학술논문
Baseline Tumor Size as Prognostic Index in Patients With Advanced Solid Tumors Receiving Experimental Targeted Agents
Original Article
Original Article
Document Type
Academic Journal
Author
Nicolo, Eleonora; Tarantino, Paolo; D'Ecclesiis, Oriana; Antonarelli, Gabriele; Bielo, Luca Boscolo; Marra, Antonio; Gandini, Sara; Crimini, Edoardo; Giugliano, Federica; Zagami, Paola; Corti, Chiara; Trapani, Dario; Morganti, Stefania; Criscitiello, Carmen; Locatelli, Marzia; Belli, Carmen; Esposito, Angela; Minchella, Ida; Cristofanilli, Massimo; Tolaney, Sara M.; Curigliano, Giuseppe
Source
The Oncologist. January 2024, Vol. 29 Issue 1, p75, 9 p.
Subject
Language
English
ISSN
1083-7159
Abstract
Introduction The extension of solid tumors at diagnosis, namely disease stage, has traditionally driven the choice of treatment (surgery, radiotherapy, and systemic therapy) of non-metastatic disease. In general, more intensive [...]
Background: Baseline tumor size (BTS) has been associated with outcomes in patients with cancer treated with immunotherapy. However, the prognostic impact of BTS on patients receiving targeted therapies (TTs) remains undetermined. Methods: We reviewed data of patients with advanced solid tumors consecutively treated within early-phase clinical trials at our institution from 01/2014 to 04/2021. Treatments were categorized as immunotherapy-based or TT- based (biomarker-matched or not). BTS was calculated as the sum of RECIST1.1 baseline target lesions. Results: A total of 444 patients were eligible; the median BTS was 69 mm (IQR 40-100). OS was significantly longer for patients with BTS lower versus higher than the median (16.6 vs. 8.2 months, P < .001), including among those receiving immunotherapy (12 vs. 75 months, P = .005). Among patients receiving TT, lower BTS was associated with longer PFS (4.7 vs. 3.1 months, P = .002) and OS (20.5 vs. 9.9 months, P < .001) as compared to high BTS. However, such association was only significant among patients receiving biomarker-matched TT, with longer PFS (6.2 vs. 3.3 months, P < .001) and OS (21.2 vs. 6.7 months, P < .001) in the low-BTS subgroup, despite a similar ORR (28% vs. 22%, P = .57). BTS was not prognostic among patients receiving unmatched TT, with similar PFS (3.7 vs. 4.4 months, P = .30), OS (19.3 vs. 11.8 months, P = .20), and ORR (33% vs. 28%, P = .78) in the 2 BTS groups. Multivariate analysis confirmed that BTS was independently associated with PFS (P = .03) and OS (P < .001) but not with ORR (P = .11). Conclusions: Higher BTS is associated with worse survival outcomes among patients receiving biomarker-matched, but not biomarkerunmatched TT Key words: baseline tumor size; tumor burden; targeted therapy; biomarker; phase I trials; solid tumor.
Background: Baseline tumor size (BTS) has been associated with outcomes in patients with cancer treated with immunotherapy. However, the prognostic impact of BTS on patients receiving targeted therapies (TTs) remains undetermined. Methods: We reviewed data of patients with advanced solid tumors consecutively treated within early-phase clinical trials at our institution from 01/2014 to 04/2021. Treatments were categorized as immunotherapy-based or TT- based (biomarker-matched or not). BTS was calculated as the sum of RECIST1.1 baseline target lesions. Results: A total of 444 patients were eligible; the median BTS was 69 mm (IQR 40-100). OS was significantly longer for patients with BTS lower versus higher than the median (16.6 vs. 8.2 months, P < .001), including among those receiving immunotherapy (12 vs. 75 months, P = .005). Among patients receiving TT, lower BTS was associated with longer PFS (4.7 vs. 3.1 months, P = .002) and OS (20.5 vs. 9.9 months, P < .001) as compared to high BTS. However, such association was only significant among patients receiving biomarker-matched TT, with longer PFS (6.2 vs. 3.3 months, P < .001) and OS (21.2 vs. 6.7 months, P < .001) in the low-BTS subgroup, despite a similar ORR (28% vs. 22%, P = .57). BTS was not prognostic among patients receiving unmatched TT, with similar PFS (3.7 vs. 4.4 months, P = .30), OS (19.3 vs. 11.8 months, P = .20), and ORR (33% vs. 28%, P = .78) in the 2 BTS groups. Multivariate analysis confirmed that BTS was independently associated with PFS (P = .03) and OS (P < .001) but not with ORR (P = .11). Conclusions: Higher BTS is associated with worse survival outcomes among patients receiving biomarker-matched, but not biomarkerunmatched TT Key words: baseline tumor size; tumor burden; targeted therapy; biomarker; phase I trials; solid tumor.