Multicenter phase II study of peri-irradiation chemotherapy plus intensity-modulated radiotherapy with concurrent weekly docetaxel for inoperable or medically unresectable nonmetastatic gastric cancer
Mené en Chine sur 36 patients atteints d'un carcinome gastrique inopérable ou non résécable, cet essai multicentrique de phase II évalue la faisabilité et l'efficacité, du point de vue de la réponse clinique complète et des taux de survie à 2 ans, d'une chimioradiothérapie concomitante en combinaison avec une chimiothérapie par docétaxel-cisplatine-fluorouracile avant et après la radiothérapie
Purpose : To assess the efficacy and feasibility of concurrent chemoradiotherapy (CCRT) plus pre- and post-radiation chemotherapy for patients with non-metastatic gastric carcinoma who didn’t undergo surgery. Methods and Materials : Patients with inoperable (due to medical comorbid conditions or patient’s refusal to undergo surgery) or unresectable gastric cancer received up to 2 21-day cycles of pre- and post-radiation chemotherapy (docetaxel 37.5 mg/m2 on days 1 and 8, cisplatin 25 mg/m2 on days 1-3, and a continuous infusion of fluorouracil [FU] 750 mg/m2 on days 1-5), respectively. CCRT between pre- and post-radiation chemotherapy was initiated on day 43 and consisted of intensity-modulated radiotherapy (50.4 Gy) plus concurrent docetaxel 20 mg/m2 weekly for 6 weeks. Results : 36 patients were evaluable. 21 patients with comorbid conditions were unsuitable for surgery (group 1), 8 had unresectable disease (group 2), and 7 refused surgery (group 3). The clinical complete response (cCR) rate for the 36 evaluable patients was 36% (95% confidence interval [CI], 19-53%) and the overall response rate was 83% (95% CI, 75-97%). The median survival time and estimated 2- year survival rate were 25.8 months (95% CI, 7.1-44.5 months) and 52% (95% CI, 38-67%), respectively. The estimated median OSs and 2-year OS rates for the group 1, 2 and 3 were 37.0 months (95% CI, 7.9–66.1 months) and 52% (95% CI, 31-73%), 17.7 months (95% CI, 7.8–27.6 months) and 20% (95% CI, 0-49%), and 38.9 months (95% CI, 16..6–58.3 months) and 67% (95% CI, 30-100%), respectively. Achieving a cCR was associated with significantly better overall survival (P = 0.004) and progression-free survival (P = 0.003). The most common grade 3 or greater toxicity during the chemotherapy phase was neutropenia. Common grade 3/4 toxicities during CCRT were nausea and vomiting. Conclusions : This regimen is tolerable and shows promising efficacy in inoperable or medically unresectable G Gastric cancer; Chemoradiotherapy; Complete response; DCF; Docetaxel;