569P - Somore trial: combining sorafenib (SOR) with capecitabine (CAP) yields highly encouraging survival results and elevated metabolic response rate in c...

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
Presenter Amélie Deleporte
Authors A. Deleporte1, A. Hendlisz1, T. Delaunoit2, R. Marechal3, M. Peeters4, S. Holbrechts5, M. van den Eynde6, G. Houbiers7, M. Moreau8, P. Flamen9
  • 1Institut Jules Bordet, 1000 - Brussels/BE
  • 2Gastroenterology, Entité Jolimontoise, La Louviere/BE
  • 3Service Médico-chirurgical De Gastroentérologie, Hopital Universitaire Erasme, Brussels/BE
  • 4Medical Oncology, Universitair Ziekenhuis Antwerpen, Antwerpen/BE
  • 5Medical Oncology, Hopital Ambroise Pare, Mons/BE
  • 6Medical Oncology, Cliniques universitaires St-Luc, 1200 - Brussels/BE
  • 7Gastroenterology, Hopital Saint Joseph, Liege/BE
  • 8Data Center, Institut Jules Bordet, Brussels/BE
  • 9Nuclear Medicine, Institut Jules Bordet, Brussels/BE

Abstract

Background

Several phases I and II trials including mCRC and metastatic breast cancer patients have suggested an interesting clinical activity in solid tumors with a SOR-CAP combination. SoMore's aim is to assess its potential benefit in chemorefractory mCRC and the predictive value of early metabolic response (MR) on survival.

Methods

SoMore (EUDRACT 2010-023695-91) is a multicentric phase II in PS 0-1 chemorefractory mCRC pts. Two co-primary objectives were defined 1) to demonstrate that overall survival (OS) at 6 months is > 30% (67 pts needed to have 90% power to detect a true rate of 50% at 1-sided level 2.5%); 2) to compare OS between early PET responders and non responders (62 deaths required before analysis -on pts assessable for MR- to detect a true HR < 0.385, assuming a 67% rate of early responders). Pts received a 1st cycle of SOR (600mg/day) CAP (1700 mg/m2/day, day 1-14 every 21 days), then subsequent cycles with a SOR dose of 800mg/day until progression or unacceptable toxicity. FDGPET-CT was performed at baseline and before second cycle. Investigator-independent centralized PET analysis was carried out with metabolic non response defined by < 15% FDG uptake decrease in a dominant proportion (≥50%) of predefined target lesions (SUVmax> 2.5 liver uptake; size > 15 mm).

Results

Between February and October 2011, 92 eligible pts were recruited in 6 centers: 50 male pts (54%), ECOG PS 0/1 : 51 (55%)/41 (45%), median age of 61 years. A median of 5 treatment cycles were given (0-18 + , treatment ongoing in 11 pts). No toxic death was observed. Grade III-IV toxic reactions were reported in 53% of the pts, mainly fatigue (17%), hand-foot skin reaction (13%), diarrhea (13%). 3/81 pts stopped their treatment due to toxicity. OS rate at 6 months was 65/92 (71%, 95% CI : 61%-79%), significantly higher than 50% (p < 0.001). PET showed a MR in 65% [54%-74%] of the 79 evaluable pts. Data are not yet mature to analyze the predictive value of PET on survival.

Conclusions

SoMore largely met one of its primary objectives with an observed 71% OS at 6 months for this heavily pretreated mCRC population with manageable toxicity. Data about PET assessment according to mOS and PFS will likely be mature at the time of the meeting and presented if available.

Disclosure

All authors have declared no conflicts of interest.