Novel bladder preservation therapy for locally invasive bladder cancer: Combined therapy using balloon-occluded arterial infusion of anticancer agent and hemodialysis with concurrent radiation

Abstract

Abstract.We investigated the effect of balloon-occluded arterial infusion (BOAI) of anticancer agent (cisplatin/gemcitabine), used concomitantly with hemodialysis, which delivers an extremely high concentration of anticancer agent to the site of a tumor without systemic adverse effects, along with concurrent radiation (referred to as the OMC-regimen) in patients with advanced bladder cancer. One hundred and ninety-two patients were assigned to receive either the OMCregimen (n=96) or total cystectomy (n=96). Patients in the OMC-regimen group who failed to achieve CR underwent cystectomy, or secondary BOAI with an increased amount of CDDP or gemcitabine (1600 mg). The OMC-regimen allowed >89% (69/77) of patients with locally invasive tumors to achieve CR [>70% (70/96) of all patients including those with T4 and N(+) disease]. Most (68/69) of the CR patients were still alive with no evidence of recurrence after a mean follow-up of 161 (range 12-805) weeks. The 5-and 15-year overall survival rates were 91.5 and 81.3% (vs. 59.8% and 40.1% for cystectomy, P<0.0001), respectively. No patients suffered Grade III or more severe toxicities. In contrast, at 5 and 15 years after surgery in the total cystectomy group, about 50 and 60% of patients had suffered disease progression or had died, respectively. The OMC-regimen, a new bladderpreservation strategy for patients with locally invasive bladder cancer, can be curative not only in patients for whom cystectomy is indicated, but also in patients whose condition is not amenable to curative treatment and for whom merely palliative therapy would otherwise seem the only option.

Selective bladder preservation with curative intent for muscle‐invasive bladder cancer: A contemporary review

“…27,28 Several groups incorporated IAC into the trimodality protocol ( Table 2). CRT incorporating IAC produced high CR rates of 76-93%, [29][30][31][32] which could be attributed to a high drug concentration at the primary lesion, with OS and BIS equivalent to those of conventional CRT regimens. However, IAC results in a unique complication, pelvic neuropathy, with an incidence of 20-30%.…”

“…32 The regimen consisted of conformal radiation at 60.4 Gy with balloon-occluded IAC with high-dose cisplatin (100-300 mg as a single bolus). Hemodialysis was combined through two double-lumen catheters placed in the bilateral common iliac vein to reduce IACrelated toxicities.…”

Radiotherapy in localized bladder cancer: what is the evidence?

“…A study of intra-arterial chemotherapy with 40 Gy of radiotherapy for pT1G3 bladder cancer for 11 patients seems to compare favourably with conventional treatments after short follow-up [48]. Most recently, Azuma et al [49 ] have reported on treatments undertaken between 1998 and 2008. Concurrent radiotherapy (60.4 Gy) with intraarterial cisplatin/gemcitabine and haemodialysis, a complex arrangement of pelvic catheters was used to deliver and retrieve the chemotherepeutic agents to maximize tumour dose while minimizing systemic exposure.…”

Chimioradiothérapie concomitante des tumeurs infiltrantes de la vessie : acquis, controverses et perspectives

“…Associée à la radiothérapie, elle est à l'origine d'un taux de réponse complète de 76 à 93 % avec cependant un taux élevé de neuropathie pelvienne pouvant atteindre les 20 à 30 % [112][113][114][115]. Dans la série d'Azuma et al, les dossiers de 96 patients ayant eu une cystectomie radicale ont été comparé rétrospectivement à ceux de 92 autres non candidats à une chirurgie ou la refusant et ayant eu une radiothérapie associée à une chimiothérapie intra-artérielle.…”

“…Le groupe irradié comportait plus de patients avec un indice de performance faible, plus de tumeurs de haut grade, et plus de tumeurs de stade T4 ou N1, mais malgré ce biais de sélection, le taux de survie à 5 et à 15 ans était en faveur de la radiothérapie : 91 % et 81 % contre 60 % et 40 %. Aucune toxicité de grade 3 ou plus n'a été observée [115].…”