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Poster Display session 2

3755 - A new docetaxel (DOC)-based triplet regimen does not improve the outcome of metastatic (M) or locally advanced (LA) gastric cancer (GC) as compared with an epirubicin (EPI) standard triplet regimen: a GISCAD trial.

Date

29 Sep 2019

Session

Poster Display session 2

Topics

Tumour Site

Gastric Cancer

Presenters

Roberto Labianca

Citation

Annals of Oncology (2019) 30 (suppl_5): v253-v324. 10.1093/annonc/mdz247

Authors

R. Labianca1, G. Rosati2, N. Fazio3, L. Cavanna4, D. Ferrari5, M. Di Bartolomeo6, S. Mosconi7, M. Giordano8, N. Silvestris9, F. Artioli10, R.V. Iaffaioli11, E.A. Veltri12, D. Amoroso13, A. Ciarlo14, S. Barni15, S. Cascinu16, C. Davite17, A. Di Sanzo17, A. Casolaro17

Author affiliations

  • 1 Oncologia Medica, Azienda Ospedaliera Papa Giovanni XXIII, 24127 - Bergamo/IT
  • 2 Medical Oncology, A.O. S.Carlo, 85100 - Potenza/IT
  • 3 Unit Of Gastrointestinal Medical Oncology And Neuroendocrine Tumors, Istituto Europeo di Oncologia, 20141 - Milan/IT
  • 4 Oncology Department, Azienda Ospedaliera Piacenza, 29121 - Piacenza/IT
  • 5 Oncologia Medica, A. O. San Paolo, 20142 - Milano/IT
  • 6 Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, 20133 - Milan/IT
  • 7 Oncologia Medica, A.O. Papa Giovanni XXIII, 24127 - Bergamo/IT
  • 8 Oncologia Medica, Presidio Ospedaliero Ospedale Sant'Anna, 22100 - San Fermo della Battaglia/IT
  • 9 Medical Oncology Unit, Istituto Tumori Giovanni Paolo II, 70126 - Bari/IT
  • 10 Ausl Modena, Ospedale Ramazzini, 41015 - Carpi/IT
  • 11 Oncologia Medica, Istituto Nazionale Tumori - IRCCS - Fondazione Pascale, 80131 - Napoli/IT
  • 12 Medical Oncology, Ospedale Santa Maria Goretti, 04100 - Latina/IT
  • 13 Medical Oncology, Ospedale Versilia USL12, 55041 - Lido di Camaiore (LU)/IT
  • 14 Oncologia Medica, USL4 Ospedale di Prato, 59100 - Prato/IT
  • 15 Oncologia Medica, AO Treviglio-Caravaggio, 20047 - Treviglio (BG)/IT
  • 16 Oncology, Azienda Ospedaliero - Universitaria Policlinico di Modena, 41125 - Modena/IT
  • 17 Operative Office, Nerviano Medical Service, 20014 - Nerviano (MI)/IT

Resources

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Abstract 3755

Background

EOX (EPI + oxaliplatin-OHP + capecitabine-CAPE) is still one of the standard regimens for M or LA GC, but the role of EPI is today widely questioned and DOC replaced it in many institutions. A new DOC-based combination was developed with attempt at increasing efficacy/activity vs EOX without the heavy toxicity of the “classic” DOC regimen.

Methods

From 1/2013 to 11/2018, 169 previously untreated patients (pts) with M (87,6%) or LA GC were randomized by 23 centers between low-TOX (arm A) and EOX (arm B): Arm A: DOC: 35 mg/m2 iv, d 1 and 8 + OHP: 80 mg/m2 iv, d 1 + CAPE: 750 mg/ m2 x2 daily p.o. for 2 weeks Arm B: EPI: 50 mg/m2 iv, d 1 +OHP: 130 mg/m2 iv, d 1 +CAPE: 625 mg/m2 x2 daily p.o. for 3 weeks Both regimens recycled q 3 weeks If no PD or heavy toxicity, pts were programmed on therapy for a maximum of 5 (if CR) or 6 courses (if PR or SD). The primary endpoint was PFS, the secondary OS, ORR, DCR and tolerability. The study was designed to detect a 35% (80% power at a two side 5% significance level) PFS increase with low-TOX and an interim analysis for futility was planned after the first 127 events (75% of expected).

Results

At the cut-off date of interim analysis, 164 pts (median age 62 y; 63,9% male; ECOG PS: 0 in 75,7%) have available data for evaluation of primary efficacy analysis. The median PFS (KM) was 5.8 months (95% CI: 5.0 – 7.8) in arm A vs 6.5 months (95% CI: 5.0 – 8.9) in arm B, without statistical difference (NS). Also OS was comparable in the two arms: 12.2 (95% CI: 8.6 -16.0) vs 12.8 months (95% CI: 9.1-21.0). ORR were 22% and 35.4% and DCR 59.8% and 65.9%, respectively, again NS. The median number of courses per patient was 6 and treatment modification was higher in arm A (90,2% vs 78%) with a weakly higher number of AE with CTC ≥ 3 in arm A (54 vs 41).

Conclusions

These results indicate that, on the basis of the planned futility analysis, it is unlikely that low-TOX regimen is able to reach the target of improvement against EOX, both in efficacy/activity and in tolerability. Therefore, if the clinician’s choice is in favour of a triplet (i.e. in aggressive or very symptomatic disease), EOX could remain a standard option.

Clinical trial identification

NCT02076594.

Editorial acknowledgement

Legal entity responsible for the study

GISCAD.

Funding

Study carried out within the Rete Oncologica Lombarda-ROL project and founded as per the Deliberazioni di Giunta Regionale (DGR) di Regione Lombardia n° VIII/010761 dell’11-12-2009 e DGR IX/1485 del 30-03-2011”.

Disclosure

All authors have declared no conflicts of interest.

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