Rebecca: a Large Cohort Study of Regorafenib (Reg) in the Real-Life Setting in Patients (Pts) Previously Treated for Metastatic Colorectal Cancer (Mcrc)

e14148 Background: Metastatic colorectal cancer (mCRC) management has been improved by targeted therapies. The evaluation of the use of panitumumab (PANI), after approval, in the real life is strategic to assess health politics. Clinical trials concern usually patients younger and with better health status. Little is known about elderly people (over 70 years old). The observatory of Cancer Bretagne - Pays de Loire is a network of private and public cancer centers. Methods: Patients with wild-type KRAS, EGFR-expressing, mCRC progressing after fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy , received PANI,6 mg/kg biweekly. Sex, age, primary tumor, line of treatment, toxicity, reason of discontinuation, response, progression free survival (PFS) and overall survival (OS) were collected. Results: 269 patients (183 men and 86 women) treated between second half of 2008 and end of 2010 have been included. Median age: 67 years [36-90] (Amado et al, 2008 : 62.5 years [29-82]). Primary tumor was : colon (74%), rectum (24%) and double site (2%). PANI was used mostly at line 2 (19%), 3 (31%) or 4 (29%). Discontinuation of treatment was due to disease progression: 53%, death: 12% and toxicities: 5% (skin toxicities 3.5%). Clinical response was evaluated for the first 201 patients: partial response (PR): 20%, stable disease (SD): 19% and progression (P): 60% (Amado et al, 2008 PR : 17%, SD : 34%, P : 49%). Median duration of treatment was 2.3 months [0.26-17.52]. Median of OS was 6.71 months which is lower than previously described (Amado : 8.1 months). Median duration between end of treatment and death when death is the cause of end of treatment was 17 days [4-57] (n=24). From our data of 269 patients, a comparison between 123 patients over 70 and 146 patients under 69 will be shown at the meeting. Conclusions: Analysis of patients treated with PANI for a mCRC allows assessing the proper, per label use, in the real life. Complete results on clinical response, PFS, OS and safety as well as previously published data will be shown at the meeting.

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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.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.588 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 588-588 ◽

Cited By ~ 1

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]

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Secondary Metastases Resection After Bevacizumab Plus Irinotecan-Based Chemotherapy in First-Line Therapy of Metastatic Colorectal Cancer in a Real-Life Setting: Results of the ETNA Cohort

Targeted Oncology ◽

10.1007/s11523-015-0377-6 ◽

2015 ◽

Vol 11 (1) ◽

pp. 83-92 ◽

Cited By ~ 2

Author(s):

Magali Rouyer ◽

◽

Denis Smith ◽

Christophe Laurent ◽

Yves Becouarn ◽

...

Keyword(s):

Colorectal Cancer ◽

Metastatic Colorectal Cancer ◽

Real Life ◽

First Line ◽

First Line Therapy ◽

Line Therapy ◽

Real Life Setting

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

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.4_suppl.621 ◽

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.

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