633P - Efficacy and safety of dose-dense taxotere cisplatin fluorouracil regimen (mTCF-dd) in a large cohort of patients (pts) with metastatic or locally...

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Oesophageal Cancer
Presenter Laura Toppo
Citation Annals of Oncology (2016) 27 (6): 207-242. 10.1093/annonc/mdw371
Authors L. Toppo1, G. Tomasello1, M. Ghidini1, C. Caminiti2, G. Maglietta2, S. Lazzarelli1, W. Liguigli1, M. Rovatti3, V. Ranieri3, G. Tanzi4, F. Buffoli5, M. Martinotti3, R. Passalacqua1
  • 1Division Of Oncology, ASST CREMONA, 26100 - Cremona/IT
  • 2Unità Ricerca Ed Innovazione, Azienda Ospedaliera di Parma, Parma/IT
  • 3Surgery Unit, ASST CREMONA, Cremona/IT
  • 4Oncology, ASST CREMONA, Cremona/IT
  • 5Endoscopic Unit, ASST CREMONA, Cremona/IT

Abstract

Background

TCF is one of the most effective first-line options in metastatic GEC. We previously reported the significant activity of mTCF-dd (Tomasello G et al: Gastric Cancer 2014 Oct;17(4):711-7). Aim of this study is to describe clinical outcomes, safety and studying potential clinical prognostic factors of this intensified regimen in a very large consecutive cohort of pts coming from a single center

Methods

201 consecutive pts with measurable or evaluable GEC treated in the same

institution were longitudinally followed. 136 were enrolled in 3 different Clinical Trials and 65 treated according to clinical practice. We considered pts with PS ECOG 0-2 and adequate organ function who received from 2004 to 2015 mTCF-dd: Docetaxel (50-85 mg/m2 d 1), Cisplatin (50-75 mg/m2 d 1),l-Folinic Acid (100 mg/m2 d 1-2), 5-FU (400 mg/m2 bolus d 1-2, and 600 mg/m2 as a 44 h c.i. d 1), plus Pegfilgrastim 6 mg d 3, q2w. Analysis was done according to ITT principle.

Results

Median age was 63 (range 25-81), M:F 140:51. Metastatic sites were: liver 38%, peritoneum 33.5%, bone 14%, lung 12%. A median of 4 cycles (range 1-8) per patient were administered: 15% required a dose reduction, 48% were treated without any delay. At a median follow up of 60 months, 192 pts were evaluable. We observed 6% CR, 52% PR, 14% SD, 13% PD and 13% NE, for an ORR of 59% (95% CI 52-66); DCR was 76%. Median OS was 11.1 months (95% CI 9.5-13.5). Most frequent grade 3/4 toxicities: neutropenia (26%), asthenia (31%), thrombocytopenia (17%), hypokalemia (16%), diarrhea (13%), febrile neutropenia (11%). 18 pts (9%) became resectable after mTCF-dd and underwent surgery. Finally, we identified 18 pts (9%) [12 metastatic, 6 locally advanced] with OS > 3 years and 7 (4%) still maintaining a response at the time of the current analysis.Moreover, we identifued a specific cohort of 21 pts with bone metastases at diagnosis bearing a very poor prognosis (OS: 7.8 m 95% CI 3.8-10 ). A multivariate Cox model will be presented at the meeting.

Conclusions

mTCF-dd in GEC is an effective and feasible option. A careful monitoring of adverse events is recommended. A biomolecular analysis of long-term survivors is underway.

Clinical trial identification

The clinical trials were promoted as GOIRC (GRUPPO ONCOLOGICO DI RICERCA ITALIANO- GOIRC 01/2009)

Legal entity responsible for the study

Azienda Socio Sanitaria di Cremona

Funding

MEDEA ONLUS

Disclosure

R. Passalacqua: Member of Scientific Boards: Amgen, Lilly, Pfizer, Novartis. All other authors have declared no conflicts of interest.