Akahoshi, Yu and Inamoto, Yoshihiro and Spyrou, Nikolaos and Nakasone, Hideki and Diniz, Marcio A. and Asada, Noboru and Ayuk, Francis and Choe, Hannah K. and Doki, Noriko and Eto, Tetsuya and Etra, Aaron M. and Hexner, Elizabeth O. and Hiramoto, Nobuhiro and Hogan, William J. and Holler, Ernst and Kataoka, Keisuke and Kawakita, Toshiro and Tanaka, Masatsugu and Tanaka, Takashi and Uchida, Naoyuki and Vasova, Ingrid and Yoshihara, Satoshi and Ishimaru, Fumihiko and Fukuda, Takahiro and Chen, Yi-Bin and Kanda, Junya and Nakamura, Ryotaro and Atsuta, Yoshiko and Ferrara, James L. M. and Kanda, Yoshinobu and Levine, John E. and Teshima, Takanori (2025) Refinement of day 28 treatment response criteria for acute GVHD: a collaboration study of the JSTCT and MAGIC. BLOOD ADVANCES, 9 (18). pp. 4640-4653. ISSN 2473-9529, 2473-9537
Full text not available from this repository. (Request a copy)Abstract
Overall response (OR) that combines complete (CR) and partial responses (PR) is the conventional end point for acute graft-versus-host disease (GVHD) trials. Because PR includes heterogeneous clinical presentations, reclassifying PR could produce a better end point. Patients in the primary treatment cohort from the Japanese Society for Transplantation and Cellular Therapy (JSTCT) were randomly divided into training and validation sets. In the training set, a classification and regression tree algorithm generated day 28 refined response (RR) criteria based on symptoms at treatment and day 28. We then evaluated RR for primary and second-line treatments, using the area under the receiver operating characteristic curve (AUC) and negative predictive value (NPV) for 6-month nonrelapse mortality as performance measures. RR considered patients with grade 0/1 at day 28 without additional treatment as responders. RR for primary treatment produced higher AUCs than OR with small improvement of NPVs in both validation sets: JSTCT (AUC, 0.73 vs 0.69 [P < .001]; NPV, 92.0% vs 89.6% [P < .001]) and the Mount Sinai Acute GVHD International Consortium (MAGIC; AUC, 0.71 vs 0.68 [P = .032]; NPV, 90.9% vs 89.8% [P = .009]). RR for second-line treatment produced similar AUCs but much higher NPVs than OR in both validation sets of JSTCT (AUC, 0.64 vs 0.63 [P = .775]; NPV, 74.5% vs 66.0% [P < .001]) and MAGIC (AUC, 0.67 vs 0.64 [P = .105]; NPV, 86.8% vs 76.1% [P = .004]). Classifying persistent but mild skin symptoms as responses and residual lower gastrointestinal GVHD as nonresponses were major drivers in improving the prognostic performance of RR. Our externally validated day 28 RR would serve as a better end point than conventional criteria in future first- and second-line treatment trials.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | VERSUS-HOST-DISEASE; ALGORITHM PROBABILITY; INITIAL TREATMENT; SURVIVAL; MULTICENTER; ITACITINIB; BIOMARKERS; ACCURACY; OUTCOMES; THERAPY; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 24 Mar 2026 12:49 |
| Last Modified: | 24 Mar 2026 12:49 |
| URI: | https://pred.uni-regensburg.de/id/eprint/68064 |
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