SoMore trial: Early metabolic response assessment of a sorafenib (SOR) and capecitabine (CAP) combination in chemorefractory metastatic colorectal cancer (mCRC).

Deleporte, Amélie;Hendlisz, Alain;Garcia, Camilo;Delaunoit, Thierry;Flamen, Patrick;et.al.
(2014) 2014 ASCO GI Annual Meeting — Location: (United States) San Francisco, CA (16.January.2014)

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  • Deleporte, Amélie
    Author
  • Hendlisz, Alain
    Author
  • Garcia, Camilo
    Author
  • Delaunoit, Thierry
    Author
  • Van den Eynde, MarcUCLouvain
    Author
  • Filleul, BertrandUCLouvain
    Author
  • Lhommel, Renaudorcid-logoUCLouvain
    Author
  • Flamen, Patrick
    Author
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Abstract
Background: The SOR-CAP combination has shown clinical activity in several phase I-II trials involving metastatic breast cancer and mCRC patients (pts). SoMore aims to substantiate the combination’s effects in mCRC refractory to all medications and the predictive value of early metabolic response (MR) on survival. Methods: SoMore (EUDRACT 2010-023695-91) has 2 coprimary objectives: 1) to demonstrate an overall survival (OS) rate at 6 months (mths) > 30%, and 2) to compare OS between pts with and without MR. CAP was given at 1700 mg/m²/day (D), 2 weeks out of 3. SOR was administered at 600mg/D for the first cycle, then at 800mg/D until progression or unacceptable toxicity. FDGPET-CT was performed at baseline and before the 2nd cycle. MR analysis was centralized and blinded for the investigators. Results: From February to October 2011, 92 eligible pts were prospectively recruited in 6 Belgian centers: M/F: 54%/46%; ECOG PS 0/1: 55%/45%; median age: 61. A median of 5 treatment cycles were given (0-28+). Grade 3-4 toxic reactions were reported in 61.2%, mainly fatigue (18%), hand-foot skin reaction (14%) and diarrhea (11%), but no toxic death. 6.9% of the pts stopped therapy due to toxicity. 6 mths OS was 71% (95% CI: 61%-79%), significantly >30% (p<0.001). 47% of the 79 pts evaluable for metabolic assessment showed homogeneous MR (HMR) of all metastatic lesions, 32% mixed MR and 21% homogeneous non-MR. Median overall OS and PFS of the intent-to-treat population and of pts with and without HMR are shown in the table below. Hazard ratio for HMR was 0.34 (95% CI, 0.21 to 0.56) p-value <0.001 for PFS and 0.59 (95% CI, 0.37 to 0.96) p-value 0.03 for OS. Conclusions: These data suggest robust efficacy for the SOR-CAP combination in heavily pretreated mCRC, associated with high but manageable toxicity. Early MR assessment, by detecting unresponsive lesions within the whole body tumoral load, is able to capture the pts’ likelihood of benefit, opening the path to personalized medicine. Clinical trial information: NCT0129092
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Deleporte, A., Hendlisz, A., Garcia, C., Delaunoit, T., Maréchal, R., Peeters, M., Holbrechts, S., Van den Eynde, M., Houbiers, G., Filleul, B., Van Laethem, J.-L., Rolfo, C. D., Diaz, M., Lhommel, R., Demolin, G., Moreau, M., Ameye, L., Paesmans, M., Piccart-Gebhart, M. J., & Flamen, P. (2014). SoMore trial: Early metabolic response assessment of a sorafenib (SOR) and capecitabine (CAP) combination in chemorefractory metastatic colorectal cancer (mCRC). Journal of Clinical Oncology, 32, 524. https://doi.org/10.1200/jco.2014.32.3_suppl.524 (Original work published 2014)