Aim

To determine the efficacy of preoperative chemoradiotherapy as per the CROSS protocol for oesophageal/gastroesophageal junction cancer (OEGEJC), when expanded to patients outside of the inclusion/exclusion criteria defined in the original clinical trial.

Materials and methods

Data were collected retrospectively on 229 OEGEJC patients referred for curative-intent preoperative chemoradiotherapy. Outcomes including pathological complete response (pCR), overall survival (OS), cancer-specific survival and recurrence-free survival (RFS) of patients who met CROSS inclusion criteria (MIC) versus those who failed to meet criteria (FMIC) were determined.

Results

In total, 42.8% of patients MIC, whereas 57.2% FMIC; 16.6% of patients did not complete definitive surgery. The MIC cohort had higher rates of pCR, when compared with the FMIC cohort (33.3% versus 20.6%, P = 0.039). The MIC cohort had a better RFS, cancer-specific survival and OS compared with the FMIC cohort (P = 0.006, P = 0.004 and P = 0.009, respectively). Age >75 years and pretreatment weight loss >10% were not associated with a poorer RFS (P = 0.541 and 0.458, respectively). Compared with stage I–III patients, stage IVa was associated with a poorer RFS (hazard ratio (HR) = 2.158; 95% confidence interval (CI) = 1.339–3.480, P = 0.001). Tumours >8 cm in length or >5 cm in width had a trend towards worse RFS (HR = 2.060; 95% CI = 0.993–4.274, P = 0.052).

Conclusion

Our study showed that the robust requirements of the CROSS trial may limit treatment for patients with potentially curable OEGEJC and can be adapted to include patients with a good performance status who are older than 75 years or have >10% pretreatment weight loss. However, the inclusion of patients with celiac nodal metastases or tumours >8 cm in length or >5 cm in width may be associated with poor outcomes.

中文翻译：

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放宽 CROSS 试验的纳入标准是否会影响食道癌和胃食道癌患者根治性三联治疗的结果？

目标

当扩展到原始临床试验中定义的纳入/排除标准之外的患者时，根据 CROSS 方案确定术前放化疗对食管/胃食管结合部癌 (OEGEJC) 的疗效。

材料和方法

回顾性收集了 229 名 OEGEJC 患者的数据，这些患者被转诊接受了以治愈为目的的术前放化疗。确定符合 CROSS 纳入标准 (MIC) 与不符合标准 (FMIC) 的患者的病理完全缓解 (pCR)、总生存期 (OS)、癌症特异性生存期和无复发生存期 (RFS) 等结果。

结果

总共有 42.8% 的患者 MIC，而 57.2% FMIC；16.6% 的患者没有完成根治性手术。与 FMIC 队列相比，MIC 队列的 pCR 率更高（33.3% 对 20.6%，P = 0.039）。与 FMIC 队列相比，MIC 队列具有更好的 RFS、癌症特异性生存期和 OS（分别为P = 0.006、P = 0.004 和P = 0.009）。年龄 > 75 岁和治疗前体重减轻 > 10% 与较差的 RFS 无关（分别为P = 0.541 和 0.458）。与 I-III 期患者相比，IVa 期与较差的 RFS 相关（风险比 (HR) = 2.158；95% 置信区间 (CI) = 1.339-3.480，P= 0.001)。肿瘤长度 > 8 cm 或宽度 > 5 cm 有恶化 RFS 的趋势（HR = 2.060；95% CI = 0.993–4.274，P = 0.052）。

结论

我们的研究表明，CROSS 试验的严格要求可能会限制对可能治愈的 OEGEJC 患者的治疗，并且可以适应包括具有良好体能状态且年龄超过 75 岁或治疗前体重减轻超过 10% 的患者。然而，纳入腹腔淋巴结转移或肿瘤长度 > 8 cm 或宽度 > 5 cm 的患者可能与不良预后相关。