Prognostic Value of Pet‐ct After First‐line Immunochemotherapy for Follicular Lymphoma in the Phase Iii Gallium Study

Trotman, Judith; Barrington, Sally; Belada, David; Meignan, Michel; MacEwan, Robert; Ptáčník, Václav; Rosta, András; Fingerle-Rowson, Guenter; Mattiello, Federico; Nielsen, Tina; Sahin, Denis; Hiddemann, Wolfgang; Marcus, Robert; Davies, Andrew

doi:10.1002/hon.2437_20

Cited by 14 publications

(28 citation statements)

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“…PFS was defined as the time from randomization to the first occurrence of disease progression or relapse as assessed by the investigator according to revised response criteria for malignant lymphoma without positron emission tomography (PET) and with PET (at baseline and at end of induction and where PET was available) or death from any cause, as described previously . Response was assessed according to revised response criteria for malignant lymphoma with and without PET (at baseline, mid‐induction and at end of induction and where PET was available).…”

Section: Methodsmentioning

confidence: 99%

Role of obinutuzumab exposure on clinical outcome of follicular lymphoma treated with first‐line immunochemotherapy

Jamois

Gibiansky²,

Gibiansky³

et al. 2019

Brit J Clinical Pharma

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Aims Obinutuzumab (G) is a humanized type II, Fc‐glycoengineered anti‐CD20 monoclonal antibody used in various indications, including patients with previously untreated front‐line follicular lymphoma. We investigated sources of variability in G exposure and association of progression‐free survival (PFS) with average concentration over induction (CmeanIND) in front‐line follicular lymphoma patients treated with G plus chemotherapy (bendamustine, CHOP, or CVP) in the GALLIUM trial. Methods Individual exposures (CmeanIND) were obtained from a previously established population pharmacokinetic model updated with GALLIUM data. Multivariate Cox proportional hazard models and univariate Kaplan–Meier plots investigated relationships of PFS with exposure and other potential prognostic factors. Results Overall, G exposure was lower in high body‐weight patients and in males, and slightly lower in patients with high baseline tumour burden. Analysis of clinical outcomes showed that variability in G exposure did not impact PFS in G‐bendamustine‐treated patients; PFS was inferior in males and patients with FCGR2a/2b T232 T low‐affinity receptor variant, and superior in patients with FCGR2a/2b I232T variant. In G‐CHOP/CVP arms, PFS improved with increasing CmeanIND (hazard ratio = 1.74 and 0.394 at 5th and 95th percentile compared to median CmeanIND) and was inferior in patients with high baseline tumour size and B symptoms. Conclusions It remains unclear whether for G‐CHOP/CVP patients lower G exposure is a consequence of adverse disease biology and/or resistance to chemotherapy backbone (higher clearance in nonresponder patients, as demonstrated for rituximab) rather than being the cause of poorer clinical outcome. A study with >1 dose level of G could help resolve this uncertainty.

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Section: Methodsmentioning

confidence: 99%

Role of obinutuzumab exposure on clinical outcome of follicular lymphoma treated with first‐line immunochemotherapy

Jamois

Gibiansky²,

Gibiansky³

et al. 2019

Brit J Clinical Pharma

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“…For patients in the GALLIUM trial, EOI PET scan information was available for 595 patients, MRD status in 785 patients, and both in 298 patients. 6,31,32 Analysis of EOI response (according to 2014 Lugano criteria) 33 revealed no significant differences in outcomes between G-chemo and R-chemo (OR 84% for G-chemo versus 79% for R-chemo [p=0.30]). 32 Furthermore, complete metabolic response (CMR) was 78% for G-chemo versus 73% for R-chemo (p=0.18).…”

Section: Professor Judith Trotmanmentioning

confidence: 99%

“…6,31,32 Analysis of EOI response (according to 2014 Lugano criteria) 33 revealed no significant differences in outcomes between G-chemo and R-chemo (OR 84% for G-chemo versus 79% for R-chemo [p=0.30]). 32 Furthermore, complete metabolic response (CMR) was 78% for G-chemo versus 73% for R-chemo (p=0.18). One possible explanation for a lack of difference in CMR rate may be due to the study not being sufficiently powered (n=595) to address metabolic response.…”

Section: Professor Judith Trotmanmentioning

confidence: 99%

“…One possible explanation for a lack of difference in CMR rate may be due to the study not being sufficiently powered (n=595) to address metabolic response. [32][33][34] There was a rapid, pronounced, and ongoing separation in PFS between patients achieving CMR and those failing to do so (HR: 0.21; 95% CI: 0.13-0.34; p<0.0001). 32 Additionally, the Lugano 2014 criteria showed a significant difference in OS between patients achieving CMR at EOI and those failing to do so (HR: 0.22; 95% CI 0.11-0.45; p<0.0001).…”

Section: Professor Judith Trotmanmentioning

confidence: 99%

“…[32][33][34] There was a rapid, pronounced, and ongoing separation in PFS between patients achieving CMR and those failing to do so (HR: 0.21; 95% CI: 0.13-0.34; p<0.0001). 32 Additionally, the Lugano 2014 criteria showed a significant difference in OS between patients achieving CMR at EOI and those failing to do so (HR: 0.22; 95% CI 0.11-0.45; p<0.0001). 32 Within 2.5 years after induction, 13% (9/69) of patients failing to obtain CMR had died from their lymphoma compared to 1% (5/450) of those achieving CMR.…”

Section: Professor Judith Trotmanmentioning

confidence: 99%

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Expectations and Experience: Optimising Efficacy and Maintaining Quality of Life in Follicular Lymphoma

Fricker¹

2019

EMJ Hematol

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Prof Salles provided an update on the ongoing first-line follicular lymphoma (FL) studies, demonstrating how analysis of the GALLIUM study data regarding the use of different chemotherapy backbones consistently showed the benefits of obinutuzumab (G) chemotherapy (G-chemo) versus rituximab (R) chemotherapy (R-chemo) in FL patients. An update from the PRIMA study showed that 10-year progression-free survival (PFS) was improved following the use of R maintenance compared with observation following induction. Prof Salles also provided an overview of the RELEVANCE study data, which showed that R plus lenalidomide was not superior to standard R-chemo for the treatment of first-line FL. Prof Seymour presented data showing that two-thirds of premature FL deaths occur in patients experiencing disease progression within 2 years of treatment, highlighting the need to identify patients at early risk of progression. Prof Seymour explored various prognostic and predictive tools that could be used to identify patients at high risk of death, but he noted that until these prognostic tools are available in the clinic, the high-risk population remains unidentifiable. Furthermore, the accuracy of these prognostic indices needs to be improved. Data analysis from the GALLIUM study showed that G-chemo decreased the risk of a disease progression event in the first 2 years by 46% compared to R-chemo. Prof Trotman explored the use of PET imaging and detection of minimal residual disease (MRD) to assess treatment outcomes. Prof Trotman showed that PET status at the end of induction is highly prognostic of the outcome. An exploratory analysis of the GALLIUM data showed that the application of the Lugano 2014 response criteria showed a rapid, deep separation of the PFS curves of patients achieving a complete metabolic response (CMR) versus those who did not. There was almost a 5-fold increase in risk of progression and in risk of death in patients failing to achieve CMR. An exploratory analysis of the MRD status of GALLIUM patients showed that a greater proportion of patients in the G-chemo arm achieved MRD-negative status at the end of induction (EOI). Interestingly, patients achieved similar MRD outcomes with G-chemo, regardless of chemotherapy backbone. Both PET and MRD status after induction were independently predictive of PFS. Dr Pettengell and Mr Bouguet discussed FL from both the clinician’s and the patient’s perspective, with a focus on health-related quality of life (HRQoL). They demonstrated how a marked decrease in HRQoL at progression highlights the importance of extending remission for FL patients. Dr Pettengell presented data from GALLIUM showing comparable quality of life for patients treated with either G-chemo or R-chemo. They also presented patient surveys showing that FL has a substantial physical and psychological impact on patients that both lasts beyond treatment and persists even during long-term remission.

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A comparison of the prognostic performance of the Lugano 2014 and RECIL 2017 response criteria in patients with NHL from the phase III GOYA and GALLIUM trials

Kostakoglu,

Martelli,

Sehn

et al. 2023

eJHaem

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The Lugano 2014 criteria are the standard for response assessment in lymphoma. We compared the prognostic performance of Lugano 2014 and the more recently developed response evaluation criteria in lymphoma (RECIL 2017), which relies primarily on computed tomography and uses unidimensional measurements, in patients with previously untreated diffuse large B‐cell lymphoma (DLBCL) and follicular lymphoma (FL) from the phase III GOYA and GALLIUM trials, respectively. Concordance between responses according to the Lugano 2014 and RECIL 2017 criteria was analyzed. Landmark analyses of progression‐free survival (PFS) and overall survival (OS) by end of treatment (EOT) and end of induction (EOI) response status according to RECIL 2017 and Lugano 2014 criteria, and prognostic value of response at EOT/EOI were also compared. Overall, 1333 patients were included from GOYA and 502 from GALLIUM. Complete response (CR) status according to RECIL 2017 criteria showed high concordance with complete metabolic response (CMR) status by Lugano 2014 criteria in both GOYA (92.5%) and GALLIUM (92.4%). EOT and EOI CR/CMR status by both criteria was highly prognostic for PFS in GOYA (RECIL 2017 [CR]: hazard ratio [HR], 0.35 [95% confidence interval [CI] 0.26–0.46]; Lugano 2014 [CMR]: HR, 0.35 [95% CI 0.26–0.48]; both p < .0001) and GALLIUM (RECIL 2017 [CR]: HR, 0.35 [95% CI 0.23–0.53]; Lugano 2014 [CMR]: HR, 0.21 [95% CI 0.14–0.31]; both p < .0001). In conclusion, response categorization by RECIL 2017 is similar to that by Lugano 2014 criteria, with high concordance observed. Both were prognostic for PFS and OS.

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Prognostic Value of Pet‐ct After First‐line Immunochemotherapy for Follicular Lymphoma in the Phase Iii Gallium Study

Cited by 14 publications

References 0 publications

Role of obinutuzumab exposure on clinical outcome of follicular lymphoma treated with first‐line immunochemotherapy

Role of obinutuzumab exposure on clinical outcome of follicular lymphoma treated with first‐line immunochemotherapy

Expectations and Experience: Optimising Efficacy and Maintaining Quality of Life in Follicular Lymphoma

A comparison of the prognostic performance of the Lugano 2014 and RECIL 2017 response criteria in patients with NHL from the phase III GOYA and GALLIUM trials

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