Somore Trial: Combining Sorafenib (SOR) with Capecitabine (CAP) Yields Highly Encouraging Survival Results and Elevated Metabolic Response Rate in Chemorefractory Metastatic Colorectal Cancer (MCRC)
(2012) ESMO Congress 2012
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- 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.
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Deleporte, A., Hendlisz, A., Delaunoit, T., Marechal, R., Peeters, M., Holbrechts, S., Van den Eynde, M., Houbiers, G., Moreau, M., Flamen, P., & et al. (2012). Somore Trial: Combining Sorafenib (SOR) with Capecitabine (CAP) Yields Highly Encouraging Survival Results and Elevated Metabolic Response Rate in Chemorefractory Metastatic Colorectal Cancer (MCRC). Annals of Oncology, 23(9), ix194. https://doi.org/10.1016/s0923-7534(20)33180-x (Original work published 2012)