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
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:56 |
|---|---|
| Enthalten in: |
Cancer research and treatment - 56(2024), 2 vom: 01. Apr., Seite 580-589 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Mineur, Laurent [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 15.04.2024 Date Revised 17.04.2024 published: Print-Electronic ClinicalTrials.gov: NCT01565109 Citation Status MEDLINE |
|---|
| doi: |
10.4143/crt.2023.812 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM363106626 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM363106626 | ||
| 003 | DE-627 | ||
| 005 | 20240417232221.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.4143/crt.2023.812 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1378.xml |
| 035 | |a (DE-627)NLM363106626 | ||
| 035 | |a (NLM)37817565 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Mineur, Laurent |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a 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 |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 15.04.2024 | ||
| 500 | |a Date Revised 17.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT01565109 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a CONCLUSION: Promising results from trials involving preoperative chemoradiation followed by surgery in gastric cancer need to be further evaluated in a phase III trial | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Chemoradiotherapy | |
| 650 | 4 | |a Neoadjuvant therapy | |
| 650 | 4 | |a Stomach neoplasms | |
| 650 | 4 | |a Survival | |
| 650 | 7 | |a Fluorouracil |2 NLM | |
| 650 | 7 | |a U3P01618RT |2 NLM | |
| 650 | 7 | |a Cisplatin |2 NLM | |
| 650 | 7 | |a Q20Q21Q62J |2 NLM | |
| 650 | 7 | |a Oxaliplatin |2 NLM | |
| 650 | 7 | |a 04ZR38536J |2 NLM | |
| 650 | 7 | |a Docetaxel |2 NLM | |
| 650 | 7 | |a 15H5577CQD |2 NLM | |
| 650 | 7 | |a Lenograstim |2 NLM | |
| 650 | 7 | |a 6WS4C399GB |2 NLM | |
| 700 | 1 | |a Plat, Frederi |e verfasserin |4 aut | |
| 700 | 1 | |a Desseigne, Françoise |e verfasserin |4 aut | |
| 700 | 1 | |a Deplanque, Gael |e verfasserin |4 aut | |
| 700 | 1 | |a Belkacemi, Mohamed |e verfasserin |4 aut | |
| 700 | 1 | |a Moureau-Zabotto, Laurence |e verfasserin |4 aut | |
| 700 | 1 | |a Beyrne, Carlos D |e verfasserin |4 aut | |
| 700 | 1 | |a Jalali, Khadija |e verfasserin |4 aut | |
| 700 | 1 | |a Obled, Stéphane |e verfasserin |4 aut | |
| 700 | 1 | |a Smith, Denis |e verfasserin |4 aut | |
| 700 | 1 | |a Vazquez, Léa |e verfasserin |4 aut | |
| 700 | 1 | |a Boustany, Rania |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Cancer research and treatment |d 2001 |g 56(2024), 2 vom: 01. Apr., Seite 580-589 |w (DE-627)NLM190743158 |x 2005-9256 |7 nnns |
| 773 | 1 | 8 | |g volume:56 |g year:2024 |g number:2 |g day:01 |g month:04 |g pages:580-589 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.4143/crt.2023.812 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 56 |j 2024 |e 2 |b 01 |c 04 |h 580-589 | ||