eUpdate – Gastric Cancer Treatment Recommendations
Published: 4 November 2019. Authors: ESMO Guidelines Committee
Note: Other eUpdates have been published for these guidelines. All currently valid eUpdates can be accessed from the page displaying the full guidelines on this topic.
Clinical Practice Guidelines
This update refers to the Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Smyth EC, Verheij M, Allum W et al. Ann Oncol 2016; 27 (Suppl 5): v38–v49.
Section
Management of advanced/metastatic disease, second- and further-line treatment
Text update
This sentence:
“Treatment options may be used sequentially in second and third line, but there is no clear evidence for a benefit beyond second line treatment.”
Is replaced with:
In a phase III randomised trial of patients with chemorefractory gastric cancer (patient treated with at least two prior lines of chemotherapy), trifluridine/tipiracil improved overall survival (OS) compared to placebo {OS 5.7 versus 3.6 months hazard ratio (HR) 0.69 [95% confidence interval (CI) 0.56–0.85], two-sided P=0.00058}.
Recommendation:
Third-line chemotherapy with trifluridine/tipiracil is recommended for patients who are of PS 0–1 [I, A].
Section
ESMO-Magnitude of Clinical Benefit Scale (MCBS) table for new therapies in gastric cancer
The ESMO-MCBS table published in the eUpdate on Gastric Treatment Recommendations published on 6 May 2019 is updated to include a new line for trifluidine/tipiracil.
ESMO-Magnitude of Clinical Benefit Scale (MCBS) table for new therapies in gastric cancera
Therapy |
FLOT in locally advanced disease |
|---|---|
Disease setting |
Patients with resectable gastric or gastro-oesophageal junction adenocarcinoma who had clinical stage cT2 or higher, nodal positive (cN+) disease or both |
|
Trial |
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 [1, 2] NCT01216644 |
Phase |
III |
Control |
Epirubicin, cisplatin and fluorouracil or capecitabine Median OS: 35 months OS at 3 years: 48% |
Absolute survival gain |
Median OS gain: 15 months OS gain at 3 years: 9% |
HR (95% CI) |
OS HR: 0.77 (0.63–0.94) |
QoL/toxicity |
QoL not available AEs similar |
ESMO-MCBS scoreb |
A (Form 1) |
Therapy |
TAS-102 plus BSC versus placebo plus BSC in metastatic disease |
|---|---|
Disease setting |
Patients who have been treated with two prior lines of chemotherapy |
|
Trial |
Randomised, double-blind, phase 3 study evaluating TAS-102 plus BSC versus placebo plus BSC in patients with metastatic gastric cancer refractory to standard treatments [3] NCT02500043 |
Phase |
III |
Control |
Placebo OS: 3.6 months |
Absolute survival gain |
OS gain: 2.1 months |
HR (95% CI) |
OS HR: 0.69 (0.56-0.85) |
QoL/toxicity |
- |
ESMO-MCBS scoreb |
3 (Form 2a) |
aEMA approvals since January 2016, except docetaxel, oxaliplatin, fluorouracil and leucovorin (FLOT).
bESMO-MCBS version 1.1 [4]. The scores have been calculated by the ESMO-MCBS Working Group and validated by the ESMO Guidelines Committee.
AE, adverse event; BSC, best supportive care; CI, confidence interval; EMA, European Medicines Agency; ESMO-MCBS, ESMO-Magnitude of Clinical Benefit Scale; FLOT, 5-fluorouracil/leucovorin, oxaliplatin, docetaxel; HR, hazard ratio; OS, overall survival; QoL, quality of life; TAS, trifluridine/tipiracil.
References
- Al-Batran SE, Hofheinz RD, Pauligk C et al. Histopathological regression after neoadjuvant docetaxel, oxaliplatin, fluorouracil, and leucovorin versus epirubicin, cisplatin, and fluorouracil or capecitabine in patients with resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4-AIO): results from the phase 2 part of a multicentre, open-label, randomised phase 2/3 trial. Lancet Oncol 2016; 17: 1697–1708.
- Al-Batran SE, Homann N, Pauligk C 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: 1948–1195.
- Shitara K, Doi T, Dvorkin M et al. Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018;19(11): 1437–1448.
- Cherny NI, Dafni U, Bogaerts J et al. ESMO-Magnitude of Clinical Benefit Scale Version 1.1. Ann Oncol 2017; 28: 2340–2366.