The purpose of this study is to evaluate whether the R0 rate, pathological response degree, patterns of recurrence and long-term outcomes may be initially predicted in patients with locally advanced gastroesophageal junction and gastric cancer treated with a neoadjuvant approach and salvage surgery.
Patients with locally advanced gastroesophageal junction and gastric cancer with T3-4 and/or N+ are included. Initially, patients are diagnosed by computerized tomography scan and endoscopic ultrasound. The neoadjuvant strategy consisted of 3-4 cycles of preoperative chemotherapy (group A) or 3-4 courses of induction chemotherapy followed by concurrent chemoradiotherapy (group B). Chemoradiotherapy comprised weekly chemotherapy concurrently with daily external beam radiotherapy up to 45 Gy). Surgery is scheduled 4 to 6 weeks after the end of CRT. Pathological response is graded according to the Becker criteria. Statistical analysis is performed IBM SPSS v20. Nonlinear mixed effects (NLME) modelling is applied to evaluate the impact of dynamic changes in tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR) on the clinical outcome of these patients.
Study Type
OBSERVATIONAL
Enrollment
121
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Overall Survival
Overall survival was defined as the period from diagnosis until death (from any cause). Nonlinear mixed effects population modelling to evaluate the impact in clinical outcome of dynamic markers as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR).
Time frame: From date of diagnosis until death, assessed up to 10 years
Disease Free Survival
DFS was defined as the time from diagnosis to the first date of local or distant cancer. Nonlinear mixed effects population modelling to evaluate the impact in clinical outcome of dynamic markers as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR).
Time frame: From date of diagnosis until treatment failure, assessed up to 10 years
Pathological Response at the Time of Surgery
Specimen analysis according to TNM classification. Pathological complete response is defined as no invasive cancer cells in the surgical specimen.
Time frame: Weeks 10 to 28
R0 Resection rate at the Time of Surgery
The R0 resection rate after the neoadjuvant protocol. R0 is defined as a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.
Time frame: Weeks 10 to 28
Tumor Regression Grade at the Time of Surgery
Estimate of tumor regression grade at the time of surgery according to Becker Criteria: Grade 1a, No residual tumor; Grade 1b, \<10% residual tumor; Grade 2, 10-50% residual tumor; Grade 3, \>50% residual tumor.
Time frame: Weeks 10 to 28
Lymph nodes response at the Time of Surgery
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Participants were assessed for node-negative lymph nodes at the time of surgery according to TNM classification. Node-negative (pN0) participants had no regional lymph node metastasis.
Time frame: Weeks 10 to 28
Estimate of TN Change From Baseline to Surgery
Estimate of TN change due to neoadjuvant treatment is defined as the estimate of the evidence of downstaging between baseline and surgery
Time frame: Weeks 10 to 28