Summary of studies highlighting the role of immunotherapy in radical treatment in cervical cancer
| Role | Author, year | Type | Sample size | Inclusion criteria | Treatment | Median follow up | Disease response | Toxicity |
|---|---|---|---|---|---|---|---|---|
| Neo-adjuvant | Chen et al. [12], 2024 | Single-arm, phase 2 trial | 55 | FIGO 2018 stage IIB–IVA disease), ECOG PS score 0–2 | 2 cycles neoadjuvant camrelizumab + TP, CCRT with concurrent triweekly camrelizumab + cisplatin, maintenance camrelizumab upto 1 year | 9.5 months | 98.1% complete remission5.5% treatment failure 1-year PFS 90.6% | Grade 3–4 neutropenia (18.2%), thrombocytopenia (9.1%) and anemia (27.3%). Serious AE: 12.7%, most commonly due to infectious complications |
| Li et al. [13], 2024 | Multicentre single-arm, phase 2 trial | 85 | FIGO 2018 IB3, IIA2, or IIB/IIIC1r, ECOG PS 0–1 | 1 cycle TP + 2 cycles TP-camrelizumab, CCRT for stable disease or progressive disease, SURGERY for complete or partial response | 11 months | 19% complete response, 79% partial response | Grade 3–4 lymphopenia 25%, neutropenia 12%, leukopenia 8% | |
| Concurrent | Lorusso et al. [26], 2024 | Randomised phase 3 | 1,060 | High-risk, LACC | 5 cycles of pembrolizumab (200 mg) or placebo q3 weeks plus CCRT, & 15 cycles of pembrolizumab (400 mg) or placebo q6 weeks | 17.9 months | 2-year PFS 68% in pembrolizumab-CCRT group vs. 57% in placebo-CCRTHR for progression 0.72-year OS: 87% in pembrolizumab-CCRT and 81% in the placebo-CCRTHR for death 0.73 | Grade ≥ 3 AE 75% in pembrolizumab-CCRT and 69% in placebo-CCRT |
| Rodrigues et al. [29], 2024 | Multicentre phase 1 | 16 | Stage IB3–IVA cervical cancers | Concurrent nivolumab + CCRT (with cisplatin) and maintenance (till 6 month post CCRT) (13 cycles) | 16.6 months | 1-year PFS 81.2% | 3/16 patients experienced dose limiting toxicity | |
| Duska et al. [31], 2020 | Randomized phase 2 | 52 | LACC (stage IB–IVA FIGO 2009) | Pembrolizumab post CRT (arm 1) or during CRT (arm 2) | 4.8 months | NA | Grade ≥ 2 AE in 88% | |
| Mayadev et al. [30], 2020 | Phase 1 | 32 | FIGO stage IB2–IVA cervical cancer with positive pelvic, para-aortic LNs, or both | CCRT (6 weekly doses of cisplatin) + sequential ipilimumab q21 days for 4 cycles | 14.8 months | 1-year OS 90%, and PFS 81% | 9.5% self-limiting grade 3 AE (lipase increase; dermatitis) | |
| Chen et al. [32], 2025 | Single-center, single-arm, prospective phase 2 | 82 | Stage IB3–IVA (2018 FIGO) | CCRT with cisplatin and toripalimab and adjuvant 6 cycles of cisplatin-paclitaxel-toripalimab | 21 months | 1 and 2-year PFS: 90.9%, 88.5%1 and 2-year OS: 98.6%, 95.2% | Grade ≥ 3 AE: 20.7% | |
| Monk et al. [28], 2023 | Randomised, double-blind, phase 3 trial | 770 | FIGO 2009 stage IB2–IIB lymph node positive, stage ≥ III any lymph node status) and ECOG PS 0–1 | Durvalumab or placebo with and following CCRT, for up to 24 cycles | 18.5 months | 12-month PFS 76% with durvalumab and 73.3% with placebo | Grade 3–4 anaemia 20% in durvalumab vs. 15% in placebo, decreased white blood cells 10% vs. 13% serious AE 28% in durvalumab vs. 23% in placeboFive treatment-related deaths in the durvalumab |
ECOG PS: Eastern Cooperative Oncology Group performance status; TP: taxane-platinum; CCRT: concurrent chemoradiation; CRT: chemoradiotherapy; PFS: progression-free survival; AE: adverse events; HR: hazard ratio; LACC: locally advanced cervical cancer
