Avelumab for Advanced Urothelial Carcinoma: Safety Profile


Robert Dreicer, MD, MS, MACP, FASCO: Among the issues that come up when one looks at the JAVELIN Bladder 100 study, specifically avelumab, is the well-known infusion-site reactions that occur, typically early on. These are easily managed with premedication, and understanding and making sure that the infusion team—chemotherapy nurses and the entire team—and the patient, especially, understand that these are typically seen, managed easily, and do not recur with additional therapy. Therefore, updating the team and providing information to the patient, and the appropriate more aggressive use of premedications will typically mitigate any avelumab-related infusions.

In the trial, treatment emergent AEs [adverse events] of any causality grade 3 or greater were seen in about 47% of patients who received avelumab vs about 25% in the control arm. These were typical toxicities seen with checkpoint inhibitors, including fatigue and pruritus. Some arthralgia, decreased appetite, and hypothyroidism, which of course is a known potential toxicity with all checkpoint inhibitors, was seen in about 12% of patients treated with avelumab. In the control arm, these were seen in less than 1% of patients.

Most of these toxicities are well known by community medical oncologists who manage multiple disease states with checkpoint inhibitors. Although avelumab has historically been less widely utilized in advanced urothelial cancer, its toxicity profile is really of no great difference from the rest of the agents that we use routinely.

Education around that will mitigate the issues. When we talk to patients about this, the critical issue is the really dramatic improvement in overall survival. This is not a modest difference in survival. So when patients ask about an acute 2-week schedule indefinitely, we’re talking about the context of patients who have a median survival with chemotherapy in the 13- to 14-month range. We see that it is in the 21-month range in all comers. Why could it be longer in PD-L1–positive patients?

Transcript edited for clarity.

Case: A 65-Year-Old Female With Urothelial Carcinoma

Initial presentation

  • A 65-year-old female presents with 2 weeks of intermittent gross hematuria
  • SH: 30-pack year smoking history

Clinical workup

  • Labs: Hb 10.2 g/dl, WBC 2.8 x 109/L, creatinine 1.3 mg/dL, creatinine clearance 68 ml/min; other WNL
  • TURBT large bladder mass, high grade muscle invasive urothelial cancer
  • CT scan of the abdomen and pelvis: large bladder mass, pelvic and para aortic adenopathy (largest 2.2 cm); CT Chest 3 sub cm nodules uncertain significance
  • Stage T3N2M1


  • The patient received cisplatin + gemcitabine for 6 cycles; stable disease
  • Repeat imaging CT chest 2 of the sub cm lesions no longer appreciated
  • CT abd/pelvis decrease size in bladder mass, nodal findings mildly improved, no new disease
  • Avelumab 10 mg/kg IV q2W was started as maintenance therapy
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