Long-term outcomes of preoperative docetaxel with cisplatin plus S-1 therapy for gastric cancer with extensive nodal metastasis (JCOG1002).
Adenocarcinoma
/ drug therapy
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Cisplatin
/ administration & dosage
Docetaxel
/ administration & dosage
Drug Combinations
Female
Follow-Up Studies
Humans
Japan
Lymphatic Metastasis
Male
Middle Aged
Neoplasm Invasiveness
Oxonic Acid
/ administration & dosage
Preoperative Care
Prognosis
Stomach Neoplasms
/ drug therapy
Survival Rate
Tegafur
/ administration & dosage
Young Adult
DCS
Extensive lymph node metastasis
Gastric cancer
Preoperative chemotherapy
Journal
Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association
ISSN: 1436-3305
Titre abrégé: Gastric Cancer
Pays: Japan
ID NLM: 100886238
Informations de publication
Date de publication:
03 2020
03 2020
Historique:
received:
10
06
2019
accepted:
02
09
2019
pubmed:
14
9
2019
medline:
3
2
2021
entrez:
14
9
2019
Statut:
ppublish
Résumé
Preoperative chemotherapy with cisplatin plus S-1 (CS) followed by gastrectomy with D2 plus para-aortic lymph node (PAN) dissection is regarded as a standard treatment in Japan for advanced gastric cancer with bulky lymph node (BN) and/or PAN metastasis. In the JCOG1002, we added docetaxel to CS (DCS) to further improve long-term outcomes. However, the primary endpoint, clinical response rate (RR), did not reach the expected level (Ito et al. in Gastric Cancer 20:322-31, 2017). Herein, we report our long-term survival results. Patients with BN and/or PAN metastasis received 2 or 3 cycles of DCS therapy (docetaxel at 40 mg/m Between July 2011 and May 2013, 53 patients were enrolled. Clinically, 17.0% had both PAN and BN metastasis, and the rest had either PAN (26.4%) or BN (56.6%) metastasis. Among all eligible patients, the 5-year overall survival was 54.9% (95% confidence interval 40.3-67.3%) at the last follow-up in May 2018. Among 44 eligible patients with R0 resection, the 5-year relapse-free survival was 47.7% (95% confidence interval 32.5-61.5%). Adding docetaxel to CS in preoperative chemotherapy for extensive nodal metastasis improved neither short-term outcomes nor long-term survival. Preoperative chemotherapy with CS followed by D2 + PAN dissection and postoperative S-1 remains the standard of care for patients with extensive nodal metastasis.
Sections du résumé
BACKGROUND
Preoperative chemotherapy with cisplatin plus S-1 (CS) followed by gastrectomy with D2 plus para-aortic lymph node (PAN) dissection is regarded as a standard treatment in Japan for advanced gastric cancer with bulky lymph node (BN) and/or PAN metastasis. In the JCOG1002, we added docetaxel to CS (DCS) to further improve long-term outcomes. However, the primary endpoint, clinical response rate (RR), did not reach the expected level (Ito et al. in Gastric Cancer 20:322-31, 2017). Herein, we report our long-term survival results.
METHODS
Patients with BN and/or PAN metastasis received 2 or 3 cycles of DCS therapy (docetaxel at 40 mg/m
RESULTS
Between July 2011 and May 2013, 53 patients were enrolled. Clinically, 17.0% had both PAN and BN metastasis, and the rest had either PAN (26.4%) or BN (56.6%) metastasis. Among all eligible patients, the 5-year overall survival was 54.9% (95% confidence interval 40.3-67.3%) at the last follow-up in May 2018. Among 44 eligible patients with R0 resection, the 5-year relapse-free survival was 47.7% (95% confidence interval 32.5-61.5%).
CONCLUSIONS
Adding docetaxel to CS in preoperative chemotherapy for extensive nodal metastasis improved neither short-term outcomes nor long-term survival. Preoperative chemotherapy with CS followed by D2 + PAN dissection and postoperative S-1 remains the standard of care for patients with extensive nodal metastasis.
Identifiants
pubmed: 31515693
doi: 10.1007/s10120-019-01007-w
pii: 10.1007/s10120-019-01007-w
doi:
Substances chimiques
Drug Combinations
0
S 1 (combination)
150863-82-4
Tegafur
1548R74NSZ
Docetaxel
15H5577CQD
Oxonic Acid
5VT6420TIG
Cisplatin
Q20Q21Q62J
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
293-299Références
Park I, Kim S, Kim Y, Ryu K, Lee J, Lee J, et al. Clinical characteristics and treatment outcomes of gastric cancer patients with isolated para-aortic lymph node involvement. Cancer Chemother Pharmacol. 2011;67:127–36.
doi: 10.1007/s00280-010-1296-y
Yoshikawa T, Sasako M, Yamamoto S, Sano T, Imamura H, Fujitani K, et al. Phase II study of neoadjuvant chemotherapy and extended surgery for locally advanced gastric cancer. Br J Surg. 2009;96:1015–22.
doi: 10.1002/bjs.6665
Tsuburaya A, Mizusawa J, Tanaka Y, Fukushima N, Nashimoto A, Sasako M, et al. Neoadjuvant chemotherapy with S-1 and cisplatin followed by D2 gastrectomy with para-aortic lymph node dissection for gastric cancer with extensive lymph node metastasis. Br J Surg. 2014;101:653–60.
doi: 10.1002/bjs.9484
Ito S, Sano T, Mizusawa J, Takahari D, Katayama H, Katai H, et al. A phase II study of preoperative chemotherapy with docetaxel, cisplatin, and S-1 followed by gastrectomy with D2 plus para-aortic lymph node dissection for gastric cancer with extensive lymph node metastasis: JCOG1002. Gastric Cancer. 2017;20:322–31.
doi: 10.1007/s10120-016-0619-z
Therasse P, Arbuck S, Eisenhauer E, Wanders J, Kaplan R, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92:205–16.
doi: 10.1093/jnci/92.3.205
National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) v4.0. https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_40 . Accessed 9 June 2016.
Gastreic J. Japanese classification of gastric carcinoma. Gastric Cancer. 2011;14:101–12.
doi: 10.1007/s10120-011-0041-5
Koizumi W, Nakayama N, Tanabe S, Sasaki T, Higuchi K, Nishimura K, et al. A multicenter phase II study of combined chemotherapy with docetaxel, cisplatin, and S-1 in patients with unresectable or recurrent gastric cancer (KDOG 0601). Cancer Chemother Pharmacol. 2012;69:407–13.
doi: 10.1007/s00280-011-1701-1
Yamada Y, Boku N, Mizusawa J, Iwasa S, Kadowaki S, Nakayama N, et al. Docetaxel plus cisplatin and S-1 versus cisplatin and S-1 in patients with advanced gastric cancer (JCOG1013): an open-label, phase 3, randomised controlled trial. Lancet Gastroenterol Hepatol. 2019;4:501–10.
doi: 10.1016/S2468-1253(19)30083-4
Al-Batran S-E, Homann N, Pauligk C, Goetze T, Meiler J, Kasper S, et al. Perioperative chemotherapy with fluorouracil plus leucovorin, oxaliplatin, and docetaxel versus fluorouracil or capecitabine plus cisplatin and epirubicin for locally advanced, resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4): a randomised, phase 2/3 trial. Lancet. 2019;393:1948–57.
doi: 10.1016/S0140-6736(18)32557-1
Park I, Ryu M, Choi Y, Kang H, Yook J, Park Y, et al. A phase II study of neoadjuvant docetaxel, oxaliplatin, and S-1 (DOS) chemotherapy followed by surgery and adjuvant S-1 chemotherapy in potentially resectable gastric or gastroesophageal junction adenocarcinoma. Cancer Chemother Pharmacol. 2013;72:815–23.
doi: 10.1007/s00280-013-2257-z
Kang Y-K, Yook JH, Ryu M-H, Lee JS, Park Y, Chung I-J, et al. A randomized phase III study of neoadjuvant chemotherapy with docetaxel(D), oxaliplatin(O), and S-1(S) (DOS) followed by surgery and adjuvant S-1 vs. surgery and adjuvant S-1 for resectable advanced gastric cancer (PRODIGY). J Clin Oncol. 2015;33: (suppl; tps4136).
doi: 10.1200/jco.2015.33.15_suppl.tps4136
Yoshikawa T, Sakamaki K, Nishikawa K, Fujitani K, Tanabe K, Ito Y, et al. Primary results of a randomized two-by-two factorial phase II trial comparing neoadjuvant chemotherapy with two and four courses of cisplatin/S-1 (CS) and docetaxel/cisplatin/S-1 (DCS) as neoadjuvant chemotherapy for locally advanced gastric cancer. J Clin Oncol. 2019;37:(suppl 4; abstr 93).
doi: 10.1200/JCO.2019.37.4_suppl.93