Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

eUpdate – Gastric Cancer Treatment Recommendations

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

  1. 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.
  2. 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.
  3. 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.
  4. Cherny NI, Dafni U, Bogaerts J et al. ESMO-Magnitude of Clinical Benefit Scale Version 1.1. Ann Oncol 2017; 28: 2340–2366.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings