Phase III trial of adjuvant capecitabine/cisplatin (XP) versus capecitabine/cisplatin/RT (XPRT) in resected gastric cancer with D2 nodal dissection (ARTIST trial): Safety analysis

Abstract

4537 Background: Although the adjuvant chemoradiation therapy has gained popularity and has become the standard of care in patients with resected gastric cancer in U.S., the role of chemoradiation therapy after extended D2 dissection has been questioned. We conducted a phase III trial to compare capecitabine/cisplatin (XP) vs XP + radiotherapy (RT) in curatively D2 resected gastric cancer patients in terms of disease free survival and overall survival. Methods: Eligibility criteria were as follows: stage Ib (T1N1, T2bN0) - IV (M1 excluded), curatively ≥ D2 resected gastric adenocarcinoma. XP only: X 2,000 mg/m2/d D1∼14, CDDP 60 mg/m2 D1 repeated every 3 weeks, 6 cycles; XP + RT: X 2,000 mg/m2/d D1∼14, CDDP 60 mg/m2 D1 x 2 cycles ⋄ RT 45 Gy (25 fractions) + X 1,650 mg/m2/d during RT ⋄ X 2,000 mg/m2/d D1∼14, CDDP 60 mg/m2 D1 x 2 cycles. The primary endpoint is 3-year disease-free survival. Results: From October 2004 to April 2008, 458 patients (XP arm: 228 patients; XP/RT arm: 230 patients) were enrolled. In XP arm, 172 (75%) of 228 enrolled patients completed 6 cycles of chemotherapy. In XP + RT arm, 188 (82%) of 230 patients completed the full course of XP 2 cycles - X + RT - XP 2 cycles. Conclusions: Safety and feasibility analysis of the two arms will be reported at the meeting. No significant financial relationships to disclose.

Neo-adjuvant chemotherapy followed by surgery and chemotherapy or by surgery and chemoradiotherapy for patients with resectable gastric cancer (CRITICS)

“…Feasibility data of this study were reported at ASCO-GI 2009 showing good toxicity profiles with compliance rates of 75% versus 82% respectively. Survival data of this trial have to be awaited [ 37 ].…”

Shifting sands: the role of radiotherapy for patients with gastric and gastroesophageal adenocarcinoma

“…It further helps to contextualize the benefit of RT seen in INT-0116, and absence of benefit seen in ARTIST. Lastly, the treatment compliance was improved from INT-0116 to ARTIST, with 75% of the XP arm and 82% of the XPRT arm completing the prescribed adjuvant therapy (29,35). Together, ARTIST did not convincingly demonstrate a benefit of adjuvant RT to adjuvant XP-based chemotherapy in an unselected GAC population status post D2 dissection and R0 resection.…”

“…Three further large-scale RCTs have attempted to address this question: ARTIST, ARTIST-2, and CRITICS (29)(30)(31)(32)(33)(34). The ARTIST and ARTIST-2 trials, both conducted in South Korea, evaluated the role of adjuvant RT for patients status post D2 dissection and R0 resection, with planned adjuvant chemotherapy in both the control and experimental arms (29,31,33,35). In the ARTIST trial, patients were randomized postoperative to either 6 cycles of adjuvant capecitabine/cisplatin (XP; control arm), or XP with RT (XPRT; experimental arm) (29,35).…”

“…The ARTIST and ARTIST-2 trials, both conducted in South Korea, evaluated the role of adjuvant RT for patients status post D2 dissection and R0 resection, with planned adjuvant chemotherapy in both the control and experimental arms (29,31,33,35). In the ARTIST trial, patients were randomized postoperative to either 6 cycles of adjuvant capecitabine/cisplatin (XP; control arm), or XP with RT (XPRT; experimental arm) (29,35). For the XPRT arm, patients received 2 cycles of XP, followed by 45 Gy RT (in 25 daily fractions) concurrent with capecitabine (twicedaily 825 mg/m 2 ), and then 2 further cycles of XP (29).…”

Treatment of resectable gastric cancer

“…Feasibility data of this study were reported at ASCO-GI 2009 showing good toxicity profiles with compliance rates of 75% versus 82%, respectively. Survival data of this trial have to be awaited [Lee et al 2009]. With the low cure rates of the currently accepted therapies, several of the currently accruing Western trials focus on improved chemotherapy schedules: in the British MAGIC-B trial, bevacizumab is added to perioperative epirubicin, cisplatin, and capecitabine.…”