In patients whose high-risk superficial bladder cancer (carcinoma in situ) had not responded to BCG and who did not want, or could not have, their bladder removed, the immunotherapy drug pembrolizumab (an infusion into a vein every 3 weeks) made all visible cancer disappear after 3 months in 41% of patients. Severe side effects occurred in about 13%.
High-risk BCG-unresponsive carcinoma in situ with or without papillary tumours, in patients unsuitable for or declining cystectomy; ECOG 0 to 2
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Pembrolizumab | 200 mg (or 400 mg) | IV infusion over 30 minutes | Day 1 every 3 weeks (400 mg: every 6 weeks) |
Per the FDA label and the KEYNOTE-057 trial. In BCG-unresponsive disease, radical cystectomy is the main EAU recommendation.
On the page “Bladder cancer” · Non-muscle-invasive bladder cancer (NMIBC)
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 every 3 weeks for up to 24 months (maximum 35 doses), or until persistent or recurrent high-risk disease, progression, unacceptable toxicity or withdrawal. FDA label equivalent: 200 mg every 3 weeks or 400 mg every 6 weeks for up to 24 months.
Source of the regimen details: ClinicalTrials.gov NCT02625961 and the FDA label for KEYTRUDA (DailyMed)
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 BCG-unresponsive high-risk non-muscle-invasive bladder cancer (after adequate BCG) consisting of carcinoma in situ with or without papillary tumour (cohort A), with complete resection of disease at entry (residual CIS allowed), ECOG performance status 0 to 2, who were unsuitable for or declined radical cystectomy. Muscle-invasive disease or concurrent involvement of the extravesical urinary tract was an exclusion criterion.
Primary endpoint: clinical complete response rate at about 3 months after the first dose (by cystoscopy and urine cytology).
Treatment-related grade 3 or 4 adverse events in 13% (most common: arthralgia 2% and hyponatraemia 3%); serious treatment-related adverse events 8%; no treatment-related deaths.
This study is the basis of the FDA approval of pembrolizumab for BCG-unresponsive carcinoma in situ in patients who decline or are unsuitable for cystectomy. The EAU guideline mentions bladder-sparing strategies, including systemic immunotherapy, for these patients, but radical cystectomy is the main recommended treatment.
Single-arm study without a comparator group; the primary endpoint is complete response at 3 months, and the durability of response is not reported in the abstract.
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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