799P - Mvac vs platinum - gemcitabine (PG) in a risk-adapted policy of adjuvant chemotherapy (ACT) after radical cystectomy (C) in patients with invasive b...

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Urothelial Cancers
Presenter Jose A. Arranz Arija
Authors J.A. Arranz Arija1, R. Mondejar Solis2, M.P. López Martí1, P. Sabin Dominguez2, M.C. Lopez Lopez2, G. Tapia Rico2, B. Moya Ortega2, D. Urosa Velasco2, E. López Juarez2, R. González Beca2
  • 1Medical Oncology, HGU Gregorio mkarañón, 28007 - Madrid/ES
  • 2Medical Oncology, HGU Gregorio Marañón, 28007 - Madrid/ES

Abstract

Background

ACT for IBC is controversial and supported by underpowered randomized trials. Additional information from metanalysis or longitudinal studies can help to better define its role.

Patients and methods

From 1988 to 2011, patients (p) with IBC after C have been included in a risk-adapted institutional policy. After being informed of their particular risk of relapse, status of the art and toxicity of ACT, p with extravesical or N+ disease were recommended ACT although some of them chose follow-up. The opposite occurred with pT2N0 p. C and ACT cohorts were prospectively followed according to the standard clinical practice. ACT was associated with a reduction in the risk of relapse and death versus C, in patients with extravesical extension or N+ (JCO 29: 2011 suppl; abstr 4613). We present here the results of toxicity, progression-free survival (PFS), overall survival (OS) and cancer-specific survival (CSS) comparing MVAC vs PG in the cohort of p who received ACT.

Results

527 have been included, 331 C and 196 ACT: 90 MVAC x3, 90 CDDP-Gem x4, 16 Carbo-Gem x4 (106 PG). All PG were indicated after year 2000. Median follow-up was 86 m. MVAC vs PG were well balanced in sex (males 92% vs 86%), G3 (97% vs 96%), surgical complications (28% vs 26%), and %p who received full planned ACT (44% vs 52%). There were statistically significant differences in mean age (61 vs 67 y), non-papillary histology (71 vs 87%), and AJCC 2010 stage (T2N0/T3-4aN0/N + : 23%/30%/47% vs 10%/37%/53%). There were no toxic deaths. Main differences in G3-4 toxicities were anemia (11 vs 18%) neutropenia (42 vs 30%), trombopenia (5 vs 15%), emesis (12 vs 7%), and mucositis (8 vs 4%). There were no significant differences between MVAC and PG in crude PFS, OS or CSS. Table shows the Hazard Ratio (HR) of relapse and death stratified by pathological stage and adjusted by most relevant covariates in a multivariate Cox model (* p < 0.05).

PFS CSS OS
MVAC vs C Unadjusted 1.2 1.1 1
Multivariate pII Multivariate pIII Multivariate pIV 1 0.7 0.7
0.7 0.7 0.7
0.3 * 0.2 0.3 *
PG vs C Unadjusted 1.4 1.1 1
Multivariate pII Multivariate pIII Multivariate pIV 2.2 2.7 2.3
0.4 * 0.4* 0.4 *
0.4 * 0.4* 0.3 *
PG vs MVAC Unadjusted 1.1 1 1
Multivariate pII Multivariate pIII Multivariate pIV 1.6 1.6 1.7
0.7 0.8 0.9
1.2 0.9 0.8

Conclusion

In our series of IBC, comparison of MVACx3 vs PGx4 as ACT showed some differences in toxicity, but we could not find significant differences in efficacy between both schedules.

Disclosure

All authors have declared no conflicts of interest.