Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.
Upper Gastrointestinal and Soft Tissue Unit, School of Medicine, Princess Alexandra Hospital, University of Queensland, Woolloongabba, QLD, Australia.
Ann Surg Oncol. 2017 Aug;24(8):2252-2258. doi: 10.1245/s10434-017-5830-6. Epub 2017 Mar 23.
Postoperative chemoradiation and perioperative chemotherapy using epirubicin/cisplatin/5-fluorouracil (ECF) represent two standards of care for resectable gastric cancer. In the TOPGEAR (Trial Of Preoperative therapy for Gastric and Esophagogastric junction AdenocaRcinoma) trial, we hypothesized that adding preoperative chemoradiation to perioperative ECF will improve survival; however, the safety and feasibility of preoperative chemoradiation have yet to be determined.
TOPGEAR is an international phase III trial in which patients with adenocarcinoma of the stomach were randomized to perioperative ECF alone or with preoperative chemoradiation. The ECF-alone group received three preoperative cycles of ECF, while the chemoradiation group received two cycles of preoperative ECF followed by chemoradiation. Both groups received three postoperative cycles of ECF. A planned interim analysis of the first 120 patients was conducted, and was reviewed by the Independent Data Safety Monitoring Committee to assess treatment compliance, toxicity/safety, and response rates.
The proportion of patients who received all cycles of preoperative chemotherapy was 93% (ECF group) and 98% (chemoradiation group), while 65 and 53%, respectively, received all cycles of postoperative chemotherapy. Overall, 92% of patients allocated to preoperative chemoradiation received this treatment. The proportion of patients proceeding to surgery was 90% (ECF group) and 85% (chemoradiation group). Grade 3 or higher surgical complications occurred in 22% of patients in both groups. Furthermore, grade 3 or higher gastrointestinal toxicity occurred in 32% (ECF group) and 30% (chemoradiation group) of patients, while hematologic toxicity occurred in 50 and 52% of patients.
These results demonstrate that preoperative chemoradiation can be safely delivered to the vast majority of patients without a significant increase in treatment toxicity or surgical morbidity.
术后放化疗和围手术期使用表柔比星/顺铂/5-氟尿嘧啶（ECF）的化疗是可切除胃癌的两种标准治疗方法。在 TOPGEAR（胃和胃食管交界腺癌术前治疗试验）试验中，我们假设将术前放化疗加入围手术期 ECF 中将提高生存率；然而，术前放化疗的安全性和可行性尚未确定。
TOPGEAR 是一项国际 III 期试验，其中胃腺癌患者被随机分配接受围手术期 ECF 单独治疗或 ECF 联合术前放化疗。ECF 单独组接受三个术前 ECF 周期，而放化疗组接受两个周期的术前 ECF 联合放化疗。两组均接受三个术后 ECF 周期。对前 120 例患者进行了计划的中期分析，并由独立数据安全监测委员会进行了审查，以评估治疗依从性、毒性/安全性和反应率。
接受所有术前化疗周期的患者比例分别为 93%（ECF 组）和 98%（放化疗组），而分别有 65%和 53%的患者接受了所有术后化疗周期。总体而言，92%的术前放化疗患者接受了该治疗。接受手术的患者比例分别为 90%（ECF 组）和 85%（放化疗组）。两组患者均有 22%发生 3 级或更高级别的手术并发症。此外，32%（ECF 组）和 30%（放化疗组）的患者出现 3 级或更高级别的胃肠道毒性，而 50%和 52%的患者出现血液学毒性。
这些结果表明，术前放化疗可以安全地提供给绝大多数患者，而不会显著增加治疗毒性或手术发病率。
