ANALYSIS OF SAFETY OF NEOADJUVANT CHEMORADIOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED GASTRIC CANCER (RESULTS OF A MULTICENTER RANDOMIZED TRIAL)

15074 Background: Adjuvant chemotherapy has demonstrated small but significant survival benefit in locally advanced gastric cancer in several meta-analyses, while adjuvant CITX showed improved outcome of patients (pts) compared to chemotherapy alone in a few trials. However, optimal chemotherapy regimen remains to be determined. We conducted a randomized trial comparing oral (PO) CITX with intravenous (IV) CITX in gastric cancer pts with curative resection. Methods: All enrolled pts underwent radical surgery with at least D2 dissection. After stratification for pathologic stage (IB or II vs. III) and primary tumor size (=5 cm vs. >5 cm), pts were randomized to IV CITX (5-FU 500 mg/m2 weekly for 24 weeks, MMC 8 mg/m2 every 6 weeks x 4) or PO CITX (UFT 400–600 mg/day for 12 months). Pts in both arms received PSK 3 g/day PO for 4 months. The planned target number of pts was 368 to prove the non-inferiority of PO CITX compared to IV CITX in overall survival. Results: A total of 82 pts (stage IB: 6, II: 29, IIIA: 30, IIIB: 17; 44 in IV arm, 38 in PO arm) were enrolled between May 2002 and October 2005, when the trial was closed due to poor accrual. Pts characteristics were well balanced. With a median follow-up of 39 months (14–55 months) in survivors, there were no significant differences in 3-year disease-free survival (82% vs. 61%, p=0.302) and overall survival (84% vs. 79%, p=0.838) between IV and PO arms. No grade 4 toxicity was observed in both arms. IV arm demonstrated higher incidence of grade 2 or 3 neutropenia (79% vs. 52%, p=0.025), thrombocytopenia (19% vs. 0%, p=0.008), and vomiting (36% vs. 9%, p=0.013). Conclusions: Although accrual was well below that planned, the results of this trial suggest that PO CITX with UFT might have similar efficacy with lower toxicity profile compared with 5-FU and MMC CITX in adjuvant treatment for gastric cancer. No significant financial relationships to disclose.

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A prospective randomized trial comparing 5-fluorouracil (5-FU), mitomycin-C (MMC), and polysaccharide-K (PSK) versus UFT and PSK as adjuvant chemoimmunotherapy (CITX) for patients with locally advanced gastric cancer with curative resection

Journal of Clinical Oncology ◽

10.1200/jco.2008.26.15_suppl.4581 ◽

2008 ◽

Vol 26 (15_suppl) ◽

pp. 4581-4581

Author(s):

H. Lee ◽

J. Choi ◽

S. Kang ◽

S. Jeong ◽

J. Jung ◽

...

Keyword(s):

Gastric Cancer ◽

Randomized Trial ◽

Advanced Gastric Cancer ◽

Mitomycin C ◽

Curative Resection ◽

Locally Advanced ◽

Prospective Randomized Trial ◽

Locally Advanced Gastric Cancer ◽

Polysaccharide K

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ANALYSIS OF HEMATOLOGIC, HEPATIC AND PANCREATIC TOXICITY DURING NEOADJUVANT CHEMORADIOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED GASTRIC CANCER

Siberian Journal of Oncology ◽

10.21294/1814-4861-2018-17-3-20-27 ◽

2018 ◽

Vol 17 (3) ◽

pp. 20-27 ◽

Cited By ~ 1

Author(s):

V. Yu. Skoropad ◽

D. D. Kudryavtsev ◽

E. N. Anikina ◽

M. V. Poluaktova ◽

L. N. Titova

Keyword(s):

Gastric Cancer ◽

Radiation Therapy ◽

Advanced Gastric Cancer ◽

Locally Advanced ◽

Neoadjuvant Chemoradiotherapy ◽

Subtotal Resection ◽

Combined Modality Treatment ◽

Symptomatic Therapy ◽

Locally Advanced Gastric Cancer ◽

Pancreatic Toxicity

Purpose.We analyzed the frequency and severity of hematologic, hepatic and pancreatic toxicity during and after completion of neoadjuvant chemoradiotherapy in patients with gastric cancer.Material and methods. Phase II clinical trial was conducted to evaluate the efficacy of the combined modality treatment including neoadjuvant chemoradiotherapy followed by D2 gastrectomy for patients with locally advanced gastric cancer. The main inclusion criteria were: histologically verified gastric cancer, cT3-4N0, cT2-4N1-3; M0. Before starting neoadjuvant therapy, all patients underwent thoracic and abdominal CT and laparoscopy to exclude peritoneal carcinomatosis. A total dose of radiation therapy was 45 Gy (1 + 1.5 Gy/fraction/day with a 4–5 hour interval) concurrently with the modified CAPOX chemotherapy regimen. Gastrectomy or subtotal resection of the stomach was planned 4-6 weeks after the completion of chemoradiotherapy. The toxicity assessment of neoadjuvant chemoradiotherapy was performed using the NCI CTC scale, version 3.0. The assessment of hematological, hepatic and pancreatic toxicities was done.Results.Among the toxicity during and after completion of neoadjuvant chemoradiotherapy, thrombocytopenia, neutropenia and leukopenia (grade 1–2) were the most common, requiring no additional symptomatic therapy. Radiation therapy was completed in 45 (98 %) patients. Chemotherapy was completed in 42 (91 %) patients. The median time between the completion of chemoradiotherapy and surgery was 44 days. Surgery following chemoradiotherapy was performed in 100 % of patients, including R0 resection in 93 % of patients.Conclusion.Preoperative chemoradiotherapy was well tolerated by patients, could be completed in most cases and did not prevent subsequent surgical treatment.

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PATHOLOGICAL COMPLETE RESPONSE TO NEOADJUVANT CHEMORADIOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED GASTRIC CANCER

Siberian Journal of Oncology ◽

10.21294/1814-4861-2020-19-3-38-46 ◽

2020 ◽

Vol 19 (3) ◽

pp. 38-46

Author(s):

V. Yu. Skoropad ◽

D. D. Kudriavtsev ◽

L. N. Titova ◽

S. A. Moserov ◽

T. A. Agababyan ◽

...

Keyword(s):

Gastric Cancer ◽

Advanced Gastric Cancer ◽

Tumor Regression ◽

Locally Advanced ◽

Survival Rates ◽

Neoadjuvant Chemoradiotherapy ◽

Complete Response ◽

Pathological Response ◽

Locally Advanced Gastric Cancer ◽

Long Term Treatment

The impact of pathological complete response (pCR) on long-term treatment outcomes was analyzed in patients with locally advanced gastric cancer, who received prolonged neoadjuvant chemoradiotherapy.Material and Methods. The study included 45 patients with locally advanced gastric cancer. Neoadjuvant hyperfractionated accelerated radiotherapy at a total dose of 45 Gy was given concurrently with capecitabine and oxaliplatin chemotherapy. There were more men than women. The median age of the patients was 62 years. Tumors were most commonly located in the upper (46 %) and middle (38 %) thirds of the stomach. Low-grade adenocarcinoma and signet-ring cell carcinoma were the most common (65 %). According to a comprehensive examination, including CT and laparoscopy, tumors which invaded the subserous layer of the stomach wall were diagnosed in 17 (37.8 %) patients, and tumors which penetrated the serous layer or surrounding structures were found in 28 (62.2 %) patients. Regional lymph node metastases were detected in 38 (84.4 %) cases.Results. The absolute majority of patients underwent gastrectomy (43 patients, 96 %). Grade IaIb pathological response occurred in almost half of the patients (45.4 % of cases). Peritoneal metastases were found to be the most common mode of cancer dissemination; they were mostly observed in patients with poorly differentiated gastric cancer. Multivariate analysis revealed no effect of any of the factors characterizing the patient, tumor and completeness of treatment on the pathological response grade. However, a correlation between the clinical and morphological assessments of tumor regression was observed. In cases with complete or partial responses of the primary tumor and regional lymph nodes to chemoradiotherapy, 1aIb grades of pathological response were more frequently observed. It was also demonstrated a direct correlation between the pathological response grade and pathomorphological stage of the tumor (yp), as well as ypT and ypN categories. Analysis of long-term treatment outcomes showed that the overall and relapse-free 5-year survival rates were significantly higher in patients with 1a and Ib grades of pathological response. The overall 3-year survival rates were 70 ± 10 % and 41 ± 11 %, respectively (p=0.003). Multivariate analysis using the Cox regression model confirmed a statistically significant independent effect of the pathological response grade on the overall survival (p=0.015).Conclusion. Grade IaIb pathological response was observed in almost half of the patients, who received neoadjuvant chemoradiotherapy for locally advanced gastric cancer. No clinical and morphological factors influencing the pathological response grade were found. A correlation between the clinical and morphological assessments of tumor regression was observed. Patients with Ia-Ib pathological response had significantly higher overall and disease-free survival rates.

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