Discussion
toxicity, cancers, tumors, anemia
CANCERS, METASTATIC CERVICAL CANCER, ANEMIA, CERVICAL CANCER, CPS, TUMORS
The prognosis of recurrent and metastatic cervical cancer is poor and systemic therapy remains the mainstay of treatment. Although various combinations of systemic agents have improved survival outcomes, toxicity remains an issue, and median OS remains modest at around 1 year (The efficacy of treatments for patients in the second-line setting and beyond remains low. Systemic chemotherapy was commonly considered, and nab-paclitaxel was one of the more effective options among patients who were resistant to platinum-based chemotherapy. When given as a monotherapy, nab-paclitaxel yielded an ORR of 28.6%, and a PFS and OS of 5.0 and 9.4 months, respectively (The use of immune checkpoint inhibitors in this setting is also an active area of research. In KEYNOTE-158, pembrolizumab yielded an ORR of 12.2% in the overall cohort and 14.6% in those with PD-L1–positive tumors (The present study has provided evidence that combining immune checkpoint inhibitor with chemotherapy is a promising therapeutic strategy. Serplulimab plus nab-paclitaxel yielded promising antitumor activity, with 5 (23.8%) of 21 patients continuing with treatment at the time of data cutoff. The primary endpoint of ORR assessed by IRRC was 57.1%, and 3 (14.3%) patients experienced CR. Durable clinical activity was observed: median DOR has not been reached after a median follow-up of 14.6 months. The favorable ORR and DOR are further supported by the encouraging median PFS and OS data. Although cross-trial comparisons are difficult and must be interpreted with caution, the ORR in this study was numerically higher than those reported with other immune checkpoint inhibitors, indicating the clinical potential of such treatment combinations. In addition, the ORR was highest at 64.3% among patients with CPS ≥20. Of the 5 patients who had the longest DOR, 4 were CPS >50, suggesting that CPS was positively associated with the efficacy of this treatment combination.No new safety signals were observed in our study, with most common TEAEs such as anemia, elevated γ-glutamyltransferase, and incidence of irAEs consistent with previous reports (To our knowledge, this is the first published study using an immune checkpoint inhibitor plus chemotherapy in the second-line setting for advanced cervical cancer. Studies in other cancers have demonstrated that the addition of chemotherapy to PD-1/PD-L1 inhibitor improved ORR and clinical outcomes, with experts theorizing that such combination could exert a synergistic antitumor effect in patients (In conclusion, serplulimab plus nab-paclitaxel was associated with durable clinical activity in patients with advanced cervical cancer who had progressed on or were unable to tolerate first-line chemotherapy. Together with a manageable safety profile, this combination treatment represents a clinically meaningful option in the second-line setting. A phase II study of serplulimab plus bevacizumab in combination with chemotherapy in the first-line setting is currently planned for patients with recurrent or metastatic cervical cancer (ClinicalTrials.gov identifier: NCT05444374).