Monti Manlio, Morgagni Paolo, Nanni Oriana, Framarini Massimo, Saragoni Luca, Marrelli Daniele, Roviello Franco, Petrioli Roberto, Fumagalli Romario Uberto, Rimassa Lorenza, Bozzarelli Silvia, Donini Annibale, Graziosi Luigina, De Angelis Verena, De Manzoni Giovanni, Bencivenga Maria, Mengardo Valentina, Parma Emilio, Milandri Carlo, Mura Gianni, Signorini Alessandra, Baiocchi Gianluca, Molfino Sarah, Sgroi Giovanni, Steccanella Francesca, Rausei Stefano, Proserpio Ilaria, Viganò Jacopo, Brugnatelli Silvia, Rinnovati Andrea, Santi Stefano, Ercolani Giorgio, Foca Flavia, Valmorri Linda, Amadori Dino, Frassineti Giovanni Luca
Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy.
Department of General Surgery, Morgagni-Pierantoni Hospital, 47121 Forlì, Italy.
Cancers (Basel). 2020 Sep 29;12(10):2790. doi: 10.3390/cancers12102790.
Docetaxel associated with oxaliplatin and 5-fluorouracil (FLOT) has been reported as the best perioperative treatment for gastric cancer. However, there is still some debate about the most appropriate number and timing of chemotherapy cycles. In this randomized multicenter phase II study, patients with resectable gastric cancer were staged through laparoscopy and peritoneal lavage cytology, and randomly assigned (1:1) to either four cycles of neoadjuvant chemotherapy (arm A) or two preoperative + two postoperative cycles of docetaxel, oxaliplatin, and capecitabine (DOC) chemotherapy (arm B). The primary endpoint was to assess the percentage of patients receiving all the planned preoperative or perioperative chemotherapeutic cycles. Ninety-one patients were enrolled between September 2010 and August 2016. The treatment was well tolerated in both arms. Thirty-three (71.7%) and 24 (53.3%) patients completed the planned cycles in arms A and B, respectively ( 0.066), reporting an odds ratio for early interruption of treatment of 0.45 (95% confidence interval (CI): 0.18-1.07). Resection was curative in 39 (88.6%) arm A patients and 35 (83.3%) arm B patients. Five-year progression-free survival (PFS) was 51.2% (95% CI: 34.2-65.8) in arm A and 40.3% (95% CI: 28.9-55.2) in arm B ( 0.300). Five-year survival was 58.5% (95% CI: 41.3-72.2) and 53.9% (95% CI: 35.5-69.3) ( 0.883) in arms A and B, respectively. The planned treatment was more frequently completed and was more active, albeit not significantly, in the neoadjuvant arm than in the perioperative group.
多西他赛联合奥沙利铂和5-氟尿嘧啶（FLOT）已被报道为胃癌最佳的围手术期治疗方案。然而，关于化疗周期的最合适次数和时机仍存在一些争议。在这项随机多中心II期研究中，对可切除胃癌患者进行腹腔镜检查和腹腔灌洗细胞学分期，然后将其随机（1:1）分为两组，一组接受四个周期的新辅助化疗（A组），另一组接受两个术前+两个术后周期的多西他赛、奥沙利铂和卡培他滨（DOC）化疗（B组）。主要终点是评估接受所有计划的术前或围手术期化疗周期的患者百分比。2010年9月至2016年8月期间共纳入91例患者。两组对治疗的耐受性均良好。A组和B组分别有33例（71.7%）和24例（53.3%）患者完成了计划周期（P = 0.066），治疗早期中断的比值比为0.45（95%置信区间（CI）：0.18 - 1.07）。A组39例（88.6%）患者和B组35例（83.3%）患者的切除为根治性切除。A组的五年无进展生存期（PFS）为51.2%（95% CI：34.2 - 65.8），B组为40.3%（95% CI：28.9 - 55.2）（P = 0.300）。A组和B组的五年生存率分别为58.5%（95% CI：41.3 - 72.2）和53.9%（95% CI：35.5 - 69.3）（P = 0.883）。与围手术期组相比，新辅助治疗组更频繁地完成了计划治疗，且活性更高，尽管差异不显著。
