In cervical cancer that has spread to nearby tissues or lymph nodes, the standard treatment for years has been “chemoradiotherapy” (radiotherapy with weekly cisplatin). In this large study, adding the immunotherapy drug pembrolizumab during radiotherapy and continuing it for about two years raised the chance of being alive after three years from about 75% to about 83%. This drug increases immune-related side effects such as thyroid problems, which need follow-up with your doctor.
FIGO 2014 stage III to IVA
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| With chemoradiotherapy | |||
| Pembrolizumab | 200 mg | IV infusion over 30 minutes | Every 3 weeks, 5 cycles |
| With radiotherapy | |||
| Cisplatin | 40 mg/m² | IV | Weekly, 5 cycles (a sixth is optional) |
| After chemoradiotherapy | |||
| Pembrolizumab | 400 mg | IV infusion over 30 minutes | Every 6 weeks, 15 cycles |
External beam radiotherapy followed by brachytherapy.
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Pembrolizumab 200 mg IV on day 1 every 3 weeks for 5 cycles concurrent with chemoradiotherapy, then pembrolizumab 400 mg IV on day 1 every 6 weeks for 15 more cycles.
Standard chemoradiotherapy: cisplatin 40 mg/m² IV once weekly for 5 or 6 weeks, with external beam radiotherapy (EBRT) followed by brachytherapy to a minimum total dose of 80 Gy (volume-based) or 75 Gy (point-based); total radiotherapy duration no more than 50 days (up to 56 days for unforeseen delays).
IV placebo on the same schedule (5 cycles every 3 weeks, then 15 cycles every 6 weeks) with the same standard cisplatin-based chemoradiotherapy (40 mg/m² weekly, 5 or 6 weeks) and the same radiotherapy dose and duration.
Source of the regimen details: Abstract of the paper (pembrolizumab dose and schedule) and ClinicalTrials.gov NCT04221945 (cisplatin 40 mg/m² weekly for 5 or 6 weeks, total dose and duration of radiotherapy)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Adults with newly diagnosed high-risk locally advanced cervical cancer: FIGO 2014 stage IB2–IIB with lymph node involvement, or stage III–IVA regardless of nodal status; squamous, adenocarcinoma or adenosquamous histology.
Primary endpoints (dual): progression-free survival (PFS) per RECIST 1.1 by investigator assessment or histological confirmation, and overall survival (OS). Secondary endpoint: safety.
Grade 3 or higher adverse events occurred in 413 of 528 patients (78%) in the pembrolizumab group and 371 of 530 patients (70%) in the placebo group; the most common were anaemia, decreased white blood cell count and decreased neutrophil count. Potentially immune-mediated adverse events (such as hypothyroidism) were seen in 39% versus 17%.
The first trial in about two decades to improve overall survival in locally advanced cervical cancer by adding a new drug to chemoradiotherapy. In January 2024 the US FDA approved pembrolizumab with chemoradiotherapy for FIGO 2014 stage III–IVA disease. The NCCN guideline (version 2.2026) recommends adding pembrolizumab to chemoradiotherapy in selected patients with stage III–IVA disease. The greatest benefit was seen in stage III–IVA, and the benefit in node-positive stage IB2–IIB is less certain.
Interim analysis with relatively short follow-up (median 29.9 months), and median overall survival has not yet been reached. The study was not powered to assess subgroups separately (especially stage IB2–IIB). The increase in immune-mediated adverse events and the cost of long-term treatment must be taken into account.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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