Efficacy of PD-(L)1 inhibitors plus anlotinib in the second-line treatment of extensive-stage small cell lung cancer

Abstract Background The efficacy of second-line therapy for extensive-stage small cell lung cancer (ES-SCLC) is still limited, with the PFS of 2–3 months. Given the synergistic effect of PD-(L)1 inhibitors and anti-angiogenic agents, their combination represents a novel and promising strategy to rep...

Full description

Saved in:
Bibliographic Details
Main Authors: Jian Zhang, Zijie Wu, Shuyun Wang, Yanxin Sun, Jiake Wu, Dahai Wang, Yihui Ge, Juan Li, Haifeng Sun, Qinglei Cheng, Aiqin Gao, Yuping Sun
Format: Article
Language:English
Published: BMC 2025-07-01
Series:BMC Cancer
Subjects:
Online Access:https://doi.org/10.1186/s12885-025-14458-5
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1849768633919602688
author Jian Zhang
Zijie Wu
Shuyun Wang
Yanxin Sun
Jiake Wu
Dahai Wang
Yihui Ge
Juan Li
Haifeng Sun
Qinglei Cheng
Aiqin Gao
Yuping Sun
author_facet Jian Zhang
Zijie Wu
Shuyun Wang
Yanxin Sun
Jiake Wu
Dahai Wang
Yihui Ge
Juan Li
Haifeng Sun
Qinglei Cheng
Aiqin Gao
Yuping Sun
author_sort Jian Zhang
collection DOAJ
description Abstract Background The efficacy of second-line therapy for extensive-stage small cell lung cancer (ES-SCLC) is still limited, with the PFS of 2–3 months. Given the synergistic effect of PD-(L)1 inhibitors and anti-angiogenic agents, their combination represents a novel and promising strategy to reprogram the protumoral microenvironment and improve patient outcome. However, the efficacy of PD-(L)1 inhibitors plus anlotinib as the second-line treatment of ES-SCLC is undetermined in the real world. Methods We retrospectively analyzed 389 ES-SCLC patients from 3 cancer centers. All the patients received one of the following second-line schemes: PD-(L)1 inhibitors plus anlotinib (I + A), PD-(L)1 inhibitors plus chemotherapy (I + C), or chemotherapy alone (C). The efficacy, including the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety were compared among the three groups. We also analyzed the impact of first-line immune checkpoint inhibitors (ICIs) on the efficacy of second-line I + A. Results The baseline clinical characteristics among three groups were largely balanced. I + A treatment demonstrated significantly higher ORR (30.2%) and DCR (82.6%) compared with I + C (ORR = 17.6%, DCR = 68.8%) and C (ORR = 18.0%, DCR = 53.9%). Furthermore, I + A group showed the longest mPFS (7.2 months) and mOS (33.5 months), compared to I + C (mPFS = 4.6 months, mOS = 19.0 months, both P < 0.001) and C (mPFS = 3.4 months, P < 0.01; mOS = 18.3 months, P = 0.083). The benefit of I + A treatment persists independent of the administration of first-line ICIs. A stratified analysis revealed that female patients and those with oligometastasis (≤ 3 metastatic sites) benefit more from I + A treatment than male patients and those with polymetastasis. In terms of safety, I + A group displayed the lowest incidence of ≥ grade 3 myelosuppression compared to the I + C and C groups (3.5% vs. 11.2% vs. 16.3%, P < 0.01). However, I + A treatment was associated with a higher prevalence of immune-related pneumonia (2.3% vs. 0% vs. 0%, P < 0.05) and hemoptysis (1.4% vs. 0% vs. 0.6%, P < 0.05) compared to I + C and C treatment. Conclusions PD-(L)1 inhibitors and anlotinib has promising efficacy and manageable toxicity as the second-line therapy of ES-SCLC.
format Article
id doaj-art-1e64966de4b64567a67e97bb44bc32e8
institution DOAJ
issn 1471-2407
language English
publishDate 2025-07-01
publisher BMC
record_format Article
series BMC Cancer
spelling doaj-art-1e64966de4b64567a67e97bb44bc32e82025-08-20T03:03:44ZengBMCBMC Cancer1471-24072025-07-012511910.1186/s12885-025-14458-5Efficacy of PD-(L)1 inhibitors plus anlotinib in the second-line treatment of extensive-stage small cell lung cancerJian Zhang0Zijie Wu1Shuyun Wang2Yanxin Sun3Jiake Wu4Dahai Wang5Yihui Ge6Juan Li7Haifeng Sun8Qinglei Cheng9Aiqin Gao10Yuping Sun11Phase I Clinical Research Center, Shandong Cancer Hospital and Institute, Zhangqiu District People’s Hospital, Shandong First Medical University, Shandong Academy of Medical SciencesPhase I Clinical Research Center, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical SciencesPhase I Clinical Research Center, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical SciencesSchool of Clinical Medicine, Weifang Medical UniversityPhase I Clinical Research Center, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical SciencesPhase I Clinical Research Center, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical SciencesPhase I Clinical Research Center, Shandong University Cancer CenterPhase I Clinical Research Center, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical SciencesSchool of Clinical Medicine, Weifang Medical UniversityPhase I Clinical Research Center, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical SciencesDepartment of Thoracic Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical SciencesPhase I Clinical Research Center, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical SciencesAbstract Background The efficacy of second-line therapy for extensive-stage small cell lung cancer (ES-SCLC) is still limited, with the PFS of 2–3 months. Given the synergistic effect of PD-(L)1 inhibitors and anti-angiogenic agents, their combination represents a novel and promising strategy to reprogram the protumoral microenvironment and improve patient outcome. However, the efficacy of PD-(L)1 inhibitors plus anlotinib as the second-line treatment of ES-SCLC is undetermined in the real world. Methods We retrospectively analyzed 389 ES-SCLC patients from 3 cancer centers. All the patients received one of the following second-line schemes: PD-(L)1 inhibitors plus anlotinib (I + A), PD-(L)1 inhibitors plus chemotherapy (I + C), or chemotherapy alone (C). The efficacy, including the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety were compared among the three groups. We also analyzed the impact of first-line immune checkpoint inhibitors (ICIs) on the efficacy of second-line I + A. Results The baseline clinical characteristics among three groups were largely balanced. I + A treatment demonstrated significantly higher ORR (30.2%) and DCR (82.6%) compared with I + C (ORR = 17.6%, DCR = 68.8%) and C (ORR = 18.0%, DCR = 53.9%). Furthermore, I + A group showed the longest mPFS (7.2 months) and mOS (33.5 months), compared to I + C (mPFS = 4.6 months, mOS = 19.0 months, both P < 0.001) and C (mPFS = 3.4 months, P < 0.01; mOS = 18.3 months, P = 0.083). The benefit of I + A treatment persists independent of the administration of first-line ICIs. A stratified analysis revealed that female patients and those with oligometastasis (≤ 3 metastatic sites) benefit more from I + A treatment than male patients and those with polymetastasis. In terms of safety, I + A group displayed the lowest incidence of ≥ grade 3 myelosuppression compared to the I + C and C groups (3.5% vs. 11.2% vs. 16.3%, P < 0.01). However, I + A treatment was associated with a higher prevalence of immune-related pneumonia (2.3% vs. 0% vs. 0%, P < 0.05) and hemoptysis (1.4% vs. 0% vs. 0.6%, P < 0.05) compared to I + C and C treatment. Conclusions PD-(L)1 inhibitors and anlotinib has promising efficacy and manageable toxicity as the second-line therapy of ES-SCLC.https://doi.org/10.1186/s12885-025-14458-5Extensive-stage small cell lung cancer (ES-SCLC)PD-(L)1 inhibitorsAnlotinibEfficacySafety
spellingShingle Jian Zhang
Zijie Wu
Shuyun Wang
Yanxin Sun
Jiake Wu
Dahai Wang
Yihui Ge
Juan Li
Haifeng Sun
Qinglei Cheng
Aiqin Gao
Yuping Sun
Efficacy of PD-(L)1 inhibitors plus anlotinib in the second-line treatment of extensive-stage small cell lung cancer
BMC Cancer
Extensive-stage small cell lung cancer (ES-SCLC)
PD-(L)1 inhibitors
Anlotinib
Efficacy
Safety
title Efficacy of PD-(L)1 inhibitors plus anlotinib in the second-line treatment of extensive-stage small cell lung cancer
title_full Efficacy of PD-(L)1 inhibitors plus anlotinib in the second-line treatment of extensive-stage small cell lung cancer
title_fullStr Efficacy of PD-(L)1 inhibitors plus anlotinib in the second-line treatment of extensive-stage small cell lung cancer
title_full_unstemmed Efficacy of PD-(L)1 inhibitors plus anlotinib in the second-line treatment of extensive-stage small cell lung cancer
title_short Efficacy of PD-(L)1 inhibitors plus anlotinib in the second-line treatment of extensive-stage small cell lung cancer
title_sort efficacy of pd l 1 inhibitors plus anlotinib in the second line treatment of extensive stage small cell lung cancer
topic Extensive-stage small cell lung cancer (ES-SCLC)
PD-(L)1 inhibitors
Anlotinib
Efficacy
Safety
url https://doi.org/10.1186/s12885-025-14458-5
work_keys_str_mv AT jianzhang efficacyofpdl1inhibitorsplusanlotinibinthesecondlinetreatmentofextensivestagesmallcelllungcancer
AT zijiewu efficacyofpdl1inhibitorsplusanlotinibinthesecondlinetreatmentofextensivestagesmallcelllungcancer
AT shuyunwang efficacyofpdl1inhibitorsplusanlotinibinthesecondlinetreatmentofextensivestagesmallcelllungcancer
AT yanxinsun efficacyofpdl1inhibitorsplusanlotinibinthesecondlinetreatmentofextensivestagesmallcelllungcancer
AT jiakewu efficacyofpdl1inhibitorsplusanlotinibinthesecondlinetreatmentofextensivestagesmallcelllungcancer
AT dahaiwang efficacyofpdl1inhibitorsplusanlotinibinthesecondlinetreatmentofextensivestagesmallcelllungcancer
AT yihuige efficacyofpdl1inhibitorsplusanlotinibinthesecondlinetreatmentofextensivestagesmallcelllungcancer
AT juanli efficacyofpdl1inhibitorsplusanlotinibinthesecondlinetreatmentofextensivestagesmallcelllungcancer
AT haifengsun efficacyofpdl1inhibitorsplusanlotinibinthesecondlinetreatmentofextensivestagesmallcelllungcancer
AT qingleicheng efficacyofpdl1inhibitorsplusanlotinibinthesecondlinetreatmentofextensivestagesmallcelllungcancer
AT aiqingao efficacyofpdl1inhibitorsplusanlotinibinthesecondlinetreatmentofextensivestagesmallcelllungcancer
AT yupingsun efficacyofpdl1inhibitorsplusanlotinibinthesecondlinetreatmentofextensivestagesmallcelllungcancer