Long-Term Experience with Hyperthermic Chemotherapy (HIVEC) Using Mitomycin-C in Patients with Non-Muscle Invasive Bladder Cancer in Spain
(1) Background: Intravesical mitomycin-C (MMC) combined with hyperthermia is increasingly used in non-muscle invasive bladder cancer (NMIBC), especially in the context of a relative BCG shortage. We aim to determine real-world data on the long-term treatment outcomes of adjunct hyperthermic intraves...
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2021
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oai:doaj.org-article:9b65c64de03b41c6bd661e55f24012212021-11-11T17:43:34ZLong-Term Experience with Hyperthermic Chemotherapy (HIVEC) Using Mitomycin-C in Patients with Non-Muscle Invasive Bladder Cancer in Spain10.3390/jcm102151052077-0383https://doaj.org/article/9b65c64de03b41c6bd661e55f24012212021-10-01T00:00:00Zhttps://www.mdpi.com/2077-0383/10/21/5105https://doaj.org/toc/2077-0383(1) Background: Intravesical mitomycin-C (MMC) combined with hyperthermia is increasingly used in non-muscle invasive bladder cancer (NMIBC), especially in the context of a relative BCG shortage. We aim to determine real-world data on the long-term treatment outcomes of adjunct hyperthermic intravesical chemotherapy (HIVEC) with MMC and a COMBAT® bladder recirculation system (BRS); (2) Methods: A prospective observational trial was performed on patients with NMIBC treated with HIVEC using BRS in nine academic institutions in Spain between 2012–2020 (HIVEC-E). Treatment effectiveness (recurrence, progression and overall mortality) was evaluated in patients treated with HIVEC MMC 40mg in the adjuvant setting, with baseline data and a clinical follow-up, that comprise the Full Analysis Set (FAS). Safety, according to the number and severity of adverse effects (AEs), was evaluated in the safety (SAF) population, composed by patients with at least one adjunct HIVEC MMC instillation; (3) Results: The FAS population (<i>n</i> = 502) received a median number of 8.78 ± 3.28 (range 1–20) HIVEC MMC instillations. The median follow-up duration was 24.5 ± 16.5 (range 1–81) months. Its distribution, based on EAU risk stratification, was 297 (59.2%) for intermediate and 205 (40.8%) for high-risk. The figures for five-year recurrence-free and progression-free survival were 50.37% (53.3% for intermediate and 47.14% for high-risk) and 89.83% (94.02% for intermediate and 84.23% for high-risk), respectively. A multivariate analysis identified recurrent tumors (HR 1.83), the duration of adjuvant HIVEC therapy <4 months (HR 1.72) and that high-risk group (HR 1.47) were at an increased risk of recurrence. Independent factors of progression were high-risk (HR 3.89), recurrent tumors (HR 3.32) and the induction of HIVEC therapy without maintenance (HR 2.37). The overall survival was determined by patient age at diagnosis (HR 3.36) and the treatment duration (HR 1.82). The SAF population (<i>n</i> = 592) revealed 406 (68.58%) patients without AEs and 186 (31.42%) with at least one AE: 170 (28.72%) of grade 1–2 and 16 (2.7%) of grade 3–4. The most frequent AEs were dysuria (10%), pain (7.1%), urgency (5.7%), skin rash (4.9%), spasms (3.7%) and hematuria (3.6%); (4) Conclusions: HIVEC using BRS is efficacious and well tolerated. A longer treatment duration, its use in naïve patients and the intermediate-risk disease are independent determinants of success. Furthermore, a monthly maintenance of adjunct MMC HIVEC diminishes the progression rate of NMIBC.Ana PlataFélix Guerrero-RamosCarlos GarciaAlejandro González-DíazIgnacio Gonzalez-ValcárcelJosé Manuel de la MorenaFrancisco Javier Díaz-GoizuetaJulio Fernández del ÁlamoVictoria GonzaloJavier MonteroAlejandro Sousa-EscandónJuan LeónJose Luis PontonesFrancisco DelgadoMiguel AdriazolaÁngela PascualJesús CallejaAna RuanoLuis Martínez-PiñeiroJavier C. AnguloMDPI AGarticlebladder neoplasiahyperthermic intravesical chemotherapymitomycin-Cbladder recirculation systemMedicineRENJournal of Clinical Medicine, Vol 10, Iss 5105, p 5105 (2021) |
| institution |
DOAJ |
| collection |
DOAJ |
| language |
EN |
| topic |
bladder neoplasia hyperthermic intravesical chemotherapy mitomycin-C bladder recirculation system Medicine R |
| spellingShingle |
bladder neoplasia hyperthermic intravesical chemotherapy mitomycin-C bladder recirculation system Medicine R Ana Plata Félix Guerrero-Ramos Carlos Garcia Alejandro González-Díaz Ignacio Gonzalez-Valcárcel José Manuel de la Morena Francisco Javier Díaz-Goizueta Julio Fernández del Álamo Victoria Gonzalo Javier Montero Alejandro Sousa-Escandón Juan León Jose Luis Pontones Francisco Delgado Miguel Adriazola Ángela Pascual Jesús Calleja Ana Ruano Luis Martínez-Piñeiro Javier C. Angulo Long-Term Experience with Hyperthermic Chemotherapy (HIVEC) Using Mitomycin-C in Patients with Non-Muscle Invasive Bladder Cancer in Spain |
| description |
(1) Background: Intravesical mitomycin-C (MMC) combined with hyperthermia is increasingly used in non-muscle invasive bladder cancer (NMIBC), especially in the context of a relative BCG shortage. We aim to determine real-world data on the long-term treatment outcomes of adjunct hyperthermic intravesical chemotherapy (HIVEC) with MMC and a COMBAT® bladder recirculation system (BRS); (2) Methods: A prospective observational trial was performed on patients with NMIBC treated with HIVEC using BRS in nine academic institutions in Spain between 2012–2020 (HIVEC-E). Treatment effectiveness (recurrence, progression and overall mortality) was evaluated in patients treated with HIVEC MMC 40mg in the adjuvant setting, with baseline data and a clinical follow-up, that comprise the Full Analysis Set (FAS). Safety, according to the number and severity of adverse effects (AEs), was evaluated in the safety (SAF) population, composed by patients with at least one adjunct HIVEC MMC instillation; (3) Results: The FAS population (<i>n</i> = 502) received a median number of 8.78 ± 3.28 (range 1–20) HIVEC MMC instillations. The median follow-up duration was 24.5 ± 16.5 (range 1–81) months. Its distribution, based on EAU risk stratification, was 297 (59.2%) for intermediate and 205 (40.8%) for high-risk. The figures for five-year recurrence-free and progression-free survival were 50.37% (53.3% for intermediate and 47.14% for high-risk) and 89.83% (94.02% for intermediate and 84.23% for high-risk), respectively. A multivariate analysis identified recurrent tumors (HR 1.83), the duration of adjuvant HIVEC therapy <4 months (HR 1.72) and that high-risk group (HR 1.47) were at an increased risk of recurrence. Independent factors of progression were high-risk (HR 3.89), recurrent tumors (HR 3.32) and the induction of HIVEC therapy without maintenance (HR 2.37). The overall survival was determined by patient age at diagnosis (HR 3.36) and the treatment duration (HR 1.82). The SAF population (<i>n</i> = 592) revealed 406 (68.58%) patients without AEs and 186 (31.42%) with at least one AE: 170 (28.72%) of grade 1–2 and 16 (2.7%) of grade 3–4. The most frequent AEs were dysuria (10%), pain (7.1%), urgency (5.7%), skin rash (4.9%), spasms (3.7%) and hematuria (3.6%); (4) Conclusions: HIVEC using BRS is efficacious and well tolerated. A longer treatment duration, its use in naïve patients and the intermediate-risk disease are independent determinants of success. Furthermore, a monthly maintenance of adjunct MMC HIVEC diminishes the progression rate of NMIBC. |
| format |
article |
| author |
Ana Plata Félix Guerrero-Ramos Carlos Garcia Alejandro González-Díaz Ignacio Gonzalez-Valcárcel José Manuel de la Morena Francisco Javier Díaz-Goizueta Julio Fernández del Álamo Victoria Gonzalo Javier Montero Alejandro Sousa-Escandón Juan León Jose Luis Pontones Francisco Delgado Miguel Adriazola Ángela Pascual Jesús Calleja Ana Ruano Luis Martínez-Piñeiro Javier C. Angulo |
| author_facet |
Ana Plata Félix Guerrero-Ramos Carlos Garcia Alejandro González-Díaz Ignacio Gonzalez-Valcárcel José Manuel de la Morena Francisco Javier Díaz-Goizueta Julio Fernández del Álamo Victoria Gonzalo Javier Montero Alejandro Sousa-Escandón Juan León Jose Luis Pontones Francisco Delgado Miguel Adriazola Ángela Pascual Jesús Calleja Ana Ruano Luis Martínez-Piñeiro Javier C. Angulo |
| author_sort |
Ana Plata |
| title |
Long-Term Experience with Hyperthermic Chemotherapy (HIVEC) Using Mitomycin-C in Patients with Non-Muscle Invasive Bladder Cancer in Spain |
| title_short |
Long-Term Experience with Hyperthermic Chemotherapy (HIVEC) Using Mitomycin-C in Patients with Non-Muscle Invasive Bladder Cancer in Spain |
| title_full |
Long-Term Experience with Hyperthermic Chemotherapy (HIVEC) Using Mitomycin-C in Patients with Non-Muscle Invasive Bladder Cancer in Spain |
| title_fullStr |
Long-Term Experience with Hyperthermic Chemotherapy (HIVEC) Using Mitomycin-C in Patients with Non-Muscle Invasive Bladder Cancer in Spain |
| title_full_unstemmed |
Long-Term Experience with Hyperthermic Chemotherapy (HIVEC) Using Mitomycin-C in Patients with Non-Muscle Invasive Bladder Cancer in Spain |
| title_sort |
long-term experience with hyperthermic chemotherapy (hivec) using mitomycin-c in patients with non-muscle invasive bladder cancer in spain |
| publisher |
MDPI AG |
| publishDate |
2021 |
| url |
https://doaj.org/article/9b65c64de03b41c6bd661e55f2401221 |
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