In patients whose advanced bladder cancer had grown after platinum chemotherapy, the immunotherapy drug pembrolizumab, compared with other chemotherapy, lengthened typical survival by about 3 months (10.3 versus 7.4 months) and had far fewer severe side effects.
Progression after platinum-based chemotherapy or recurrence within 12 months of perioperative platinum, no prior immunotherapy; ECOG 0 to 2
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Pembrolizumab | 200 mg (or 400 mg) | IV over 30 minutes | Day 1 every 3 weeks (400 mg: every 6 weeks) |
Per the FDA label and the KEYNOTE-045 trial.
On the page “Bladder cancer” · Advanced or metastatic disease: after first line
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 day 1 every 3 weeks until progression, unacceptable toxicity or completion of 2 years; in complete response, stopping after at least 24 weeks of treatment was allowed.
At the investigator's choice, IV on day 1 every 3 weeks: paclitaxel 175 mg/m², docetaxel 75 mg/m² or vinflunine 320 mg/m² (84, 84 and 87 patients).
Source of the regimen details: Full text of the paper (PMC5635424) and ClinicalTrials.gov NCT02256436
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.
542 patients aged 18 years or older with advanced urothelial carcinoma (renal pelvis, ureter, bladder or urethra; predominantly transitional cell) that had progressed after platinum chemotherapy for advanced disease or recurred within 12 months after neoadjuvant/adjuvant platinum; up to 2 prior lines of chemotherapy; measurable disease; ECOG 0 to 2 (ECOG 2 with a poor prognostic factor was not allowed). Prior anti-PD-1/PD-L1/CTLA-4 therapy was an exclusion criterion.
Co-primary endpoints: overall survival and progression-free survival in all patients and in patients with a PD-L1 combined positive score of 10% or more.
Treatment-related adverse events of any grade occurred in 60.9% versus 90.2%, and grade 3, 4 or 5 events in 15.0% versus 49.4%.
KEYNOTE-045 made pembrolizumab the standard second-line treatment after platinum chemotherapy in patients who have not received immunotherapy.
Open-label trial; progression-free survival was not improved. With immunotherapy moving into the first line, fewer patients are in this situation.
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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