Abstract 5091
Background
S-1 has been shown to be an effective adjuvant treatment for East Asian patients who underwent gastrectomy with a D2 lymph-node dissection for stage II/III gastric cancer. We designed a phase I/II study to evaluate the efficacy, toxicity and feasibility of administering S-1 in the adjuvant setting after R0-Resection of adenocarcinoma of the stomach and esophagogastric junction in caucasian patients.
Methods
Eligible patients with histologically confirmed adenocarcinoma T2/T3/T4, any N category, M0 or any uT, N+, M0 of the stomach or esophago gastric junction had undergone R0-resection with or without neoadjuvant treatment and D2 lymph node dissection. They had performance status of ECOG 0-1 and adequate organ function. Treatment was orally administered S-1 (30mg/m² twice daily) for 14 days every three weeks for 18 cycles (54 weeks). A primary endpoint of the study is the determination of the recommended dose for S-1. Follow up will be continued until one year after last patient’s end of treatment.
Results
Between Oct 2015 and Feb 2018, 30 patients were enrolled in 12 German centres. Male/female ratio was 56.7%/43.3%, median age was 61.5 years. Of 30 patients included, 10 were diagnosed with gastric cancer, 20 with EGJ cancer (3 AEG I, 6 AEG II and 11 AEG III). Of 30 patients starting adjuvant therapy, 17 completed all 18 cycles, 2 patients had to terminate study treatment due to adverse events. Five patients terminated study treatment due to patients wish, 4 patients suffered a relapse or distant metastasis. Nine patients had to be reduced to dose level 25 mg/m², 1 patient had to be reduced to 20 mg/m². One patient was underdosed for the first 6 cycles and received full dosage from cycle 7. Of patients completing all 18 cycles, 5 had did so with reduced dosage of S-1. Documented grade ≥ 3 adverse events were neutropenia (n = 2), diarrhoea (n = 2), vomiting (n = 1), polyneuropathy (n = 1), palmar-plantar erythrodysaesthesia syndrome (n = 1) and rash (n = 1).
Conclusions
From this first analysis we can conclude that adjuvant treatment with S-1 for one year of patients suffering from gastric adenocarcinoma or EGJ cancer after R0-resection is a feasible and safe option for Caucasian patients.
Clinical trial identification
2014-004116-11.
Editorial acknowledgement
Legal entity responsible for the study
AIO-Studien-gGmbH, Berlin.
Funding
Funded by AIO-Studien-gGmbH, supported by Taiho Pharmaceutical Co., Ltd and Nordic Pharma Group.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
5472 - Early response evaluation and CEA response in patients treated in a Danish randomized study comparing trifluridine/tipiracil (TAS-102) with or without bevazicumab in patients with chemorefractory metastatic colorectal cancer (mCRC)
Presenter: Camilla Qvortrup
Session: Poster Display session 2
Resources:
Abstract
2037 - Updated survival analysis of the randomized phase III trial comparing S-1 versus capecitabine in the first-line treatment of metastatic colorectal cancer (SALTO) by the Dutch Colorectal Cancer Group.
Presenter: Johannes Kwakman
Session: Poster Display session 2
Resources:
Abstract
3053 - JFMC51-1702-C7: Phase II study investigating efficacy and safety of trifluridine/tipiracil (FTD/TPI) plus bevacizumab (BEV) in patients (pts) with metastatic colorectal cancer (mCRC) refractory or intolerant to standard chemotherapies.
Presenter: Keisuke Kazama
Session: Poster Display session 2
Resources:
Abstract
3183 - Bevacizumab plus trifluridine/tipiracil in elderly patients with previously untreated metastatic colorectal cancer (KSCC 1602): A single-arm, Phase 2 study
Presenter: Akitaka Makiyama
Session: Poster Display session 2
Resources:
Abstract
3233 - Biweekly TAS-102 and Bevacizumab as a Third-Line Chemotherapy for metastatic colorectal cancer: A Phase II Multicenter Clinical Trial (TAS-CC4 study)
Presenter: Yoichiro Yoshida
Session: Poster Display session 2
Resources:
Abstract
5907 - Liquid biopsy concordance based on clonality and timing of testing in patients with metastatic colorectal cancer
Presenter: Pashtoon Kasi
Session: Poster Display session 2
Resources:
Abstract
1866 - Plasma clearance of RAS mutation under therapeutic pressure is a rare event in metastatic colorectal cancer
Presenter: Emilie Moati
Session: Poster Display session 2
Resources:
Abstract
2312 - High Circulating miR-1247 is a marker for poor prognosis in patients with metastatic colorectal cancer treated with chemotherapy and cetuximab
Presenter: Jakob Schou
Session: Poster Display session 2
Resources:
Abstract
5602 - Clinical relevance of circulating tumor (ct)DNA genotyping for first line cetuximab-based treatment monitoring in metastatic colorectal cancer (mCRC): a prospective multicentric study
Presenter: JOANA Vidal Barrull
Session: Poster Display session 2
Resources:
Abstract
3182 - Clonal hematopoiesis mutations in plasma cfDNA RAS/BRAF genotyping of metastatic colorectal cancer
Presenter: Beili Wang
Session: Poster Display session 2
Resources:
Abstract