Skip to content
DraconiticResearch
Search Sources API
190,839 studies31 sourcesUpdated 36 min ago
Peer-reviewedCC BY 4.0PLOS One

Efficacy and safety of immune checkpoint inhibitors combined with TKIs for recurrent or metastatic cervical cancer with PIK3CA mutation

  • Lele Chang1
  • Yaxin Kang2
  • Mingxuan Zhu3
  • Jing Liu4
  • Chunyan Lan
  • Qin Xu
4 affiliations
  1. 1Department of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, Fujian, P. R. China
  2. 2Department of Gynecologic Oncology, Sun Yat-sen University Cancer Centre, Guangzhou, Guangdong, P. R. China
  3. 3State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, Guangdong, P. R. China
  4. 4Fujian Key Laboratory of Advanced Technology for Cancer Screening and Early Diagnosis, Fujian Cancer Hospital, Fuzhou, Fujian, China
Open at sourcePDFDOICite

Abstract

Background: PIK3CA mutations are among the most common driver mutations in cervical cancer (CC), yet therapeutic strategies targeting PIK3CA mutations are still under investigation. This study aims to evaluate the efficacy and safety of immune checkpoint inhibitors (ICIs) combined with tyrosine kinase inhibitors (TKIs) in patients with PIK3CA-mutated recurrent or metastatic (R/M) CC. Methods: This study was based on two prospective clinical trials (ChiCTR1900023015 and the CLAP study) and retrospective data from Fujian Cancer Hospital, comparing ICIs combined with TKIs with physician’s-choice Non-ICI/TKI conventional treatments in PIK3CA-mutated R/M CC. The primary endpoint was objective response rate (ORR), and secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results: A total of 55 patients were included, with 27 in the ICIs plus TKIs treatment group and 28 in the Non-ICI/TKI conventional treatment group. The ORR in the ICIs plus TKIs group was 85.19% (95% CI, 67.52%−94.08%), significantly higher than 28.57% (95% CI, 15.25%−47.06%) in the Non-ICI/TKI conventional treatment group (P < 0.001). The PFS in the ICIs plus TKIs group was 21.03 months, significantly longer than 9.13 months in the Non-ICI/TKI conventional treatment group (HR, 0.49; 95% CI, 0.26–0.94, P = 0.033). Although the OS difference was not statistically significant (HR, 0.65; 95% CI, 0.31–1.34, P = 0.24), the ICIs plus TKIs group showed superior clinical efficacy. The incidence of hypertension (P < 0.001), rash (P = 0.004), hypothyroidism (P < 0.001), proteinuria (P = 0.010), and palmoplantar erythrodysesthesia syndrome (P = 0.023) was higher in the ICIs plus TKIs group compared to the Non-ICI/TKI conventional treatment group. The observed adverse events were generally manageable. Although grade ≥3 adverse events occurred, no grade ≥3 immune-related adverse events or treatment-related deaths were observed. Conclusion: ICIs plus TKIs demonstrated significant efficacy in treating PIK3CA-mutated R/M CC. Although there were some safety concerns, the adverse reactions were manageable, no grade ≥3 immune-related adverse events or treatment-related deaths were observed.

Related

  1. Efficacy and safety of PD-1/PD-L1 inhibitors plus chemotherapy ± bevacizumab for recurrent or metastatic cervical cancer: a systematic review and meta-analysis of randomized controlled trials
    Raoshan Luo, Minghong Li, Li Ma +1
    Frontiers in ImmunologyPeer-reviewedCC BY 4.0Full textObstetrics, gynaecology & paediatricsCrossrefEurope PMCPMCEurope PMC
  2. Long-term survival with immune checkpoint inhibitors combined with bevacizumab in advanced clear cell renal cell carcinoma : A case report
    Jing Zhang, Chun-Qiao Chen, Hui Huang +3
    MedicinePeer-reviewedCC BYFull textGeneral medicineEurope PMC
  3. Recursive partitioning analysis model based on ¹⁸F-FDG PET/CT metabolic parameters for recurrent or metastatic nasopharyngeal carcinoma treated with PD-1 inhibitors and chemotherapy.
    Huan Zhang, Ting Shen, Rongqin Fan +10
    Cancer imaging : the official publication of the International Cancer Imaging SocietyPeer-reviewedCC BY-NC-NDFull textMedical imaging & radiologyEurope PMC
  4. Immune checkpoint inhibitors combined with VEGF/VEGFR-targeted therapy in microsatellite-stable advanced colorectal cancer: clinical advances and the potential for immune-sensitive tumor conversion
    Ruoxin Wang, Xiaofang Zhou, Meiqin Yuan +1
    Frontiers in ImmunologyPeer-reviewedCC BY 4.0Full textOncologyCrossref
  5. Efficacy and Safety of Immune Checkpoint Inhibitors for Lung Cancer Complicated by Interstitial Pneumonia: The CS-Lung 003 Study, Branch Number 28.
    Kosuke Hamai, Nobuhiro Kanaji, Naoki Watanabe +12
    Thoracic cancerPeer-reviewedCC BYFull textOncologyEurope PMC

Cite

BibTeXRIS
BibTeX
@article{chang2026efficacy,
  title = {{Efficacy and safety of immune checkpoint inhibitors combined with TKIs for recurrent or metastatic cervical cancer with PIK3CA mutation}},
  author = {Lele Chang and Yaxin Kang and Mingxuan Zhu and Jing Liu and Chunyan Lan and Qin Xu},
  journal = {PLOS One},
  year = {2026},
  month = sep,
  doi = {10.1371/journal.pone.0350571},
  url = {https://doi.org/10.1371/journal.pone.0350571},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Efficacy and safety of immune checkpoint inhibitors combined with TKIs for recurrent or metastatic cervical cancer with PIK3CA mutation
AU  - Lele Chang
AU  - Yaxin Kang
AU  - Mingxuan Zhu
AU  - Jing Liu
AU  - Chunyan Lan
AU  - Qin Xu
PY  - 2026
DA  - 2026/09/29
JO  - PLOS One
DO  - 10.1371/journal.pone.0350571
UR  - https://doi.org/10.1371/journal.pone.0350571
AB  - Background: PIK3CA mutations are among the most common driver mutations in cervical cancer (CC), yet therapeutic strategies targeting PIK3CA mutations are still under investigation. This study aims to evaluate the efficacy and safety of immune checkpoint inhibitors (ICIs) combined with tyrosine kinase inhibitors (TKIs) in patients with PIK3CA-mutated recurrent or metastatic (R/M) CC. Methods: This study was based on two prospective clinical trials (ChiCTR1900023015 and the CLAP study) and retrospective data from Fujian Cancer Hospital, comparing ICIs combined with TKIs with physician’s-choice Non-ICI/TKI conventional treatments in PIK3CA-mutated R/M CC. The primary endpoint was objective response rate (ORR), and secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results: A total of 55 patients were included, with 27 in the ICIs plus TKIs treatment group and 28 in the Non-ICI/TKI conventional treatment group. The ORR in the ICIs plus TKIs group was 85.19% (95% CI, 67.52%−94.08%), significantly higher than 28.57% (95% CI, 15.25%−47.06%) in the Non-ICI/TKI conventional treatment group (P < 0.001). The PFS in the ICIs plus TKIs group was 21.03 months, significantly longer than 9.13 months in the Non-ICI/TKI conventional treatment group (HR, 0.49; 95% CI, 0.26–0.94, P = 0.033). Although the OS difference was not statistically significant (HR, 0.65; 95% CI, 0.31–1.34, P = 0.24), the ICIs plus TKIs group showed superior clinical efficacy. The incidence of hypertension (P < 0.001), rash (P = 0.004), hypothyroidism (P < 0.001), proteinuria (P = 0.010), and palmoplantar erythrodysesthesia syndrome (P = 0.023) was higher in the ICIs plus TKIs group compared to the Non-ICI/TKI conventional treatment group. The observed adverse events were generally manageable. Although grade ≥3 adverse events occurred, no grade ≥3 immune-related adverse events or treatment-related deaths were observed. Conclusion: ICIs plus TKIs demonstrated significant efficacy in treating PIK3CA-mutated R/M CC. Although there were some safety concerns, the adverse reactions were manageable, no grade ≥3 immune-related adverse events or treatment-related deaths were observed.
SN  - 1932-6203
ER  -