Cancer Res Treat.  2024 Apr;56(2):580-589. 10.4143/crt.2023.812.

NESC Multicenter Phase II Trial in the Preoperative Treatment of Gastric Adenocarcinoma with Chemotherapy (Docetaxel-Cisplatin-5FU+Lenograstim) Followed by Chemoradiation Based 5FU and Oxaliplatin and Surgery

• Mineur L
• Plat F
• Desseigne F
• Deplanque G
• Belkacemi M
• Moureau-Zabotto L
• Beyrne CD
• Jalali K
• Obled S
• Smith D
• Vazquez L
• Boustany R

• KMID: 2554347
• DOI: http://doi.org/10.4143/crt.2023.812

Abstract

Purpose
Preoperative chemoradiation (CRT) is expected to increase the rate of curative resection and complete histological response. In this trial, we investigated the efficacy of a neoadjuvant CRT regimen in gastric adenocarcinoma (NCT01565109 trial).
Materials and Methods
Patients with stage IB to IIIC gastric adenocarcinoma, endoscopy ultrasound and computed tomography–scan diagnosed, were eligible for this phase II trial. Neoadjuvant treatment consisted of 2 cycles of chemotherapy with DCF (docetaxel, cisplatin, and 5-fluorouracil [5FU]) followed by preoperative CRT with oxaliplatin, continuous 5FU and radiotherapy (45 Gy in 25 fractions of 1.8 Gy, 5 fractions per week for 5 weeks) administered before surgery. R0-resection rate, pathological complete response (pathCR) rate, and survival (progression-free survival [PFS] and overall survival [OS]) were evaluated as primary endpoints.
Results
Among 33 patients included, 32 patients (97%) received CRT and 26 (78.8%) were resected (R0 resection for all patients resected). Among resected patients, we report pathCR in 23,1% and pathologic major response (tumor regression grade 2 according to Mandard’s classification) in 26,9%. With a median follow-up duration of 5.82 years (range, 0.4 to 9.24 years), the estimated median OS for all 33 patients was not reached; 1-, 3-, and 5-year OS rates were 85%, 61%, and 52%, respectively. Among resected patients, those whose histological response was tumor grade regression (TRG) 1-2 had significantly better OS and PFS rates than those with a TRG 3-4-5 response (p=0.019 and p=0.016, respectively).
Conclusion
Promising results from trials involving preoperative chemoradiation followed by surgery in gastric cancer need to be further evaluated in a phase III trial.

Keyword

Chemoradiotherapy; Stomach neoplasms; Neoadjuvant therapy; Survival

Figure

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  Fig. 1. Study population. ITT, intention-to-treat; PP, per-protocol.

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  Fig. 2. Kaplan-Meier estimates survivals. CI, confidence interval.

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  Fig. 3. Kaplan-Meier plots of overall survival in the per-protocol–population: tumor grade regression (TRG) 1-2 vs. TRG 3-4-5. CI, confidence interval.

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  Fig. 4. Kaplan-Meier plots of progression-free survival in the per-protocol–population: tumor grade regression (TRG) 1-2 vs. TRG 3-4-5. CI, confidence interval.

Reference

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