Preliminary results of a phase 1b study of fruquintinib plus sintilimab in advanced colorectal cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 2514-2514
Author(s):  
Ye Guo ◽  
Weijie Zhang ◽  
Jieer Ying ◽  
Yanqiao Zhang ◽  
Yueyin Pan ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Advanced Colorectal Cancer ◽  
Objective Response ◽  
Occult Blood ◽  
Continuous Group ◽  
Fecal Occult Blood ◽  
Fecal Occult ◽  
Grade 3 ◽  
Vegfr Inhibitor ◽  
Stage 1

2514 Background: To explore the safety and synergistic anti-tumor effect of fruquintinib (a VEGFR inhibitor) in combination with sintilimab (an anti-PD-1 Ab) in patients (pts) with advanced colorectal cancer (CRC) and other solid tumors. Methods: This is an ongoing phase Ib/II, multicenter, two-stage study. Pts with variety cancer types, including CRC, were enrolled and is continuously enrolling in the study. For this interim analysis, all pts were analyzed for safety whereas only CRC pts were analyzed for efficacy. MMR status were analyzed for all enrolled CRC pts. Stage 1 was classical “3+3” dose escalation with pts assigned to one of the following 4 cohorts, fruquintinib taken orally at 3mg (Cohort A, 3 weeks on/ 1 week off), 4mg (Cohort B, 3 weeks on/ 1 week off), 5mg-intermittent (Cohort C, 2 weeks on/ 1 week off) or 3mg-continuous (Cohort E, once daily), while sintilimab was given at 200mg intravenously with Q4W in Cohort A and Cohort B whereas Q3W in Cohort C and Cohort E. DLT was observed for 28 days. Stage 2 was dose expansion with pts receiving 5mg-intermittent or 3mg-continuous fruquintinib plus sintilimab (200mg, Q3W). The primary endpoints were safety and tolerability and secondary endpoint was objective response rate (ORR). Results: As of Jan 5, 2021, 44 CRC pts which failed to at least 2 previous lines of therapy containing fluoropyrimidine, oxaliplatin or irinotecan were enrolled. They received either 5mg-intermittent or 3mg-continous dosage (n = 22, each), the ORR was 22.7% (10/44, 95% CI: 11.5-37.8%) with 27.3% (6/22, 95% CI: 10.7-50.2%) in 5mg-intermittent group and 18.2% (4/22, 95% CI: 5.2-40.3%) in 3mg-continuous group. With a median follow-up time of 8.3 (range: 0-9.6) months, the K-M estimated median PFS was 6.8 (95% CI:5.6-NA) months and 4.3 (95% CI:3.5-NA) months for 5mg-intermittent group and 3mg-continuous group, respectively. Overall, 60 pts were enrolled for safety analysis, including 23 in stage1 and 37 (only CRC) in stage 2. In stage 1, all pts experienced TEAEs, 52.2% of which were ≥ grade 3. The most frequently reported TEAEs were TSH increasing (73.9%), fecal occult blood positive (56.5%), and Palmar-plantar erythrodysaesthesia syndrome (PPES) (56.5%). SAEs occurred in 8 (34.8%) pts and no treatment-related death was reported. One patient in Cohort B reported manageable DLT. In stage 2, all pts experienced TEAEs, 18 (48.6%) pts experienced ≥ grade 3 TEAEs with 6 (31.6%) in 5mg-intermittent group and 12 (66.7%) in 3mg-continuous group. The most common TEAEs were proteinuria (45.9%) and TSH increasing (37.8%). TEAEs leading to either fruquintinib or sintilimab discontinuation occurred in 3 (5%) pts each. Conclusions: Fruquintinib plus sintilimab showed promising efficacy and favorable safety profile in advanced CRC. Clinical trial information: NCT03903705.

Impact of screening on presentation and survival of colorectal cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1535-1535
Author(s):  
M. S. Beg ◽  
A. Gupta ◽  
R. Komrokji ◽  
M. Atiq ◽  
S. Ali ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Early Stage ◽  
Occult Blood ◽  
Individual Case ◽  
Fecal Occult Blood Testing ◽  
Fecal Occult Blood ◽  
Effective Population ◽  
Fecal Occult ◽  
Stage 1 ◽  
Stage Stage

1535 Background: There is an increasing emphasis and utilization of colorectal cancer (CRC) screening. We evaluated the effect of screening on CRC presentation and outcome. Methods: We reviewed all the invasive CRC cases diagnosed between Jan 1995-Dec 2005 at the Cincinnati Veteran’s Affairs hospital. Individual case records were reviewed and the data collected including patient demographics, treatment, outcome, mode of presentation as well as whether CRC was detected as a result of screening. Results: Altogether 288 patients were diagnosed with CRC during the study period. The median age at presentation was 69.3 years and 18.8% were African-Americans. Early stage CRC was diagnosed in 63.4% cases (stage 1: 32.7%, stage 2: 30.8%) and 33.3% were diagnosed at advanced stage (stage 3: 18.1% and stage 4: 15.3%). Seventy seven (26.7%) CRCs were asymptomatic at presentation and were diagnosed as a result of screening. Predominant screening modalities included fecal occult blood testing (46.8%) and flexible sigmoidoscopy (22.1%). The proportion of screen- detected cases increased from 19% in 1995–1999 to 32% in 2000–05 (p = 0.047). Demographics, including age and race, as well as the site of CRC were similar to symptomatic cases. Screen-detected cancers presented early, with 77.9% presenting at early stage (stage 1: 55.8%, stage 2: 22.1%), compared to 51.5% (stage 1: 21.0%, stage 2: 30.5%) of symptomatic cancers (p <0.01). Only 1.3% of screen-detected CRC was found to be metastatic as compared to 21.0% of the symptomatic cases. The screen-detected cancers had significant survival advantage compared to symptomatic cases; with median survival being 81 months vs. 43 months in the latter (p =0.018). A proportional hazard regression analysis indicated that this improvement in survival was related to the fact that screening resulted in earlier stage at diagnosis. Only 20.3% of screen-detected CRC received adjuvant chemotherapy compared to 41.4% of symptomatic cases (p=0.002). Conclusions: An increasing proportion of CRC is being diagnosed as a result of screening. These cancers present at an earlier stage and are associated with a significantly improved survival. However, most CRC still presents symptomatically and more effective population screening is needed. No significant financial relationships to disclose.

scholarly journals Immunochemical Fecal Occult Blood Test for Detection of Advanced Colonic Adenomas and Colorectal Cancer: Comparison with Colonoscopy Results

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Bianca Rosa Viana Freitas ◽  
Cristiane Kibune Nagasako ◽  
Celia Regina Pavan ◽  
Sônia Letícia Silva Lorena ◽  
Fabio Guerrazzi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Sensitivity And Specificity ◽  
Occult Blood ◽  
Fecal Occult Blood ◽  
Screening Programs ◽  
Fecal Occult ◽  
Colonic Adenomas ◽  
Lack Of Information ◽  
Risk Patients ◽  
Advanced Adenomas

Background. Fecal immunochemical tests (FITs) have been used for colorectal cancer (CRC) screening in several countries. There is lack of information concerning diagnostic performances of this method in Brazil.Methods. Patients scheduled for elective colonoscopy provided one stool sample one week before colonoscopy. The accuracy of a qualitative FIT for detection of CRC and advanced adenomas was determined.Results. Overall 302 patients completed the study. Among them, 53.5% were high risk patients referred for screening or surveillance. Nine (3%) CRCs and 11 (3.6%) advanced adenomas were detected by colonoscopy. Sensitivity and specificity for CRC were, respectively, 88.9% and 87.6%. For advanced adenomas, sensitivity was 63.6% and specificity 87.6%.Conclusion. Our results showed good sensitivity and specificity of the FIT for detecting advanced neoplasias. This method may be a valuable tool for future screening programs in Brazil.

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