scholarly journals P-123 Outcomes and predictive factors of regorafenib benefit in patients with metastatic colorectal cancer in a real-life setting

2020 ◽  
Vol 31 ◽  
pp. S130
Author(s):  
N. Martínez Lago ◽  
B. Carnero Lopez ◽  
J. De la Cámara Gomez ◽  
F. Vázquez-Rivera ◽  
A. Fernández Montes ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Predictive Factors ◽  
Real Life ◽  
Real Life Setting

Ziv-aflibercept (Z) in combination with FOLFIRI for second-line treatment of patients with metastatic colorectal cancer (mCRC): Interim safety data from the global Aflibercept Safety and Quality-of-Life Program (ASQoP and AFEQT) in patients age 65 or older.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 588-588 ◽  
Author(s):  
Roberto Bordonaro ◽  
Giovanni Luca Frassineti ◽  
Libero Ciuffreda ◽  
Giuseppe Aprile ◽  
Anne Thomas ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Interim Analysis ◽  
Safety Data ◽  
Real Life ◽  
The United States ◽  
Open Label ◽  
Real Life Setting ◽  
Safety Population ◽  
Initial Starting

588 Background: The prespecified analysis of patients (pts) ≥65 y in the VELOUR study demonstrated a safety profile similar to that of ziv-aflibercept (Z) (known as aflibercept outside the United States) plus FOLFIRI in the overall VELOUR population. The global ASQoP/AFEQT Program comprises 2 clinical studies (ASQoP [NCT01571284]; AFEQT [NCT01670721]) designed to capture QoL and safety data from a population similar to VELOUR but treated in a real-life setting. We report safety data from the fourth interim analysis of pts ≥65 y. Methods: ASQoP/AFEQT are single-arm, open-label trials evaluating Z in metastatic colorectal cancer pts previously treated with an oxaliplatin-containing regimen. Eligible pts received Z (4 mg/kg) q2w on day 1 of each cycle followed by FOLFIRI until disease progression, unacceptable toxicity, death, or investigator/pt decision. Initial starting doses of FOLFIRI and dose modifications are at treating physician’s discretion. The % of pts ≥65 y with grade (G) 3 or 4 AEs in the combined safety population of ASQoP/AFEQT are compared with the prespecified analysis in pts ≥65 y from the Z + FOLFIRI arm of VELOUR. Results: At data cutoff, the overall safety population comprised 688 pts with ≥1 completed treatment cycle; 303 (44.1%) were ≥65 y. In the overall safety population ≥1 G3/4 AE was reported in 72.2% of pts vs. 83.5% in overall VELOUR. Most G3/4 AEs were G3. There were no reports of G4 hypertension, diarrhea, or fatigue. Median number of cycles was 6 in ASQoP/AFEQT and 9 in the Z + FOLFIRI arm of VELOUR. Table shows summary of AEs in pts ≥65 y. Conclusions: This interim analysis from ASQoP/AFEQT in pts ≥65 y has identified no new safety signals and provides additional safety data suggesting an acceptable toxicity profile in this real-life setting. Clinical trial information: NCT01571284. [Table: see text]

Cetuximab in first-line treatment of metastatic colorectal cancer in a real-life setting: Preliminary results of the EREBUS cohort.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 621-621
Author(s):  
Denis Smith ◽  
Magali Rouyer ◽  
Emmanuel Mitry ◽  
Alain Monnereau ◽  
Antonio Sa Cunha ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Tumor Resection ◽  
Real Life ◽  
Line Treatment ◽  
Duration Of Treatment ◽  
Preliminary Results ◽  
Administration Regimen ◽  
Real Life Setting ◽  
Metastatic Sites

621 Background: Cetuximab (CTX) has demonstrated to improve survival outcomes in metastatic colorectal cancer (mCRC), but little data for real-life use is available. Methods: EREBUS is a French multicentre (n=92) hospital-based cohort. Patients initiating CTX in 2009 and 2010 were identified retrospectively from registries of nominative drug dispensations. Those with wild-type KRAS gene receiving 1st-line treatment for mCRC were followed-up for 12 months. Data were collected from patient medical records and response based on physician assessments (CT-Scan). Presented here are preliminary results of the EREBUS cohort about administration regimen and according response rates for patients included in 2009. Results: Of the 190 patients included in the cohort, data has been collected for 160 (84.2%): median age at baseline 65.5 years, 70.6% male. Regarding cancer characteristics, 79.4% of patients had a colon cancer and 53.8% a primary tumor resection. Metastatic sites were liver in 73.1% of patients, peritoneum in 29.4%, lymph nodes in 26.3%, and lung in 25.6%. For patients for which the ECOG status was available (54.4%): 79.3% have an ECOG score between 0 and 1, 20.7% ≥2. Half the patients (48.8%) had only one metastatic site. CTX was given every three weeks to 2 patients (1.3%), every two weeks to 113 of patients (70.6%), and weekly to 45 (28.1%). For those receiving CTX every two weeks: 64.9% had irinotecan-based regimens (vs. 45.5% of those receiving CTX weekly, p=0.03), 31.5% had oxaliplatin-based regimens (vs. 47.7%, p=0.06), median duration of CTX use was 3.8 months (vs. 5.3 months, p=0.69) and that of 1st-line therapy 6.3 months (vs. 7.5 months, p=0.97), 69.0% discontinued 1st-line treatment (vs. 82.2%, p=0.09) – mainly for progression (71.8 vs. 75.7%, p=0.66) or toxicity (20.5 vs. 10.8%, p=0.20). Overall response evaluated for 100 patients receiving CTX every two weeks out of 113 was 46.0% (vs. 52.6%, p=0.49, evaluated for 38 receiving CTX weekly). Conclusions: CTX administration every two weeks was the most frequent regimen. In this preliminary analysis, patients receiving weekly or every two weeks regimens had similar duration of treatment and response rate.

scholarly journals P-50 Prognostic factors in patients receiving trifluridine/tipiracil for refractory metastatic colorectal cancer in the real-life setting: The ROS study

2021 ◽  
Vol 32 ◽  
pp. S113
Author(s):  
P. García-Alfonso ◽  
J. Reina Zoilo ◽  
E. Mata Velasco ◽  
M. Llanos ◽  
A. Illán Varella ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Prognostic Factors ◽  
Metastatic Colorectal Cancer ◽  
Real Life ◽  
The Real ◽  
Real Life Setting

Ziv-aflibercept (Z) in combination with FOLFIRI for second-line treatment of patients (pts) with metastatic colorectal cancer (mCRC): Interim safety data from the global Aflibercept Safety and Quality-of-Life Program in pts pretreated with bevacizumab (B).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 528-528 ◽  
Author(s):  
Alberto F. Sobrero ◽  
Roberto Bordonaro ◽  
Katia Bencardino ◽  
Filippo Pietrantonio ◽  
Stefan Bauer ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Safety Data ◽  
Real Life ◽  
The United States ◽  
Median Number ◽  
Open Label ◽  
Real Life Setting ◽  
Safety Population ◽  
Initial Starting

528 Background: In the VELOUR study, adding ziv-aflibercept (Z) (known as aflibercept outside the United States) to FOLFIRI resulted in improved OS, PFS, and RR in metastatic colorectal cancer (mCRC) patients (pts) who had received prior oxaliplatin. Prior treatment with bevacizumab (B) did not appear to impact safety profile of Z. The global ASQoP/AFEQT studies are 2 clinical studies (ASQoP [NCT01571284]; AFEQT [NCT01670721]) designed to capture QoL and safety data from a population similar to VELOUR but treated in a real-life setting. We report safety data from the 4th interim analysis in B-pretreated pts. Methods: ASQoP/AFEQT are single-arm, open-label trials of Z in mCRC pts previously treated with an oxaliplatin-containing regimen. Eligible pts receive Z (4 mg/kg) q2w on day 1 of each cycle followed by FOLFIRI until disease progression, unacceptable toxicity, death, or investigator/pt decision. Initial starting doses of FOLFIRI and subsequent modifications are at treating physician’s discretion. % of pts with grade (G) 3 or 4 AEs in the combined B-pretreated safety population of ASQoP/AFEQT is compared with B-pretreated pts in the Z + FOLFIRI arm of VELOUR. Results: At data cutoff, overall safety population comprised 688 pts with ≥1 completed treatment cycle; 343 (49.9%) were B-pretreated. Currently, median number of cycles administered to ASQoP/AFEQT pts is 6; in VELOUR, pts in Z + FOLFIRI arm had a median of 9. Table shows summary of TEAEs in B-pretreated pts. Conclusions: Thisinterim safety analysis of ASQoP/AFEQT in B-pretreated pts identified no new safety signals for Z and a trend toward decreased G3/4 events. The analysis provides additional safety data suggesting an acceptable toxicity profile in a real-life setting. Clinical trial information: NCT01571284. [Table: see text]

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