STARLORD研究的初步结果：一项单中心前瞻性II期研究，评估立体定向放疗用于不适合同步放化疗的局部晚期非小细胞肺癌。
Preliminary results of the STARLORD study: a mono-institutional prospective phase II experience of STereotActic Radiotherapy for LOcally advanced non small cell lung cancer ineligible for concurrent chemoRaDiation.
文献信息
| PMID | 42879832 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | F Cuccia |
| 作者单位 | Radiation Oncology, ARNAS Civico Hospital, Palermo, Italy. Electronic address: francesco.cuccia@arnascivico.it. |
| 期刊 | Clinical oncology (Royal College of Radiologists (Great Britain)) |
| SCI 分区 | Q3 |
| IF | 3 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 鼻科 |
中文摘要
目的： 对于不适合同步放化疗（cCRT）的不可切除III期非小细胞肺癌（NSCLC）患者，立体定向体部放疗（SBRT）可能提供良好的疗效-毒性平衡。
材料和方法： STARLORD（立体定向放疗用于不适合同步放化疗的局部晚期非小细胞肺癌）是一项前瞻性II期研究，评估在化疗后使用Radixact系统进行SBRT的安全性和早期结局。
结果： 连续分析了26例IIIB-IIIC期NSCLC患者，中位年龄75.5岁（IQR，72.2-79.8），84.6%的患者为IIIB期疾病，15.4%为IIIC期。诱导化疗后，对原发肿瘤和纵隔病变均进行SBRT，分5次照射，中位总剂量分别为40 Gy（IQR，40-45 Gy）和35 Gy（IQR，35-40 Gy）。76.9%的患者接受了巩固免疫治疗。中位随访17.3个月后，急性3级（G3）吞咽困难发生率为7.7%，未观察到晚期≥3级毒性。1年局部控制（LC）率为86.7%，两例纵隔进展分别发生在SBRT后11和12个月。中位远处无进展生存期（mDPFS）为15.6个月，1年DPFS率为56.7%。随访期间记录到4例死亡，导致1年总生存（OS）率为90.9%，IIIC期疾病（log-rank P = .00027）和年龄≥75岁（log-rank P = .032）的患者结局更差。
结论： 在我们的经验中，对于不适合同步放化疗的局部晚期NSCLC的较虚弱患者，SBRT耐受性良好，并提供了有希望的疾病控制结局。
英文摘要
AIMS: For patients with unresectable stage III non-small cell lung cancer (NSCLC) ineligible for concurrent chemo-radiation (cCRT), stereotactic body radiotherapy (SBRT) may provide a favorable efficacy-toxicity balance.
MATERIALS AND METHODS: STARLORD (STereotActic Radiotherapy for LOcally advanced non--small cell lung cancer ineligible for concurrent chemoRaDiation) is a prospective phase II study evaluating safety and early outcomes of SBRT after chemotherapy is delivered with Radixact system.
RESULTS: Twenty-six consecutive patients with stage IIIB-IIIC NSCLC were analyzed with median age 75.5 years (IQR, 72.2-79.8), with 84.6% of patients presenting stage IIIB disease and 15.4% stage IIIC. Following induction chemotherapy, SBRT was delivered to both the primary tumor and mediastinal disease in 5 fractions, for median total doses, respectively, of 40 Gy (IQR, 40-45 Gy) and 35 Gy (IQR, 35-40 Gy). Consolidation immunotherapy was administered in 76.9% of patients. After a median follow-up of 17.3 months, acute grade 3 (G3) dysphagia was observed in 7.7%, no late grade ≥3 toxicities were observed. The 1-year local control (LC) rate was 86.7%, with two mediastinal progressions occurring 11 and 12 months after SBRT. Median distant progression-free survival (mDPFS) was 15.6 months with a 1-year DPFS rate of 56.7%. Four deaths were recorded during follow-up, resulting in a 1-year overall survival (OS) rate of 90.9%, with worse outcomes for patients with stage IIIC disease (log-rank P = .00027) and aged ≥75 years (log-rank P = .032).
CONCLUSIONS: In our experience, for frailer patients with unresectable locally advanced NSCLC, SBRT is well tolerated and provides promising disease control outcomes.