Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
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- The primary endpoint is overall survival (OS).
- Secondary endpoints (progression-free survival [PFS] and overall response rate assessed with Response Evaluation Criteria in Solid Tumors v1.1 criteria) will be compared only if the primary endpoint shows superiority for liposomal irinotecan + 5-FU/ LV + OX over nab-paclitaxel + gemcitabine.
Hongjae Chon, Hyung Soon Park, Beodeul Kang, et al.
The abstract concludes:
In second-line setting for mPC after progression on gemcitabine-based therapy, both nal-IRI/FL and FOLFIRINOX regimen showed comparable efficacy and acceptable safety outcomes. FOLFIRINOX regimen might be preferentially considered in patients with liver metastasis.
- multi-center, open label, randomized phase II trial. Patients ≥ 18 years of age with histologically or cytologically confirmed PDAC, previously treated with gemcitabine (-based) therapy, or progression within 6 months of adjuvant gemcitabine-based treatment are eligible. After a safety run-in of the nal-IRI plus S-1 regimen, patients will be randomized between nal-IRI plus S-1 and nal-IRI plus 5-FU/LV.
Clinical trial information: NCT03986294.
Published simultaneously in the NEJM:
K. Shitara and OthersCCO Independent Conference Coverage of the 2020 ASCO Virtual Scientific Meeting: