Clinical response and pharmacokinetics of bendamustine as a component of salvage R-B(O)AD therapy for the treatment of primary central nervous system lymphoma (PCNSL)
A relatively high proportion of patients diagnosed with primary CNS lymphoma will experience recurrent disease, yet therapy options are limited in salvage therapy. This is the first study to evaluate a bendamustine-based combination regimen for the treatment of relapsed/refractory PCNSL and to chara...
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Published in | BMC cancer Vol. 18; no. 1; p. 729 |
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Format | Journal Article |
Language | English |
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09.07.2018
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Abstract | A relatively high proportion of patients diagnosed with primary CNS lymphoma will experience recurrent disease, yet therapy options are limited in salvage therapy. This is the first study to evaluate a bendamustine-based combination regimen for the treatment of relapsed/refractory PCNSL and to characterize bendamustine pharmacokinetics in the human CSF.
Patients received bendamustine 75 mg/m
for two days as part of R-B(O)AD administered intravenously every 4 weeks for up to 4 cycles. Response and adverse events of the regimen were assessed. A sparse sampling strategy and population based modeling approach was utilized for evaluation of plasma and CSF levels of bendamustine.
Ten patients were enrolled into study of whom 70% were of refractory disease and with high IELSG prognostic risk scores. The ORR of R-BOAD was 50% (95% CI, 0.24 to 0.76) with one patient achieving CR and four PR. Primary toxicity of the regimen was reversible myelosuppression, mostly grade 3 or 4 neutropenia. The C
mean for plasma and CSF were 2669 ng/mL and 0.397 ng/mL, respectively, and patients with response at deep tumor sites displayed higher trends in peak exposure. Pharmacokinetic data was best described by a four-compartment model with first-order elimination of drug from central plasma and CSF compartments.
R-BOAD is an effective salvage option for PCNSL, but with significant hematologic toxicity. Bendamustine CSF levels are minimal; however correspond to plasma exposure and response.
ClinicalTrials.gov NCT03392714 ; retrospectively registered January 8, 2018. |
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AbstractList | A relatively high proportion of patients diagnosed with primary CNS lymphoma will experience recurrent disease, yet therapy options are limited in salvage therapy. This is the first study to evaluate a bendamustine-based combination regimen for the treatment of relapsed/refractory PCNSL and to characterize bendamustine pharmacokinetics in the human CSF.
Patients received bendamustine 75 mg/m
for two days as part of R-B(O)AD administered intravenously every 4 weeks for up to 4 cycles. Response and adverse events of the regimen were assessed. A sparse sampling strategy and population based modeling approach was utilized for evaluation of plasma and CSF levels of bendamustine.
Ten patients were enrolled into study of whom 70% were of refractory disease and with high IELSG prognostic risk scores. The ORR of R-BOAD was 50% (95% CI, 0.24 to 0.76) with one patient achieving CR and four PR. Primary toxicity of the regimen was reversible myelosuppression, mostly grade 3 or 4 neutropenia. The C
mean for plasma and CSF were 2669 ng/mL and 0.397 ng/mL, respectively, and patients with response at deep tumor sites displayed higher trends in peak exposure. Pharmacokinetic data was best described by a four-compartment model with first-order elimination of drug from central plasma and CSF compartments.
R-BOAD is an effective salvage option for PCNSL, but with significant hematologic toxicity. Bendamustine CSF levels are minimal; however correspond to plasma exposure and response.
ClinicalTrials.gov NCT03392714 ; retrospectively registered January 8, 2018. BACKGROUNDA relatively high proportion of patients diagnosed with primary CNS lymphoma will experience recurrent disease, yet therapy options are limited in salvage therapy. This is the first study to evaluate a bendamustine-based combination regimen for the treatment of relapsed/refractory PCNSL and to characterize bendamustine pharmacokinetics in the human CSF.METHODSPatients received bendamustine 75 mg/m2 for two days as part of R-B(O)AD administered intravenously every 4 weeks for up to 4 cycles. Response and adverse events of the regimen were assessed. A sparse sampling strategy and population based modeling approach was utilized for evaluation of plasma and CSF levels of bendamustine.RESULTSTen patients were enrolled into study of whom 70% were of refractory disease and with high IELSG prognostic risk scores. The ORR of R-BOAD was 50% (95% CI, 0.24 to 0.76) with one patient achieving CR and four PR. Primary toxicity of the regimen was reversible myelosuppression, mostly grade 3 or 4 neutropenia. The Cmax mean for plasma and CSF were 2669 ng/mL and 0.397 ng/mL, respectively, and patients with response at deep tumor sites displayed higher trends in peak exposure. Pharmacokinetic data was best described by a four-compartment model with first-order elimination of drug from central plasma and CSF compartments.CONCLUSIONSR-BOAD is an effective salvage option for PCNSL, but with significant hematologic toxicity. Bendamustine CSF levels are minimal; however correspond to plasma exposure and response.TRIAL REGISTRATIONClinicalTrials.gov NCT03392714 ; retrospectively registered January 8, 2018. Background A relatively high proportion of patients diagnosed with primary CNS lymphoma will experience recurrent disease, yet therapy options are limited in salvage therapy. This is the first study to evaluate a bendamustine-based combination regimen for the treatment of relapsed/refractory PCNSL and to characterize bendamustine pharmacokinetics in the human CSF. Methods Patients received bendamustine 75 mg/m.sup.2 for two days as part of R-B(O)AD administered intravenously every 4 weeks for up to 4 cycles. Response and adverse events of the regimen were assessed. A sparse sampling strategy and population based modeling approach was utilized for evaluation of plasma and CSF levels of bendamustine. Results Ten patients were enrolled into study of whom 70% were of refractory disease and with high IELSG prognostic risk scores. The ORR of R-BOAD was 50% (95% CI, 0.24 to 0.76) with one patient achieving CR and four PR. Primary toxicity of the regimen was reversible myelosuppression, mostly grade 3 or 4 neutropenia. The C.sub.max mean for plasma and CSF were 2669 ng/mL and 0.397 ng/mL, respectively, and patients with response at deep tumor sites displayed higher trends in peak exposure. Pharmacokinetic data was best described by a four-compartment model with first-order elimination of drug from central plasma and CSF compartments. Conclusions R-BOAD is an effective salvage option for PCNSL, but with significant hematologic toxicity. Bendamustine CSF levels are minimal; however correspond to plasma exposure and response. Trial registration ClinicalTrials.gov NCT03392714; retrospectively registered January 8, 2018. Keywords: Bendamustine, CSF, Pharmacokinetics, Primary CNS lymphoma, Salvage therapy Abstract Background A relatively high proportion of patients diagnosed with primary CNS lymphoma will experience recurrent disease, yet therapy options are limited in salvage therapy. This is the first study to evaluate a bendamustine-based combination regimen for the treatment of relapsed/refractory PCNSL and to characterize bendamustine pharmacokinetics in the human CSF. Methods Patients received bendamustine 75 mg/m2 for two days as part of R-B(O)AD administered intravenously every 4 weeks for up to 4 cycles. Response and adverse events of the regimen were assessed. A sparse sampling strategy and population based modeling approach was utilized for evaluation of plasma and CSF levels of bendamustine. Results Ten patients were enrolled into study of whom 70% were of refractory disease and with high IELSG prognostic risk scores. The ORR of R-BOAD was 50% (95% CI, 0.24 to 0.76) with one patient achieving CR and four PR. Primary toxicity of the regimen was reversible myelosuppression, mostly grade 3 or 4 neutropenia. The Cmax mean for plasma and CSF were 2669 ng/mL and 0.397 ng/mL, respectively, and patients with response at deep tumor sites displayed higher trends in peak exposure. Pharmacokinetic data was best described by a four-compartment model with first-order elimination of drug from central plasma and CSF compartments. Conclusions R-BOAD is an effective salvage option for PCNSL, but with significant hematologic toxicity. Bendamustine CSF levels are minimal; however correspond to plasma exposure and response. Trial registration ClinicalTrials.gov NCT03392714; retrospectively registered January 8, 2018. Evidence from previous preclinical tissue distribution studies and single agent intravenous drug therapy trials in CNS malignancies suggests that bendamustine penetrates brain and tumor tissue [12, 21–23], and while cerebrospinal fluid (CSF) drug concentrations are commonly used as a surrogate marker of CNS delivery, there are no clinical data available on the pharmacokinetics (PK) of bendamustine in the CSF. In light of rarity of the disease and difficulties in obtaining extensive data samples, a nonlinear mixed-effects modeling approach was considered appropriate for drug evaluation. [...]we evaluated the PK of plasma and CSF drug levels through a population based model approach in a R/R PCNSL cohort with the goals to define the currently unknown PK profile of bendamustine in the CSF and to further characterize the relationship between plasma and CSF drug levels, and the influence of exposure on response to therapy. Sex/ Age (years) ECOG PS IELSG score* Disease state Previous therapy Tumor location R-B(O)AD cycles completed Final response PFS/OS (months) 1 F/68 2 5 Ref HDMTX+ AraC D; periventricular, basal ganglia 3 PD 1.8/7.3 2 F/55 2 4 Ref HDMTX+ AraC D; periventricular, corpus callosum 2 PD 2.5/6.8 3 M/75 1 4 Rel HDMTX + WBRT; MPV-A ND; L optic nerve 4 CR 21.7/> 21.7 4 M/42 2 3 Ref HDMTX D; basal ganglia 2 PD 1.6/9.1 5 M/78 2 3 Rel HDMTX+ AraC ND; L parietal 4 PR 6.9/> 6.9 6 F/55 2 4 Ref HDMTX+ AraC ND; L frontal, R temporal 3 PD 2.8/3.3 7 F/47 1 2 Ref HDMTX+ AraC Dt; L frontal, periventricular 1 PR 2.8/2.8 8 F/73 2 5 Rel HDMTX+ AraC ND; L frontal 4 PR 4.4/4.4 9 M/75 2 4 Ref HDMTX+ AraC NDt; L frontal 2 SD 4.2/> 4.2 10 M/65 2 5 Ref HDMTX Dt; L frontal, basal ganglia 2 PR 3.9/3.9 Abbreviations: M, male; F, female; PS, performance status; Rel, relapsed; Ref, refractory; HDMTX, high dose methotrexate; AraC, cytarabine; WBRT, whole brain radiotherapy; MPV-A, methotrexate, vincristine, procarbazine, cytarabine; D, deep; ND, non-deep; L, left; R, right; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; PFS, progression free survival; OS, overall survival *IELSG risk = intermediate (IELSG score 2–3), high (IELSG score 4–5) tPatients with leptomeningeal involvement in recurrent disease Efficacy and safety The ORR of R-B(O)AD was 50% (95% CI, 0.24 to 0.76), one patient achieving CR (10%) and four PR (40%). Best-fit curves from the final population PK model are shown for plasma () and CSF (−---) Table 2 Population PK model parameter estimates and nonparametric bootstrap 90% confidence intervals Parameter Estimate RSE (%) /CV (%) Bootstrap Replicates Median CI (90%) V1 14.9 19.2 14.1 4.9 20.7 CL 32.5 10.5 31.4 23.9 39.2 V2 0.508 14.4 0.455 0.186 0.846 Q1 0.238 15.3 0.205 0.041 0.660 V3 0.323 9.8 0.322 0.186 0.442 Q2 0.569 15.8 0.569 0.344 0.836 V4 0.032 40.9 0.032 0.014 0.041 Q3 0.793 16.8 0.795 0.573 1.360 CLcsf 0.075 43.5 0.075 0.059 0.140 IIV V1 0.230 42.9 0.220 0.011 0.480 IIV CL 0.089 39.9 0.086 0.014 0.190 RV 0.420 17.4 0.390 0.210 0.620 Abbreviations: RSE (%, for structural parameter estimates), relative standard error; CV (%, for IIV), coefficient of variance; CI, confidence interval; V (L), volume of distribution; CL (L/h), elimination clearance; Q (L/h), inter-compartmental clearance; CLcsf (L/h), CSF compartment clearance; IIV, inter-individual variability; RV, residual variability Discussion This was a prospective pilot trial investigating a bendamustine-based combination regimen in patients with R/R primary CNS lymphoma. |
ArticleNumber | 729 |
Audience | Academic |
Author | Kim, Hyeoung-Joon Ahn, Jae-Sook Jung, Sung-Hoon Kim, Therasa Choi, He Yun Lee, Je-Jung Yang, Deok-Hwan Yoo, Hee-Doo Lee, Hyun-Seo |
Author_xml | – sequence: 1 givenname: Therasa surname: Kim fullname: Kim, Therasa organization: College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, 1 Gwanakro, Gwanakgu, Seoul, 08826, Republic of Korea – sequence: 2 givenname: He Yun surname: Choi fullname: Choi, He Yun organization: Research Center for Cancer Immunotherapy, Chonnam National University Hwasun Hospital, 322 Seoyangro, Hwasun, Jeollanamdo, 58128, Republic of Korea – sequence: 3 givenname: Hyun-Seo surname: Lee fullname: Lee, Hyun-Seo organization: Research Center for Cancer Immunotherapy, Chonnam National University Hwasun Hospital, 322 Seoyangro, Hwasun, Jeollanamdo, 58128, Republic of Korea – sequence: 4 givenname: Sung-Hoon surname: Jung fullname: Jung, Sung-Hoon organization: Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, 322 Seoyangro, Hwasun, Jeollanamdo, 58128, Republic of Korea – sequence: 5 givenname: Jae-Sook surname: Ahn fullname: Ahn, Jae-Sook organization: Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, 322 Seoyangro, Hwasun, Jeollanamdo, 58128, Republic of Korea – sequence: 6 givenname: Hyeoung-Joon surname: Kim fullname: Kim, Hyeoung-Joon organization: Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, 322 Seoyangro, Hwasun, Jeollanamdo, 58128, Republic of Korea – sequence: 7 givenname: Je-Jung surname: Lee fullname: Lee, Je-Jung organization: Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, 322 Seoyangro, Hwasun, Jeollanamdo, 58128, Republic of Korea – sequence: 8 givenname: Hee-Doo surname: Yoo fullname: Yoo, Hee-Doo email: yooheedoo@gmail.com organization: Department of Biostatistics and Bioinformatics, Pharma Partnering Inc., 74 Olympicro, Songpagu, Seoul, 05556, Republic of Korea. yooheedoo@gmail.com – sequence: 9 givenname: Deok-Hwan surname: Yang fullname: Yang, Deok-Hwan email: drydh1685@hotmail.com, drydh1685@hotmail.com organization: Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, 322 Seoyangro, Hwasun, Jeollanamdo, 58128, Republic of Korea. drydh1685@hotmail.com |
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CitedBy_id | crossref_primary_10_1080_10428194_2020_1791849 crossref_primary_10_3892_mco_2021_2371 crossref_primary_10_1111_bjh_16167 crossref_primary_10_1177_1747519820945931 crossref_primary_10_3892_or_2022_8325 |
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Keywords | Primary CNS lymphoma Bendamustine Pharmacokinetics Salvage therapy CSF |
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Snippet | A relatively high proportion of patients diagnosed with primary CNS lymphoma will experience recurrent disease, yet therapy options are limited in salvage... Background A relatively high proportion of patients diagnosed with primary CNS lymphoma will experience recurrent disease, yet therapy options are limited in... Evidence from previous preclinical tissue distribution studies and single agent intravenous drug therapy trials in CNS malignancies suggests that bendamustine... BACKGROUNDA relatively high proportion of patients diagnosed with primary CNS lymphoma will experience recurrent disease, yet therapy options are limited in... Abstract Background A relatively high proportion of patients diagnosed with primary CNS lymphoma will experience recurrent disease, yet therapy options are... |
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SubjectTerms | Adult Aged Analysis Antineoplastic Combined Chemotherapy Protocols - therapeutic use Bendamustine Bendamustine Hydrochloride - administration & dosage Bendamustine Hydrochloride - pharmacokinetics Cancer therapies Central nervous system Central Nervous System Neoplasms - drug therapy Chemotherapy CSF Diagnosis Dosage and administration Drug dosages Drug therapy Female Homeopathy Humans Lymphoma Lymphoma - drug therapy Male Materia medica and therapeutics Metabolites Middle Aged Nervous system Neurotoxicity NMR Non-Hodgkin's lymphomas Nuclear magnetic resonance Pharmacokinetics Pilot Projects Plasma Primary CNS lymphoma Salvage Therapy Studies Therapeutics |
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Title | Clinical response and pharmacokinetics of bendamustine as a component of salvage R-B(O)AD therapy for the treatment of primary central nervous system lymphoma (PCNSL) |
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