Prognostic models integrating quantitative parameters from baseline and interim positron emission computed tomography in patients with diffuse large B‐cell lymphoma: post‐hoc analysis from the SAKK38/07 clinical trial

Q3 · MEDICINE

Article

Author: Bargetzi, Mario ; Zucca, Emanuele ; Schär, Sämi ; Cascione, Luciano ; Facchinelli, Davide ; Hayoz, Stefanie ; Mamot, Christoph ; Dirnhofer, Stefan ; Ruberto, Teresa ; Giovanella, Luca ; Ceriani, Luca

AbstractPositron emission computed tomography (PET/CT) in patients with diffuse large B‐cell lymphoma (DLBCL) enrolled in a prospective clinical trial were reviewed to test the impact of quantitative parameters from interim PET/CT scans on overall (OS) and progression‐free (PFS) survival. We centrally reviewed baseline and interim PET/CT scans of 138 patients treated with rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone given every 14 days (R‐CHOP14) in the SAKK38/07 trial (ClinicalTrial.gov identifier: NCT00544219). Cutoff values for maximum standardized uptake value (SUVmax), metabolic tumor volume (MTV), total lesion glycolysis (TLG) and metabolic heterogeneity (MH) were defined by receiver operating characteristic analysis. Responses were scored using the Deauville scale (DS). Patients with DS 5 at interim PET/CT (defined by uptake >2 times higher than in normal liver) had worse PFS (P = 0.014) and OS (P < 0.0001). A SUVmax reduction (Δ) greater than 66% was associated with longer PFS (P = 0.0027) and OS (P < 0.0001). Elevated SUVmax, MTV, TLG, and MH at interim PET/CT also identified patients with poorer outcome. At multivariable analysis, ΔSUVmax and baseline MTV appeared independent outcome predictors. A prognostic model integrating ΔSUVmax and baseline MTV discriminated three risk groups with significantly (log‐rank test for trend, P < 0.0001) different PFS and OS. Moreover, the integration of MH and clinical prognostic indices could further refine the prediction of OS. PET metrics‐derived prognostic models perform better than the international indices alone. Integration of baseline and interim PET metrics identified poor‐risk DLBCL patients who might benefit from alternative treatments.

01 Jan 2008·Pakistan journal of pharmaceutical sciences

Report: in vitro dissolution studies of different brands of sustained release diclofenac sodium matrix tablet available in Bangladesh.

Article

Author: Rouf, Abu Shara Shamsur ; Abdullah, M D Addnan ; Bepary, Sukumar

Commercially available national thirteen brands and three international brands of diclofenac sodium sustained release matrix tablets were studied in simulated gastric medium (pH 1.2) for 2 hours time period and simulated intestinal medium (pH 6.8) for 10 hours time period using USP reference dissolution apparatus. All the national and international brands complied with the USP in-vitro dissolution specification for drug releases in simulated gastric medium. However, four of the national brands (Code: DS-5, DS-8, DS-12, and DS-13) failed to fulfill their official requirement of 80% drug release within 8th hour in simulated intestinal medium. Drug release of those four national brands were 78.1%, 74.9%, 72.1%, and 77.8% respectively within the specified time period, however one national brand (Code: DS-2) released 83.2% drug within 6th hour in intestinal medium. Drug release profiles were analyzed for Higuchi equation, zero order, and first order to reveal the release kinetics perspective of diclofenac sodium sustained release matrix tablets. It was found that zero order release kinetics was predominant release mechanism than first order and Higuchi release kinetics for those brands (Code: DS-1, DS-3, DS-4, DS-6, DS-7, DS-9, DS-10, DS-11, DS-X, DS-Y and DS-Z) which complied with the USP in vitro dissolution specification for drug releases. On the other hand, first order release kinetics was predominant for five national substandard formulation brands (Code: DS-2, DS-5, DS-8, DS-12 and DS-13).

Haematologica

Positron emission tomography-imaging assessment for guiding strategy in patients with relapsed/refractory large B-cell lymphoma receiving CAR T cells

Article

Author: Meignin, Veronique ; Mesguich, Charles ; Feugier, Pierre ; Tabouret-Viaud, Claire ; Galtier, Jean ; Mebarki, Miryam ; Gros, François-Xavier ; Madelaine, Isabelle ; Di Blasi, Roberta ; Durand, Amandine ; Raffy, Léo ; Vercellino, Laetitia ; Rubio, Marie-Thérèse ; Casasnovas, Olivier ; Olivier, Pierre ; Chartier, Loic ; Meignan, Michel ; Thieblemont, Catherine

The aim of this study was to evaluate the prognostic impact of the F-fluorodeoxyglucose positron emission tomography response at 1 month (M1) and 3 months (M3) after anti-CD19 chimeric antigen receptor (CAR) T-cell therapy in a multicenter cohort of 160 patients with relapsed/refractory large B-cell lymphomas (R/R LBCL). In total, 119 (75%) patients reached M1 evaluation; 64 (53%, 64/119) had a complete response (CR); 91% were Deauville Score (DS) 1-3. Progressionfree survival (PFS) and overall survival (OS) were significantly worse in patients with DS-5 at M1, than in patients with DS 1-3 (PFS hazard ratio [HR]=6.37, 95% confidence interval [CI]: 3.5-11.5 vs. OS HR=3.79, 95% CI: 1.7-8.5) and DS-4 (PFS HR=11.99, 95% CI: 5.0-28.9 vs. OS HR=12.49, 95% CI: 2.8-55.8). The 1-year PFS rates were 78.9% (95% CI: 58.9-89.9) for DS-4 at M1, similar to 67.3% (95% CI: 51.8-78.8) for patients with DS 1-3 at M1, very different to 8.6% (95% CI: 1.8-22.4) for DS-5, respectively. Only eight of 30 (26%) patients with DS-4 progressed. Response at M3 evaluated in 90 (57%) patients was prognostic for PFS with lower discrimination (HR=3.28, 95% CI: 1.5-7.0; P=0.003) but did not predict OS (HR=0.61, 95% CI: 0.2-2.3; P=0.45). Patients with a high baseline total metabolic tumor volume (TMTV) >80 mL had worse PFS (HR=2.05, 95% CI: 1.2-3.5; P=0.009) and OS (HR=4.52, 95% CI: 2.5-8.1; P<0.001) than patients with low TMTV. Multivariable analyses identified baseline elevated lactate dehydrogenase, DS-5, CAR T cells at M1 for PFS and baseline elevated lactate dehydrogenase, TMTV >80 mL, and DS-5 at M1 for OS. In conclusion, baseline TMTV and response at M1 strongly predicts outcomes of patients with R/R LBCL undergoing CAR T-cell therapy.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Preclinical	CN	Dashi Pharmaceutical (Guangdong) Co., Ltd.	11 Oct 2022

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