Overall survival results from a phase III trial of trifluridine/tipiracil versus placebo in patients with metastatic gastric cancer refractory to standard therapies (TAGS)

Tabernero, Josep; Shitara, Kohei; Dvorkin, Mikhail; Mansoor, Was; Arkenau, H-T.; Prokharau, Aliaksandr; Alsina, María; Ghidini, Michele; Faustino, C.; Gorbunova,; Zhavrid, Edvard; Nishikawa, Kazuhiro; Hosokawa, Ayumu; Ganea, Doina; Yalçın, Şuayib; Fujitani, Kazumasa; Beretta, Giordano D.; Winkler, R; Makris, Lukas; Doi, Toshihiko; Ilson, David H.

doi:10.1093/annonc/mdy208.001

Cited by 10 publications

(6 citation statements)

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“…Therefore, palliative third-line chemotherapy with cytotoxic agents (e.g., irinotecan, paclitaxel, or docetaxel) not used in second-line therapy can be recommended (moderate, strong for). Recently, a phase III study of patients with metastatic gastric cancer refractory to standard therapies showed a benefit in terms of OS with TAS-102 (trifluridine/tipiracil) compared to that for best supportive care [221]. TAS -102 can be considered if it is approved for use in gastric cancer (high, weak for).…”

Section: Palliative Therapymentioning

confidence: 99%

Korean Practice Guideline for Gastric Cancer 2018: an Evidence-based, Multi-disciplinary Approach

2019

J Gastric Cancer

335

210

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Section: Palliative Therapymentioning

confidence: 99%

Korean Practice Guideline for Gastric Cancer 2018: an Evidence-based, Multi-disciplinary Approach

2019

J Gastric Cancer

335

210

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“…Although phase III data are lacking, third-line chemotherapy is widely utilised in patients in whom previous lines have failed, especially in Asia [ 8 ]. In the TAGS study, trifluridine/tipiracil improved OS [5.7 versus 3.6 months; HR =0.69 (95% CI 0.56–0.85); P = 0.0003] compared with placebo as third-line or later therapy for advanced GC [ 9 ]. Currently, there are no standard, internationally recognised guidelines for third-line therapy for patients with advanced GC/GEJC, underscoring the need for effective therapies with acceptable safety profiles [ 5 , 6 , 8 , 10 ].…”

Section: Introductionmentioning

confidence: 99%

Phase III, randomised trial of avelumab versus physician’s choice of chemotherapy as third-line treatment of patients with advanced gastric or gastro-oesophageal junction cancer: primary analysis of JAVELIN Gastric 300

et al. 2018

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BackgroundThere currently are no internationally recognised treatment guidelines for patients with advanced gastric cancer/gastro-oesophageal junction cancer (GC/GEJC) in whom two prior lines of therapy have failed. The randomised, phase III JAVELIN Gastric 300 trial compared avelumab versus physician’s choice of chemotherapy as third-line therapy in patients with advanced GC/GEJC.Patients and methodsPatients with unresectable, recurrent, locally advanced, or metastatic GC/GEJC were recruited at 147 sites globally. All patients were randomised to receive either avelumab 10 mg/kg by intravenous infusion every 2 weeks or physician’s choice of chemotherapy (paclitaxel 80 mg/m2 on days 1, 8, and 15 or irinotecan 150 mg/m2 on days 1 and 15, each of a 4-week treatment cycle); patients ineligible for chemotherapy received best supportive care. The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety.ResultsA total of 371 patients were randomised. The trial did not meet its primary end point of improving OS {median, 4.6 versus 5.0 months; hazard ratio (HR)=1.1 [95% confidence interval (CI) 0.9–1.4]; P = 0.81} or the secondary end points of PFS [median, 1.4 versus 2.7 months; HR=1.73 (95% CI 1.4–2.2); P > 0.99] or ORR (2.2% versus 4.3%) in the avelumab versus chemotherapy arms, respectively. Treatment-related adverse events (TRAEs) of any grade occurred in 90 patients (48.9%) and 131 patients (74.0%) in the avelumab and chemotherapy arms, respectively. Grade ≥3 TRAEs occurred in 17 patients (9.2%) in the avelumab arm and in 56 patients (31.6%) in the chemotherapy arm.ConclusionsTreatment of patients with GC/GEJC with single-agent avelumab in the third-line setting did not result in an improvement in OS or PFS compared with chemotherapy. Avelumab showed a more manageable safety profile than chemotherapy.Trial registrationClinicalTrials.gov: NCT02625623.

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“…The TAGS study is a pivotal phase III study that investigated the efficacy and safety of TAS-102 (trifluridine/tipiraci or Lonsurf) plus best supportive care (BSC) compared with placebo plus BSC in patients with metastatic gastric cancer that was refractory to standard treatments. [21] TAS-102 provided a 31% reduction in the risk of death compared with placebo with median OS of 5.7 months compared with 3.6 months for placebo (HR, 0.69; P = 0.0003). Based on this study, the Food and Drug Administration has granted a priority review for TAS-102 for use in previously treated patients with advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction.…”

Section: Gastric and Esophageal Cancermentioning

confidence: 94%

Recent advances in the systemic treatment of gastrointestinal malignancy

Paluri

Jacob

Kasi

2019

Indian J Med Paediatr Oncol

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In the following article, practice changing updates on gastrointestinal cancers management have been discussed. For metastatic colorectal cancer with RAS wild-type, fluoropyrimidine plus panitumumab combination has been the preferred maintenance option for patients who have stopped oxaliplatin. The cytoreductive surgery alone showed satisfactory survival outcomes in colorectal cancer patients with peritoneal carcinomatosis. Dose escalation of regorafenib showed better clinical outcomes than the standard dosing regimen. Adjuvant FOLFIRINOX is the new treatment option for selected resected pancreatic cancer patients. Neoadjuvant treatment is the new paradigm for borderline and resectable pancreatic cancer patients. Several options for advanced hepatocellular cancers now available and more clinical studies are required for optimal treatment sequencing. Trifluridine/tipiracil showed improved overall survival in esophageal cancers beyond the second line.

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Overall survival results from a phase III trial of trifluridine/tipiracil versus placebo in patients with metastatic gastric cancer refractory to standard therapies (TAGS)

Cited by 10 publications

References 0 publications

Korean Practice Guideline for Gastric Cancer 2018: an Evidence-based, Multi-disciplinary Approach

Korean Practice Guideline for Gastric Cancer 2018: an Evidence-based, Multi-disciplinary Approach

Phase III, randomised trial of avelumab versus physician’s choice of chemotherapy as third-line treatment of patients with advanced gastric or gastro-oesophageal junction cancer: primary analysis of JAVELIN Gastric 300

Recent advances in the systemic treatment of gastrointestinal malignancy

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