First multicentric real-life experience with the combination of CCNU and temozolomide in newly diagnosed MGMT promoter methylated IDH wildtype glioblastoma

Autor: Lazaros Lazaridis, Elisabeth Bumes, Dorothee Cäcilia Spille, Tim Schulz, Sina Heider, Sarina Agkatsev, Teresa Schmidt, Tobias Blau, Christoph Oster, Jonas Feldheim, Walter Stummer, Almuth Friederike Kessler, Clemens Seidel, Oliver Grauer, Peter Hau, Ulrich Sure, Kathy Keyvani, Ulrich Herrlinger, Christoph Kleinschnitz, Martin Stuschke, Ken Herrmann, Cornelius Deuschl, Stella Breuer, Elke Hattingen, Björn Scheffler, Sied Kebir, Martin Glas
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Popis: Background The randomized phase 3 CeTeG/NOA-09 trial assessed whether CCNU plus temozolomide was superior to temozolomide alone in newly diagnosed MGMT promoter methylated glioblastoma patients. Survival was significantly improved from 31.4 months (temozolomide) to 48.1 months (CCNU plus temozolomide). In view of this encouraging data, we assessed safety and efficacy of this regimen under real-life conditions. Methods We retrospectively collected clinical and radiographic data from adult newly diagnosed MGMT promoter methylated IDH wildtype glioblastoma patients from five neuro-oncology centers in Germany. For inclusion in our analysis, treatment with CCNU and temozolomide had to be performed for at least six weeks (one course). Results Seventy patients were included. Median progression-free survival was 14.4 months and median overall survival 33.8 months. Patients with TTFields treatment for at least 8 weeks and CCNU plus temozolomide (n = 22, 31%) had a prolonged progression-free survival compared to those with TTFields treatment for less than eight weeks (n = 48, 69%) (21.5 versus 11.2 months; P = .0105). In a multivariable Cox regression analysis, TTFields treatment for eight weeks or longer together with CCNU plus temozolomide and a Karnofsky performance score ≥ 90% were independent prognostic factors for progression-free and overall survival. Pseudoprogression occurred in n = 16 (33%) of investigated n = 49 (70%) patients. In n = 31 (44%) patients high-grade hematotoxicity was observed. Conclusions The results from this multicentric trial indicate that—under real-life conditions—toxicity and survival estimates are comparable to the CeTeG/NOA-09 trial. TTFields therapy for at least eight weeks in combination with this regimen was independently associated with prolonged survival.
Databáze: OpenAIRE