gimeracil +oteracil +tegafur +folinic acid (TAS-118) / Otsuka - LARVOL DELTA

Perioperative TAS-118 plus oxaliplatin in patients with locally advanced gastric cancer: APOLLO-11 study. (PubMed, Gastric Cancer) - "Perioperative chemotherapy with TAS-118 plus oxaliplatin with D2 gastrectomy is feasible."

Journal • Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Feasibility and pathological response of TAS-118 + oxaliplatin as perioperative chemotherapy for patients with locally advanced gastric cancer (APOLLO-11). (ASCO-GI 2020) - P3; "Background: TAS-118 is a novel oral agent, containing S-1 and leucovorin. In the SOLAR study (NCT02322593), TAS-118 + oxaliplatin (OHP) significantly improved overall survival compared to S-1 + cisplatin for patients (pts) with advanced gastric cancer (GC)... Preoperative TAS-118 + OHP followed by D2 gastorectomy was well tolerated and showed promising efficacy. Clinical trial information: 000024688. Research Funding: Taiho"

Clinical

A feasibility study of TAS-118 plus oxaliplatin as perioperative chemotherapy for locally advanced gastric cancer (ESMO 2017) - P3; "In a phase II study, S-1 plus LV and oxaliplatin was more active than S-1 plus LV or S-1 plus cisplatin with acceptable toxicities for patients with advanced gastric cancer. Secondary endpoints include the treatment completion rate of chemotherapy and surgery, relative dose intensity, clinical and pathological response rates for preoperative chemotherapy, R0 resection rate, down staging rate, relapse free and overall survival, and safety. This IIT study is conducted in 3 sites in Japan and has initiated from November 2016."

Clinical • Gastric Cancer

Phase II trial of nafamostat mesilate/gemcitabin/S-1 for unresectable pancreatic cancer. (PubMed, PLoS One) - "NAM/GEM/S-1 therapy is safe and could be promising option for unresectable pancreatic cancer, especially for stage IV cancer."

Journal • P2 data • Allergy • Febrile Neutropenia • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor

A phase III study of TAS-118 plus oxaliplatin versus S-1 plus cisplatin as first-line chemotherapy in patients with advanced gastric cancer (SOLAR study) (ESMO-GI 2019) - P3; "TAS-118 is an oral drug containing S-1 that is a fluoropyrimidine preparation combining tegafur, a prodrug of 5-fluorouracil, gimeracil, and oteracil potassium, and leucovorin. Non-hematological toxicities of TAS-118 plus oxaliplatin were greater but manageable. TAS-118 plus oxaliplatin can be a new standard first-line chemotherapy for AGC."

Clinical • Late-breaking abstract • P3 data

[VIRTUAL] Feasibility study of TAS-118 plus oxaliplatin as perioperative chemotherapy for patients with locally advanced gastric cancer (APOLLO-11). (ASCO-GI 2021) - "Clinical trial information: UMIN000024688)Research Funding: Taiho and Yakult Background: TAS-118 (S-1 and leucovorin) + oxaliplatin (L-OHP) improved overall survival (OS) compared to S-1 + cisplatin for patients (pts) with advanced gastric cancer (GC) (Kang, Lancet Oncol. Taken together with the feasibility and efficacy of pre-op chemo, peri-op chemo with TAS-118 + L-OHP with D2 gastrectomy was well tolerated and showed promising efficacy."

Clinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

[VIRTUAL] Feasibility study of TAS-118 plus oxaliplatin as perioperative chemotherapy for patients with locally advanced gastric cancer (APOLLO-11). (ASCO-GI 2021) - "Clinical trial information: UMIN000024688)Research Funding: Taiho and Yakult Background: TAS-118 (S-1 and leucovorin) + oxaliplatin (L-OHP) improved overall survival (OS) compared to S-1 + cisplatin for patients (pts) with advanced gastric cancer (GC) (Kang, Lancet Oncol. Taken together with the feasibility and efficacy of pre-op chemo, peri-op chemo with TAS-118 + L-OHP with D2 gastrectomy was well tolerated and showed promising efficacy. ("

Clinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

"T3-4N1-3M0胃癌の周術期化学療法でTAS-118とオキサリプラチンの併用は実施可能で有望な効果【ASCO GI 2021】：がんナビ 胃がんで、より強力な周術期化学療法ができそうです。 #胃がん #GI21 https://t.co/7f3MIiA8b2" (@cancer_navi)

Gastrointestinal Cancer

S-1 plus leucovorin and oxaliplatin versus S-1 plus cisplatin as first-line therapy in patients with advanced gastric cancer (SOLAR): a randomised, open-label, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "TAS-118 plus oxaliplatin showed a clinically meaningful improvement in efficacy compared with S-1 plus cisplatin, and could be considered a new first-line treatment option for advanced gastric cancer in Asian patients."

Clinical • Journal • P3 data • Gastric Cancer • Gastrointestinal Cancer • Hematological Disorders • Infectious Disease • Neutropenia • Oncology • Pain • Pneumonia • Respiratory Diseases • Solid Tumor • Tuberculosis

TAS-118 plus oxaliplatin in advanced gastric cancer: is it worth it? (PubMed, Lancet Oncol) - No abstract available

Journal • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

SOLAR: Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer (clinicaltrials.gov) - P3; N=711; Completed; Sponsor: Taiho Pharmaceutical Co., Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

Upcoming first-line chemotherapy for HER2-negative gastric cancer in Japan: which patients benefit from immunotherapy? (PubMed, Future Oncol) - No abstract available

Clinical • Journal • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

S-1 plus leucovorin and oxaliplatin versus S-1 plus cisplatin as first-line therapy in patients with advanced gastric cancer (SOLAR): a randomised, open-label, phase 3 trial (Lancet Oncol) - P3, N=711; SOLAR (NCT02322593); Sponsor: Taiho Pharmaceutical Co., Ltd.; "11 untreated patients and 19 ineligible patients were excluded from the primary analysis (TAS-118 plus oxaliplatin group n=347, S-1 plus cisplatin group n=334) following recommendation from the independent data monitoring committee. After median follow-up of 26·0 months (IQR 22·0–32·8), median overall survival was 16·0 months (95% CI 13·8–18·3) in the TAS-118 plus oxaliplatin group and 15·1 months (95% CI 13·6–16·4) in the S-1 plus cisplatin group (hazard ratio 0·83, 95% CI 0·69–0·99; p=0·039)."

P3 data • Gastric Cancer • Gastrointestinal Cancer • Oncology

TAS-118 (S-1 plus leucovorin) versus S-1 in patients with gemcitabine-refractory advanced pancreatic cancer: a randomised, open-label, phase 3 study (GRAPE trial). (PubMed, Eur J Cancer) - "TAS-118 did not improve OS in patients with gemcitabine-refractory advanced pancreatic cancer compared to S-1. Further studies are needed to find patients who have benefit from adding leucovorin to S-1."

Clinical • Journal • P3 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

A phase III study of TAS-118 plus oxaliplatin versus S-1 plus cisplatin as first-line chemotherapy in patients with advanced gastric cancer (SOLAR study). (PubMed, Ann Oncol) - No abstract available

Clinical • Journal • P3 data

SOLAR: Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer (clinicaltrials.gov) - P3; N=686; Active, not recruiting; Sponsor: Taiho Pharmaceutical Co., Ltd.; Trial primary completion date: May 2020 ➔ Feb 2019

Clinical • Trial primary completion date

SOLAR: Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer (clinicaltrials.gov) - P3; N=686; Active, not recruiting; Sponsor: Taiho Pharmaceutical Co., Ltd.; Trial completion date: May 2019 ➔ May 2020; Trial primary completion date: May 2019 ➔ May 2020

Trial completion date • Trial primary completion date