Cirocchi Roberto, Farinella Eriberto, La Mura Francesco, Cavaliere Davide, Avenia Nicola, Verdecchia Giorgio Maria, Giustozzi Gianmario, Noya Giuseppe, Sciannameo Francesco
Department of General and Emergency Surgery, St. Maria Hospital, Terni, University of Perugia, Italy.
Tumori. 2010 May-Jun;96(3):392-9. doi: 10.1177/030089161009600303.
In patients with localized gastrointestinal stromal tumors, surgery remains the elective treatment. Nowadays, imatinib therapy has been standardized in advanced gastrointestinal stromal tumors, showing continuous improvements in progression-free and overall survival. A combination of imatinib therapy and surgery may also be effective in a subset of patients with metastatic or unresectable gastrointestinal stromal tumors. In this review, the authors analyzed the role of imatinib mesylate associated to surgery in unresectable and/or metastatic gastrointestinal stromal tumors.
We searched for all published and unpublished randomized controlled clinical trials and controlled clinical trials. We conducted the review according to the recommendations of The Cochrane Collaboration. We used Review Manager 5 software for the statistical analysis.
There are currently no randomized controlled clinical trials or controlled clinical trials on this issue. We performed a subgroup analysis in the patients preoperatively treated with imatinib mesylate. This subgroup revealed a minor incidence of recurrent or metastatic gastrointestinal stromal tumors and a greater incidence of locally unresectable gastrointestinal stromal tumors in the responsive disease group (P = 0.001). In this patient group, more complete resections were observed (P = 0.00001). Furthermore, in the same patient group we observed a more significant 12 and 24-month disease-free survival after imatinib treatment and complete resection (respectively P= 0.06 and P= 0.003) and also a better 24-month overall survival (P = 0.004).
There is actually only one ongoing European randomized study evaluating surgery of residual disease in patients with metastatic gastrointestinal stromal tumors responding to imatinib mesylate. Imatinib mesylate represents the standard treatment as preoperative supplement for locally unresectable and/or metastatic gastrointestinal stromal tumors, and a trial to compare the approach versus surgery alone is not necessary. For patients responding to imatinib or patients with prolonged stable disease, resection of residual disease should be considered. A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastrointestinal stromal tumor responding to imatinib mesylate, EORTC 62063, has been opened. Moreover, surgery should be considered for patients at higher risk of complications during pharmacological debulking. In advanced gastrointestinal stromal tumors, the advantages of the integrated treatment are significant in the complete or partial response disease group in terms of more complete resections and better disease-free and overall survival.
对于局限性胃肠道间质瘤患者，手术仍是首选治疗方法。如今，伊马替尼治疗在晚期胃肠道间质瘤中已标准化，在无进展生存期和总生存期方面持续改善。伊马替尼治疗与手术相结合对部分转移性或不可切除的胃肠道间质瘤患者可能也有效。在本综述中，作者分析了甲磺酸伊马替尼联合手术在不可切除和/或转移性胃肠道间质瘤中的作用。
我们检索了所有已发表和未发表的随机对照临床试验及对照临床试验。我们按照Cochrane协作网的建议进行综述。我们使用Review Manager 5软件进行统计分析。
目前尚无关于此问题的随机对照临床试验或对照临床试验。我们对术前接受甲磺酸伊马替尼治疗的患者进行了亚组分析。该亚组显示，反应性疾病组中复发性或转移性胃肠道间质瘤的发生率较低，局部不可切除的胃肠道间质瘤的发生率较高（P = 0.001）。在该患者组中，观察到更多的完整切除（P = 0.00001）。此外，在同一患者组中，我们观察到伊马替尼治疗并完整切除后12个月和24个月的无病生存期更显著（分别为P = 0.06和P = 0.003），24个月的总生存期也更好（P = 0.004）。
实际上，目前只有一项正在进行的欧洲随机研究，评估甲磺酸伊马替尼反应性转移性胃肠道间质瘤患者的残留病灶手术情况。甲磺酸伊马替尼是局部不可切除和/或转移性胃肠道间质瘤术前补充的标准治疗方法，无需进行比较该方法与单纯手术的试验。对于伊马替尼反应性患者或疾病长期稳定的患者，应考虑切除残留病灶。一项评估甲磺酸伊马替尼反应性转移性胃肠道间质瘤患者残留病灶手术的III期随机研究EORTC 62063已经启动。此外，对于药物减瘤期间并发症风险较高的患者应考虑手术。在晚期胃肠道间质瘤中，综合治疗在完全或部分反应性疾病组中的优势显著，表现为更完整的切除以及更好的无病生存期和总生存期。
