Phase 3 Trial of Postoperative Chemotherapy Alone Versus Chemoradiation Therapy in Stage III-IV Gastric Cancer Treated With R0 Gastrectomy and D2 Lymph Node Dissection

Kim, Tae Hyun; Park, Sook Ryun; Ryu, Keun Won; Kim, Young Woo; Bae, Jae-Moon; Lee, Jun Ho; Choi, Il Ju; Kim, Yeon-Joo; Kim, Dae Yong

doi:10.1016/j.ijrobp.2012.07.2378

Cited by 89 publications

(104 citation statements)

References 17 publications

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“…On study entry, all patients were required to have an Eastern Cooperative Oncology Group performance status <2. All studies required extensive lymph node dissections or the involvement of experienced surgeons (defined as performing a minimum of 20 operations for gastric cancer per year) [17,18,19,20,21,22]. Only one study enrolled patients with D0 lymphadenectomies; we did not account for this difference.…”

Section: Resultsmentioning

confidence: 99%

Chemoradiation Therapy versus Chemotherapy Alone for Gastric Cancer after R0 Surgical Resection: A Meta-Analysis of Randomized Trials

et al. 2014

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Objective: Current national guidelines include category 1 recommendations for perioperative chemotherapy or adjuvant chemoradiation with surgical resection for patients with stage IB-IIIB gastric cancer. We conducted a meta-analysis of randomized trials in which chemotherapy was prospectively tested against chemoradiation with surgical resection. Methods: We electronically searched PubMed and EMBASE for randomized, controlled clinical trials involving patients with gastric adenocarcinoma, status post-R0 resection. The interventions compared were adjuvant chemotherapy versus chemoradiation, with any chemotherapy regimen. The primary outcomes of interest were disease-free survival and overall survival. The Mantel-Haenszel random-effects model was used to calculate effect sizes. Results: Six trials that included 1,171 patients were evaluated; 599 were randomized to adjuvant chemoradiation and 572 to chemotherapy alone. Chemoradiation was associated with a significant increase in disease-free survival (odds ratio 1.48, 95% confidence interval 1.08-2.03) when compared to chemotherapy alone. However, there was no significant difference in overall survival (odds ratio 1.27, 95% confidence interval 0.95-1.71). Five trials found no statistically significant differences in toxicities between the two groups. Conclusion: In patients with gastric cancer status post-R0 resection, adjuvant chemoradiation was associated with higher disease-free survival when compared to chemotherapy alone. It remains appropriate to design trials testing new systemic agents with radiotherapy.

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Section: Resultsmentioning

confidence: 99%

Chemoradiation Therapy versus Chemotherapy Alone for Gastric Cancer after R0 Surgical Resection: A Meta-Analysis of Randomized Trials

et al. 2014

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“…The 3-year RFS and OS in the CRT group were 48 and 50 %, compared with 31 and 41 % in the surgery-only group (p \ 0.001 and p = 0.005, respectively) [5]. Several prospective trials have been published in recent years evaluating the benefit of adjuvant CRT in patients with D2 lymph node dissections [21][22][23]. A Korean phase III study applied the INT-0116 protocol to stage III-IV (M0) gastric cancer patients with D2 lymph node dissection [21].…”

Section: Discussionmentioning

confidence: 99%

“…Several prospective trials have been published in recent years evaluating the benefit of adjuvant CRT in patients with D2 lymph node dissections [21][22][23]. A Korean phase III study applied the INT-0116 protocol to stage III-IV (M0) gastric cancer patients with D2 lymph node dissection [21]. However, this study showed that adjuvant CRT only improved locoregional recurrence-free survival (LRRFS) but not disease-free survival (DFS) or OS.…”

Section: Discussionmentioning

confidence: 99%

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A phase II trial of concurrent 3D-CRT/IMRT and oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX) in gastric cancer patients with R0 gastrectomy and D2 lymph node dissection

et al. 2015

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Background To evaluate the safety and efficacy of a concurrent three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) plus oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX) regimen in completely resected gastric cancer patients with D2 lymph node dissection. Materials and methods Patients with stage IB-IIIC gastric cancer (per the AJCC, 7th edition) who had undergone R0 and D2 gastrectomy were recruited. Two cycles of FOLFOX with concurrent 3D-CRT or IMRT (50.4 Gy/28f) were administered. One and an additional five cycles of FOLFOX were delivered before and after concurrent chemoradiotherapy, respectively. Primary endpoints were relapse-free survival (RFS) and overall survival (OS), with adverse events as secondary endpoints. Results From 2008 to 2011, 110 patients were evaluable. The 1-, 2-and 3-year RFS and OS were 86.2, 72.2, 67.8 and 94.7, 87.2, 77.6 %, respectively. On multivariate analysis, stage (BIIIA vs. [IIIA) was a statistically significant factor affecting both RFS and OS. Additionally, the T-category (BT4a vs. =T4b) was a statistically significant factor affecting only the RFS. The most commonly observed grade 3 or 4 adverse events were nausea and vomiting, decreased appetite, leukopenia/neutropenia and fatigue, each of which occurred in 14.5, 11.8, 9.1 and 6.4 % patients, respectively. Conclusions Adjuvant 3D-CRT/IMRT to a dose of 50.4 Gy/28f with concurrent FOLFOX is safe and effective in patients following radical gastrectomy with D2 lymph node dissection.

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“…The National Cancer Center (NCC) in the Republic of Korea conducted a single-institution Phase III trial that included patients with Stage III-IV (M0) gastric cancer who underwent R0 and D2 dissection. 14 A total of 90 patients were randomly assigned to the chemotherapy arm (CT, n 5 44) or the CRT arm (CRT, n 5 46). With a median follow-up of 86.7 months, 46.6% patients (24 in the CT arm and 18 in the CRT arm) had disease recurrence, whereas the 5-year LRRFS was increased in the CRT group compared with the CT group (93.2% vs 66.8%; p 5 0.014, respectively); no difference in DFS and OS was observed between the two groups.…”

Section: Chemoradiation Of Locally Advanced Gastric Cancer: Establishmentioning

confidence: 99%

Chemoradiation for gastric cancer: controversies, updates and novel techniques

Fan

Zhang

2015

BJR

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The INT0116 trial established the role of adjuvant chemoradiation (CRT) in the multidisciplinary approach to the management of locally advanced gastric cancer. However, whether adjuvant CRT is indispensable for patients undergoing D2 dissection remains undefined. The adjuvant chemoradiation therapy in stomach cancer (ARTIST) trial, which was designed to compare adjuvant chemotherapy to CRT, failed to demonstrate differences in disease-free and overall survival in the whole study group; however, subgroup analysis indicated that patients with lymph node metastasis may benefit from additional radiation. A follow-up ARTIST II trial is currently under way. The efficacy of adjuvant CRT remains controversial because of variation among studies in the inclusion criteria and treatment delivery methods; however, the identification of patients who would benefit from CRT is critical. Advanced radiotherapy techniques such as intensity-modulated radiotherapy protect normal tissues via motion management and decreased radiation-induced toxicity and contribute to plan optimization. Further studies integrating clinical and molecular factors as well as neoadjuvant CRT are warranted.Gastric cancer is one of the most frequent malignancies. It is the fifth most common malignancy and the third leading cause of cancer-related death in the world.

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Phase 3 Trial of Postoperative Chemotherapy Alone Versus Chemoradiation Therapy in Stage III-IV Gastric Cancer Treated With R0 Gastrectomy and D2 Lymph Node Dissection

Cited by 89 publications

References 17 publications

Chemoradiation Therapy versus Chemotherapy Alone for Gastric Cancer after R0 Surgical Resection: A Meta-Analysis of Randomized Trials

Chemoradiation Therapy versus Chemotherapy Alone for Gastric Cancer after R0 Surgical Resection: A Meta-Analysis of Randomized Trials

A phase II trial of concurrent 3D-CRT/IMRT and oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX) in gastric cancer patients with R0 gastrectomy and D2 lymph node dissection

Chemoradiation for gastric cancer: controversies, updates and novel techniques

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