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. 2023 Feb 28;4(4):100493.
doi: 10.1016/j.jtocrr.2023.100493. eCollection 2023 Apr.

Early Tumor Shrinkage as a Predictor of Favorable Treatment Outcomes in Patients With Extensive-Stage SCLC Who Received Programmed Cell Death-Ligand 1 Inhibitor Plus Platinum-Etoposide Chemotherapy: A Prospective Observational Study

Masaki Ishida  1 , Kenji Morimoto  1 , Tadaaki Yamada  1 , Takayuki Takeda  2 , Shinsuke Shiotsu  3 , Koji Date  4 , Taishi Harada  5 , Nobuyo Tamiya  6 , Yusuke Chihara  7 , Yoshizumi Takemura  8 , Takahiro Yamada  9 , Hibiki Kanda  10 , Masahiro Iwasaku  1 , Shinsaku Tokuda  1 , Young Hak Kim  1 , Koichi Takayama  1
Affiliations

Early Tumor Shrinkage as a Predictor of Favorable Treatment Outcomes in Patients With Extensive-Stage SCLC Who Received Programmed Cell Death-Ligand 1 Inhibitor Plus Platinum-Etoposide Chemotherapy: A Prospective Observational Study

Masaki Ishida et al. JTO Clin Res Rep. .

Abstract

Introduction: In recent years, programmed cell death-ligand 1 (PD-L1) inhibitor plus platinum-etoposide chemotherapy was found to have favorable clinical outcomes in patients with extensive-stage SCLC (ES-SCLC). The usefulness of early tumor shrinkage (ETS) has been reported in various types of cancers. Nevertheless, there have been few reports evaluating ETS in ES-SCLC. Therefore, this study aimed to evaluate the role of ETS in the clinical outcomes of patients with ES-SCLC receiving chemoimmunotherapy.

Methods: We prospectively identified 46 patients with ES-SCLC who received PD-L1 inhibitor plus platinum-etoposide chemotherapy at 10 institutions in Japan between September 2019 and October 2021. Of them, 35 patients were selected for analyses.

Results: The responders (progression-free survival [PFS] ≥ 6.0 mo) had significantly greater tumor shrinkage at the first evaluation than the nonresponders (PFS < 6.0 mo) (65.0% versus 53.7%, p = 0.03). We defined the cutoff value for ETS as a 57% change from the baseline on the basis of the receiver operating characteristic results to determine the optimal tumor shrinkage rate at the first evaluation for identifying responders. The patients with ES-SCLC who achieved ETS had longer PFS and overall survival than those who did not achieve ETS (5.6 versus 4.0 mo, log-rank test p = 0.001 and 15.0 versus 8.3 mo, log-rank test p = 0.02). In the multivariate analyses, ETS was significantly associated with PFS and overall survival (hazard ratio = 0.27, 95% confidence interval: 0.12-0.63, p = 0.002 and hazard ratio = 0.34, 95% confidence interval: 0.13-0.85, p = 0.02).

Conclusions: Our prospective observational study indicated that ETS was related to favorable clinical outcomes for patients with ES-SCLC receiving PD-L1 inhibitor plus platinum-etoposide chemotherapy.

Keywords: Early tumor shrinkage; Extensive-stage-small cell lung cancer; Objective response; PD-L1 inhibitor plus platinum-etoposide chemotherapy.

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Figures

Figure 1
Figure 1
Consort diagram of this study. ES-SCLC, extensive-stage SCLC; CRT, chemoradiotherapy.
Figure 2
Figure 2
(A) Association between PFS and the tumor shrinkage at the first evaluation. (B) Receiver operation to determine the optimal cutoff value for tumor shrinkage rate at the first evaluation to predict the responder. AUC, area under the curve; PFS, progression-free survival.
Figure 3
Figure 3
Kaplan-Meier curves for (A) PFS compared with ETS (with ETS versus without ETS), (B) OS compared with ETS (with ETS versus without ETS), (C) PFS of patients who received four courses of induction chemotherapy (with ETS versus without ETS), (D) OS of patients who received four courses of induction chemotherapy (with ETS versus without ETS). PFS, progression-free survival; OS, overall survival; CI: confidence interval; ETS, early tumor shrinkage.
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