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Multicenter Study
. 2025 Mar:201:108447.
doi: 10.1016/j.lungcan.2025.108447. Epub 2025 Feb 15.

Exploration of clinical Biomarkers for guiding treatment selection between chemotherapy and combination therapy with Atezolizumab, Bevacizumab, Carboplatin, and Paclitaxel in EGFR-Mutant NSCLC patients after EGFR-TKI Therapy: The SPIRAL-STEP study

Kenji Morimoto  1 , Tadaaki Yamada  2 , Naoki Furuya  3 , Hisashi Tanaka  4 , Akihiro Yoshimura  5 , Tomohiro Oba  6 , Makoto Hibino  7 , Takahito Fukuda  8 , Yasuhiro Goto  9 , Akira Nakao  10 , Shinsuke Ogusu  11 , Yuta Okazaki  12 , Taishi Harada  13 , Takayo Ota  14 , Ken Masubuchi  15 , Koji Mikami  16 , Tae Hata  17 , Shoki Matsumoto  18 , Ryoichi Honda  19 , Koji Date  20 , Yusuke Chihara  21 , Koichi Takayama  1
Affiliations
Multicenter Study

Exploration of clinical Biomarkers for guiding treatment selection between chemotherapy and combination therapy with Atezolizumab, Bevacizumab, Carboplatin, and Paclitaxel in EGFR-Mutant NSCLC patients after EGFR-TKI Therapy: The SPIRAL-STEP study

Kenji Morimoto et al. Lung Cancer. 2025 Mar.

Abstract

Objectives: In patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations, a chemoimmunotherapy regimen of atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP) has shown promising outcomes following treatment with EGFR-tyrosine kinase inhibitors (EGFR-TKIs). However, evidence on whether ABCP provides a survival advantage over platinum-based chemotherapy in real-world clinical settings remains limited. This study aimed to investigate the efficacy and safety of ABCP versus platinum-based chemotherapy in patients with EGFR-mutant NSCLC who underwent EGFR-TKI treatment.

Materials and methods: We retrospectively assessed consecutive patients with EGFR-mutant-NSCLC who received platinum-based chemotherapy or ABCP after EGFR-TKI treatment at 20 institutions in Japan between January 2017 and July 2022.

Results: Overall, 408 patients with advanced or recurrent EGFR-mutant NSCLC were analyzed. A total of 306 patients (75.0 %) received chemotherapy (Chemo) or chemotherapy plus bevacizumab (Chemo + BEV), and 102 patients (25.0 %) received ABCP. After propensity score matching, no significant differences were noted in progression-free survival (PFS) and overall survival (OS) between the Chemo or Chemo + BEV and ABCP groups (6.0 months versus 7.2 months, log-rank test; p = 0.44 and 22.5 months versus 21.3 months, p = 0.84, respectively). Limiting to the programmed cell death-ligand 1 (PD-L1) ≥ 50 % cohort, the ABCP group had a significantly longer PFS than did the Chemo or Chemo + BEV group (7.9 months versus 4.8 months, log-rank test; p = 0.02).

Conclusion: In patients with EGFR-mutant NSCLC previously treated with EGFR-TKI, ABCP achieved comparable outcomes to those of platinum-based chemotherapy. Among patients with high PD-L1 expression, ABCP may be a superior treatment option.

Keywords: Bevacizumab; EGFR mutation; Immune checkpoint inhibitor; Non-small cell lung cancer; PD-L1.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Tadaaki Yamada received research grants from Ono Pharmaceutical, Janssen, AstraZeneca, and Takeda Pharmaceutical, and has received speaking honoraria from Eli Lilly and Chugai-Roche outside the purview of the submitted work. Hisashi Tanaka received speaking honoraria from Ono Pharmaceutical, Bristol Myers Squibb, AstraZeneca, Chugai Pharmaceutical, Boehringer-Ingelheim, Pfizer, Takeda Pharmaceutical, MSD-Merck, and Amgen. Makoto Hibino received speaking honoraria from Asahi Kasei Pharma Corporation, AstraZeneca, Boehringer Ingelheim, Bristol-Myers, Chugai Pharmaceutical Co. Ltd., and Eli Lilly, and is involved in a collaborative research project with Shionogi & Co., Ltd., outside the submitted work. Koichi Takayama received research grants from Chugai Pharmaceutical Co. Ltd. and Ono Pharmaceutical and personal fees from AstraZeneca, Chugai Pharmaceutical Co. Ltd., MSD-Merck, Eli Lilly, Boehringer Ingelheim, and Daiichi-Sankyo outside the purview of the submitted work. All remaining authors declared no conflict of interest.

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