Association of bevacizumab-free interval with efficacy of anti-EGFR therapy in patients with metastatic colorectal cancer.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 610-610
Author(s):  
Azusa Komori ◽  
Hiroya Taniguchi ◽  
Yukiya Narita ◽  
Shiori Uegaki ◽  
Sohhei Nitta ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Short Interval ◽  
Progression Free Survival ◽  
Patient Characteristics ◽  
Free Interval ◽  
Significant Difference ◽  
Group A ◽  
Group B

610 Background: Both bevacizumab (Bev) and anti-EGFR agents are sequentially used for metastatic colorectal cancer (mCRC). Some basic studies reported the interaction between Bev and anti-EGFR agents in vivo. Therefore we hypothesized the shorter Bev-free interval may lead to poor outcome of anti-EGFR therapy. The aim of this study is to examine the association of the interval between last Bev administration and initial anti-EGFR agents with efficacy of anti-EGFR therapy. Methods: We retrospectively reviewed consecutive mCRC patients who underwent combination therapy of anti-EGFR agents and irinotecan after failure of fluoropyrimidines, oxaliplatin, irinotecan, and Bev at a single institution. We divided patients in two groups (group A: the interval between Bev and anti-EGFR agents <6M, group B: ≥6M). Results: A total of 114 patients constituted the cohort of analysis. The median age was 63; 78 (68%) patients were male. Most patients (N=100, 88%) were treated with cetuximab, and 14 patients were panitumumab. Seventy-four patients were group A and 40 patients group B, respectively. There was no significant difference in patient characteristics. Response rate was 24.7% in group A, and 50.0% in group B (p=0.0072). The patients in group B have significantly longer progression free survival (4.2 vs. 6.6 M, HR 0.65, 95% CI 0.43- 0.98, p=0.042) and longer overall survival (11.6 vs. 14.3 M, HR 0.62, 95% CI 0.39- 0.97, p=0.038). Conclusions: The short interval (<6M) between last Bev and anti-EGFR agents may interfere with the efficacy of anti-EGFR therapy.

Survival outcome of bevacizumab followed by cetuximab in metastatic colorectal cancer patients.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 529-529
Author(s):  
Kozo Kataoka ◽  
Akiyoshi Kanazawa ◽  
Akio Nakajima ◽  
Hisahiro Hosogi ◽  
Seiitirou Kanaya ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Metastatic Colorectal Cancer ◽  
Progression Free Survival ◽  
Median Number ◽  
Targeted Agents ◽  
First Line ◽  
Group A ◽  
Molecular Targeted Agents ◽  
Group B

529 Background: The molecular targeted agents, such as bevacizumab and cetuximab have been shown to improve overall survival of metastatic colorectal cancer (mCRC) patients. However, we still do not know what sequence is best to use the molecular targeted agents for mCRC especially in K-ras wild case. In this analysis, we evaluate the benefits of using bevacizumab followed by cetuximab for mCRC patients retrospectively. Methods: From July 2006 to September 2010, 60 chemotherapy-naive patients who were diagnosed as mCRC, received oxaliplatin based regimen for first line, did not respond to bevacizumab containing regimen used for first line or second line, and received cetuximab or continued bevacizumab, were eligible for this analysis. 28 patients received cetuximab as third line or fourth line chemotherapy due to K-ras wild type (Group A). And 32 patients continued bevacizumab-containing regimen in spite of disease progression (Group B). Results: The median number of cycles of bevacizumab containing regimen were 9 (range, 2-30) in group A and 8 (range, 2-27) in group B, and cetuximab 12(range, 3-32) in group A. The difference of the rate of serious adverse effects was not significant between two groups. Median overall survival was significantly higher in Group A than Group B (31.2 months (95%CI: 23.2-39.3 months) and 27.0 month (95%CI: 17.2-37.6), respectively) (P<0.001). Partial response rate of cetuximab was 18%(5/28) in group A. Median progression free survival of cetuximab in group A was 4.3 months (95%CI: 2.62- 6.06). Conclusions: Using cetuximab after progression with bevacizumab might be effective sequence to improve the overall survival of K-ras wild mCRC patients. But we need further prospective study to look for the best sequence in chemotherapy for mCRC patients.

Treatments (tx) after progression to first-line FOLFOXIRI plus bevacizumab (bev) in metastatic colorectal cancer (mCRC) patients (pts): A pooled analysis of TRIBE and MOMA studies by GONO group.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3542-3542 ◽  
Author(s):  
Daniele Rossini ◽  
Roberto Moretto ◽  
Chiara Cremolini ◽  
Vittorina Zagonel ◽  
Giuseppe Tonini ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Disease Progression ◽  
Pooled Analysis ◽  
First Line ◽  
Aggressive Disease ◽  
Free Interval ◽  
Disease Biology ◽  
Significant Difference ◽  
Group A ◽  
Group B

3542 Background: FOLFOXIRI plus bev is regarded by international guidelines as a valuable option in the first-line tx of mCRC pts. One of the major concerns for the adoption of this regimen is the potential limitation of subsequent therapeutic options. The aim of the present analysis was to focus on treatments received after progression in TRIBE (NCT00719797) and MOMA (NCTNCT02271464) studies. Methods: We collected data of tx received after progression and their outcome in terms of 2ndPFS (time from 2nd line tx start to disease progression or death) and OS II (time from 2nd line tx start to death). For pts in which the same drugs used in first-line were totally or partially reintroduced, the chemotherapy-free interval (CFI, time from the last administration of irinotecan or oxaliplatin during first-line to disease progression) was calculated. Results: Out of 482 pts treated with upfront FOLFOXIRI plus bev, 429 progressed. 303 (70.6%) pts received a 2nd line tx: 93 FOLFOXIRI +/- bev (Group A), 119 FOLFOX/XELOX or FOLFIRI +/- bev (Group B) and 91 other tx (Group C), including an anti-EGFR moAb in 60 cases. No difference was observed among the three groups in terms of 2ndPFS (median 2nd PFS Group A: 5.6 vs Group B: 4.4 vs Group C: 3.9 mos; p = 0.60) or OS II (median OS II Group A: 14.9 vs Group B: 13.8 vs Group C: 11.7 mos; p = 0.49). In the subgroup of pts with a CFI < 6 mos, Group A (n = 52) reported longer 2ndPFS compared to both Group B (n = 58) (median 2ndPFS 5.3 vs 3.0 mos; HR: 0.61,95%CI 0.41-0.89; p = 0.009) and Group C (n = 58) (5.3 vs 3.2 mos; HR: 0.71, 95%CI 0.48-1.05; p = 0.07). Consistent results were achieved in OS II (Group A vs Group B; median OS 13.6 vs 10.8 mos; HR: 0.65, 95%CI 0.42-1.00; p = 0.053; Group A vs Group C 13.6 vs 8.9 mos; HR: 0.60, 95%CI 0.39-0.93; p = 0.002). In the subgroup of pts with a CFI ≥ 6 mos, no significant difference was shown between Group A (n = 41) and Group B (n = 61) or C (n = 33). Conclusions: Tx after progression to first-line FOLFOXIRI plus bev are feasible and show expected efficacy results. The reintroduction of the triplet plus bev seems more effective than doublets plus bev or other tx when a more aggressive disease biology is suggested (CFI < 6 mos).

A Comparative Study of Epidemiology, Clinicopathologic Features and Outcome of Colorectal Cancer Patients between Ain Shams University Hospitals and Luxor International Hospital

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Tarek Hussein Kamel ◽  
Amr Lotfy Farag ◽  
Dr/Sherif Hassanin Ahmed ◽  
Chresteen Talaat Samy Hanna
Keyword(s):  
Colorectal Cancer ◽  
Comparative Study ◽  
Disease Free Survival ◽  
University Hospital ◽  
Treatment Modalities ◽  
Clinicopathologic Features ◽  
Free Survival ◽  
Significant Difference ◽  
Group A ◽  
Group B

Abstract Background Colorectal cancer (CRC) is one of the leading causes of mortality and morbidity in the world. It is the third most common malignancy after lung & breast and the fourth leading cause of cancer-related deaths worldwide, accounting for approximately 1,400,000 new cases and about 700,000 deaths worldwide. Objectives The aim of this retrospective study is to compare the epidemiology, clinicopathologic features, different treatment modalities and outcomes regarding disease free survival (DFS), progression free survival (PFS) & overall survival (OS) of colorectal cancer disease between cases presented to Ain shams university hospital & to Luxor international hospital in 3 consecutive years. Patients and Methods The study is retrospective comparative study. Clinical oncology department in Ain Shams University Hospital and Luxor International Hospital. The data Collected from January 2013 to December 2015. This study analyzed hospital records of patients who diagnosed with colorectal cancer (CRC) and allocated into two groups: Group A: CRC patients presented to Ain-Shams University Hospital from January 2013 to December 2015, group B: CRC patients presented to Luxor International Hospital from January 2013 to December 2015. Results There was no statistically significant difference regarding age parameter in LIH when compared to ASU, but the study was consistent with higher incidence in patients who were aged more than forty- accounted about 70.5% in all CRC cases. Cases less than 40 years old, in group A were 35.2%, while in Group B were 23.5%. Even there was no statistically significant difference but it may be attributable to more westernization in Lower Egypt. Other explanation may be due to decreased low socioeconomic status and different lifestyle factors in more developing region what increase risk of colorectal cancer. Among our cases, there is no statistically significant difference regarding gender between the two hospitals. Both sexes almost were affected equally, females appeared to be at a slightly higher risk of developing CRC cancer with current prevalence 1.3:1 in ASU group, and 1.1:1 in LIH group. Conclusion The need to increase awareness about CRC in Egypt especially upper Egypt, is recommended. An awareness campaign should be performed to promote detection of CRC at its earliest and most curable stage by recognizing early symptoms and enabling early referrals for colonoscopy. Those at higher risk should be offered more intensive surveillance. Similarity of the data from different centers suggests that this is the picture of colorectal cancer typical of Egypt.

scholarly journals Cisplatin, Cetuximab, and Radiation in Locally Advanced Head and Neck Squamous Cell Cancer: A Retrospective Review

2015 ◽  
Vol 9 ◽  
pp. CMO.S18682 ◽  
Author(s):  
Prakash Peddi ◽  
Runhua Shi ◽  
Binu Nair ◽  
Fred Ampil ◽  
Glenn M. Mills ◽  
...  
Keyword(s):  
Head And Neck ◽  
Performance Status ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Rank Test ◽  
Advanced Head ◽  
Significant Difference ◽  
Group A ◽  
Group B

Efficacy of cisplatin versus cetuximab with radiation in locally advanced head and neck cancer (LAHNC) was evaluated. A total of 96 patients with newly diagnosed LAHNC treated at our institution between 2006 and 2011 with concurrent radiation and cisplatin (group A, n = 45), cetuximab (group B, n = 24), or started with cisplatin but switched to cetuximab because of toxicity (group C, n = 27) were reviewed. Chi-square test, analysis of variance, and log-rank test were used for analysis. The three groups had similar baseline characteristics, except for median age, T stage, albumin levels, hemoglobin levels, performance status, and comorbidities. A complete response (CR) was seen in 77%, 17%, and 67% of patients ( P < 0.001), respectively. There was no significant difference in median overall survival (OS) between groups A and C. The median OS for groups A and C was not reached (>65 months), even though it was significantly longer than median OS for group B (11.6 months; P ≤ 0.001). The 2-year OS in groups A and C is significantly higher than that in group B (70% for groups A and C, 22% for group B). There is no significant difference in progression-free survival (PFS) between groups A and C. The median PFS for these groups was not reached (>62 months), and is significantly longer than that for group B (4.3 months; P ≤ 0.001). The 2-year PFS of group A (67%) and group C (76%) was significantly longer than that of group B (20%). Cisplatin with radiation appears to be more efficacious even in suboptimal dosing than cetuximab with radiation in LAHNC but the two groups were not well matched.

Chemotherapy-free interval following initial chemotherapy in patients with stage IV colorectal cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15096-e15096
Author(s):  
G. Melmed ◽  
C. Becerra ◽  
G. Saracino ◽  
E. Bowman ◽  
A. D. McCollum
Keyword(s):  
Colorectal Cancer ◽  
Medical Center ◽  
Financial Burden ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Response Duration ◽  
Initial Response ◽  
Patient Characteristics ◽  
Health Care Economics ◽  
Free Interval

e15096 Background: Patients with metastatic colorectal cancer (mCRC) have improved survival due to recent advances in systemic therapy. It remains unclear whether patients responding to initial chemotherapy can be offered a chemotherapy free interval (CFI) without compromising survival. An initial CFI is potentially beneficial from a quality of life and health care economics standpoint. Methods: We studied patients with mCRC treated at Baylor University Medical Center (Dallas, TX) who had a CFI after first-line chemotherapy. Eligible patients had unresectable mCRC and had stable or responding disease after initial chemotherapy. Records were analyzed to record patient characteristics, chemotherapy details, initial response, duration of CFI, progression free survival (PFS), and overall survival (OS). Results: We identified 29 eligible patients treated between 11/02 and 11/08. Analyses are based on data from 8/08. Patient characteristics included: median age 63 (range 34–81), M/F 16/13, ECOG PS 0 (9) or 1 (20), and median number of sites of disease 2 (range 1–7). Initial chemotherapy regimens included mFOLFOX6 with or without bevacizumab (10), FOLFIRI/bevacizumab (12), XELOX/bevacizumab (2), 5-fluorouracil/leucovorin/bevacizumab (3), and capecitabine with or without bevacizumab (2). With a median follow-up of 31.1 months, the median duration of CFI was 8.0 months (95% CI: 4.3–9.6). In addition, the median OS was 33.7 months (95% CI: 27.8 -56.3) and PFS was 15.0 months (95% CI: 9.4–21.4). Conclusions: In this selected group of patients with mCRC, we found a CFI of 8 months. The OS nearing 34 months and PFS of 15 months compares favorably with other studies of patients treated for mCRC. An initial CFI may reduce the medical and financial burden of therapy for patients with mCRC without compromising outcomes and warrants further study. [Table: see text]

Phase 2 study of pembrolizumab in combination with azacitidine in subjects with metastatic colorectal cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3054-3054 ◽  
Author(s):  
James J. Lee ◽  
Weijing Sun ◽  
Nathan Bahary ◽  
James Ohr ◽  
John C. Rhee ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
T Cells ◽  
Metastatic Colorectal Cancer ◽  
Tumor Progression ◽  
Progression Free Survival ◽  
Phase 2 ◽  
Anti Tumor Activity ◽  
Study Therapy

3054 Background: Microsatellite stable (MSS) metastatic colorectal cancer (mCRC) has relatively poor tumoral infiltration of CD8+ T cells and is resistant to pembrolizumab (Pembro) when compared to MSI-H mCRC. DNA hypomethylating agent induces epigenetic expression of multiple genes including cancer-testis antigens in CRC, which are recognized by cytotoxic CD8+ T cells in vitro and in vivo. This trial tested whether concurrent treatment with azacitidine (Aza) could enhance the anti-tumor activity of Pembro. Methods: This is a phase 2 trial to evaluate anti-tumor activity and safety of Pembro plus Aza in patients (pts) with previously treated mCRC without any further standard chemotherapy option. Pts received Pembro 200 mg IV on day 1 of each cycle Q3W and Aza 100 mg daily SQ injection on days 1-5 of each cycle Q3W. Primary endpoint was response rate (ORR) using RECIST v1.1. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). Tumor tissues were collected for correlative studies. Results: Thirty-one pts were enrolled [median age, 61 years (range, 30-79); 17 M/14 F; ECOG PS 0/1 (58%/42%); 30 pts with MSS mCRC]. Pts received at least 2 lines of prior systemic chemotherapy for mCRC (median, 3; range, 1-5). Thirty pts received at least one dose of study therapy (median, 3 cycles; range, 1-8). Ten pts could not complete the first 3 cycles due to rapid symptomatic tumor progression. One pt with MSS mCRC achieved PR and 3 pts had SD as best response. The ORR was 3% (1/30; 95% CI, 0.1-17%). Seven pts with PD at the end of cycle 3 continued on study therapy, and 2 pts had stabilization of tumor progression. Median PFS was 2.1 months (95% CI, 1.8-2.8), and median OS was 6.2 months (95% CI, 3.5-8.7). While treatment-related adverse events (TRAEs) were reported in 63% of pts, most of the TRAEs were Gr 1/2 (96%). Frequent TRAEs possibly related to Aza were anemia (n = 5), constipation (n = 5), and leukopenia (n = 4); and possibly related to both Aza and Pembro were nausea (n = 5) and fatigue (n = 5). Gr 3 TRAEs included anemia (n = 1), ALT elevation (n = 1), and alkaline phosphatase elevation (n = 1). Conclusions: Pembro plus Aza is feasible with a tolerable safety profile but appears to have minimal anti-tumor effect for MSS mCRC. Clinical trial information: NCT02260440.

Efficacy of panitumumab plus irinotecan versus cetuximab plus irinotecan in patients with wild-type KRAS exon2 metastatic colorectal cancer previously treated with bevacizumab within 6 months.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 800-800 ◽  
Author(s):  
Kaori Hayashi ◽  
Seiichiro Mitani ◽  
Hiroya Taniguchi ◽  
Satoshi Hamauchi ◽  
Keiji Sugiyama ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Short Interval ◽  
Tumor Resection ◽  
Progression Free Survival ◽  
Interval Methods ◽  
Inclusion Criteria ◽  
Wild Type ◽  
Previously Treated ◽  
Ecog Ps

800 Background: The ASPECCT study showed panitumumab (Pmab) is non-inferior to cetuximab (Cmab) for chemotherapy-refractory and intolerant wild-type (WT) KRAS exon2 metastatic colorectal cancer (mCRC). In the subgroup analysis, Pmab provided more favorable outcomes than Cmab for patients (pts) previously treated with bevacizumab (Bmab). However, some reports suggested that anti-EGFR antibody (anti-EGFR) efficacy was reduced when received within 6 months of last administration of Bmab. In this study, we aim to evaluate the difference in efficacy between Pmab and Cmab in pts who received prior Bmab and were treated with anti-EGFR after a short interval. Methods: We retrospectively evaluated pts treated with anti-EGFR and irinotecan (IRI) after failure of Bmab, fluoropyrimidine, oxaliplatin, and IRI at two institutions. The main inclusion criteria were WT KRAS exon2 mCRC, ECOG PS 0-2, and no prior administration of anti-EGFR within 6 months after Bmab. Results: From Sep. 2008 to Mar. 2016, 124 consecutive pts met the inclusion criteria (Pmab/Cmab, 30/94). Pts’ characteristics were as follows (Pmab/Cmab): median age (range): 63/62 (38-76/27-82); male, 63%/72%; ECOG PS 0, 43%/27%; PS1, 57%/66%; PS2 0%/7%; tumor in left colon, 87%/76%; histology (por, muc), 10%/16%; ≥2 metastases, 67%/66%; ≥1 subsequent therapy, 73%/63%. Overall response and disease control rates in Pmab/Cmab were 31%/26% and 69%/67%, respectively. In Pmab/Cmab, the median overall survival was 15.8/12.2 months (HR, 0.62; 95% CI, 0.4-0.97; P=0.04) and the median progression-free survival was 6.5/5.5 months (HR, 0.75; 95% CI, 0.49-1.16, P=0.20). The adjusted HR with 10 covariates such as age, gender, PS, tumor location, histology, primary tumor resection, number of metastatic sites, liver limited disease, time from diagnosis of metastasis and initiation date of anti-EGFR plus IRI was 0.61 for PFS (p=0.1) and 0.61 for OS (p=0.04). Conclusions: Pmab plus irinotecan showed favorable outcomes compared with Cmab plus irinotecan in pts with WT KRAS exon2 mCRC within 6 months between the last administration of Bmab and initial anti-EGFR.

Weekly high-dose leucovorin versus low-dose leucovorin combined with fluorouracil in advanced colorectal cancer: results of a randomized multicenter trial. Study Group for Palliative Treatment of Metastatic Colorectal Cancer Study Protocol 1.

1996 ◽  
Vol 14 (8) ◽  
pp. 2274-2279 ◽  
Author(s):  
E Jäger ◽  
M Heike ◽  
H Bernhard ◽  
O Klein ◽  
G Bernhard ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Side Effects ◽  
Metastatic Colorectal Cancer ◽  
Low Dose ◽  
Multicenter Trial ◽  
World Health ◽  
High Dose ◽  
Who Grade ◽  
Group A ◽  
Group B

PURPOSE To determine the most effective dose of leucovorin (folinic acid [FA]) within a weekly bolus fluorouracil (FU) schedule, we conducted a randomized multicenter trial to compare therapeutic effects and toxicity of high-dose FA versus low-dose FA combined with FU at equal doses in both treatment groups. PATIENTS AND METHODS Patients with measurable inoperable or metastatic colorectal cancer were randomized to receive weekly FU 500 mg/m2 by intravenous (IV) bolus combined with high-dose FA 500 mg/m2 (group A) or low-dose FA 20 mg/m2 (group B) by 2-hour infusion. RESULTS Of 291 assessable patients (group A, n = 148; group B, n = 143), we observed, in group A, complete response (CR)/partial response (PR) in 32 (21.6%), no change (NC) in 64 (43.2%), and progressive disease (PD) in 52 (35.1%); and in group B, CR/PR in 25 (17.5%), NC in 63 (44.1%), and PD in 55 (38.5%). The median response duration was 24.8 weeks in group A and 23.1 weeks in group B. Median progression-free intervals were 29.3 weeks (group A) and 30 weeks (group B). The median survival time was 55.1 weeks in group A and 54.1 weeks in group B. Overall toxicity was moderate. Mild nausea and vomiting, and stomatitis were common side effects in both groups. The incidence of World Health Organization (WHO) grade III/IV diarrhea was significantly higher in group A (40 v 23 patients). Severe side effects were observed only in a minority of patients in both arms. WHO grade IV diarrhea was observed in seven patients: four in group A and three in group B. The rate of toxicity-related adjustments of dose and schedule was comparable in both groups. CONCLUSION High-dose FA/FU is not superior to low-dose FA/FU within a weekly treatment schedule. Response rates and survival were comparable in both treatment arms. Treatment-related toxicity was higher in group A (high-dose FA). Therefore, low-dose FA combined with weekly FU may be considered the preferred treatment for metastatic colorectal cancer.

Retrospective cohort study on the safety and efficacy of panitumumab for patients with metastatic colorectal cancer: The HGCSG1002 study—Analysis of after cetuximab refractory.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 541-541
Author(s):  
Yoshimitsu Kobayashi ◽  
Hiraku Fukushima ◽  
Takahide Sasaki ◽  
Satoshi Yuki ◽  
Hiroyuki Okuda ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Progression Free Survival ◽  
Daily Practice ◽  
Free Survival ◽  
Naive Group ◽  
Significant Difference ◽  
Heavily Pretreated ◽  
Grade 3 ◽  
Egfr Antibody

541 Background: In the previous studies, panitumumab (Pmab) has been demonstrated the efficacy for patients with metastatic colorectal cancer (mCRC) in all treatment lines. It is still controversial about the efficacy of Pmab for patients that had progressed on prior cetuximab (Cmab), though there had been a few reports (from Metges et al. and Wadlow et al.) regarding the efficacy of Pmab after Cmab refractory or intolerance. To evaluate the efficacy and safety of Pmab in patients with cetuximab-refractory mCRC, in comparison with anti-EGFR antibody naïve patients (Cmab-naïve) and Cmab-refractory or intolerance patients (prior-Cmab). Methods: Two hundred patients with mCRC treated by Pmab contained chemotherapy were retrospectively registered from 20 centers in Japan (HGCSG 1002 study). Of these, the patients that were refractory to or intolerant for 5-FU/ irinotecan/ oxaliplatin, and were administered Pmab monotherapy were included in this analysis. Results: Of 93 patients (44 prior-Cmab and 49 Cmab-naïve) were evaluated. There were no significant differences in the baseline characteristics of the patients in each group. The incidence of Grade 3 or higher any skin toxicities were higher in the Cmab-naïve (26.5.%) than in the prior-Cmab (11.4%). The overall response rate (RR) was not significantly difference (prior-Cmab/ Cmab-naïve, 9.1%/ 10.2%), but the disease control rate (DCR) was slightly higher in Cmab-naïve group (38.6%/ 55.1%, p=0.15). Progression free survival (PFS) and overall survival (OS) were follows: prior-Cmab/ Cmab-naïve, 2.8m/ 3.1m, 6.8m / 9.5m. There was a significant difference between the two groups in OS curve (p=0.04). Conclusions: Pmab was safely administered to heavily pretreated mCRC patients in daily practice. Although there were no significant differences in RR, DCS and PFS between prior-Cmab and Cmab-naïve, but the median OS was longer for the Cmab-naïve group compared with the prior-Cmab group. Therapeutic efficacies of Pmab for prior-Cmab patients did not comparable to those for Cmab-naïve patients. We are now performing a phase II trial on the efficacy of Pmab for Cmab-refractory mCRC patients.

LDH serum levels as a predictive factor for global outcome in pretreated colorectal cancer patients receiving regorafenib: Implications for clinical management.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 497-497 ◽  
Author(s):  
Michela Del Prete ◽  
Mario Scartozzi ◽  
Tiziana Prochilo ◽  
Luca Faloppi ◽  
Riccardo Giampieri ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Outcome ◽  
Cancer Patients ◽  
Progression Free Survival ◽  
Serum Levels ◽  
Roc Curve Analysis ◽  
Group A ◽  
Group B ◽  
Colorectal Cancer Patients

497 Background: Although a demonstrated clinical efficacy, a non negligible proportion of colorectal cancer patients does not seem to benefit from regorafenib and are consequently exposed to unnecessary toxicity. LDH serum levels represent an indirect marker of tumour hypoxia, neo-angiogenesis and worse prognosis in many tumour types. In colorectal cancer LDH showed a correlation with treatment outcome for patients receiving antiangiogenetic treatment, thus suggesting a possible interaction with the activity profile of these drugs. We analyzed the role of LDH serum levels in predicting clinical outcome for pre-treated metastatic colorectal cancer patients receiving regorafenib. The final aim was to individuate a potentially reliable and easy to use marker for patients stratification. Methods: 118 colorectal cancer patients treated with regorafenib were available for our analysis. For all patients, LDH values were collected within one month before the procedure and after treatment end. LDH cutoff value was determined by ROC curve analysis, patients were then divided into two groups (A and B, below and above cut-off level respectively). Patients were also classified according to the variation in LDH serum levels pre- and post-treatment (increased patients vs. decreased patients). Results: Patients in group A and B proved homogeneous for all clinical characteristics analyzed. In group A patients median progression free survival (PFS) was 3.18 months, whereas it was 1.87 months in group B patients (p = 0.0018). Median overall survival (OS) was 6.23 months and 3.28 months in group A and B respectively (p = 0.048). Significant differences were not noted among the 2 groups for response rate. All the other clinical variables analyzed failed to show any correlation with patients outcome. Conclusions: Our observations seem to suggest a role of LDH as a marker of clinical outcome in colorectal cancer patients receiving regorafenib. We can then speculate that high LDH patients may not be optimal candidates for regorafenib. After further confirmation in larger trial, these findings may be relevant for a better patients stratification and selection.

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