Study weighs impact of BCG shortage on outcomes

Bacillus Calmette-Guérin (BCG [TheraCys, TICE BCG]) is the standard of care for high-grade nonmuscle-invasive bladder cancer, but due to various factors, the supply of BCG was greatly affected 4 years ago. At the 2015 Society for Urologic Oncology annual meeting in Washington, researchers from Columbia University Medical Center (CUMC), New York sought to evaluate the effect of the BCG shortage on patient treatment and outcomes.

"Though the worldwide shortages of BCG began in the summers of 2012 and 2014, our outpatient urologic clinic at CUMC did not significantly feel the impact until October 2014. We wanted to systematically assess how the shortage was impacting our patients and establish protocol to prioritize BCG for those who needed it the most,” said lead author Jamie Pak, BA.

Pak and senior author James McKiernan, MD, reviewed the records of patients who were eligible for BCG therapy-either induction or continued maintenance therapy-during the time period of the BCG shortage at their institution. They identified 105 patients who met criteria for BCG therapy, of whom 91 (87%) experienced a divergence from the standard of care and planned treatment course. Specifically, 28 patients never received indicated BCG, 40 experienced delayed or missed doses, 14 had incomplete therapy, and nine received an alternative regimen. Only 14 patients-13%-actually received planned BCG therapy without treatment alteration.

Next: What predicted recurrence

When evaluating the effect of these altered treatment plans, 37.5% of the affected patients had recurrent disease at their first cystoscopic surveillance. Unsurprisingly, clinical stage and grade were predictive of recurrence for this patient population. However, and most importantly, also predictive of recurrence were indications for induction therapy and receipt of alternative regimens.

“Recurrence rate was the highest in those patients who required induction BCG therapy and in those who were given alternative regimens of intravesical therapy,” Pak said.

“While we hope that there are no future shortages, our data suggests that should this situation occur again, we should focus our efforts on preserving available BCG stocks for patients who need induction therapy, perhaps at the expense of longer-term maintenance therapy,” he added.

“We hope this serves as a wake-up call not only to patients and providers but also to the pharmaceutical industry and the FDA, who may need to consider a change in policies and incentives to ensure patients are not negatively impacted by drug shortages in the future. Though we understand the unfortunate events that led to this shortage, we suspect that the complexity and cost of manufacturing BCG, along with its off-patent status, may have also contributed to the slow revamping of supply."

So, will a similar supply shortage occur again? Certainly we hope it does not, but if it does, we now have evidence that alternative therapy does not mean equivalent therapy, particularly for our patients who require induction therapy.

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