Cancer Res Treat.  2019 Jan;51(1):1-11. 10.4143/crt.2018.028.

S-1 Based Doublet as an Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer: Results from the Randomized Phase III POST Trial

• Lee CK
• Jung M
• Kim HS
• Jung I
• Shin DB
• Kang SY
• Zang DY
• Kim KH
• Lee MH
• Kim BS
• Lee KH
• Cheong JH
• Hyung WJ
• Noh SH
• Chung HC
• Rha SY

• KMID: 2437593
• DOI: http://doi.org/10.4143/crt.2018.028

Abstract

PURPOSE
We conducted a randomized, multicenter, phase III trial to compare S-1 plus docetaxel (DS) with S-1 plus cisplatin (SP) as adjuvant chemotherapy for stage III gastric cancer patients.
MATERIALS AND METHODS
Stage III gastric cancer patients who had received curative gastrectomy with D2 lymphadenectomy were randomized into equal groups to receive adjuvant chemotherapy of eight cycles of DS (S-1 70 mg/m2/day on days 1-14 plus docetaxel 35 mg/m2on days 1 and 8) every 3 weeks or SP (S-1 70 mg/m2/day on days 1-14 plus cisplatin 60 mg/m2on day 1) every 3 weeks. The primary endpoint was 3-year disease-free survival (DFS) rate.
RESULTS
Between November 2010 and July 2013, 153 patients (75 patients to DS and 78 patients to SP) were enrolled from 8 institutions in Korea. After the capecitabine plus oxaliplatin was approved based on the CLASSIC study, itwas decided to close the study early. With a median follow-up duration of 56.9 months, the 3-year DFS rate between two groups was not significantly different (49.14% in DS group vs. 52.5% in SP group). The most common grade 3-4 adverse event was neutropenia (42.7% in DS and 38.5% in SP, p=0.351). SP group had more grade 3-4 anemia (1.3% vs. 11.5%, p=0.037), whereas grade 3-4 hand-foot syndrome (4.1% vs. 0%, p=0.025) and mucositis (10.7% vs. 2.6%, p=0.001) were more common in DS group. Fifty-one patients (68%) in DS group and 52 (66.7%) in SP group finished planned treatment.
CONCLUSION
Our findings suggest that SP or DS is an effective and tolerable option for patients with curatively resected stage III gastric cancer.

Keyword

Stomach neoplasms; Stage III; S-1 based doublet; Docetaxel; Cisplatin; Adjuvant chemotherapy

MeSH Terms

Anemia
Capecitabine
Chemotherapy, Adjuvant*
Cisplatin
Disease-Free Survival
Follow-Up Studies
Gastrectomy
Hand-Foot Syndrome
Humans
Korea
Lymph Node Excision
Mucositis
Neutropenia
Stomach Neoplasms*
Capecitabine
Cisplatin

Figure

• 

  Fig. 1. Median relative dose intensities per regimen and cycle. Median relative dose intensities (RDIs) of S-1 in both groups (A) and RDIs of docetaxel in docetaxel plus S-1 (DS) group or cisplatin in S-1 plus cisplatin (SP) group (B).

• 

  Fig. 2. Kaplan-Meier curves of disease-free survival (A) and overall survival (B) in the intention-to-treat population.

Reference

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