ABSTRACT
Background: Neoadjuvant chemoradiotherapy with CROSS-protocol is the standard of care for locally advanced esophageal cancer. The purpose of this study was to demonstrate an improvement in complete pathological response (ypCR) after a dose-escalation neoadjuvant protocol compared to standard treatment. Secondary endpoints were disease-free survival (DFS) and acute gastrointestinal toxicity. Material and methods: We prospectively evaluated patients with locally advanced esophageal adenocarcinoma who received neoadjuvant chemoradiotherapy. The radiation dose was 41.4 Gy in 23 fractions or 50.4 Gy in 28 fractions with weekly administration of six intravenous cycles of carboplatin AUC 2 mg/mL and intravenous paclitaxel 50 mg/m2 followed by surgery. Results: Between December 2015 and July 2020, 21 patients were treated according to the reported radiation schedules. Median age was 61 years (57-67). 20 (95.2%) tumors were located at the esophagogastric junction and 1 (4.8%) in the middle esophagus. Five (23.8%) were stage II and 16 (76.2%) stage III. Twelve (57.1%) patients received 41.4 Gy (standard group) and 9 (42.9%) received 50.4 Gy (intensification group), with 5 (41.67%) and 5 (55.6%) presenting ypCR in the standard and intensification group, respectively (p = 0.67). After a median follow-up of 17 months (8-30), DFS in the standard group was 17.78 months [95% (CI, confidence interval): 12.9-22.6] and 45.5 months (95% CI: 24.4-66.05) in the intensification group (p = 0.299). Grade III acute gastrointestinal toxicity was 16% and 33.33%, respectively (p = 0.552). Postoperative toxicity events ≥ Grade III were 5 (41.7%) and 4 (44.4%), respectively (p = 0.623). Conclusions: In our study we found a trend towards a higher complete pathological response-rate and disease-free survival in the intensification group compared to the standard group, with no differences in gastrointestinal toxicity. Well-designed randomized and controlled trials are needed to obtain conclusive data.
ABSTRACT
INTRODUCTION: neoadjuvant chemotherapy (NACT) followed by radical surgery is the optimal approach for locally advanced gastric cancer (GC). Interval timing to surgery after NACT in GC is controversial. The aim of this study was to evaluate the impact of NACT interval time on tumor response and overall survival. MATERIAL AND METHODS: a retrospective analysis from a prospective database was performed at a single referral tertiary hospital, from January 2010 to October 2018. Patients were assigned to three groups according to the surgical interval time after NACT: < 4 weeks, 4-6 weeks and > 6 weeks. Univariate and multivariable analyses were performed in order to clarify the impact of NACT on post-neoadjuvant pathological complete response rate (ypCR), downstaging (DS) and overall survival (OS). RESULTS: of the 60 patients analyzed, 18 patients (30 %) had an interval time to surgery < 4 weeks, 26 (43.3 %) between 4-6 weeks and 16 (26.7 %) > 6 weeks. Two patients (3 %) had achieved ypCR and 37 patients (62 %) had achieved DS. There were no differences in DS rates among the interval time groups (p: 0.66). According to the multivariate analysis, only poorly differentiated carcinoma was significantly related to lower DS rates (p: 0.04). Cox regression analysis showed that the NACT interval time had no impact on OS. According to the multivariate analysis, > 25 lymph node harvested (HR: 0.35) and female sex (HR: 5.67) were OS independent predictors. CONCLUSIONS: the NACT interval time prior gastrectomy for locally advanced GC is not associated with ypCR or DS and has no impact on overall survival.
Subject(s)
Neoadjuvant Therapy , Stomach Neoplasms , Female , Gastrectomy , Humans , Neoplasm Staging , Retrospective Studies , Stomach Neoplasms/drug therapy , Stomach Neoplasms/surgeryABSTRACT
INTRODUCTION: neoadjuvant chemotherapy (NACT) followed by radical surgery is the optimal approach for locally advanced gastric cancer (GC). Interval timing to surgery after NACT in GC is controversial. The aim of this study was to evaluate the impact of NACT interval time on tumor response and overall survival. MATERIAL AND METHODS: a retrospective analysis from a prospective database was performed at a single referral tertiary hospital, from January 2010 to October 2018. Patients were assigned to three groups according to the surgical interval time after NACT: < 4 weeks, 4-6 weeks and > 6 weeks. Univariate and multivariable analyses were performed in order to clarify the impact of NACT on post-neoadjuvant pathological complete response rate (ypCR), downstaging (DS) and overall survival (OS). RESULTS: of the 60 patients analyzed, 18 patients (30 %) had an interval time to surgery < 4 weeks, 26 (43.3 %) between 4-6 weeks and 16 (26.7 %) > 6 weeks. Two patients (3 %) had achieved ypCR and 37 patients (62 %) had achieved DS. There were no differences in DS rates among the interval time groups (p: 0.66). According to the multivariate analysis, only poorly differentiated carcinoma was significantly related to lower DS rates (p: 0.04). Cox regression analysis showed that the NACT interval time had no impact on OS. According to the multivariate analysis, > 25 lymph node harvested (HR: 0.35) and female sex (HR: 5.67) were OS independent predictors. CONCLUSIONS: the NACT interval time prior gastrectomy for locally advanced GC is not associated with ypCR or DS and has no impact on overall survival
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