Massachusetts General Hospital Cancer Center, Boston, MA, USA.
NRG Oncology Statistics and Data Management Center, Philadelphia, PA, USA; University of Chicago, Chicago, IL, USA.
Eur Urol Oncol. 2024 Feb;7(1):83-90. doi: 10.1016/j.euo.2023.05.013. Epub 2023 Jul 11.
Chemo-radiation is a well-established alternative to radical cystectomy in patients with muscle-invasive bladder cancer. Many patients due to age or medical comorbidity are unfit for either radical cystectomy, or standard cisplatin- or 5-fluorouracil-based chemoradiation, and do not receive appropriate treatment with curative intent. We treated patients with a less aggressive protocol employing seven weekly doses of paclitaxel and daily irradiation. In those whose tumors showed overexpression of her2/neu, seven weekly doses of trastuzumab were also administered.
To report the long-term survival outcomes and toxicity results of the of NRG Oncology RTOG 0524 study.
DESIGN, SETTING, AND PARTICIPANTS: Seventy patients were enrolled and 65 (median age: 76 yr) were deemed eligible. Patients were assigned to daily radiation and weekly paclitaxel + trastuzumab (group 1, 20 patients) or to daily radiation plus weekly paclitaxel (group 2, 45 patients) based on tumor her2/neu overexpression. Radiation was delivered in 1.8 Gy fractions to a total dose of 64.8 Gy.
The primary endpoint was unresolved treatment-related toxicity. The secondary endpoints were complete response rate, protocol completion rate, and disease-free and overall survival.
Protocol therapy was completed by 60% (group 1) and 76% (group 2); complete response rates at 12 wk were 62% in each group. Acute treatment-related adverse events (AEs) of grade ≥3 were observed in 80% in group 1 and 58% in group 2. There was one treatment-related grade 5 AE in group 1. Unresolved acute treatment-related toxicity was 35% in group 1 and 31% in group 2. The median follow-up was 2.3 yr in all patients and 7.2 yr in surviving patients. Overall survival at 5 yr was 25.0% in group 1 and 37.8% in group 2 (33.8% overall). At 5 yr, disease-free survival was 15.0% in group 1 and 31.1% in group 2.
In a cohort of patients with muscle-invasive bladder cancer who are not candidates for cystectomy or cisplatin chemotherapy, chemoradiation therapy offers a treatment with a significant response rate and 34% 5-yr overall survival. While there were many AEs in this medically fragile group, there were few grade 4 events and one grade 5 event attributable to therapy.
Patients with invasive bladder cancer who cannot tolerate surgery were treated with radiation and systemic therapy without surgically removing their bladders. Most patients tolerated the treatment, were able to keep their bladders, and showed a significant treatment response rate.
放化疗是肌层浸润性膀胱癌患者替代根治性膀胱切除术的标准治疗方法。许多患者由于年龄或合并症，无法接受根治性膀胱切除术或标准顺铂或 5-氟尿嘧啶放化疗，因此没有接受适当的治愈性治疗。我们采用每周 7 次紫杉醇和每日放疗的侵袭性较小的方案治疗患者。对于肿瘤 HER2/neu 过表达的患者，还给予每周 7 次曲妥珠单抗治疗。
报告 NRG Oncology RTOG 0524 研究的长期生存结果和毒性结果。
设计、地点和参与者：共纳入 70 例患者，65 例（中位年龄：76 岁）符合入组条件。根据肿瘤 HER2/neu 过表达情况，患者被分配接受每日放疗联合每周紫杉醇+曲妥珠单抗（组 1，20 例）或每日放疗联合每周紫杉醇（组 2，45 例）。放疗采用 1.8 Gy 分次，总剂量为 64.8 Gy。
主要终点为未解决的治疗相关毒性。次要终点为完全缓解率、方案完成率以及无病生存和总生存。
组 1 和组 2 分别有 60%（组 1）和 76%（组 2）完成了方案治疗；两组在 12 周时的完全缓解率均为 62%。组 1 急性治疗相关不良事件（AE）≥3 级发生率为 80%，组 2 为 58%。组 1 有 1 例治疗相关 5 级 AE。组 1 未解决的急性治疗相关毒性为 35%，组 2 为 31%。所有患者中位随访时间为 2.3 年，存活患者中位随访时间为 7.2 年。组 1 和组 2 的 5 年总生存率分别为 25.0%和 37.8%（总体为 33.8%）。组 1 和组 2 的 5 年无病生存率分别为 15.0%和 31.1%。
在一组不适合接受膀胱切除术或顺铂化疗的肌层浸润性膀胱癌患者中，放化疗治疗可获得显著的缓解率，5 年总生存率为 34%。在这群身体脆弱的患者中，尽管发生了许多 AE，但只有少数 4 级事件和 1 例 5 级事件与治疗有关。
不能耐受手术的浸润性膀胱癌患者接受了不切除膀胱的放疗和全身治疗。大多数患者耐受了治疗，保留了膀胱，并且显示出显著的治疗反应率。
