First-line chemotherapy with irinotecan plus capecitabine for advanced colorectal cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 14602-14602
Author(s):  
V. Michalaki ◽  
C. Gennatas ◽  
S. Gennatas ◽  
J. Vasiliou ◽  
V. Smyrniotis

14602 Background: The effective, oral fluoropyrimidine capecitabine is increasingly replacing intravenous (IV) 5-FU/LV in colorectal cancer treatment. The aim of this study was to evaluate efficacy and safety of the combination chemotherapy with irinotecan plus capecitabine (XELIRI), in patients with advanced colorectal adenocarcinoma. Methods: Patients with advanced colorectal adenocarcinoma received a first-line chemotherapy with capecitabine (1000 mg/m2 twice daily) on days 1–14 and irinotecan (240 mg/m2) on day 1 of a 21-day cycle. Results: Twenty-eight patients were evaluable for response. Baseline characteristics: 18men, 10 women; median age 65.5 years (range, 49–73); colon cancer (71%), rectal cancer (29%). Most common metastatic sites were the liver (53.5%), lymph nodes (43%), lung (21%) and bones (18%). There were 7 partial responses (25%), 8 cases of stable disease (28.5%), and 13 cases of disease progression (46.5%). The median survival was 14 months (range, 2–28.8 months) and median progression-free survival was 7 months (range, 6- 26 months). The median number of cycles received was 7 (range, 3–15 cycles). Frequently encountered therapy-related events were leukopenia and gastrointestinal side effects including diarrhea. Conclusions: First-line capecitabine/ irinotecan is an active combination for the treatment of metastatic colorectal cancer achieving high efficacy with a good safety profile. No significant financial relationships to disclose.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15194-e15194
Author(s):  
Mekhty Narimanov ◽  
Alexey Tryakin ◽  
Varlam Zarkua ◽  
Igor Bazin ◽  
August Garin ◽  
...  

e15194 Background: Cisplatin and capecitabine and docetaxel are active agents for treatment of metastatic gastric carcinoma. We underwent analysis of efficacy and toxicity of douplet (CX ) and triplet (DCX) regimens which were used in our department as a first-line chemotherapy in patients with metastatic gastric carcinoma. Methods: Pts with metastatic gastric carcinoma were nonrandomly allocated to DCX regimen (docetaxel 75 mg/m2 i.v. day 1, cisplatin 75 mg/m2 i.v. day 1, capecitabine 1650 mg/m2 per os days 1-14) or CX regimen (cisplatin 75 mg/m2 i.v. day 1, capecitabine 2000 mg/m2 per os days 1-14 ). Up to 6 cycles were provided every 3 weeks. G-CSF was not routinely used for primary prophylaxis. Results: From 2008 to 2012 81 pts were included in the study (DCX – 37 pts, CX – 44 pts). Pts characteristics were similar in both groups (table 1). Median number of cycles in both groups was 5 (range, 1-6). Grade 3-4 toxicity (per cycle) in DCX and CX groups were neutropenia 24,9% and 16,1%, deep venous thrombosis – 2% and 0%, diarrhea – 6.2% and 7,4%, stomatitis – 3.8% and 2,2%, infection – 11% and 0%, anemia 14% and 13,5% pts, respectively. No toxic deaths were observed. Median progression-free survival (PFS) in DCX and CX were 7,5 months (95% CI 6,1-8,9) and 5,4 months (95% CI 5,0-6,2; p=0.0009), median overall survival (OS) 14,5 months (95% CI 10,1-18,9) and 9,3 months (95% CI 9,2-10,2; p=0.0018), respectively. Conclusions: Addition of docetaxel to the combination of cisplatin and capecitabine associates with significant improvement of PFS and OS. Higher rate of infection requires use of G-CSF in primary prophylaxis. [Table: see text]


2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 343-343 ◽  
Author(s):  
Renata D'Alpino Peixoto ◽  
Krista Noonan ◽  
Hagen F. Kennecke ◽  
Howard John Lim

343 Background: Retrospective studies have demonstrated high response rates among patients with advanced PNETs treated with CapTem while responses are infrequently seen among non-PNETs. The objective of the study was to describe progression free survival (PFS) and overall survival (OS) among sequential NET patients treated with CapTem and to identify factors associated with response. Methods: Patients who initiated therapy with CapTem between 2009 and 2013 for advanced NETs and referred to one of 6 provincial cancer treatment centers were included. Patients received Cap 2000 mg/m2 day 1-14 and TMZ 200 mg/m2 on days 10-14 every 28 days. Their characteristics and outcomes were retrospectively analyzed. Results: In our cohort, 29 patients (16 male) with a median age of 59 (range 26 – 76) received palliative CapTem, 15 of them as first-line chemotherapy and 14 as subsequent lines. Primary tumors included pancreas (48.3%), small bowel (20.7%), lung (10.3%), unknown (10.3), rectum (6.9%) and appendix (3.4%). Median number of cycles was 3. For the entire cohort, median PFS and OS were 4.7 and 20.2 months, respectively. Although pancreatic NETs (PNETs) had shorter OS (18.8 months versus not reached, p=0.37), their PFS was longer than non-PNETs (4.9 versus 2.8 months, p=0.178). There was no difference in PFS between first or subsequent lines of therapy. Patients with Ki67 above 10% had a shorter PFS when compared to lower Ki67 (3.1 versus 5.5 months, p = 0.028). Three patients had to discontinue CapTem due to poor tolerance (2 intractable nauseas and 1 myocardial infarction). There were no treatment-related deaths. Conclusions: CapTem showed good activity among NETs, especially for PNETS, who derived the greatest benefit. Effectiveness was not exclusive to first-line therapy and seems better for well-differentiated tumors.


2019 ◽  
pp. 1-8 ◽  
Author(s):  
Rafael C. Coelho ◽  
Pedro D.P. Abreu ◽  
Mariana R. Monteiro ◽  
Ana Paula Stramosk ◽  
Alvaro Henrique I. Garces ◽  
...  

PURPOSE Gastric cancer (GC) is the fourth most common cancer and the second leading cause of cancer death worldwide. Platinum agents and fluoropyrimidines are the main compounds used in the first-line setting for advanced GC. Given the activity of fluorouracil (FU) bolus, the PFL protocol, a chemotherapy regimen combining cisplatin, FU bolus, and leucovorin, was incorporated at the Brazilian National Cancer Institute, because this schedule does not require hospitalization or infusion pumps. This study aims to evaluate the outcomes of PFL in the first-line setting for patients with advanced GC. MATERIALS AND METHODS This was a retrospective cohort study evaluating patients with advanced GC treated in the first-line setting with cisplatin 80 mg/m2 on day 1 and FU bolus 400 mg/m2 plus leucovorin 20 mg/m2 on days 1, 8, 15, and 22 every 4 weeks, from January 2008 to December 2014. RESULTS A total of 109 patients were enrolled. The median number of cycles received per patient was four (one to 11). Complete responses were achieved in 6.4% and partial responses in 14.7%. Median progression-free survival was 6.3 months (95% CI, 5.08 to 7.58 months) and median overall survival was 8.3 months (95% CI, 6.79 to 9.87 months). Thirty-four (31.2%) patients were alive in 1 year. Grade 3 and 4 adverse events were experienced by 26.6% and 3.7% of patients, respectively, with dose reduction necessary in 9.1%. CONCLUSION PFL is active in advanced GC and could be an alternative for FU continuous infusion protocols in institutions with limited resources and/or low budget, which is the reality in many nations all over the world.


2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 622-622 ◽  
Author(s):  
T. Salek ◽  
E. Sebo ◽  
D. Mazalova ◽  
J. Chovanec ◽  
M. Stresko ◽  
...  

622 Background: Cetuximab is an EGFR-targeting IgG1 monoclonal antibody that is active against EGFR-expressing Kras wild type metastatic colorectal cancer (mCRC) in monotherapy or in combination with chemotherapy. Here, we report efficacy and safety of combination of cetuximab and chemotherapy in patients (pts) with mCRC treated in major cancer centers in Slovakia from 01/2009 to 07/2010. Methods: Forty consecutive pts (28F/12M) with EGFR expressing Kras wild type mCRC (14 pts-rectal cancer, 26 pts-colon cancer) treated with irinotecan-based (29 pts-73%) and oxaliplatin-based (11 pts-27%) chemotherapy were evaluated. Median age was 59 years (44-77).17 pts were pretreated with adjuvant therapy. No of metastatic sites: 1 mts -22 pts (55%), 2 mts-13 pts (32.5%), 3 mts -5pts (12.5%). Median CEA level before therapy 13.5 (1-1,800). Results: 10 pts achieved complete remission (25%), 21 pts partial remission (52.5%), 8pts disease stabilization, 1pt disease progression. Median progression-free survival (mPFS) was 16 months, 1 year survival 65%-95% CI (50-80), median follow-up was 13 months (range 4-20m). The main Gr 3-4 toxicity was skin rash 2pts (5%) and diarrhea 2 pts (5%). Any grade toxicity: rash 32 pts (80%), diarhea 8pts (20%), neuropathy 8pts (20%), weakness 3pts (7.5%), neutropenia 2pts (5%), trombocytopenia 2pts (5%). Conclusions: Our experience confirms the efficacy and acceptable safety profile of combination chemotherapy and cetuximab in first line mCRC patients. No significant financial relationships to disclose.


2019 ◽  
Vol 105 (3) ◽  
pp. 243-252 ◽  
Author(s):  
Sara Lonardi ◽  
Guglielmo Nasti ◽  
Daniele Fagnani ◽  
Donatello Gemma ◽  
Libero Ciuffreda ◽  
...  

Aims: BEAWARE investigated the pattern of first-line bevacizumab early interruption in the Italian real-world setting of metastatic colorectal cancer. Methods: A total of 386 patients were followed for 15 months after first-line chemotherapy + bevacizumab start. The rate of bevacizumab interruption for progression or adverse drug reactions (ADRs) constituted the primary endpoint. Results: A total of 78.2% of patients interrupted bevacizumab: 56.6% for progression, 7.3% for ADRs, and 36.1% for other reasons. Median treatment duration was 6.7, 2.5, and 4.6 months, respectively. Median progression-free survival was 10.3 months; however, 35.8% of patients were not progressed and were thus censored at the data cutoff of 15 months, while 21.8% were still receiving bevacizumab. Patients discontinuing for progression/ADRs more frequently had metastases in >1 site ( p = .0001), and a shorter median progression-free survival (6.9 vs 13.9 months, p < .0001). Conclusions: In Italy, first-line bevacizumab is interrupted mainly for progression, only 7.3% due to adverse events, and about one third of cases for other reasons. In clinical practice, the attitude to treat until progression as per guidelines might be implemented. ClinicalTrials.gov Identifier: NCT01609075


2018 ◽  
Author(s):  
Nikhil Chauhan ◽  
Mary F Mulcahy ◽  
Riad Salem ◽  
Al B Benson III ◽  
Eveline Boucher ◽  
...  

BACKGROUND Colorectal cancer is one of the most common cancers and causes of cancer-related death. Up to approximately 70% of patients with metastatic colorectal cancer (mCRC) have metastases to the liver at initial diagnosis. Second-line systemic treatment in mCRC can prolong survival after development of disease progression during or after first-line treatment and in those who are intolerant to first-line treatment. OBJECTIVE The objective of this study is to evaluate the efficacy and safety of transarterial radioembolization (TARE) with TheraSphere yttrium-90 (90Y) glass microspheres combined with second-line therapy in patients with mCRC of the liver who had disease progression during or after first-line chemotherapy. METHODS EPOCH is an open-label, prospective, multicenter, randomized, phase 3 trial being conducted at up to 100 sites in the United States, Canada, Europe, and Asia. Eligible patients have mCRC of the liver and disease progression after first-line chemotherapy with either an oxaliplatin-based or irinotecan-based regimen and are eligible for second-line chemotherapy with the alternate regimen. Patients were randomized 1:1 to the TARE group (chemotherapy with TARE in place of the second chemotherapy infusion and subsequent resumption of chemotherapy) or the control group (chemotherapy alone). The addition of targeted agents is permitted. The primary end points are progression-free survival and hepatic progression-free survival. The study objective will be considered achieved if at least one primary end point is statistically significant. Secondary end points are overall survival, time to symptomatic progression defined as Eastern Cooperative Oncology Group Performance Status score of 2 or higher, objective response rate, disease control rate, quality-of-life assessment by the Functional Assessment of Cancer Therapy-Colorectal Cancer questionnaire, and adverse events. The study is an adaptive trial, comprising a group sequential design with 2 interim analyses with a planned maximum of 420 patients. The study is designed to detect a 2.5-month increase in median progression-free survival, from 6 months in the control group to 8.5 months in the TARE group (hazard ratio [HR] 0.71), and a 3.5-month increase in median hepatic progression-free survival time, from 6.5 months in the control group to 10 months in the TARE group (HR 0.65). On the basis of simulations, the power to detect the target difference in either progression-free survival or hepatic progression-free survival is >90%, and the power to detect the target difference in each end point alone is >80%. RESULTS Patient enrollment ended in October 2018. The first interim analysis in June 2018 resulted in continuation of the study without any changes. CONCLUSIONS The EPOCH study may contribute toward the establishment of the role of combination therapy with TARE and oxaliplatin- or irinotecan-based chemotherapy in the second-line treatment of mCRC of the liver. CLINICALTRIAL ClinicalTrials.gov NCT01483027; https://clinicaltrials.gov/ct2/show/NCT01483027 (Archived by WebCite at http://www.webcitation.org/734A6PAYW) INTERNATIONAL REGISTERED REPOR RR1-10.2196/11545


2020 ◽  
pp. 75-80
Author(s):  
S.A. Lyalkin ◽  
◽  
L.A. Syvak ◽  
N.O. Verevkina ◽  
◽  
...  

The objective: was to evaluate the efficacy of the first line chemotherapy in patients with metastatic triple negative breast cancer (TNBC). Materials and methods. Open randomized study was performed including 122 patients with metastatic TNBC. The efficacy and safety of the first line chemotherapy of regimens АТ (n=59) – group 1, patients received doxorubicine 60 мг/м2 and paclitaxel 175 мг/м2 and ТР (n=63) – group 2, patients received paclitaxel 175 мг/м2 and carboplatin AUC 5 were evaluated. Results. The median duration of response was 9.5 months (4.5–13.25 months) in patients received AT regimen and 8.5 months (4.7–12.25 months), in TP regimen; no statistically significant differences were observed, р=0.836. The median progression free survival was 7 months (95% CI 5–26 months) in group 1 and 7.5 months (95% CI 6–35 months) in group 2, p=0.85. Both chemotherapy regimens (AT and TP) had mild or moderate toxicity profiles (grade 1 or 2 in most patients). No significant difference in gastrointestinal toxicity was observed. The incidence of grade 3–4 neutropenia was higher in patients of group 2 (TP regimen): 42.8% versus 27% (р<0.05). Conclusions. Both regimens of chemotherapy (AT and TP) are appropriate to use in the first line setting in patients with metastatic TNBC. Key words: metastatic triple negative breast cancer, chemotherapy, progression free survival, chemotherapy toxicity.


2020 ◽  
Vol 2020 (11) ◽  
Author(s):  
Nobumasa Tamura ◽  
Yoshitaka Honma ◽  
Shigeki Sekine ◽  
Shunsuke Tsukamoto ◽  
Hidekazu Hirano ◽  
...  

ABSTRACT Amphicrine carcinoma (AmC) is a unique epithelial tumor displaying exocrine and endocrine features in the same cell. It shows an adenocarcinoma-like cellular form and has endocrine granules. There are few reports describing chemotherapy for AmC. Here, we describe a case with metastatic AmC from the rectum that was treated with FOLFOXIRI chemotherapy. A 64-year-old man was diagnosed with a submucosal lesion on the scar produced after an endoscopic mucosal resection, which had been performed for adenocarcinoma of the rectum 2 years before. The endoscopic submucosal dissection revealed AmC. The abdominoperineal resection including lymph nodes dissection was performed. Thereafter, computed tomography showed multiple liver metastases, and FOLFOXIRI was administered. The best overall response was partial response, and progression-free survival was 8.7 months. After 16.0 months since first-line chemotherapy the patient died. We can therefore conclude that FOLFOXIRI may be effective for AmC of the rectum.


Author(s):  
Sanne ten Hoorn ◽  
Dirkje W. Sommeijer ◽  
Faye Elliott ◽  
David Fisher ◽  
Tim R. de Back ◽  
...  

Abstract Background Patient selection for addition of anti-EGFR therapy to chemotherapy for patients with RAS and BRAF wildtype metastatic colorectal cancer can still be optimised. Here we investigate the effect of anti-EGFR therapy on survival in different consensus molecular subtypes (CMSs) and stratified by primary tumour location. Methods Retrospective analyses, using the immunohistochemistry-based CMS classifier, were performed in the COIN (first-line oxaliplatin backbone with or without cetuximab) and PICCOLO trial (second-line irinotecan with or without panitumumab). Tumour tissue was available for 323 patients (20%) and 349 (41%), respectively. Results When using an irinotecan backbone, anti-EGFR therapy is effective in both CMS2/3 and CMS4 in left-sided primary tumours (progression-free survival (PFS): HR 0.44, 95% CI 0.26–0.75, P = 0.003 and HR 0.12, 95% CI 0.04–0.36, P < 0.001, respectively) and in CMS4 right-sided tumours (PFS HR 0.17, 95% CI 0.04–0.71, P = 0.02). Efficacy using an oxaliplatin backbone was restricted to left-sided CMS2/3 tumours (HR 0.57, 95% CI 0.36–0.96, P = 0.034). Conclusions The subtype-specific efficacy of anti-EGFR therapy is dependent on the chemotherapy backbone. This may provide the possibility of subtype-specific treatment strategies for a more optimal use of anti-EGFR therapy.


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