493P - Secondary resectability rates observed in a multicenter randomized phase II study of modified capecitabine/irinotecan (mXELIRI) plus bevacizumab (b...

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Colon Cancer
Rectal Cancer
Presenter Werner Scheithauer
Citation Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370
Authors W. Scheithauer1, G. Prager1, R. Greil2, B. Mlineritsch2, R. Schaberl-Moser3, A. Gerger3, F. Längle4, I. Viragos-Toth4, J. Andel5, A. Pichler6, M. Pecherstorfer7, A. Kretschmer8, A. Seebacher9, B. Jagdt10, W. Eisterer11, P. Krippl12
  • 1Medicine I, Clin. Div. Of Oncology And Comprehensive Cancer Center, Medizinische Universitaet Wien (Medical University of Vienna), 1090 - Vienna/AT
  • 2Iiird Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute And Cancer Cluster, Paracelsus University Hospital Salzburg, 5020 - Salzburg/AT
  • 3Department Of Internal Medicine, Medical University Graz, 8036 - Graz/AT
  • 4General Surgery, Krankenhaus Wiener Neustadt, 2700 - Wiener Neustadt/AT
  • 52nd Medical Department, County Hospital Steyr, 4400 - Steyr/AT
  • 6Department Of Hematology/oncology, Landeskrankenhaus Hochsteiermark-Leoben, Leoben/AT
  • 7Karl Langsteiner University Of Health Sciences, University Hospital Krems, 3500 - Krems/AT
  • 8Interne Abteilung, Landesklinikum(LK) Waldviertel Waidhofen a.d.Thaya, 3830 - Waidhofen a.d.Thaya/AT
  • 93rd Medical Department, Hanusch Krankenhaus, Vienna/AT
  • 10Department Of Internal Medicine, Krankenhaus der Barmherzigen Schwestern Ried im Innkreis, 4910 - Ried im Innkreis/AT
  • 11Department Of Hemto-oncology, Landeskrankenhaus LKH Klagenfurt am Woerthersee, 9020 - Klagenfurt/AT
  • 12Internal Medicine, Landeskrankenhaus (LKH) Fuerstenfeld, 8280 - Fuerstenfeld/AT

Abstract

Background

Fluoropyrimidines plus irinotecan or oxaliplatin combination chemotherapy + bev represents an effective treatment option in patients (pts) with mCRC invariable of the RAS mutational status. Not in the primary focus of a sequential study treatment protocol in pts with high tumour burden, resectability becomes more and more of interest since it implicates the only potential for cure.

Methods

Previously untreated mCRC pts were randomized into two different treatment arms: in Arm A pts started with mXELIRI (capecitabine [cape] 800mg/m2 bid d1-14, irinotecan 200 mg/m2 iv d1) + bev 7.5 mg/kg iv d1 q3w, in Arm B treatment started with XELOX (cape 1000mg/m2 bid d1-14, oxaliplatin 130mg/m2 iv. d1) + bev 7.5mg/kg iv d1 q3w. After 8 cycles, maintenance treatment (bev 7.5 mg/kg q3w ± cape 1000 mg/m2 bid, days 1-14 q3w) was started until progression (PD). Upon PD, pts were crosswise treated with the regimen of the other arm for 6 cycles, again follwed by maintenance treatment until PD. We herin report the secondary resection rates noted in this trial.

Results

120 pts were randomized to Arm A (n = 58) or Arm B (n = 62). Median age (65 years), gender (68% male) and RAS mutational status were similar in both arms (33% wildtype, 38% mutated). 24 pts (20%) could be converted in a resectable stage and underwent R0 liver- (n = 16; 8 pts in both arms), lung- (n = 4, 2 pts in both arms), ovarian metastasis- (n = 2 in Arm B) and inoperable primary tumor-resection (n = 3 in Arm B) after a median of 6 months (range 4-27). 22 pts were resected during 1st-line, 2 pts during 2nd-line treatment. At a median follow-up time of 10 months after secondary surgery 9 pts (2 in Arm A, 7 in Arm B) had disease recurrence. Perioperative AEs included 5 thromboembolic events (1 lethal), 3 wound healing complications, 4 fistula/abscess, hyperbilirubinaemia x2 and 1 post-surgical perforation.

Conclusions

Both treatment regimens are effective and tolerable treatment options in patients with mCRC, and have resulted in secondary resectability in 20% invariable of the RAS mutational status.

Clinical trial identification

NCT02119026, release 01.April 2014

Legal entity responsible for the study

Medicine I, Clin. Div. of Oncology and Comprehensive Cancer Center, Medizinische Universitaet Wien (Medical University of Vienna),

Funding

Roche Austria GmbH

Disclosure

W. Scheithauer: Personal honoraries for advisory board & invited speaker activities from Roche-Austria. G. Prager: Research grant from Roche Austria (Passionate-Trial). R. Greil: By Roche: research support, honoraria, travel costs, advisory boards; non related to abstract under submission, no stock options. A. Gerger: Research grant from Roche - Passionate trial. A. Pichler: Honorarium for speech "Rectum carcinoma" Amgen, Oct 2015. All other authors have declared no conflicts of interest.