cohorts.…”

Section: Discussionmentioning

confidence: 99%

“…Three cohorts were published prior to SCHOLAR-5, including singlecenter cohorts from the US (Batlevi et al, 2020) and Japan (Fuji et al, 2020) and a large multicenter cohort from the US (Link et al, 2019). 5,6,21 Two additional multicenter cohort studies were conducted at approximately the same time as SCHOLAR-5, namely the ReCORD-FL and LEO CReWE cohorts. 22,23 There were similarities across all of the patient cohorts.…”

Section: Discussionmentioning

confidence: 99%

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Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study

et al. 2022

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The SCHOLAR-5 study examines treatment patterns and outcomes of real-world follicular lymphoma (FL) patients on 3rd line of treatment (LoT) or higher, for whom existing data are limited. SCHOLAR-5 is a retrospective cohort study using data from adults (≥ 18 years) with grade 1-3a FL, initiating ≥3rd LoT after June 2014 at major lymphoma centers in the United States (US) and Europe. Objective response rate (ORR), complete response (CR), progression free survival (PFS) and overall survival (OS) were analyzed by LoT. Time-to-event outcomes were assessed using Kaplan-Meier methods. Of 128 patients, 87 initiated 3rd LoT, 63 initiated 4th LoT, and 47 initiated 5th LoT. At 1st eligible LoT, 31% progressed within 24-months of 1st LoT anti-CD20 combination therapy, 28% had prior autologous stem-cell transplantation, and 31% were refractory to the previous LoT. The most common regimen in each LoT was chemoimmunotherapy; however, experimental drugs were increasingly used at later LoTs. In the US, anti-CD20 monotherapy was more common at ≥3rd LoT compared to Europe, where stem cell transplants were more common. ORR at 3rd LoT was 68% (CR 44%), but decreased after each LoT to 37% (CR 22%) in ≥5 LoT. Median OS and PFS at 3rd LoT were 68 and 11 months, respectively, and reduced to 43 and 4 months at ≥5 LoT. Treatments were heterogenous at each LoT in both the US and Europe. Few FL patients achieved complete response in later LoT, and duration of response and survival diminished with each subsequent line.

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Section: Discussionsupporting

confidence: 62%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study

et al. 2022

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“…A second important limitation pertains to the representative cohort studies that were included in the analyses. A series of three recent studies [ 7 , 19 , 20 ] were the primary sources of insight here. Notably, the results of these studies were presented by line of treatment such that some patients provided data at multiple points.…”

Section: Discussionmentioning

confidence: 99%

“…Treatments identified from studies that met the inclusion criteria were simplified for the purpose of analysis into the following categories: standard of care (SoC), PI3k-δ inhibitors, Lenalidomide + Rituximab, Bortezomib + Rituximab, Obinutuzumab + Benda, 90Y + Anti-CD20 combination, Autologous stem cell transplant (SCT), and Allogeneic SCT. The evidence base included data from three studies [ 7 , 19 , 20 ] that included a heterogenous sampling of both treatments and patient populations. These were considered to be representative of typical care and thus were dubbed to be representative cohorts .…”

Section: Methodsmentioning

confidence: 99%

Clinical outcomes in patients relapsed/refractory after ≥2 prior lines of therapy for follicular lymphoma: a systematic literature review and meta-analysis

Kanters¹,

Ball

Kahl

et al. 2023

BMC Cancer

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Background Patients with follicular lymphoma (FL) can have high response rates to early lines of treatment. However, among FL patients relapsed/refractory (r/r) after ≥2 prior lines of therapy (LOT), remission tends to be shorter and there is limited treatment guidance. This study sought to evaluate the clinical outcomes for r/r FL after ≥2 prior LOT identified through systematic literature review. Methods Eligible studies included comparative or non-comparative interventional or observational studies of systemic therapies among adults with FL r/r after ≥2 prior LOT published prior to 31st May 2021. Prior LOT must have included an anti-CD20 monoclonal antibody and an alkylating agent, in combination or separately. Overall response rate (ORR) and complete response (CR) were estimated using inverse-variance weighting with Freeman-Tukey double-arcsine transformations. Kaplan-Meier (KM) curves for progression-free survival (PFS) and overall survival (OS) estimated by reconstructing digitized curves using the Guyot algorithm, and survival analyses were conducted, stratified by ≥2 prior LOT and ≥ 3 prior LOT groups (as defined in the source material). Restricting the analyses to the observational cohorts was investigated as a sensitivity analysis. Results The analysis-set included 20 studies published between 2014 and 2021. Studies were primarily US and/or European based, with the few exceptions using treatments approved in US/Europe. The estimated ORR was 58.47% (95% confidence interval [CI]: 51.13–65.62) and proportion of patients with CR was 19.63% (95% CI: 15.02–24.68). The median OS among those ≥2 prior LOT was 56.57 months (95% CI: 47.8–68.78) and median PFS was 9.78 months (95% CI: 9.01–10.63). The 24-month OS decreased from 66.50% in the ≥2 prior LOT group to 59.51% in the ≥3 prior LOT group, with a similar trend in PFS at 24-month (28.42% vs 24.13%). Conclusions This study found that few r/r FL patients with ≥2 prior LOT achieve CR, and despite some benefit, approximately 1/3 of treated patients die within 24 months. The shorter median PFS with increasing prior LOT suggest treatment durability is suboptimal in later LOT. These findings indicate that patients are underserved by treatments currently available in the US and Europe.

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Efficacy and safety of tisagenlecleucel in adult Japanese patients with relapsed or refractory follicular lymphoma: results from the phase 2 ELARA trial

et al. 2022

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Background Tisagenlecleucel yielded a high durable response rate in patients with relapsed/refractory (r/r) follicular lymphoma (FL) in the global phase 2 ELARA trial. Here, we report the efficacy, safety, and cellular kinetics of tisagenlecleucel in a subgroup of Japanese patients with r/r FL from ELARA. Methods ELARA (NCT03568461) is a global single-arm trial of tisagenlecleucel in patients with r/r FL who received ≥ 2 prior lines of therapy. The primary endpoint was the complete response rate (CRR), and the secondary endpoints were the overall response rate, duration of response, progression-free survival, overall survival, safety, and cellular kinetics. Results As of March 29, 2021, nine Japanese patients were enrolled and received tisagenlecleucel with a median follow-up of 13.6 months (range, 10.5‒19.3). Per independent review committee, CRR was 100% (95% CI 63.1‒100). Within 8 weeks of infusion, cytokine release syndrome (CRS) of any grade was reported in 6 patients (66.7%); however, no grade ≥ 3 CRS or any grade serious neurological events or treatment-related deaths were observed. Conclusion Tisagenlecleucel showed high efficacy and manageable safety in adult Japanese patients with r/r FL. Moreover, the clinical outcomes were similar to the global population, which supports the potential of tisagenlecleucel in Japanese patients with r/r FL.

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A multi-center retrospective analysis of patients with relapsed/refractory follicular lymphoma after third-line chemotherapy

Cited by 5 publications

References 25 publications

Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study

Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study

Clinical outcomes in patients relapsed/refractory after ≥2 prior lines of therapy for follicular lymphoma: a systematic literature review and meta-analysis

Efficacy and safety of tisagenlecleucel in adult Japanese patients with relapsed or refractory follicular lymphoma: results from the phase 2 ELARA trial

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