Aims

A novel bladder preservation therapy, the OMC (Osaka Medical College) regimen, which combines radiation therapy with balloon-occluded arterial infusion of anticancer agents, is a treatment option for patients with muscle-invasive bladder cancer (MIBC). We retrospectively analysed the effects of changes in radiation dose and irradiation field on treatment efficacy and adverse events.The purpose of this study is to use the results of this study to help determine a course of radiation therapy for bladder preservation therapy of cT2N0M0 MIBC.

Materials and methods

We examined 352 patients with clinical stage T2N0M0 (cT2N0M0) MIBC classified into the following groups based on the irradiation method: group A, the whole pelvis (50 Gy/25 fractions) + local bladder (10 Gy/5 fractions); group B, the small pelvis (50 Gy/25 fractions) + local bladder (10 Gy/5 fractions); group C, the whole pelvis (40 Gy/20 fractions) + local bladder (10 Gy/5 fractions).

Results

The complete response rate, 3-year overall survival and progression-free survival rates in group A were 92.9%, 94.9% and 82.1%, respectively; in group B were 87.2%, 86.7% and 76.7%, respectively; and in group C were 95.2%, 92.6% and 71.1%, respectively. No significant differences between the groups were noted. The incidence of ≥grade 3 urinary tract and gastrointestinal toxicities were not significantly different among the groups (group A: 7.8%, 1.7%; B, 11.1%, 0%; C, 7.1%, 1.8%, respectively). The 3-year progression-free rates of the common iliac lymph node (CILN) region in patients who received whole-pelvis and small-pelvis irradiation were 99.0 and 89.0% (P < 0.01), respectively, with the latter group having significantly high lymph node recurrence in the CILN region.

Conclusions

Our findings showed that the optimal radiation therapy for patients with cT2N0M0 MIBC undergoing the OMC regimen is whole-pelvis irradiation including the CILN region, with a total dose of 50 Gy/25 fractions.

中文翻译：

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临床分期 T2N0M0 膀胱癌患者保留膀胱的放射治疗优化

目标

一种新的膀胱保留疗法，OMC（大阪医学院）方案，将放射疗法与抗癌剂的球囊闭塞动脉输注相结合，是肌肉浸润性膀胱癌（MIBC）患者的一种治疗选择。我们回顾性分析了放射剂量和照射野的变化对治疗效果和不良事件的影响。本研究的目的是利用本研究的结果来帮助确定cT2N0M0 MIBC膀胱保留治疗的放射治疗疗程。

材料和方法

我们检查了 352 名临床分期为 T2N0M0 (cT2N0M0) MIBC 的患者，根据照射方法分为以下几组：A 组，全骨盆（50 Gy/25 次分割）+局部膀胱（10 Gy/5 次分割）；B组，小骨盆（50 Gy/25次）+局部膀胱（10 Gy/5次）；C 组，全骨盆（40 Gy/20 次）+ 局部膀胱（10 Gy/5 次）。

结果

A组的完全缓解率、3年总生存率和无进展生存率分别为92.9%、94.9%和82.1%；B组分别为87.2%、86.7%和76.7%；C组分别为95.2%、92.6%和71.1%。没有注意到组之间的显着差异。≥3级泌尿道和胃肠道毒性的发生率在各组之间没有显着差异（A组：7.8%，1.7%；B，11.1%，0%；C，7.1%，1.8%）。接受全盆腔和小盆腔照射的患者髂总淋巴结（CILN）区域3年无进展率分别为99.0%和89.0%（P <0.01），后一组有显着性差异。 CILN 区域淋巴结复发。

结论

我们的研究结果表明，接受 OMC 方案的 cT2N0M0 MIBC 患者的最佳放射治疗是包括 CILN 区域在内的全盆腔照射，总剂量为 50 Gy/25 次。