693P - Efficacy and safety of dose-dense chemotherapy with modified TCF regimen (TCF-DD) in elderly patients with metastatic gastric cancer (mGC)

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Cytotoxic agents
Gastric Cancer
Geriatric Oncology
Therapy
Biological therapy
Presenter Gianluca Tomasello
Authors G. Tomasello1, W. Liguigli1, S. Lazzarelli1, R. Poli1, F.M. Negri2, L. Toppo1, M. Brighenti1, M. Ratti1, F. Gerevini1, R. Passalacqua3
  • 1Oncology Division, Istituti Ospitalieri di Cremona, 26100 - Cremona/IT
  • 2Oncology, Istituti Ospitalieri di Cremona, 26100 - Cremona/IT
  • 3Division Of Oncology, Istituti Ospitalieri di Cremona, 26100 - Cremona/IT

Abstract

Background

GC is more common in elderly patients (pts). Most oncologists are reluctant to treat this pts population with the most active poli-chemotherapy combinations because of safety concerns. Subgroup analysis of elderly pts enrolled in European studies show limited and conflicting data. We previously reported on the feasibility and high activity of a dose-dense TCF regimen (TCF-dd) (Tomasello 2010). This study aims to evaluate the efficacy and safety of this schema in the elderly pts subgroup (≥ 65 years).

Methods

From 11/04 to 05/12, 111 consecutive pts with MGC (median age 65, range 31-81) were enrolled in a single-centre phase II study. Pts received Docetaxel 70 mg/m2 d1, CDDP 60 mg/m2 d1, l-AF 100 mg/m2 d1-2 followed by 5-FU 400 mg/m2 bolus d1-2, and then 600 mg/m2 as a 22h c.i. d1-2, q2w, plus G-CSF d3. Pts ≥ 65y (56) received the same schedule reduced by 30%.

Results

96 pts evaluable for response and all for toxicity. In pts ≥ 65y we observed 4 CR (7%) 25 PR (45%) 10 SD (18%) 7 PD (13%); in younger pts: 2 CR (4%) 30 PR (55%) 9 SD (16%) 9 PD (17%); ORR by ITT 56% (95% IC 45-64). Median OS was 11.9 months (9,4-14,8); in elderly and younger pts 11,2 (8,4-11,1) and 12,7 (9-16,5) respectively. Out of 48 evaluable pts ≥ 65y, 26 (54%) were treated at full doses without any delay. In the elderly most frequent G3-4 toxicities were neutropenia (14%) thrombocytopenia (15%) febrile neutropenia (7%) asthenia (27%) and hypokalemia (17%); in the younger: neutropenia (56%) thrombocytopenia (21%) febrile neutropenia (16%) asthenia (43%) hypokalemia (21%).

Conclusions

This study shows that elderly pts can be treated with a TCF-dd regimen reduced by 30% achieving similar efficacy results of younger patients with lesser toxicity.

Disclosure

All authors have declared no conflicts of interest.