Preliminary trial of adjuvant surgery for advanced gastric cancer (original) (raw)
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Adjuvant and Neoadjuvant Therapy for Gastric Carcinoma
American Journal of Cancer, 2006
ABSTRACT Despite its declining incidence, gastric cancer remains one of the leading causes of cancer-related death worldwide. The definitive management of localized gastric cancer has been the center of much international controversy over the years; surgery remains the mainstay, with debate centering on the required extent of lymph node resection. The role of adjuvant chemotherapy has been studied for decades, but because trials have been underpowered, it has been difficult to demonstrate a statistically significant benefit. Recently, four large meta-analyses have been published on adjuvant chemotherapy in gastric cancer. The first three have been criticized for their methodology, but the most recent meta-analysis was well conducted and showed a statistically significant benefit in favor of adjuvant chemotherapy. The heterogeneity of chemotherapy schedules included in this meta-analysis, however, makes it difficult to define the current standard. Randomized trials in the metastatic setting have shown that the combinations of epirubicin, cisplatin, and infusional fluorouracil (ECF) and docetaxel, cisplatin, and fluorouracil (TCF) have demonstrated superiority over other regimens. The role of preoperative chemotherapy is currently under investigation, with results from the MAGIC (Medical Research Council Adjuvant Gastric Infusional Chemotherapy) trial demonstrating a significant improvement in resectability, progression-free survival, and overall survival with perioperative therapy in patients with operable gastric cancer. Postoperative chemoradiotherapy has also been adopted as a standard of care in the US following the publication of the results of the Intergroup Study, INT-0116, although there remains debate over the relative benefits of more radical surgery versus the use of radiation with adjuvant treatment. It is clear that adjuvant therapy is now an appropriate addition to surgery, although there are still further questions regarding the optimal protocols.
Adjuvant Therapy of Resected Gastric Cancer Is Necessary
Seminars in Oncology, 2005
The currently reported 5-year survival rates for patients with resected stage II, IIIA, IIIB, and IV gastric cancer are 34%, 20%, 8%, and 7%, respectively. A subtotal or total gastrectomy with a D1 en bloc dissection of lymphatic tissue is the standard surgical treatment. Several meta-analyses of post-operative adjuvant trials have reported a significant benefit for chemotherapy-treated patients. Because most relapses occur locally, post-operative adjuvant chemoradiotherapy was studied in patients who received surgery alone or surgery followed by 5-fluorouracil and leucovorin (5-FU/LV, Mayo Clinic regimen) given before, after, and concurrently with radiotherapy in the Intergroup 0116 trial. The 3-year survival and 3-year disease-free survival rates were significantly higher in the adjuvant treatment group, making this regimen the adjuvant standard in the United States. A second trial, the MAGIC trial, also showed improved survival and disease-free survival with epirubicin, cisplatin, and 5-FU (ECF) given every 3 weeks pre-and post-operatively. Other agents in combination with perioperative radiotherapy and surgery are being investigated to treat patients with gastric cancer. New target-oriented agents, as well as tailored therapy based on the molecular profile of both the tumor and the patient, might also contribute to improved results.
Journal of Gastrointestinal Cancer, 2020
Background and Aims: Although the number of gastric cancer patients aged !85 years indicated for endoscopic submucosal dissection (ESD) has increased, little is known about the outcomes and prognostic factors. This study aimed to investigate the clinical outcomes and prognostic factors for overall survival (OS) of patients aged !85 years who underwent ESD for gastric cancer. Methods: We retrospectively reviewed 108 patients aged !85 years with 149 gastric cancers treated by ESD between 1999 and 2014 at our institution. The clinical outcomes and prognosis were evaluated. Furthermore, the relationships between patient and lesion characteristics with OS were determined using the Kaplan-Meier method and a Cox proportional hazards model. Results: All patients had Eastern Cooperative Oncology Group performance status (PS) of 0 to 1. En bloc, R0, and curative resections were achieved in 98.0%, 91.3%, and 72.7%, respectively, without severe adverse events requiring surgery. During a median follow-up period of 40.2 months (range, 1.8-108.7 months), 23 patients died, including 2 of gastric cancer. The 3-year (54.3% vs 95.9%) and 5-year (54.3% vs 76.3%) OS rates were significantly lower in patients with a low (<44.6) as opposed to a higher (!44.6) prognostic nutritional index (PNI) (P < .001). The PNI was independently prognostic of OS (hazard ratio, 7.0; 95% confidence interval, 2.2-22.9; P Z .001). Conclusions: ESD is feasible for gastric cancer patients aged !85 years with good PS. However, low PNI was found to be prognostic of reduced OS, indicating the need to evaluate the PNI in determining whether to perform ESD.
BMC Cancer, 2011
Background: Radical surgery is the cornerstone in the treatment of resectable gastric cancer. The Intergroup 0116 and MAGIC trials have shown benefit of postoperative chemoradiation and perioperative chemotherapy, respectively. Since these trials cannot be compared directly, both regimens are evaluated prospectively in the CRITICS trial. This study aims to obtain an improved overall survival for patients treated with preoperative chemotherapy and surgery by incorporating radiotherapy concurrently with chemotherapy postoperatively. Methods/design: In this phase III multicentre study, patients with resectable gastric cancer are treated with three cycles of preoperative ECC (epirubicin, cisplatin and capecitabine), followed by surgery with adequate lymph node dissection, and then either another three cycles of ECC or concurrent chemoradiation (45 Gy, cisplatin and capecitabine). Surgical, pathological, and radiotherapeutic quality control is performed. The primary endpoint is overall survival, secondary endpoints are disease-free survival (DFS), toxicity, health-related quality of life (HRQL), prediction of response, and recurrence risk assessed by genomic and expression profiling. Accrual for the CRITICS trial is from the Netherlands, Sweden, and Denmark, and more countries are invited to participate. Conclusion: Results of this study will demonstrate whether the combination of preoperative chemotherapy and postoperative chemoradiotherapy will improve the clinical outcome of the current European standard of perioperative chemotherapy, and will therefore play a key role in the future management of patients with resectable gastric cancer.
British journal of cancer, 2001
Adjuvant chemotherapy of gastric cancer after curative resection is still subject to discussion. In this study 137 patients with gastric adenocarcinoma, all with positive nodes, were randomized after curative resection so that 69 received epidoxorubicin (EPI), leucovorin (LV) and 5-fluorouracil (5-FU) on days 1-3 every 3 weeks for 7 months, whereas the remaining 68 did not. After a follow-up period of 5 years, 21 of the 69 treated patients (30%) and nine controls (13%) were still alive; median survival time was 18 months for the controls and 31 months for the patients treated with adjuvant chemotherapy (P< 0.01).
Phase II study of neoadjuvant chemotherapy and extended surgery for locally advanced gastric cancer
British Journal of Surgery, 2009
Background: Locally advanced gastric cancer with extensive lymph node metastasis is usually considered unresectable and so treated by chemotherapy. This trial explored the safety and efficacy of preoperative chemotherapy followed by extended surgery in the management of locally advanced gastric adenocarcinoma. Methods: Patients with gastric cancer with extensive lymph node metastasis received two or three 28-day cycles of induction chemotherapy with irinotecan (70 mg/m 2 on days 1 and 15) and cisplatin (80 mg/m 2 on day 1), and then underwent gastrectomy with curative intent with D2 plus para-aortic lymphadenectomy. Primary endpoints were 3-year overall survival and incidence of treatment-related death. Results: The study was terminated because of three treatment-related deaths when 55 patients had been enrolled (mortality rate above 5 per cent). Two deaths were due to myelosuppression and one to postoperative complications. Clinical response and R0 resection rates were 55 and 65 per cent respectively. The pathological response rate was 15 per cent. Median overall survival was 14•6 months and the 3-year survival rate 27 per cent. Conclusion: This multimodal treatment of locally advanced gastric cancer provides reasonable 3-year survival compared with historical data, but at a considerable cost in terms of morbidity and mortality.