Safety and efficacy of first-line XELIRI with or without bevacizumab in patients with metastatic colorectal cancer: Analysis of two phase II studies.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 560-560
Author(s):  
P. Garcia-Alfonso ◽  
S. Alvarez ◽  
A. Munoz ◽  
P. Lopez ◽  
C. Riesco ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii ◽  
Safety Data ◽  
Patient Characteristics ◽  
First Line ◽  
Two Phase ◽  
Safety And Efficacy ◽  
Phase Ii Studies

560 Background: The safety and efficacy of first-line XELIRI (capecitabine in combination with irinotecan) and XELIRI plus bevacizumab (BEV) have been evaluated in patients with metastatic colorectal cancer (mCRC). To date, however, no randomized studies comparing these regimens have been performed. This retrospective analysis compared efficacy and safety data for the two regimens from separate phase II studies performed at a single institution. Methods: Patients with histologically documented metastatic or recurrent CRC and no prior treatment for advanced disease received irinotecan 175 mg/m2 on day 1 and oral capecitabine 1,000 mg/m2 twice daily on days 2-8 every 2 weeks (XELIRI study). For patients age ≥65 years, the starting doses of irinotecan and capecitabine were reduced to 140 mg/m2 and 750 mg/m2, respectively. In the second study, patients received the same regimen plus BEV 5 mg/kg on day 1 (XELIRI + BEV study). Results: A total of 53 and 46 patients were entered into the XELIRI and XELIRI + BEV studies, respectively. Patient characteristics were generally similar in both groups. Efficacy results for the ITT populations are summarized in the Table. Patients treated with XELIRI + BEV had a significantly higher ORR and longer median TTP vs. XELIRI alone and a numerically longer median OS was observed (p=NS). The overall incidence of adverse events (all grades or grade 3/4) was similar in the two groups, although alopecia, mucositis, hand–foot syndrome, and haemorrhage were more common with XELIRI + BEV vs. XELIRI alone (all p<0.05). Conclusions: In this retrospective comparison of two studies, the addition of BEV to XELIRI appeared to improve outcome relative to XELIRI alone in the first-line treatment of patients with mCRC. The overall incidence of adverse events was similar in the two groups. [Table: see text] No significant financial relationships to disclose.

The efficacy of first-line IRIS with or without bevacizumab in patients with metastatic colorectal cancer: Analysis of two phase II studies.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e14604-e14604
Author(s):  
Satoshi Yuki ◽  
Hiraku Fukushima ◽  
Toraji Amano ◽  
Michio Nakamura ◽  
Mineo Kudo ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii ◽  
Performance Status ◽  
Safety Data ◽  
Hazard Ratio ◽  
First Line ◽  
Two Phase ◽  
Phase Ii Studies ◽  
Study Results

e14604 Background: The safety and efficacy of first-line IRIS (S-1 in combination with irinotecan; Komatsu Y, et al. Oncology, 2011) and IRIS/Bev (IRIS in combination with bevacizumab (Bev); Komatsu Y, et al. Acta Oncol, 2012/Yuki S, et al. 2013 ASCO-GI) have been evaluated in patients with metastatic colorectal cancer (mCRC). This time, no randomized studies comparing these regimens have been performed. This retrospective analysis compared efficacy and safety data for the two regimens from separate phase II studies performed at Hokkaido Gastrointestinal Cancer Study Group (HGCSG). Methods: Patients with histologically confirmed unresectable metastatic or recurrent CRC and received no prior chemotherapy were enrolled. In the first trial, patients received irinotecan 100 mg/m2 on day 1,15 and oral S-1 40 mg/m2 twice daily on days 1-14 every 4 weeks (IRIS study: HGCSG0302). In the second trial, patients received the same regimen plus Bev 5 mg/kg on day 1,15 (IRIS/Bev study). Results: A total of 40 and 52 patients were enrolled the IRIS and IRIS/Bev studies, respectively. Patient characteristics were generally similar in both groups, whereas there were more cases of good performance status and less number of metastatic organ in IRIS/Bev group. The median overall survival was 39.6 months in IRIS/Bev, as compared with 23.4 months in IRIS, corresponding to a hazard ratio for death of 0.418 (p<0.001). The median progression-free survival was 17.0 months in IRIS/Bev, as compared with 8.6 months in IRIS (hazard ratio for disease progression, 0.418; p<0.001); the corresponding response rate were 63.5 percent and 52.5 percent (p=0.393).In a multivariate analysis of PFS and OS, IRIS/Bev (n=52) was significantly associated with longer PFS and OS compared with IRIS alone (n=40). Conclusions: In this retrospective comparison of two studies, the addition of Bev to IRIS appeared to improve outcome compared with IRIS alone in the first-line treatment of patients with mCRC.

The efficacy of first-line IRIS with or without bevacizumab in patients with metastatic colorectal cancer: Including multivariate analysis of two phase II studies.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 603-603
Author(s):  
Satoshi Yuki ◽  
Yoshito Komatsu ◽  
Hiraku Fukushima ◽  
Takahide Sasaki ◽  
Yoshimitsu Kobayashi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Multivariate Analysis ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii ◽  
Performance Status ◽  
Hazard Ratio ◽  
First Line ◽  
Two Phase ◽  
Phase Ii Studies ◽  
Study Results

603 Background: The safety and efficacy of first-line IRIS (S-1 in combination with irinotecan) and IRIS/Bev (IRIS in combination with bevacizumab [Bev]) have been evaluated in patients with metastatic colorectal cancer (mCRC). To date, no randomized studies comparing these regimens have been performed. This retrospective analysis compared efficacy data for the two regimens from separate phase II studies performed at Hokkaido Gastrointestinal Cancer Study Group (HGCSG). Methods: Patients with histologically confirmed unresectable metastatic or recurrent CRC and received no prior chemotherapy were enrolled. In the first trial, patients received irinotecan 100 mg/m2 on day 1,15 and oral S-1 40 mg/m2 twice daily on days 1-14 every 4 weeks (IRIS study: HGCSG0302). In the second trial, patients received the same regimen plus Bev 5 mg/kg on day 1,15 (IRIS/Bev study). Results: A total of 40 and 52 patients were enrolled the IRIS and IRIS/Bev studies, respectively. Patient characteristics were generally similar in both groups, whereas there were more cases of good performance status and less number of metastatic organ in IRIS/Bev group. The median overall survival was 39.6 months in IRIS/Bev, as compared with 23.4 months in IRIS, corresponding to a hazard ratio for death of 0.418 (p<0.001). The median progression-free survival was 17.0 months in IRIS/Bev, as compared with 8.6 months in IRIS (hazard ratio for disease progression, 0.402; p < 0.001); the corresponding response rate were 63.5 percent and 52.5 percent (p = 0.393). In a multivariate analysis of PFS and OS, IRIS/Bev was significantly associated with longer PFS and OS compared with IRIS alone. Conclusions: In this retrospective comparison of two studies, the addition of Bev to IRIS appeared to improve outcome compared with IRIS alone in the first-line treatment of patients with mCRC.

scholarly journals An Open‐Label Phase II Study Evaluating the Safety and Efficacy of Ramucirumab Combined With mFOLFOX‐6 as First‐Line Therapy for Metastatic Colorectal Cancer

2014 ◽  
Vol 19 (4) ◽  
pp. 350-351 ◽  
Author(s):  
Rocio Garcia‐Carbonero ◽  
Fernando Rivera ◽  
Joan Maurel ◽  
Jean‐Pierre M. Ayoub ◽  
Malcolm J. Moore ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
First Line ◽  
Open Label ◽  
Safety And Efficacy ◽  
First Line Therapy ◽  
Line Therapy ◽  
Open Label Phase

Prescribing patterns for bevacizumab in first-line metastatic colorectal cancer: Exploring the introduction of a new drug into routine clinical practice.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 665-665 ◽  
Author(s):  
Kathryn Maree Field ◽  
Jayesh Desai ◽  
Jeanne Tie ◽  
Suzanne Kosmider ◽  
Susie Bae ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Metastatic Colorectal Cancer ◽  
Clinical Care ◽  
Safety Data ◽  
Prescribing Patterns ◽  
Trial Participation ◽  
Poor Performance Status ◽  
First Line ◽  
Line Chemotherapy

665 Background: Clinical trials support the addition of bevacizumab (Bev) to first line chemotherapy for metastatic colorectal cancer (mCRC). However, given that there are alternate biological agents that can be used with chemotherapy; and rare but potentially serious toxicities with Bev, there has been variable use of the drug in routine care. The purpose of this study was to prospectively explore 1st line use of Bev in routine clinical care. Methods: A multi-site data collection was initiated in July 2009 when Bev became publicly available in Australia. A particular focus was capturing information regarding clinician decision-making that is not routinely recorded or is often poorly documented. Comprehensive comorbidity data was collected, along with specific factors, both patient (pt) and disease-related, that may impact on treatment decisions. Major adverse events that may be related to Bev were also recorded. Results: For the 2-year period from July 2009-June 2011, a database search identified 278 pts diagnosed with mCRC at five participating hospitals. 240 pts (86%) had received 1st line chemotherapy. 102 (43%) also received Bev, the majority in combination with oxaliplatin based chemotherapy (n = 81, 79%). Bev use increased significantly from 40.4% (34/84) of all pts receiving chemotherapy in July-December 2009, to 65.8% (25/38) in January-June 2011 (p=0.0114). Overall the most frequent reasons for clinicians advising against the use of Bev were a bleeding or asymptomatic primary in situ (n=28, 23%), known hypertension (n=14, 11%), clinical trial participation (n=14, 11%), poor performance status (n=9, 7%), and perceived risk of arterial ischemic event (n=8, 6.5%). There have been four episodes of gastro-intestinal perforation, 3 in pts receiving Bev (2.9% of Bev treated patients). Conclusions: Bev use in first line mCRC has significantly increased over time, presumably as further positive safety data emerges regarding safety in older and frailer pts, and clinician prescribing experience increases. The major grounds for not using Bev in the 1st line mCRC setting were specific clinical contexts where the risk of adverse events may be increased.

Phase I/II study of capecitabine plus irinotecan (XELIRI) in combination with bevacizumab as first-line therapy in metastatic colorectal cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13504-13504
Author(s):  
I. Kocakova ◽  
S. Spelda ◽  
I. Kocak ◽  
R. Demlova ◽  
M. Simickova ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Phase I ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii ◽  
Performance Status ◽  
Hematologic Toxicity ◽  
Response Evaluation ◽  
First Line ◽  
Pretreatment Level ◽  
Phase Ii Studies

13504 Background: First-line treatment of metastatic colorectal cancer (MCRC) is based on regimens combining oxaliplatin or irinotecan with intravenous 5-fluorouracil (5-FU) and leucovorin (FOLFOX or FOLFIRI/IFL). A few phase II studies of capecitabine with irinotecan (XELIRI) proved to be comparable to FOLFIRI. Methods: A phase I/II study was conducted to assess the efficacy and tolerability of XELIRI + bevacizumab in MCRC. Indication for the therapy: histologically confirmed colorectal adenocarcinoma, metastatic inoperable disease, no prior systematic therapy for metastases, performance status 0–1, normal hematological, biochemical parameters, no other malignity. Therapy consisted of capecitabine 1000mg/m2 bid on days 2–15 and intravenous irinotecan 250mg/m2 on day 1, bevacizumab 7.5mg/kg on day 1, q 21 days. The response was evaluated after 2 or 3 cycles by RECIST criteria. Results: From March 2005 to December 2005 14 patients (pts) 9 males, 5 females with median age 53 years (range 39–67) have been included. 9 pts were initially disseminated, 5 pts relapsed after adjuvant therapy. Liver metastases were in 12 pts, number of metastatic sites was from 1 to 4, median 2. The overall number of cycles was 96, range 2–13, median 7 cycles. 13 pts have been evaluable for response. The CR occurred in 1 (7%) patient, PR in 10 (77%) pts, SD in 2 pts. During therapy CEA and Ca19–9 declined in all pts. Pretreatment level of CEA: median 32 μg/l, range: 2.4 - 9 265 μg/l. CEA at the response evaluation: median 5.3 μg/l, range: 1.2 - 573 μg/l. Pretreatment level of Ca19–9: median 119,7 kU/l, range: 0 - 4 692. kU/l. Ca19–9 at the response evaluation: median 17.4 kU/l, range: 0–666 kU/l. The toxicity: epistaxis in 1 patient, proteinuria < 1 gram / day in 2 pts and granulocytopenia G3 in 1 patient. No other hematologic toxicity > G2 has occurred. The therapy has been continued in all pts so far with median time of therapy 6 months. The time to disease progression and overall survival has not been reached yet. Conclusions: Irinotecan / capecitabine + bevacizumab has shown high efficacy with response rate 84% and low toxicity. The regimen seems to be appropriate for using in further phase II studies. No significant financial relationships to disclose.

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