Neoadjuvant chemohyperthermia: Our experience after 10 years. / Quimiohipertermia neoadyuvante: nuestra experiencia después de 10 años.

Neoadjuvant chemohyperthermia (QHT) with MMC has demonstrated its efficacy in NMIBC both in the level of complete response at the time of TURBT and reduction of recurrences after several years of follow up. We present our experience with this treatment. METHODS: We performed a case control study in a group of 104 patients with middle-high risk NMIBC. 43 of them received neoadjuvant recirculated intravesical QHT and 61 passively administered standard adjuvant MMC. Patient follow up was 43 months (3 - 108) evaluating their clinical efficacy and adverse effects in both groups. RESULTS: After neoadjuvant QHT, 27 patients showed CR (63%), 13 PR (30.2%) and 3 NR (6.9%). 5 year recurrence rate after QHT passive MMC were 16.2% and 26.2% respectively. No patient in the QHT group presented tumor progression compared to 5% progressions in the group treated with MMC at room temperature and 1.6% deaths due to metastatic disease. 94% QHT programmed doses were administered in comparison to 97%in the group of standard MMC. In the QHT group there were 60.5% grade 1-2 AEs in comparison with 49% in the standard MMC group (p<0.4). Likewise, 9.3% cases in the QHT group presented Grade 3 AEs versus 6.5% in the standard MMC (p<0,06). CONCLUSIONS: Recirculating neoadjuvant QHT achieves a reduction in tumor recurrence after 4 years with a similar AE rate in comparison with passive instillation of MMC.

Analysis of tolerance and security of chemo hyperthermia with Mitomycin C for the treatment of non-muscle invasive bladder cancer. / Aálisis de tolerancia y seguridad de la quimiohipertermia con Mitomicina C en el tratamiento del cúncer de vejiga no músculo invasivo.

OBJECTIVES: The treatment of non muscle invasive bladder cancer (NMIBC) continues to be a challenge. Hyperthermia (HT) combined with intravesical chemotherapy is used to enhance the effects of chemotherapy. METHODS: A review of the publications was carried out to synthesize the adverse effects (AE) reported by the use of chemohyperthermia (QHT) with Mitomycin-C (MMC). The most relevant data are exposed for each of the devices currently used in the QHT. RESULTS: SYNERGO®: The dropout rate varied between 3-40%, and the AE rate is up to 88%. The most common AEs were pain (2-40%), thermal reaction of the posterior wall (13-100%), bladder spasms (2-32%), dysuria (3-60%) and hematuria (2-62%). COMBAT BRS®: The dropout rate is 3-11%. The AEs reported were CTCAE Grade 1-2: Pain 13-27%, bladder spasms 6-27%and hematuria 3-20% are the most relevant. In general, CTCAE grade 3-4 toxicity is not reported. UNITHERMIA®: The dropout rate is 7-12%. The AEs described are: Pain 6-23%, bladder spasms 6-23%, hematuria 9-11, frequency 15-25% and allergy 6-11%. The majority of toxicities are CTCAE grade 1-2 (17-53%), with grade 3-4 in 9-15% and Grade 5 in 0-2%. QHT adds little to the AEs of the treatment with MMC. It neither adds severe effects, nor increases dropouts significantly, and does not increase the incidence of allergic reactions. The comparative study between BCG and QHT-MMC, is less likely to present urinary frequency, nocturia, incontinence, hematuria, fever, fatigue and arthralgia in patients in the QHT group. CONCLUSIONS: QHT has proven to be a safe alternative for the treatment of intermediate and high risk NMIBC, with AE mainly grade 1-2. The AEs reported have little variation with respect to the dose of MMC used, presenting different "profiles" related to the device used for its administration. The treatments with QHTMMC are well tolerated, without adding significantly more AE than the instillations of MMC alone and presenting a better toxicity profile than those reflected in the literature with respect to the treatment with BCG.

Análisis de tolerancia y seguridad de la quimiohipertermia con Mitomicina C en el tratamiento del cáncer de vejiga no músculo invasivo / Analysis of tolerance and security of chemo hyperthermia with Mitomycin C for the treatment of non-muscle invasive bladder cancer

OBJETIVO: El tratamiento del cáncer de vejiga no músculo invasivo (CVNMI) continúa siendo un reto. La hipertermia (HT) combinada con la quimioterapia intravesical se usa para mejorar los efectos de la quimioterapia. MÉTODOS: Se realizó una revisión de las publicaciones para sintetizar los efectos adversos (EA) reportados por el uso de la quimiohipertermia (QHT) con Mitomicina- C (MMC). Se exponen los datos más relevantes para cada uno de los dispositivos empleados actualmente en la QHT. RESULTADOS: SYNERGO(R): La tasa de abandono varió entre 3-40%, y la tasa de EA es de hasta el 88%. Los EA con mayor frecuencia fueron dolor (2-40%), reacción térmica de la pared posterior (13-100%), espasmos vesicales (2-32%), disuria (3-60%) y hematuria (2-62%).COMBAT BRS®: La tasa de abandono de tratamiento es del 3-11%. Los EA reportados fueron CTCAE Grado 1-2: Dolor 13-27%, espasmos vesicales 6-27% y hematuria 3-20% son los más relevantes. En general, no se informan de toxicidad CTCAE grado 3-4. UNITHERMIA(R): La tasa de abandono de tratamiento es del 7-12%. Los EA descritos son: Dolor 6-23%, espasmos vesicales 6-23%, hematuria 9-11%, frecuencia 15-25% y alergia 6-11. La mayoría de las toxicidades son CTCAE grado 1-2 (17-53%), siendo grado 3-4 en 9-15% y Grado 5 en 0-2%. La QHT añade poco a los EA del tratamiento con MMC. No agrega efectos severos, no incrementa de forma significativa los abandonos al tratamiento, y no aumenta la incidencia de reacciones alérgicas. El estudio comparativo entre BCG y QHT-MMC encuentra menor probabilidad de presentar frecuencia miccional, nicturia, incontinencia, hematuria, fiebre, fatiga y artralgia, en los pacientes del grupo de QHT. CONCLUSIONES: La QHT ha demostrado ser una alternativa segura para el tratamiento de los CVNMI de riesgo intermedio y alto, con EA principalmente grado 1-2. Los EA reportados tienen poca variación con respecto a la dosis de MMC empleada, presentando diferentes "perfiles" relacionados con el dispositivo usado para su administración. Los tratamientos con QHT-MMC son bien tolerados, sin añadir significativamente más EA que las instilaciones de MMC sola y presentando mejor perfil de toxicidad que los reflejados en la literatura con respecto al tratamiento con BCG

OBJECTIVES: The treatment of non muscle invasive bladder cancer (NMIBC) continues to be a challenge. Hyperthermia(HT) combined with intravesical chemotherapy is used to enhance the effects of chemotherapy. METHODS: A review of the publications was carried out to synthesize the adverse effects (AE) reported by the use of chemohyperthermia (QHT) with Mitomycin-C (MMC). The most relevant data are exposed for each of the devices currently used in the QHT. RESULTS: SYNERGO(R): The dropout rate varied between 3-40%, and the AE rate is up to 88%. The most common AEs were pain (2-40%), thermal reaction of the posterior wall (13-100%), bladder spasms (2-32%), dysuria (3-60%) and hematuria (2-62%). COMBAT BRS(R): The dropout rate is 3-11%. The AEs reported were CTCAE Grade 1-2: Pain 13-27%, bladder spasms 6-27% and hematuria 3-20% are the most relevant. In general, CTCAE grade 3-4 toxicity is not reported. UNITHERMIA(R): The dropout rate is 7-12%. The AEs described are: Pain 6-23%, bladder spasms 6-23%, hematuria 9-11%, frequency 15-25% and allergy 6-11%. The majority of toxicities are CTCAE grade 1-2 (17-53%), with grade 3-4 in 9-15% and Grade 5 in 0-2%. QHT adds little to the AEs of the treatment with MMC. It neither adds severe effects, nor increases dropouts significantly, and does not increase the incidence of allergic reactions. The comparative study between BCG and QHT-MMC, is less likely to present urinary frequency, nocturia, incontinence, hematuria, fever, fatigue and arthralgia in patients in the QHT group. CONCLUSIONS: QHT has proven to be a safe alternative for the treatment of intermediate and high risk NMIBC, with AE mainly grade 1-2. The AEs reported have little variation with respect to the dose of MMC used, presenting different "profiles" related to the device used for its administration. The treatments with QHTMMC are well tolerated, without adding significantly more AE than the instillations of MMC alone and presenting a better toxicity profile than those reflected in the literature with respect to the treatment with BCG

Quimiohipertermia neoadyuvante: nuestra experiencia después de 10 años / Neoadjuvant chemohyperthermia: Our experience after 10 years

La quimiohipertermia (QHT) neoadyuvante con MMC ha demostrado su eficacia en el CVNMI tanto a nivel de respuestas completas en el momento de la RTU vesical como en la reducción de recidivas tras varios años de seguimiento. Presentamos nuestra experiencia con este tratamiento. Métodos: Realizamos un estudio de casos y controles de un grupo de 104 pacientes con CVNMI de riesgo medio-alto. De ellos, 43 recibieron QHT intravesical neoadyuvante recirculante y 61 recibieron MMC adyuvante estándar instilada de forma pasiva. Los pacientes fueron seguidos 43 meses (3 - 108) evaluándose su eficacia clínica y efectos adversos en ambos grupos. Resultados: Tras la QHT neoadyuvante, 27 pacientes mostraron RC (63%), 13 mostraron RP (30,2%) y los 3 mostraron NR (6,9%). La recurrencia a 5 años tras QHT fue del 16,2% y del 26,2% tras la MMC pasiva. Ningún paciente del grupo de QHT presentó progresión tumoral frente a un 5% de progresiones en el grupo tratado con MMC a temperatura ambiente y un 1,6% de exitus por enfermedad metastásica. Un 94% de las dosis de QHT pudieron ser administradas frente a un 97 en el grupo de MMC pasiva. En el grupo de QHT aparecieron un 60,5% de EA grado 1-2 frente al 49% en el en el grupo de MMC pasiva (p<0,4). Igualmente, un 9,3% del grupo de QHT presentaron EA grado 3 frente a un 6,5% en la MMC pasiva (p<0,6). Conclusiones: La QHT neoadyuvante recirculante consigue una reducción de las recidivas tumorales tras 4 años de tratamiento con un nivel de EA similar al de la instilación pasiva de MMC

Neoadjuvant chemohyperthermia (QHT) with MMC has demonstrated its efficacy in NMIBC both in the level of complete response at the time of TURBT and reduction of recurrences after several years of follow up. We present our experience with this treatment. METHODS: We performed a case control study in a group of 104 patients with middle-high risk NMIBC. 43 of them received neoadjuvant recirculated intravesical QHT and 61 passively administered standard adjuvant MMC. Patient follow up was 43 months (3 - 108) evaluating their clinical efficacy and adverse effects in both groups. Results: After neoadjuvant QHT, 27 atients showed CR (63%), 13 PR (30.2%) and 3 NR (6.9%). 5 year recurrence rate after QHT passive MMC were 16.2% and 26.2% respectively. No patient in the QHT group presented tumor progression compared to 5% progressions in the group treated with MMC at room temperature and 1.6% deaths due to metastatic disease. 94% QHT programmed doses were administered in comparison to 97% in the group of standard MMC. In the QHT group there were 60.5% grade 1-2 AEs in comparison with 49% in the standard MMC group (p<0.4). Likewise, 9.3% cases in the QHT group presented Grade 3 AEs versus 6.5% in the standard MMC (p<0,06). Conclusions: Recirculating neoadjuvant QHT achieves a reduction in tumor recurrence after 4 years with a similar AE rate in comparison with passive instillation of MMC