Phase III trial to compare capecitabine/cisplatin (XP) versus XP plus concurrent capecitabine-radiotherapy in gastric cancer (GC): The final report on the ARTIST trial.

Authors

null

Jeeyun Lee

Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea

Jeeyun Lee , Do Hoon Lim , Sung Kim , Se Hoon Park , Joon Oh Park , Ho Yeong Lim , Seung Tae Kim , Kyoung-Mee Kim , Won Ki Kang

Organizations

Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, Department of Surgery, Samsung Medical Center, Seoul, South Korea, Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, Department of Pathology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea

Research Funding

Other

Background: The adjuvant chemoradiation therapy in stomach cancer (ARTIST) trial is the first study to investigate the efficacy of postoperative chemoradiation therapy as adjuvant treatment in gastric cancer patients with curative resection and extended D2 lymph node dissection. In this study, we report on the final analysis of the disease free survival (DFS) and survival (OS). Methods: XP arm received six cycles of XP (capecitabine 2000 mg/m2 per day on days 1 to 14 and cisplatin 60 mg/m2 on day 1, repeated every 3 weeks) chemotherapy. XP/XRT/XP arm received two cycles of XP followed by 45 Gy radiotherapy (capecitabine 1650 mg/m2/d for 5 weeks) and two cycles of XP. Preplanned subgroup analyses on Lauren classification and lymph node status were performed. EGFR, HER2 and MET overexpression were studied in this patient cohort and correaltive analyses with DFS and OS were performed. Results: Of 458 patients, 228 patients were randomized to the XP arm and 230 patients were randomized to the XP/XRT/XP arm. At final analysis, the addition of radiotherapy to XP chemotherapy did not significantly prolong DFS (HR 1.352, 95% CI 0.952 - 1.922; P=0.0922). In the intestinal subtype, however, DFS on the XP/XRT/XP arm was significantly prolonged when compared with XP alone (HR 2.883, 95% CI, 1.36 - 6.111, P=0.0057). In contrast, the addition of RT to XP in diffuse type GC did not considerably prolong DFS (HR 1.161, 95% CI, 0.753-1.791; P=0.4985). In accordance with the results from the first report, the DFS was superior in XP/XRT/XP then XP alone in LN(+) group. Currently, biomarker analyses including HER1, HER2, MET are being carried out. The correlative analyses between these markers and DFS/OS will be presented. Conclusions: Overall, the ARTIST trial was a negative trial with no significant difference in DFS between XP alone and XP/XRT/XP. However, XP/XRT/XP significantly prolonged DFS in intestinal type by Lauren classification when compared to XP alone. After a longer follow up duration, XP/XRT/XP seemed to benefit LN(+) GC patients. Hence, a subsequent ARTIST-II (TS-1 alone, TS-1/oxaliplatin, TS-1/oxaliplatin/RT) is enrolling patients with pathologic LN(+) GC. Clinical trial information: 00323830.

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Abstract Details

Meeting

2014 ASCO Annual Meeting

Session Type

Oral Abstract Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Clinical Trial Registration Number

00323830

Citation

J Clin Oncol 32:5s, 2014 (suppl; abstr 4008)

DOI

10.1200/jco.2014.32.15_suppl.4008

Abstract #

4008

Abstract Disclosures