Abstract
BackgroundBladder hyperthermic intracavitary chemotherapy (HIVEC) has good effectiveness for bladder cancer, but conventional HIVEC systems lack precision and convenient application. To test the safety of a new HIVEC device (BR-TRG-II-type) in pigs and to perform a preliminary clinical trial in patients with bladder cancer.MethodsThis device was tested on six pigs to optimize the temperature and time parameters. Then, 165 patients (HIVEC after transurethral resection (TUR), n = 128; or HIVEC, n = 37) treated between December 2006 and December 2016 were recruited. Mitomycin C (MMC) was the chemotherapeutic agent. A serum pharmacokinetic study was performed. The primary endpoints were tumor recurrence, disease-free survival (DFS), and cumulative incidence rate (CIR) during follow-up. The adverse effects were graded.ResultsThe animal experiment showed that 45 °C for 1 h was optimal. HIVEC was successful, with the infusion tube temperature stably controlled at about 45 °C, and outlet tube temperature of about 43 °C in all patients, for three sessions. Serum MMC levels gradually increased during HIVEC and decreased thereafter. The mean DFS was 39 ± 3.21 months (ranging from 8 to 78 months), and the DFS rate was 89.1% during follow-up. No adverse events occurred.ConclusionThe use of the BR-TRG-II-type HIVEC device is feasible for the treatment of bladder cancer. Future clinical trials in patients with different stages of bladder cancer will further confirm the clinical usefulness of this device.Trial registrationchictr.org.cn: ChiCTR1900022099 (registered on Mar. 252,019). Retrospectively registered.
Highlights
Bladder hyperthermic intracavitary chemotherapy (HIVEC) has good effectiveness for bladder cancer, but conventional Hyperthermic intracavitary chemotherapy (HIVEC) systems lack precision and convenient application
On the basis of the BR-TRG-I-type hyperthermic intraperitoneal perfusion chemotherapy (HIPEC) device, we developed the BR-TRGII-type HIVEC device, which has been shown to be safe and efficient in preventing the recurrence of non-muscle invasive bladder cancer (NMIBC) after transurethral resection (TUR) and prolonging diseasefree survival (DFS) [12]
The treatment temperature during HIVEC was measured by the device using temperature probes inserted in a blind pipe in an inflated water sac linked to an infusion tube near an infusion tube and in a blind pipe in an inflated water sac linked to an outlet tube near the 24 F 3-way Foley catheter
Summary
Bladder hyperthermic intracavitary chemotherapy (HIVEC) has good effectiveness for bladder cancer, but conventional HIVEC systems lack precision and convenient application. The standard procedure for bladder cancer removal is still transurethral resection (TUR) or surgical resection [2], but recurrence is always a major concern. Preventing recurrence of bladder cancer after TUR and preventing progression in patients unsuitable for TUR or surgical resection remain major problems in oncology [11, 12]. Bladder hyperthermic intracavitary chemotherapy (HIVEC) combines the advantages of local hyperthermia with intracavitary chemotherapy, which have a synergistic or at least additive effect in preventing bladder cancer recurrence post TUR or surgical resection [13,14,15,16]. Available systems have issues in the precision of temperature control to the target site [6,7,8,9, 11,12,13,14, 16,17,18,19], limiting their efficacy and safety [3, 10, 13,14,15,16,17,18]
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