Background <p>To compare the real-world efficacy and safety of bispecific antibodies (BsAbs, PD-1/CTLA-4) versus PD-1 inhibitors (ICIs), each combined with platinum-based chemotherapy ± bevacizumab, as first-line treatment for persistent, recurrent, or metastatic cervical cancer (p/r/m CC).</p> Methods <p>In our single-center retrospective matched cohort study, 121 patients treated between January 2021 and February 2025 were recruited. They were divided into two groups: the bispecific antibody combination group and the PD-1 inhibitor combination group. After propensity score matching (PSM, 1:1, caliper = 0.2), early response to treatment, survival outcomes, and treatment-related adverse events (TRAEs) were assessed. Subgroup analyses, prognostic analyses, and sensitivity analyses were also conducted.</p> Results <p>After PSM, 86 patients were analyzed (43 per group). The median follow-up duration was 20.8&#xa0;months (interquartile range [IQR], 12.1–27.1&#xa0;months). Early response assessment after two treatment cycles showed no significant difference between the BsAb-Combo and PD-1i-Combo groups (ORR 60.5% vs. 51.2%, <i>p</i> = 0.385; DCR 95.3% vs. 97.7%, <i>p</i> = 1.000). The mPFS was 20.2&#xa0;months (95% CI, 18.6–not reached) in the BsAb-Combo group and 27.2&#xa0;months (95% CI, 12.6–not reached) in the PD-1i-Combo group (HR = 0.88, 95% CI 0.44–1.75; log-rank <i>p</i> = 0.708). Grade 3–5 decreased white blood cell count was more frequent with PD-1i-Combo (37.2% vs. 9.3%, <i>p</i> = 0.002), whereas all-grade diarrhea was more common with BsAb-Combo (46.5% vs. 25.6%, <i>p</i> = 0.043). Subgroup analyses suggested that persistent/recurrent with distant metastases tended to benefit more from BsAb-Combo. In multivariate Cox models, ECOG Performance Status 2, lung metastasis, and ≥ 1-year maintenance therapy were independent prognostic factors for PFS.</p> Conclusion <p>BsAbs (PD-1/CTLA-4) combined with platinum-based chemotherapy ± bevacizumab demonstrated comparable efficacy and safety to PD-1 inhibitors and showed a favorable hazard-ratio trend. Hypothesis-generating signals observed in select subgroups, such as those with persistent or recurrent disease with distant metastases, warrant confirmation in prospective studies with extended follow-up.</p>

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Bispecific antibodies (PD-1/CTLA-4) vs. PD-1 inhibitors with platinum-based chemotherapy±bevacizumab as first-line therapy for persistent, recurrent, or metastatic cervical cancer: a retrospective matched cohort study

  • Xin Wang,
  • Yaqin Wu,
  • Jian Huang,
  • Dan Zong,
  • Xia He

摘要

Background

To compare the real-world efficacy and safety of bispecific antibodies (BsAbs, PD-1/CTLA-4) versus PD-1 inhibitors (ICIs), each combined with platinum-based chemotherapy ± bevacizumab, as first-line treatment for persistent, recurrent, or metastatic cervical cancer (p/r/m CC).

Methods

In our single-center retrospective matched cohort study, 121 patients treated between January 2021 and February 2025 were recruited. They were divided into two groups: the bispecific antibody combination group and the PD-1 inhibitor combination group. After propensity score matching (PSM, 1:1, caliper = 0.2), early response to treatment, survival outcomes, and treatment-related adverse events (TRAEs) were assessed. Subgroup analyses, prognostic analyses, and sensitivity analyses were also conducted.

Results

After PSM, 86 patients were analyzed (43 per group). The median follow-up duration was 20.8 months (interquartile range [IQR], 12.1–27.1 months). Early response assessment after two treatment cycles showed no significant difference between the BsAb-Combo and PD-1i-Combo groups (ORR 60.5% vs. 51.2%, p = 0.385; DCR 95.3% vs. 97.7%, p = 1.000). The mPFS was 20.2 months (95% CI, 18.6–not reached) in the BsAb-Combo group and 27.2 months (95% CI, 12.6–not reached) in the PD-1i-Combo group (HR = 0.88, 95% CI 0.44–1.75; log-rank p = 0.708). Grade 3–5 decreased white blood cell count was more frequent with PD-1i-Combo (37.2% vs. 9.3%, p = 0.002), whereas all-grade diarrhea was more common with BsAb-Combo (46.5% vs. 25.6%, p = 0.043). Subgroup analyses suggested that persistent/recurrent with distant metastases tended to benefit more from BsAb-Combo. In multivariate Cox models, ECOG Performance Status 2, lung metastasis, and ≥ 1-year maintenance therapy were independent prognostic factors for PFS.

Conclusion

BsAbs (PD-1/CTLA-4) combined with platinum-based chemotherapy ± bevacizumab demonstrated comparable efficacy and safety to PD-1 inhibitors and showed a favorable hazard-ratio trend. Hypothesis-generating signals observed in select subgroups, such as those with persistent or recurrent disease with distant metastases, warrant confirmation in prospective studies with extended follow-up.