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中低分割螺旋断层放疗治疗老年局限性前列腺癌的Ⅰ-Ⅱ期临床试验:长期结果。

Moderate hypofractionated helical tomotherapy for older patients with localized prostate cancer: long-term outcomes of a phase I-II trial.

机构信息

Medical School of Chinese PLA, Beijing, China.

Department of Radiotherapy, Peking University International Hospital, Beijing, China.

出版信息

Radiol Oncol. 2022 Mar 28;56(2):216-227. doi: 10.2478/raon-2022-0011.

DOI:10.2478/raon-2022-0011
PMID:35344645
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9122298/
Abstract

BACKGROUND

Our previous study showed that two different regimens of moderate hypofractionated radiotherapy (HFRT) delivered with helical tomotherapy (HT) are well tolerated in older prostate cancer patients. We provide a longterm efficacy and toxicity after > 7 years of follow-up.

PATIENTS AND METHODS

The study recruited 33 patients from February 2009 to July 2011 (76 Gy/34F; Group-1); and 34 from July 2011 to February 2014 (71.6 Gy/28F; 50.4 Gy/25F for the risk of pelvic lymph nodes involvement (LNI) >15%; Group-2). The primary outcomes were biochemical failure (BF), biochemical failure and clinical disease failure (BCDF), progression-free survival (PFS), overall survival (OS), late genitourinary (GU) and gastrointestinal (GI) toxicity.

RESULTS

The average ages of two groups were 80 and 77 years and the proportions of patients with LNI > 15% were 69.7% and 73.5%, respectively. At the final follow-up in February 2020, 27.3% and 20.6% cases experienced BF, with a median time until BF of 3.3 years. A total of 38.8% patients reached primary endpoints, in which 18 deaths were reported BCDF events (45.5% . 32.4%, p = 0.271). There was no significant difference in 7-year PFS (68.6% . 74.8%, p = 0.591), BCDF (45.5% . 32.4%, p = 0.271) and OS (71.9% . 87.5%, p = 0.376) for full set analysis and for subgroup analysis (all p > 0.05). The incidence of grade ≥ 2 late GU (6.2% . 6.3%, p = 0.127) and GI toxicities (9.4% . 15.6%, p = 0.554) was comparable.

CONCLUSIONS

In older patients with localized prostate cancer, two moderate hypofractionated regimens were all well tolerated with similar, mild late toxicities and satisfactory survival, without necessity of prophylactic pelvic node irradiation.

摘要

背景

我们之前的研究表明,螺旋断层放疗(HT)治疗的两种不同中分割低剂量放疗方案在老年前列腺癌患者中具有良好的耐受性。我们提供了超过 7 年随访后的长期疗效和毒性。

患者和方法

该研究于 2009 年 2 月至 2011 年 7 月招募了 33 名患者(76 Gy/34F;组 1);2011 年 7 月至 2014 年 2 月招募了 34 名患者(71.6 Gy/28F;50.4 Gy/25F 用于风险为盆腔淋巴结受累(LNI)>15%的患者;组 2)。主要结局为生化失败(BF)、生化失败和临床疾病失败(BCDF)、无进展生存期(PFS)、总生存期(OS)、晚期泌尿生殖系统(GU)和胃肠道(GI)毒性。

结果

两组的平均年龄分别为 80 岁和 77 岁,LNI>15%的患者比例分别为 69.7%和 73.5%。在 2020 年 2 月的最终随访中,27.3%和 20.6%的病例发生 BF,中位 BF 时间为 3.3 年。共有 38.8%的患者达到主要终点,其中 18 例死亡为 BCDF 事件(45.5%、32.4%,p=0.271)。7 年 PFS(68.6%、74.8%,p=0.591)、BCDF(45.5%、32.4%,p=0.271)和 OS(71.9%、87.5%,p=0.376)的 7 年无进展生存期无显著差异)对于完整数据集分析和亚组分析(均 p>0.05)。≥2 级晚期 GU(6.2%、6.3%,p=0.127)和 GI 毒性(9.4%、15.6%,p=0.554)的发生率相当。

结论

在局限性前列腺癌的老年患者中,两种中分割低剂量放疗方案均具有良好的耐受性,晚期毒性轻微,生存满意,无需预防性盆腔淋巴结照射。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2e9/9122298/c796ba4094d1/raon-56-216-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2e9/9122298/d8f8074d325e/raon-56-216-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2e9/9122298/24ca32488d23/raon-56-216-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2e9/9122298/a7f36f2ac620/raon-56-216-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2e9/9122298/c796ba4094d1/raon-56-216-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2e9/9122298/d8f8074d325e/raon-56-216-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2e9/9122298/24ca32488d23/raon-56-216-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2e9/9122298/a7f36f2ac620/raon-56-216-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2e9/9122298/c796ba4094d1/raon-56-216-g004.jpg

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引用本文的文献

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Moderately Hypofractionated Helical Tomotherapy for Prostate Cancer: Ten-year Experience of a Mono-institutional Series of 415 Patients.中分割螺旋断层放疗治疗前列腺癌:单机构 415 例患者十年经验。
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