Feasibility of preoperative and postoperative chemoradiotherapy in gastric adenocarcinoma. Two phase II studies done in parallel. F茅d茅ration Francophone de Canc茅rologie Digestive 0308

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• 作者：Pierre Michel^a ; ^{Pierre.michel@chu-rouen.fr" class="auth_mail} ; Gilles Breysacher^b ; Franç ; oise Mornex^c ; Jean Franç ; ois Seitz^d ; Denis Pere-Verge^e ; Isabelle Martel-Lafay^f ; Roger Faroux^g ; Sophie Chapet^h ; Iradj Sobhaniⁱ ; Denis Pezet^j ; Thomas Aparicio^k ; Suzanne Nguyen^l ; Bertrand Dousset^m ; Jean-Louis Jouveⁿ ; Emilie Maillard^o
• 关键词：Gastric cancer ; Chemo radiotherapy ; Adjuvant treatment
• 刊名：European Journal of Cancer
• 出版年：April, 2014
• 年：2014
• 卷：50
• 期：6
• 页码：1076-1083
• 全文大小：439 K

文摘

Background

For resectable gastric cancer, both postoperative chemoradiotherapy and perioperative chemotherapy demonstrate high-level evidence for improved survival in Western populations. To evaluate the feasibility of pre- or postoperative chemoradiotherapy, we proposed two multicentre phase II studies.

Patients and methods

Patients with localised, histologically confirmed gastric cancer and Eastern Cooperative Oncology Group (ECOG) performance status <2 judged suitable for curative resection were eligible. Eligible patients were assigned to either preoperative chemoradiotherapy followed by surgical resection or surgical resection followed by chemoradiotherapy depending on each centre. Chemoradiotherapy regimen included four courses of FOLFIRI (5 Fluorouracil, Leucovorin, Irinotecan) regimen then Concurrent fluorouracil at 200 mg/m²/d by continuous infusion 5 days each week. A dose of 50 Gy in 25 fractions in the preoperative study, or 45 Gy in 25 fractions in the postoperative study, was delivered. The primary end-point for both studies was the proportion of patients, who completed the therapeutic sequence.

Results

Between September 2007 and January 2010, 63 patients were included in both studies. The postoperative study was stopped for futility at the first step. In the preoperative study, 31 patients (73.8%, confidence interval (CI) 95%: 65.8-90.1%) received complete therapeutic sequence. Serum albumin and dietary restriction evaluated by QLQ-STO22 (Quality of Life-Stomach module) score were significantly linked with chemoradiotherapy feasibility in univariate analysis with respectively Odds-ratio (OR) 1.16 [CI 95%: 1.01-1.33] and 0.17 [0.03-0.89], p = 0.04. Median overall survival time was 26.4 months in the preoperative study.

Conclusion

Feasibility of chemoradiotherapy was not achieved for these studies: 73.8% (CI 95%: 65.8-90.1) and 42.9% (CI 95%: 21.8-66%) in preoperative and postoperative settings respectively.