Epirubicin Shortage and Alternative Options

The following information was sent from Prof Damien Bolton, USANZ President, and A/Prof Weranja Ranasinghe, GUSAG Leader, to Australian USANZ Members this week.

Intravesical Chemotherapy Post-TURBT: Epirubicin Shortage and Alternative Options

A single postoperative dose of intravesical chemotherapy remains the standard of care following TURBT to reduce recurrence in patients with low-grade non–muscle-invasive bladder cancer1. Epirubicin has been used as an alternative to mitomycin C in this setting, particularly when immediate post operative instillation is required or in maintenance protocols targeting low-grade recurrences1.

Epirubicin offers several advantages: a long shelf life and significantly lower cost due to PBS subsidisation. However, a national shortage has recently been identified, largely driven by declining use in cancer therapy in general. Currently, epirubicin is predominantly available in only in the powder form (not covered through PBS), at a prohibitively high cost (~AUD $1000 for 80 mg).

USANZ Guidance:

USANZ recommends mitomycin C as the preferred intravesical agent post-TURBT and for maintenance therapy. While not PBS-listed, mitomycin is included on the formulary of most public hospital pharmacies and should be readily accessible for use within the public system.

In the Event of Mitomycin Unavailability:

  • If mitomycin is not available at your site (including private hospitals), we recommend engaging your pharmacy to have it added to the formulary.
  • If neither mitomycin nor epirubicin is accessible, PBS-subsidised alternatives include intravesical doxorubicin and gemcitabine.
  • Doxorubicin and gemcitabine have demonstrated efficacy when administered immediately post-TURBT, with recurrence reductions of approximately 43–45%2,3 and 34%4 respectively.
  • While these agents offer reasonable alternatives, current evidence suggests their efficacy may be slightly inferior to epirubicin2,5.

References

  1. Guidelines E. EAU Guidelines: Non-muscle-invasive Bladder Cancer. 
  2. Abern MR, Owusu RA, Anderson MR, Rampersaud EN, Inman BA. Perioperative intravesical chemotherapy in non-muscle-invasive bladder cancer: a systematic review and meta-analysis. J Natl Compr Canc Netw. Apr 1 2013;11(4):477-84. doi:10.6004/jnccn.2013.0060
  3. Zincke H, Utz DC, Taylor WF, Myers RP, Leary FJ. Influence of thiotepa and doxorubicin instillation at time of transurethral surgical treatment of bladder cancer on tumor recurrence: a prospective, randomized, double-blind, controlled trial. J Urol. Mar 1983;129(3):505-9. doi:10.1016/s0022-5347(17)52205-3
  4. Messing EM, Tangen CM, Lerner SP, et al. Effect of Intravesical Instillation of Gemcitabine vs Saline Immediately Following Resection of Suspected Low-Grade Non-Muscle-Invasive Bladder Cancer on Tumor Recurrence: SWOG S0337 Randomized Clinical Trial. JAMA. May 8 2018;319(18):1880-1888. doi:10.1001/jama.2018.4657
  5. Ali-el-Dein B, el-Baz M, Aly AN, Shamaa S, Ashamallah A. Intravesical epirubicin versus doxorubicin for superficial bladder tumors (stages pTa and pT1): a randomized prospective study. J Urol. Jul 1997;158(1):68-73; discussion 73-4. doi:10.1097/00005392-199707000-00018
     

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