The novel bladder preservation therapy BOAI-CDDP-radiation (OMC-regimen): A new treatment option for invasive bladder cancer patients with lymph node metastasis

Haruhito Azuma, Teruo Inamoto, Kiyoshi Takahara, Hayahito Nomi, Hajime Hirano, Naokazu Ibuki, Hiroshi Uehara, Kazumasa Komura, Koichiro Minami, Taizo Uchimoto, Kenkichi Saito, Tomoaki Takai, Naoki Tanda, Kazuhiro Yamamoto, Yoshihumi Narumi, Satoshi Kiyama

Research output: Contribution to journalArticle

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Abstract

We have developed a novel bladder preservation therapy for patients with muscle-invasive bladder cancer and lymph node metastasis: balloon-occluded arterial infusion (BOAI) of cisplatin/gemcitabine, with concomitant hemodialysis and irradiation [the so-called 'OMC (Osaka Medical College) regimen']. The OMC regimen delivers an extremely high concentration of anticancer agent to the site of the tumor, as well as the pelvic area, without causing any adverse systemic effects. In this study, we investigated the efficiency of the OMC regimen in 34 patients who underwent BOAI with cisplatin (100, 200 or 300 mg) along with 60 Gy of irradiation; patients who failed to achieve CR underwent secondary BOAI with gemcitabine (1,600 mg). The overall clinical response was 73.5% (CR: 35.3%; PR: 17.6%; SD: 20.6%). The 5-year overall and progression-free survival rates were 54.4% and 52.5%, respectively. For treatment failure, N2 stage was selected as a significant risk factor by simple and multiple logistic regression analyses. Cox proportional hazards analyses showed that N2 stage, T4 stage and the presence of hydronephrosis were significant risk factors for overall survival. Indeed, 55.6% of patients with N1 stage achieved a complete response (CR) (vs. 12.5% for N2 patients, p=0.0151), and 90% (9/10) of the CR patients survived without recurrence with an intact bladder after a mean follow-up of 85 (range 7-193) weeks. The 3-year progrssion-free survival rate with an intact bladder was 65.8% (vs. 37.5% for N2, p=0.034), and the 5-year overall survival rate was 71.8% (vs. 30.6% for N2, p=0.004). No patients suffered severe toxicities of Grade II or more; the oldest patient, aged 85 years, successfully completed this therapy. In conclusion, the OMC regimen can be regarded as a new option for patients with macroscopic lymph node involvement, especially those at stage N1. Therapy will improve the feasibility of radical cure even without the need for cystectomy in patients for whom surgery after neoadjuvant chemotherapy would otherwise be necessary, and also facilitate potential cure in patients for whom, otherwise, merely palliative treatment would seem the only option.

Original languageEnglish
Pages (from-to)1895-1903
Number of pages9
JournalInternational Journal of Oncology
Volume45
Issue number6
DOIs
Publication statusPublished - 01-01-2014

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Urinary Bladder Neoplasms
Urinary Bladder
Lymph Nodes
Radiation
Neoplasm Metastasis
gemcitabine
Therapeutics
Survival Rate
Cisplatin
Hydronephrosis
Cystectomy
Treatment Failure
Palliative Care
Antineoplastic Agents
Disease-Free Survival
Renal Dialysis
Logistic Models
Regression Analysis
Recurrence
Drug Therapy

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Azuma, Haruhito ; Inamoto, Teruo ; Takahara, Kiyoshi ; Nomi, Hayahito ; Hirano, Hajime ; Ibuki, Naokazu ; Uehara, Hiroshi ; Komura, Kazumasa ; Minami, Koichiro ; Uchimoto, Taizo ; Saito, Kenkichi ; Takai, Tomoaki ; Tanda, Naoki ; Yamamoto, Kazuhiro ; Narumi, Yoshihumi ; Kiyama, Satoshi. / The novel bladder preservation therapy BOAI-CDDP-radiation (OMC-regimen) : A new treatment option for invasive bladder cancer patients with lymph node metastasis. In: International Journal of Oncology. 2014 ; Vol. 45, No. 6. pp. 1895-1903.
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abstract = "We have developed a novel bladder preservation therapy for patients with muscle-invasive bladder cancer and lymph node metastasis: balloon-occluded arterial infusion (BOAI) of cisplatin/gemcitabine, with concomitant hemodialysis and irradiation [the so-called 'OMC (Osaka Medical College) regimen']. The OMC regimen delivers an extremely high concentration of anticancer agent to the site of the tumor, as well as the pelvic area, without causing any adverse systemic effects. In this study, we investigated the efficiency of the OMC regimen in 34 patients who underwent BOAI with cisplatin (100, 200 or 300 mg) along with 60 Gy of irradiation; patients who failed to achieve CR underwent secondary BOAI with gemcitabine (1,600 mg). The overall clinical response was 73.5{\%} (CR: 35.3{\%}; PR: 17.6{\%}; SD: 20.6{\%}). The 5-year overall and progression-free survival rates were 54.4{\%} and 52.5{\%}, respectively. For treatment failure, N2 stage was selected as a significant risk factor by simple and multiple logistic regression analyses. Cox proportional hazards analyses showed that N2 stage, T4 stage and the presence of hydronephrosis were significant risk factors for overall survival. Indeed, 55.6{\%} of patients with N1 stage achieved a complete response (CR) (vs. 12.5{\%} for N2 patients, p=0.0151), and 90{\%} (9/10) of the CR patients survived without recurrence with an intact bladder after a mean follow-up of 85 (range 7-193) weeks. The 3-year progrssion-free survival rate with an intact bladder was 65.8{\%} (vs. 37.5{\%} for N2, p=0.034), and the 5-year overall survival rate was 71.8{\%} (vs. 30.6{\%} for N2, p=0.004). No patients suffered severe toxicities of Grade II or more; the oldest patient, aged 85 years, successfully completed this therapy. In conclusion, the OMC regimen can be regarded as a new option for patients with macroscopic lymph node involvement, especially those at stage N1. Therapy will improve the feasibility of radical cure even without the need for cystectomy in patients for whom surgery after neoadjuvant chemotherapy would otherwise be necessary, and also facilitate potential cure in patients for whom, otherwise, merely palliative treatment would seem the only option.",
author = "Haruhito Azuma and Teruo Inamoto and Kiyoshi Takahara and Hayahito Nomi and Hajime Hirano and Naokazu Ibuki and Hiroshi Uehara and Kazumasa Komura and Koichiro Minami and Taizo Uchimoto and Kenkichi Saito and Tomoaki Takai and Naoki Tanda and Kazuhiro Yamamoto and Yoshihumi Narumi and Satoshi Kiyama",
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Azuma, H, Inamoto, T, Takahara, K, Nomi, H, Hirano, H, Ibuki, N, Uehara, H, Komura, K, Minami, K, Uchimoto, T, Saito, K, Takai, T, Tanda, N, Yamamoto, K, Narumi, Y & Kiyama, S 2014, 'The novel bladder preservation therapy BOAI-CDDP-radiation (OMC-regimen): A new treatment option for invasive bladder cancer patients with lymph node metastasis', International Journal of Oncology, vol. 45, no. 6, pp. 1895-1903. https://doi.org/10.3892/ijo.2014.2378

The novel bladder preservation therapy BOAI-CDDP-radiation (OMC-regimen) : A new treatment option for invasive bladder cancer patients with lymph node metastasis. / Azuma, Haruhito; Inamoto, Teruo; Takahara, Kiyoshi; Nomi, Hayahito; Hirano, Hajime; Ibuki, Naokazu; Uehara, Hiroshi; Komura, Kazumasa; Minami, Koichiro; Uchimoto, Taizo; Saito, Kenkichi; Takai, Tomoaki; Tanda, Naoki; Yamamoto, Kazuhiro; Narumi, Yoshihumi; Kiyama, Satoshi.

In: International Journal of Oncology, Vol. 45, No. 6, 01.01.2014, p. 1895-1903.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The novel bladder preservation therapy BOAI-CDDP-radiation (OMC-regimen)

T2 - A new treatment option for invasive bladder cancer patients with lymph node metastasis

AU - Azuma, Haruhito

AU - Inamoto, Teruo

AU - Takahara, Kiyoshi

AU - Nomi, Hayahito

AU - Hirano, Hajime

AU - Ibuki, Naokazu

AU - Uehara, Hiroshi

AU - Komura, Kazumasa

AU - Minami, Koichiro

AU - Uchimoto, Taizo

AU - Saito, Kenkichi

AU - Takai, Tomoaki

AU - Tanda, Naoki

AU - Yamamoto, Kazuhiro

AU - Narumi, Yoshihumi

AU - Kiyama, Satoshi

PY - 2014/1/1

Y1 - 2014/1/1

N2 - We have developed a novel bladder preservation therapy for patients with muscle-invasive bladder cancer and lymph node metastasis: balloon-occluded arterial infusion (BOAI) of cisplatin/gemcitabine, with concomitant hemodialysis and irradiation [the so-called 'OMC (Osaka Medical College) regimen']. The OMC regimen delivers an extremely high concentration of anticancer agent to the site of the tumor, as well as the pelvic area, without causing any adverse systemic effects. In this study, we investigated the efficiency of the OMC regimen in 34 patients who underwent BOAI with cisplatin (100, 200 or 300 mg) along with 60 Gy of irradiation; patients who failed to achieve CR underwent secondary BOAI with gemcitabine (1,600 mg). The overall clinical response was 73.5% (CR: 35.3%; PR: 17.6%; SD: 20.6%). The 5-year overall and progression-free survival rates were 54.4% and 52.5%, respectively. For treatment failure, N2 stage was selected as a significant risk factor by simple and multiple logistic regression analyses. Cox proportional hazards analyses showed that N2 stage, T4 stage and the presence of hydronephrosis were significant risk factors for overall survival. Indeed, 55.6% of patients with N1 stage achieved a complete response (CR) (vs. 12.5% for N2 patients, p=0.0151), and 90% (9/10) of the CR patients survived without recurrence with an intact bladder after a mean follow-up of 85 (range 7-193) weeks. The 3-year progrssion-free survival rate with an intact bladder was 65.8% (vs. 37.5% for N2, p=0.034), and the 5-year overall survival rate was 71.8% (vs. 30.6% for N2, p=0.004). No patients suffered severe toxicities of Grade II or more; the oldest patient, aged 85 years, successfully completed this therapy. In conclusion, the OMC regimen can be regarded as a new option for patients with macroscopic lymph node involvement, especially those at stage N1. Therapy will improve the feasibility of radical cure even without the need for cystectomy in patients for whom surgery after neoadjuvant chemotherapy would otherwise be necessary, and also facilitate potential cure in patients for whom, otherwise, merely palliative treatment would seem the only option.

AB - We have developed a novel bladder preservation therapy for patients with muscle-invasive bladder cancer and lymph node metastasis: balloon-occluded arterial infusion (BOAI) of cisplatin/gemcitabine, with concomitant hemodialysis and irradiation [the so-called 'OMC (Osaka Medical College) regimen']. The OMC regimen delivers an extremely high concentration of anticancer agent to the site of the tumor, as well as the pelvic area, without causing any adverse systemic effects. In this study, we investigated the efficiency of the OMC regimen in 34 patients who underwent BOAI with cisplatin (100, 200 or 300 mg) along with 60 Gy of irradiation; patients who failed to achieve CR underwent secondary BOAI with gemcitabine (1,600 mg). The overall clinical response was 73.5% (CR: 35.3%; PR: 17.6%; SD: 20.6%). The 5-year overall and progression-free survival rates were 54.4% and 52.5%, respectively. For treatment failure, N2 stage was selected as a significant risk factor by simple and multiple logistic regression analyses. Cox proportional hazards analyses showed that N2 stage, T4 stage and the presence of hydronephrosis were significant risk factors for overall survival. Indeed, 55.6% of patients with N1 stage achieved a complete response (CR) (vs. 12.5% for N2 patients, p=0.0151), and 90% (9/10) of the CR patients survived without recurrence with an intact bladder after a mean follow-up of 85 (range 7-193) weeks. The 3-year progrssion-free survival rate with an intact bladder was 65.8% (vs. 37.5% for N2, p=0.034), and the 5-year overall survival rate was 71.8% (vs. 30.6% for N2, p=0.004). No patients suffered severe toxicities of Grade II or more; the oldest patient, aged 85 years, successfully completed this therapy. In conclusion, the OMC regimen can be regarded as a new option for patients with macroscopic lymph node involvement, especially those at stage N1. Therapy will improve the feasibility of radical cure even without the need for cystectomy in patients for whom surgery after neoadjuvant chemotherapy would otherwise be necessary, and also facilitate potential cure in patients for whom, otherwise, merely palliative treatment would seem the only option.

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