Panitumumab as a single agent in 269 metastatic colorectal cancer patients in the real practice: A post EMA approval study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14148-e14148
Author(s):  
Francoise Grude ◽  
Jean François Ramée ◽  
Laurent Guivarch ◽  
Sophie Rochard ◽  
Olivier Dupuis ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Clinical Response ◽  
Median Duration ◽  
Primary Tumor ◽  
Real Life ◽  
Published Data ◽  
Health Politics ◽  
The Real ◽  
End Of Treatment

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.

Efficacity and safety of panitumumab in mCRC patients: A post-AMM OMIT study.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 608-608 ◽  
Author(s):  
Francoise Grude ◽  
Jean François Ramée ◽  
Laurent Guivarch ◽  
Jean-Yves Douillard ◽  
Sophie Rochard ◽  
...  
Keyword(s):  
Clinical Response ◽  
Median Duration ◽  
Primary Tumor ◽  
Real Life ◽  
Published Data ◽  
Duration Of Treatment ◽  
Health Politics ◽  
The Real ◽  
End Of Treatment ◽  
Kras Status

608 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. OMIT Bretagne - Pays de Loire is a network of private and public cancer centers. Methods: Data from patients treated with PANI in mCRC were collected. Previously published data are recited. Sex, age, primary tumor, Kras status, line of treatment, toxicity, reason of discontinuation, response, progression free survival (PFS) and overall survival (OS) have been studied. Results: Data of 322 patients treated between second half of 2008 and end of 2010 have been collected. PANI was used alone (85.5%) or with chemotherapy (14.5%) : mainly FOLFIRI, IRINOTECAN or FOLFOX). KRAS status was wild-type (WT 96.5%), mutated (0.5%), undetermined (2.5%) or not searched (0.5%). Only KRAS WT patients treated with monotherapy of PANI at 6 mg/kg every 2 weeks were analysed (n=263). Sexe : 177 men and 86 women. Median age : 67 years [36-90] (Van Custem JCO 2007: 62 years [27-83]). Primary tumor of patients was : colon (75%), rectum (22%) and others (3%). They received PANI mostly at line 2 (25%), 3 (46%) or 4 (19%). Discontinuation of treatment was mostly due to disease progression : 64%, death: 15% and toxicities : 7% (skin toxicities 3.7%). Clinical response was evaluated for the first 84 patients: partial response (PR): 30%, stable disease (SD): 14% and progression (P): 56%. In KRAS WT patients treated by PANI, Amado described 17% of PR, 34% of SD and 49% of P (Amado JCO 2008). Median duration of treatment was 69 days [0;360] (n=249). Median duration between end of treatment and death when death is the cause of end of treatment was 13 days [0;54] (n=35). Median of OS was 137 days [0;816] (n=143) which is lower than previously described (Van Cutsem JCO 2007 : 192 days regardless of KRAS status ; Amado JCO 2008 : 243 days in KRAS WT). Conclusions: The OMIT analysis of patients treated by PANI in Bretagne/Pays de Loire for a mCRC allows to assess the good use, according to its label, in the real life. Complete results about clinical response, PFS (cut-off 01/12/2011), OS and safety as well as previously published data will be shown at the meeting.

What is the benefit for patients suffering from metastatic colorectal cancer (mCRC) after bevacizumab-based regimen (BBR), cetuximab-based regimen (CBR), and panitumumab (P)?

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 595-595
Author(s):  
J. Metges ◽  
J. Ramée ◽  
J. Raoul ◽  
A. Gourlaouen ◽  
M. Porneuf ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Metastatic Colorectal Cancer ◽  
Targeted Therapies ◽  
Primary Tumor ◽  
Progression Free Survival ◽  
Tumor Site ◽  
Primary Tumor Site ◽  
Health Politics ◽  
Private And Public

595 Background: Metastatic colorectal cancer (mCRC) management has been clearly improved by targeted therapies such as anti VEGF and /or anti-HER1 drugs. The evaluation of the use of targeted therapies in the real world is strategic to assess health politics. OMIT Bretagne-Pays de la Loire is a network of private and public cancer centers that has been leading cohort studies evaluating Folfiri-bevacizumab treatment, the cost of targeted therapies and the succession of targeted therapies. Methods: The purpose of this study is to evaluate the benefit and safety of three consecutive targeted therapies in patients with KRAS wild-type unresectable mCRC. Sex, age, localization of the primary tumor site, successive chemotherapeutic regimens, toxicities, response rates, progression free survival and overall survival have been studied. Results: 34 patients (22 men, 12 women, median age 63 years [43-82]) have been prospectively recruited between 2003 and 2010. All of them received bevacizumab specially in association with FOLFIRI, cetuximab in association with irinotecan, panitumumab as monotherapy and others chemotherapies than FOLFOX, FOLFIRI, XELOX. The primary tumor site was colon (71%), junction (5%), and rectum (24%). 22 patients had metastatic colorectal tumor, 28 were operated on their primary tumor and 12 underwent resection after one line of treatment. Patients received successively 3 to 8 different lines of treatment for progressive mCRC. Toxicities of targeted therapies were manageable. Objective responses were observed in 38% (13) of the patients treated with BBR, 37% (11) treated with CBR and 25% (6) treated with P. Disease stabilization was achieved in 32% (11) of the patients treated with BBR, in 10% (3) with CBR and in 8% (2) with P. PFS at 80 months is 15%. Median OS from first metastatic line at death was 47.43 months (24.23-70.84). PFS and OS curves will be shown during the meeting. Conclusions: Our study clearly shows that patients receiving successively the three schedules (BBR, CBR, P) have a high overall survival with manageable side effects. No significant financial relationships to disclose.

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

The "real life" impact of adding bevacizumab to first-line treatment of metastatic colorectal cancer: A retrospective large database study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e14571-e14571
Author(s):  
Ariel Hammerman ◽  
Sari Greenberg-Dotan ◽  
Erez Battat ◽  
Haim Bitterman ◽  
Baruch Brenner
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Combination Chemotherapy ◽  
Real Life ◽  
Progression Free Survival ◽  
Line Treatment ◽  
Database Study ◽  
The Real ◽  
Life Impact ◽  
Retrospective Database

e14571 Background: Bevacizumab is included in the Israeli National List of Reimbursed Drugs (NLRD) for 1st line treatment of all metastatic colorectal cancer (mCRC) patients since 7/2006. This study evaluates the "real life" impact of adding bevacizumab to 1st line treatment of mCRC by comparing patients' outcomes before and after the drug's availability in the NLRD. Methods: We conducted a retrospective database study ,using the computerized databases of Clalit Health Services' (CHS), Israel's largest health care provider, to compare two cohorts: (A) all CHS' patients diagnosed with mCRC between 1/2000-12/2004 that received 1st line irinotecan or oxaliplatin-based combination chemotherapy (before bevacizumab was introduced), and (B) all CHS's patients that started 1st line treatment with irinotecan or oxaliplatin-based combination chemotherapy and bevacizumab between 7/2006 and 8/2009 (allowing a minimum follow-up of 3 years). The primary endpoint was overall survival (OS) and the secondary endpoints were 1st line progression free survival (PFS) and metastatectomy rates. Since data on actual progression status was unavailable, PFS was defined as the duration of 1st line treatment. As CHS covers more than 50% of the Israeli population, our study may represent the general care received by Israeli patients with mCRC. Results: The study population included 1,739 patients: 1,052 in cohort A and 687 in cohort B. Patient demographics were similar between the cohorts. Median OS was 15.0 months for cohort A (95% CI: 13.4–16.6) and 23.0 months for cohort B (95% CI: 21.7–24.3), with an unadjusted hazard ratio (HR) of 0.71 (95% CI: 0.64-0.80, p<0.0001). Median PFS was 9.8 months (95% CI: 9.0–10.5) for cohort A and 14.0 months (95% CI: 13.0-15.0) for cohort B, with a HR of 0.80 (95% CI: 0.71-0.87, p<0.0001). The rate of metastatectomies was significantly higher in cohort B (8.1% vs. 3.9%; P = 0.001). Conclusions: In this retrospective database analysis, OS, PFS and metastatectomy rates of 1st line treatment of mCRC were significantly higher in the later period of the study. The addition of bevacizumab to standard treatment of mCRC may have had a major contribution to this improvement.

Trifluridine/tipiracil or regorafenib in refractory metastatic colorectal cancer patients: An AGEO prospective “real life” study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4036-4036
Author(s):  
Clélia Coutzac ◽  
Isabelle Trouilloud ◽  
Pascal Artru ◽  
Julie Henriques ◽  
Thérese Masson ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Multivariable Analysis ◽  
Tumor Resection ◽  
Real Life ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Published Data ◽  
Number Of Patients ◽  
Metastatic Sites

4036 Background: Regorafenib (R) and trifluridine/tipiracil (T) have proved their efficacy in patients (pts) with metastatic colorectal cancer (mCRC) refractory to standard chemotherapy and targeted therapies. However, it remains unclear which drug should be administered first. Methods: This observational study was prospectively conducted in 13 centers between 6/2017 and 9/2019 in France. All consecutive pts with chemoresistant mCRC and receiving T and/or R were eligible. The aim of this study was to describe efficacy and tolerability of T and/or R. Overall survival (OS) and progression-free survival (PFS) of pts receiving T then R (T/R) and the opposite sequence (R/T) were also assessed. Results: A total of 237 pts (25% R and 75% T) were enrolled (109 male, median age: 67 years (32-91), mean previous lines of treatment: 2.5 (1-7)). Baseline ECOG PS was 0-1 in 77% of pts. As compared to R pts, T pts were significantly older (68 years vs 63; p = 0.033) and with > 3 metastatic sites (44% vs 30%, p = 0.018). Median OS were 6.6 and 6.2. months in the T and R group, respectively (NS). Median PFS were 2.4 and 2.1 months in the T and R group, respectively (NS). After matching 46 paired pts according to primary tumor resection, age and number of metastatic sites, a trend to a longer OS (9.5 vs 6.8 months; p = 0.17) and a significantly longer PFS (2.8 vs 2 months; p = 0.048) were observed in the T group. Among the overall population, 24% of pts received R/T or T/R sequence. Median OS from first treatment were 10.7 months in the R/T group and 9.8 months in the T/R (NS). Treatment sequence was not an independent prognostic factor for OS or PFS in multivariable analysis. Tolerability profiles were similar to previously published data, but dose reductions were more frequent in the R group (44 vs 27%, p = 0.008). Conclusions: Efficacy and safety results in this real life prospective study are in line with those published phase III trials. Both treatments seem similar in term of efficacy favoring T for clinical use as shown by the higher number of patients receiving this drug.

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