Phase III Trial to Compare Adjuvant Chemotherapy With Capecitabine and Cisplatin Versus Concurrent Chemoradiotherapy in Gastric Cancer: Final Report of the Adjuvant Chemoradiotherapy in Stomach Tumors Trial, Including Survival and Subset Analyses.

Abstract

PURPOSE:

The Adjuvant Chemoradiotherapy in Stomach Tumors (ARTIST) trial tested whether the addition of radiotherapy to adjuvant chemotherapy improved disease-free survival (DFS) in patients with D2-resected gastric cancer (GC).

PATIENTS AND METHODS:

Between November 2004 and April 2008, 458 patients with GC who received gastrectomy with D2 lymph node dissection were randomly assigned to either six cycles of adjuvant chemotherapy with capecitabine and cisplatin (XP) or to two cycles of XP followed by chemoradiotherapy and then two additional cycles of XP (XPRT). This final update contains the first publication of overall survival (OS), together with updated DFS and subset analyses.

RESULTS:

With 7 years of follow-up, DFS remained similar between treatment arms (hazard ratio [HR], 0.740; 95% CI, 0.520 to 1.050; P=.0922). OS also was similar (HR, 1.130; 95% CI, 0.775 to 1.647; P=.5272). The effect of the addition of radiotherapy on DFS and OS differed by Lauren classification (interaction P=.04 for DFS; interaction P=.03 for OS) and lymph node ratio (interaction P<.01 for DFS; interaction P<.01 for OS). Subgroup analyses also showed that chemoradiotherapy significantly improved DFS in patients with node-positive disease and with intestinal-type GC. There was a similar trend for DFS and OS by stage of disease.

CONCLUSION:

In D2-resected GC, both adjuvant chemotherapy and chemoradiotherapy are tolerated and equally beneficial in preventing relapse. Because results suggest a significant DFS effect of chemoradiotherapy in subsets of patients, the ARTIST 2 trial evaluating adjuvant chemotherapy and chemoradiotherapy in patients with node-positive, D2-resected GC is under way.

• Authors: Se Hoon Park, Tae Sung Sohn, Jeeyun Lee, Do Hoon Lim, Min Eui Hong, Kyoung-Mee Kim, Insuk Sohn, Sin Ho Jung, Min Gew Choi, Jun Ho Lee, Jae Moon Bae, Sung Kim, Seung Tae Kim, Joon Oh Park, Young Suk Park, Ho Yeong Lim, Won Ki Kang
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 33 Issue 28 Pg. 3130-6 (Oct 01 2015) ISSN: 1527-7755 [Electronic] United States
• PMID: 25559811 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 by American Society of Clinical Oncology.

Chemical References

• Capecitabine
• Cisplatin

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Capecitabine (adverse effects, therapeutic use)
• Chemoradiotherapy, Adjuvant (adverse effects, mortality)
• Chemotherapy, Adjuvant
• Cisplatin (adverse effects, therapeutic use)
• Disease-Free Survival
• Female
• Gastrectomy (adverse effects, mortality)
• Humans
• Kaplan-Meier Estimate
• Lymph Node Excision
• Male
• Middle Aged
• Neoplasm Staging
• Proportional Hazards Models
• Republic of Korea
• Stomach Neoplasms (mortality, pathology, therapy)
• Time Factors
• Treatment Outcome
• Young Adult