A functional physiopathologic mechanism of MBO development may be an early prognostic factor for desobstruction. A high proportion of desobstruction was observed, suggesting that the combination of antisecretories with different mechanism of action warrants further investigation.
was given by intravenous infusion on day 1, q3w. After 6 cycles of inducing therapy, patients would receive anlotinib (12mg, po, d1w14, q3w) until disease progression or intolerable adverse events. The primary endpoint was PFS; Secondary endpoints included ORR, DCR, DOR and safety.Results: At the data cut-off date of April, 2021, a total of 21 patients were enrolled, the median (range) age was 58 (48-66) years, 15 (71%) were males, ECOG PS 0/1 was 10 (48%)/11 (52%), 18 (86%) had more than one metastatic tumor. Among 17 efficacy-available patients, the ORR (CR/PR) was 53% (9/17) and the DCR (CR/PR/SD) was 88% (15/17) in best overall response assessment, of which the longest duration of treatment was 12.1 months and the response was still ongoing. The median PFS was not reached. The Grade 3/4 treatment related adverse events(TRAE, 10%) were hypertension (19%), hypertriglyceridemia (14%), neutropenia (14%), lipase elevated (10%). One grade 5 TRAE was pancytopenia that occurred at 2.7 mths.
Conclusions:The update results suggested that anlotinib combined with XELOX as first line regimen followed by anlotinib monotherapy showed a promising clinical benefit and favorable safety profile for mCRC. And the results needed to be confirmed in trials continued subsequently.
Background: To date, no biomarkers for second-line anti-angiogenic treatment in RAS wild type (wt) metastatic colorectal cancer (mCRC) patients (pts) with progression after first-line anti-epidermal growth factor receptor (EGFR) agents have been validated. Data on dynamic change of circulating pro-angiogenic factors levels during treatment from the pre-planned interim analysis of DISTINCTIVE trial (NCT04252456) are presented.Methods: RAS wt mCRC pts progressing on first-line oxaliplatin-based + anti-EGFR are treated with second-line FOLFIRI-aflibercept. They are prospectively allocated to a favorable (>4 ng/ml) or unfavorable (4 ng/ml) prognostic group, according to Elisaassessed baseline VEGFR2 plasma levels. Circulating angiogenic factors changes between baseline (BL), first tumor assessment (TA1) and disease progression (PD) are assessed. Primary endpoint is overall survival (OS) according to VEGFR2 levels. Secondary endpoints are OS, progression free survival (PFS), response rate, safety and angiogenic factors levels. Statistical analysis is performed with MedCalc (survival distribution: Kaplan-Meier; survival comparison: log-rank test).Results: Globally, 73 pts were enrolled from 04/2018 to 06/2020; 44 were eligible for interim analysis. Median OS was 11.9 months (m) (95%CI:10-14.2). OS was significantly improved (not reached [NR] vs 11.2 m, 95%CI:8.2-14.2) in pts with increase of interleukin-8 levels between BL and PD (HR 0.30, p¼0.0226) and between TA1 and PD (HR 0.16, p¼0.0092) and increase of neuropilin-1 between TA1 and PD (HR 0.18, p¼0.0143). Median PFS was 8.3 m (95% CI 4.2-24.2). PFS was longer in pts with decreased levels between BL and PD of endoglin (9.
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