Efficacy of sorafenib in symptomatic patients with pretreated progressive desmoid tumors.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e23556-e23556
Author(s):  
Ferhat Ferhatoglu ◽  
Nail Paksoy ◽  
Izzet Dogan ◽  
Naziye Ak ◽  
Metin Pehlivan ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Systemic Therapy ◽  
Performance Status ◽  
Progression Free Survival ◽  
Desmoid Tumors ◽  
Ecog Performance Status ◽  
Abdominal Tumor ◽  
Free Survival ◽  
Gardner Syndrome ◽  
History Of

e23556 Background: Desmoid tumor (DT) is a rare disease characterized by histologically monoclonal fibroblastic proliferation. DT does not have metastatic spread potentially but can be infiltrative and locally aggressive and decrease patients' quality of life. Although current treatment guidelines recommend active surveillance as initial therapy, systemic therapy should be considered in rapidly progressing or symptomatic patients. Systemic treatments for DT include hormonal blockade, cytotoxic chemotherapy, and tyrosine-kinase inhibitors. In this real-life study, we aimed to evaluate the efficacy of sorafenib in patients with progressing or symptomatic DT. Methods: The clinical, pathological, and treatment data of the patients were retrospectively evaluated. Also, prognostic parameters for overall survival were assessed. We used SPSS v.25 for statistical analysis. Kaplan-Meier and Cox-regression analysis were used for survival analysis. Results: Seventeen patients were included in the study. The ratio of female/male patients was 2.4, and the median age was 32 (range,14-65). Four (23.5%) patients had Gardner syndrome. The rates of extra-abdominal and ıntra-abdominal tumor locations were 64.7% and 35.3%, respectively. The median follow-up duration before sorafenib was 6±0.84 years. Before sorafenib, 15 patients had underwent surgical resection. Four (23.5%) patients received adjuvant radiotherapy. All patients received median two-line systemic therapy, and four (23.5%) patients had received chemotherapy. The median treatment duration of sorafenib was 23.4±2.2 months. One- and two-year progression-free survival ratios were 94.1% and 80.7%, respectively. Grade 3-4 toxicities were observed in six (35.2%) of the patients. In univariate analysis, we found that gender (p = 0.012), ECOG performance status (p = 0.032), and history of Gardner syndrome (p = 0.021) were statistically significant prognostic factors for progression-free survival. However, there was no statistically significant between extra-abdominal and ıntra-abdominal tumor locations (p = 0.56). Conclusions: In the study, we observed that sorafenib was an effective treatment option for previously treated advanced desmoid tumors. Despite a small number of patients, we detected that male gender, poor ECOG performance status, and history of Gardner syndrome were negative prognostic factors for progression-free survival.

Retrospective analysis of glioblastoma multiforme (GBM) patients treated initially with BCNU compared to temozolomide (TMZ) with concomitant radiation therapy

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2071-2071
Author(s):  
M. Vinjamuri ◽  
R. Adumala ◽  
R. Altaha ◽  
J. Hobbs ◽  
E. Crowell
Keyword(s):  
Overall Survival ◽  
Prognostic Factors ◽  
Retrospective Analysis ◽  
Performance Status ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Survival Curves ◽  
Ecog Performance Status ◽  
Free Survival ◽  
Significant Difference

2071 Background: TMZ and radiation as initial treatment has become the standard of care for GBM. There are no randomized studies comparing TMZ to BCNU in GBM. Methods: We did a retrospective analysis of all 100 GBM patients (pts) diagnosed by our pathology department in the last 10 years. 20 pts were excluded, in 12 pts no chemotherapy was given and there was no data available for 8 pts. BCNU treatment was given in earlier years than TMZ generally. Overall survival (OS), progression free survival (PFS) and four prognostic factors were compared between BCNU and TMZ treated groups. Results: Results show that there is no significant difference in OS and PFS between the two groups. Survival curves were superimposable. This is despite the fact that tumor size and ECOG performance status were worse, though not significantly so in the BCNU group. Age was the only variable that correlated with survival. After correcting for age there was still no difference in PFS and OS between the BCNU and TMZ group. Conclusions: Our study fails to shows superiority of TMZ over BCNU despite the fact that the BCNU group had worse prognostic factors. A randomized comparison of these two agents seems justifiable. [Table: see text] No significant financial relationships to disclose.

Clinical correlates of response to anti-PD-1 (aPD1)-based therapy in patients (pts) with metastatic melanoma (MM).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21000-e21000
Author(s):  
Elizabeth J. Davis ◽  
Shilin Zhao ◽  
Fei Ye ◽  
Katherine Rappazzo ◽  
Jeffrey Alan Sosman ◽  
...  
Keyword(s):  
Performance Status ◽  
Progression Free Survival ◽  
Clinical Predictors ◽  
Ecog Performance Status ◽  
Free Survival ◽  
Size Number ◽  
Multivariable Analyses ◽  
Status Number ◽  
Univariate Analyses ◽  
Selection Of

e21000 Background: aPD1, alone or in combination with ipilimumab (IPI), produces durable responses in a subset of MM. Tumor features that correlate with treatment response, including size, number, and location of metastases (mets) are not well defined. Methods: We collected clinical data from mm pts treated at one center who received aPD1 (n = 185) or aPD1 + IPI (n = 42). We correlated number of mets, size of largest tumor, and organ involvement with response rate (RR), progression-free survival (PFS) and overall survival (OS). Results: Among all pts, RR was 67% for aPD1 + IPI and 41% for aPD1 alone. In univariate analyses, responders to aPD1 had lower diameter of largest tumor (4cm vs. 5.5cm; p = 0.02) whereas aPD1 + IPI had equivalent largest tumor diameters (p = 0.65). Regarding sites of mets, liver mets were associated with lower RR in aPD1 treated pts (26% vs. 46%), lower PFS (median 138 vs. 326 days, p = 0.02), and lower OS (median 334 vs. 1080 days, p < 0.01). No associations with RR, PFS, or OS were observed with liver mets in aPD1 + IPI treated pts. We also did not observe any differences between pts who did or did not have lung, lymph node, or brain mets for either aPD1 or aPD1 + IPI. Interestingly, superior RR to aPD1 + IPI was observed in pts with bone mets compared to those without bone mets (91% vs. 58%, p = 0.048). Regarding number of sites, RR to aPD1 was greater in pts with ≤10 mets compared with those with > 10 (46% vs. 28%, p = 0.02), although no consistent relationship was observed at lower cutoffs. In multivariable analyses, diameter of largest tumor (tumor bulk) was independently associated with PFS (OR, 1.11, p < 0.001) and OS (OR 1.08, p < 0.001) whereas AJCC stage, lactate dehydrogenase, liver mets, ECOG performance status, number of mets, and prior therapies were not significant. Tumor bulk and other risk factors were not associated with PFS or OS in aPD1 + IPI. Conclusions: Tumor bulk was strongly and independently associated with clinical outcomes in aPD1 but not IPI + aPD1. Other associations with disease sites (liver and bone) need further validation. In conjunction with molecular biomarkers, clinical predictors may help guide selection of aPD1 or aPD1 + IPI.

Carfilzomib (K) in relapsed and refractory multiple myeloma (RRMM): Frailty subgroup analysis from phase III ASPIRE and ENDEAVOR.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 8028-8028 ◽  
Author(s):  
Thierry Facon ◽  
Ruben Niesvizky ◽  
Katja Weisel ◽  
Sara Bringhen ◽  
P. Joy Ho ◽  
...  
Keyword(s):  
Performance Status ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Ecog Performance Status ◽  
Free Survival ◽  
Frailty Status ◽  
Improved Outcomes ◽  
Comorbidity Index ◽  
Post Hoc ◽  
Frailty Score

8028 Background: K-based regimens improved progression-free survival (PFS) and overall survival (OS) in RRMM patients (pts) in ASPIRE (K [27 mg/m2]-lenalidomide-dexamethasone [KRd] vs Rd) and ENDEAVOR (K [56 mg/m2]-dexamethasone [Kd56] vs bortezomib-dexamethasone [Vd]), regardless of age. Frailty scores have been developed based on age, comorbidities, and functional status (Palumbo Blood 2015;125:2068–74; Facon Blood 2015;126:4239). We assessed post hoc pt outcomes by frailty status. Methods: PFS, OS, and safety were assessed by treatment arm and frailty score (based on age, medical history-derived Charlson Comorbidity Index, and ECOG performance status); frailty scores: 0 = fit, 1 = intermediate (int), and ≥2 = frail. Results: Pt frailty status was balanced between treatment arms in ASPIRE and ENDEAVOR. Median PFS and OS were longer with K-based regimens vs controls in ASPIRE and ENDEAVOR across frailty subgroups (Table). Rates of treatment-emergent adverse events are summarized in the Table. Conclusions: Kd56 and KRd consistently improved outcomes vs Vd and Rd, respectively, in all frailty subgroups as defined by the algorithm above. These findings support the favorable benefit-risk profile of KRd and Kd56 regardless of frailty score. Clinical trial information: NCT01080391 and NCT01568866. [Table: see text]

Prognostic Factors Influencing Progression-Free Survival Determined From a Series of Sporadic Desmoid Tumors: A Wait-and-See Policy According to Tumor Presentation

2011 ◽  
Vol 29 (26) ◽  
pp. 3553-3558 ◽  
Author(s):  
Sébastien Salas ◽  
Armelle Dufresne ◽  
Binh Bui ◽  
Jean-Yves Blay ◽  
Philippe Terrier ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Prognostic Factors ◽  
Tumor Size ◽  
Univariate Analysis ◽  
Progression Free Survival ◽  
Surgical Margins ◽  
Desmoid Tumors ◽  
Tumor Site ◽  
Free Survival ◽  
Wait And See

Purpose Desmoid tumors are mesenchymal fibroblastic/myofibroblastic proliferations with locoregional aggressiveness and high ability to recur after initial treatment. We present the results of the largest series of sporadic desmoid tumors ever published to determine the prognostic factors of these rare tumors. Patients and Methods Four hundred twenty-six patients with a desmoid tumor at diagnosis were included, and the following parameters were studied: age, sex, delay between first symptoms and diagnosis, tumor size, tumor site, previous history of surgery or trauma in the area of the primary tumor, surgical margins, and context of abdominal wall desmoids in women of child-bearing age during or shortly after pregnancy. We performed univariate and multivariate analysis for progression-free survival (PFS). Results In univariate analysis, age, tumor size, tumor site, and surgical margins (R2 v R0/R1) had a significant impact on PFS. PFS curves were not significantly different for microscopic assessment of surgical resection quality (R0 v R1). In multivariate analysis, age, tumor size, and tumor site had independent values. Three prognostic groups for PFS were defined on the basis of the number of independent unfavorable prognostic factors (0 or 1, 2, and 3). Conclusion This study clearly demonstrates that there are different prognostic subgroups of desmoid tumors that could benefit from different therapeutic strategies, including a wait-and-see policy.

scholarly journals Impact of Superselective Intra-Arterial and Systemic Chemoradiotherapy for Gingival Carcinoma; Analysis of Treatment Outcomes and Prognostic Factors

2020 ◽  
Author(s):  
Yuki Mukai ◽  
Yuichiro Hayashi ◽  
Izumi Koike ◽  
Toshiyuki Koizumi ◽  
Madoka Sugiura ◽  
...  
Keyword(s):  
Overall Survival ◽  
Multivariate Analysis ◽  
Prognostic Factors ◽  
Clinical Stage ◽  
Performance Status ◽  
Univariate Analysis ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Free Survival

Abstract Background: We compared outcomes and toxicity between radiation therapy (RT) with concurrent retrograde super-selective intra-arterial chemotherapy (IACRT) and RT with concurrent systemic chemoradiotherapy (SCRT), for gingival carcinoma (GC).　Methods: We included 84 consecutive patients who were treated for GC ≥ stage III, from 2006 to 2018, in this retrospective analysis (IACRT group: n=66; SCRT group: n=18).Results: Median follow-up time was 24 (range: 1–124) months. The median prescribed dose was 60 (6–70.2) Gy (IACRT group: 60 Gy; SCRT group:69 Gy). At 3 years, the two groups significantly differed in overall survival (OS; IACRT: 78.75%, 95% confidence interval [CI]: 66.00–87.62; SCRT: 50.37%, 95% CI: 27.58–73.0; P = 0.039), progression-free survival (PFS; IACRT: 75.64%, 95% CI: 62.69–85.17; SCRT: 41.96%, 95% CI: 17.65–70.90; P = 0.028) and local control (LC; IACRT: 77.17%, 95% CI: 64.23–86.41; SCRT: 41.96%, 95% CI: 17.65–70.90; P = 0.015). In univariate analysis, age ≥ 65, decreased performance status (PS) and SCRT were significantly associated with worse outcomes (P < 0.05). In multivariate analysis, age ≥ 65 years, clinical stage IV, and SCRT were significantly correlated with poor OS (P < 0.05). Patients with poorer PS had significantly worse PFS.Conclusions: This is the first report to compare outcomes from IACRT and SCRT among patients with GC. IACRT is an effective and organ-preserving treatment for GC.Trial registration: retrospectively registered

FOLFOXIRI plus bevacizumab (BEV) in patients (pts) with previously untreated metastatic colorectal cancer (mCRC): Preliminary safety results from the OPAL study.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 515-515
Author(s):  
Alexander Stein ◽  
Djordje Atanackovic ◽  
Bert Hildebrandt ◽  
Patrick Stuebs ◽  
Claus-Christoph Steffens ◽  
...  
Keyword(s):  
Performance Status ◽  
Maintenance Phase ◽  
Progression Free Survival ◽  
Induction Treatment ◽  
Induction Phase ◽  
Ecog Performance Status ◽  
Free Survival ◽  
Safety Population ◽  
Secondary Endpoints ◽  
Ecog Ps

515 Background: The addition of BEV to standard doublet chemotherapy (CT) improves outcomes vs CT alone in pts with mCRC. Use of more intensive triplet CT may prolong overall survival (OS), progression-free survival (PFS), increase response rates and improve resectability rates but at the expense of greater toxicity. The OPAL study examined the effect of BEV + FOLFOXIRI on PFS in pts with previously untreated unresectable mCRC. Here we report preliminary safety findings. Methods: Eligible pts had histologically confirmed mCRC, ECOG PS ≤1 and were 18–70 years old. Pts received ≤12 cycles of FOLFOXIRI (infusional 5-fluorouracil [FU] 3200 mg/m2, folinic acid [FA] 200 mg/m2, oxaliplatin 85 mg/m2, irinotecan 165 mg/m2) + BEV 5 mg/kg q2w (induction phase) followed by ≤40 cycles of 5-FU/FA + BEV q2w (maintenance phase). PFS was the primary endpoint; secondary endpoints included OS, proportion of pts achieving resectability and safety. Results: 96 pts were enrolled. Of these, 90 received study medication and formed the safety population: 64 male, 26 female; median age 58 (range 28–71) years; ECOG performance status 0/1 in 49/41 pts. All pts have completed induction treatment and the study is ongoing. In total, 61 serious AEs occurred in 34 pts (38%). AEs resulting in death occurred in 3 pts (3%); these were not considered treatment-related by the investigators. The incidence of AEs of special interest with BEV was low. Main AEs reported during the induction phase are summarised in the table. Conclusions: BEV + FOLFOXIRI was generally well tolerated in this mCRC pt population. The incidence of AEs was as previously reported [Falcone et al. ASCO 2010] and there were no new safety signals. Clinical trial information: NCT00940303. [Table: see text]

Analysis of predictive factors of ramucirumab plus paclitaxel for advanced gastric cancer.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 185-185
Author(s):  
Naoki Fukuda ◽  
Daisuke Takahari ◽  
Hiroki Osumi ◽  
Tomohiro Matsushima ◽  
Izuma Nakayama ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Predictive Factors ◽  
Performance Status ◽  
Objective Response ◽  
Progression Free Survival ◽  
Independent Factor ◽  
Ecog Performance Status ◽  
Free Survival ◽  
Gastric Cancer Patients

185 Background: Ramucirumab (RAM) is a novel anti-VEGF antibody approved in 2015 in Japan. Predictive factors for RAM in combination with paclitaxel (PTX) remain largely unknown. Methods: We reviewed 77 consecutive advanced gastric cancer patients who were treated with RAM plus PTX between June 2015 and June 2016 in our institution. We evaluated treatment outcome and analyzed potential predictive factors by univariate and multivariate analyses. Results: Median age was 67 years (range 35-83) and 51 % of the patients were male. The ECOG performance status (PS) was ≥ 2 in 8 patients. 89% (69/77) patients were treated as second line chemotherapy. Objective response rate (ORR) in patients who have measurable disease was 52 % (17/33). Median progression free survival (PFS) and overall survival (OS) and was 6.0 months (95% confidence interval [CI] = 4.3-7.1) and 10.4 months (95% CI 6.8-13.6), respectively. The most frequent adverse events were peripheral neuropathy (44%), G3 ≥ neutropenia (34%), hypertension (32%) and bleeding (27%). At multivariate analysis, hypertension was independent factor for OS (Hazard ratio [HR] = 0.35, 95% CI = 0.14-0.90, P = 0.03). Also, bleeding (HR = 0.23, 95% CI = 0.09-0.55, P = 0.001) was independent factor for PFS and hypertension (HR = 0.47, 95% CI = 0.22-1.02, P = 0.06) had trend toward to show better PFS. Conclusions: RAM plus PTX showed promising efficacy for advanced gastric cancer. RAM related toxicities such as hypertension and bleeding/hemorrhage were independent factors for better outcome. Further investigation is warranted to verify our analysis.

scholarly journals Phase 2 trial of hypoxia activated evofosfamide (TH302) for treatment of recurrent bevacizumab-refractory glioblastoma

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Andrew J. Brenner ◽  
John Floyd ◽  
Lisa Fichtel ◽  
Joel Michalek ◽  
Kunal P. Kanakia ◽  
...  
Keyword(s):  
Median Time ◽  
Phase Ii ◽  
Phase 1 ◽  
Performance Status ◽  
Progression Free Survival ◽  
Recurrent Glioblastoma ◽  
Ecog Performance Status ◽  
Free Survival ◽  
Time To Death ◽  
Phase 2 Trial

AbstractEvofosfamide (Evo or TH302) is a hypoxia-activated prodrug which is reduced leading to the release of alkylating agent bromo-isophosphoramide mustard, which has shown safety and signals of efficacy in a prior phase 1 study in recurrent glioblastoma. We performed a dual center single-arm Phase II study to expand on the safety and efficacy of Evo plus bevacizumab in bevacizumab refractory glioblastoma. 33 patients with bevacizumab refractory GBM received Evo 670 mg/m2 in combination with Bevacizumab 10 mg/kg IV every 2 weeks. Assessments included adverse events, response, and survival. Median age of patients was 47 (range 19–76) and 24 (69%) were male. At the time of study entry, 9 (26%) had ongoing corticosteroid use. ECOG performance status was 0 or 1 in 83% of patients. Patients were mostly heavily pretreated with 77% have three or more prior regimens. A total of 12 patients (36%) suffered grade 3–4 drug associated adverse event (AE); no grade 5 AE were reported. Of the 33 evaluable patients, best response was PR in 3 (9%), SD in 14 (43%), and PD in 16 (48%) with responses confirmed by a second reviewer. Median time to progression of disease was 53 days (95% CI 42–113) and Median time to death was 129 days (95% CI 86–199 days). Progression free survival at 4 months (PFS-4) on Evo-Bev was 31%, which was a statistically significant improvement over the historical rate of 3%. The median overall survival of patients receiving Evo-Bevacizumab was 4.6 months (95% CI 2.9–6.6). The progression free survival of patients on Evo-Bevacizumab met the primary endpoint of progression free survival at 4 months of 31%, although the clinical significance of this may be limited. Given the patient population and Phase II design, these clinical outcomes will need further validation.

scholarly journals Real-World Data for Lenvatinib in Hepatocellular Carcinoma (ELEVATOR): A retrospective multicenter study

Liver Cancer ◽  
2022 ◽  
Author(s):  
Sabrina Welland ◽  
Catherine Leyh ◽  
Fabian Finkelmeier ◽  
André Jefremow ◽  
Kateryna Shmanko ◽  
...  
Keyword(s):  
Overall Survival ◽  
Real World ◽  
Median Overall Survival ◽  
Performance Status ◽  
Progression Free Survival ◽  
Inclusion Criteria ◽  
First Line ◽  
Ecog Performance Status ◽  
Free Survival ◽  
First Line Treatment

Background Lenvatinib is approved as first-line treatment for patients with advanced hepatocellular carcinoma (HCC). The efficacy of lenvatinib in Caucasian real-world patients is insufficiently defined. The purpose of this study was to evaluate the efficacy of lenvatinib in a multi-center cohort (ELEVATOR) from Germany and Austria. Methods A retrospective data analysis of 205 patients treated with first-line systemic lenvatinib at 14 different sites was conducted. Overall survival, progression free survival, overall response rate and adverse event rates were assessed and analyzed. Results Patients receiving lenvatinib in the real-world setting reached a median overall survival of 12.8 months, which was comparable to the results reported from the REFLECT study. Median overall survival (mOS) and progression free survival (mPFS) was superior in those patients who met the inclusion criteria of the REFLECT study compared to patients who failed to meet the inclusion criteria (mOS 15.6 vs 10.2 months, HR 0.55, 95% CI 0.38-0.81, p=0.002; mPFS 8.1 vs 4.8 months HR 0.65, 95% CI 0.46-0.91, p=0.0015). For patients with an impaired liver function according to the Albumin-Bilirubin (ALBI) grade, or reduced ECOG performance status ≥2, survival was significantly shorter compared to patients with sustained liver function (ALBI grade 1) and good performance status (ECOG performance status 0), respectively (HR 1.69, 95% CI 1.07-2.66, p=0.023; HR 2.25, 95% CI 1.19-4.23, p=0.012). Additionally, macrovascular invasion (HR 1.55, 95% CI 1.02-2.37, p=0.041) and an AFP ≥200 ng/mL (HR 1.56, 95% CI 1.03-2.34, p=0.034) were confirmed as independent negative prognostic factors in our cohort of patients with advanced HCC. Conclusion Overall, our data confirm the efficacy of lenvatinib as first-line treatment and did not reveal new or unexpected side effects in a large retrospective Caucasian real-world cohort, supporting the use of lenvatinib as meaningful alternative for patients that cannot be treated with IO-based combinations in first-line HCC.

Efficacy and safety of bevacizumab (BEV)-based combination regimens in patients with metastatic colorectal cancer (mCRC): Randomized phase II study of BEV + FOLFIRI versus BEV + XELIRI (FNCLCC ACCORD 13/0503 study)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4086-4086
Author(s):  
M. Ducreux ◽  
A. Adenis ◽  
J. Mendiboure ◽  
E. François ◽  
E. Boucher ◽  
...  
Keyword(s):  
Phase Ii ◽  
Performance Status ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
Ecog Performance Status ◽  
Free Survival ◽  
First Line Therapy ◽  
Number Of Cycles ◽  
Combination Regimens

4086 Background: The combination of BEV and chemotherapy is highly effective in patients with mCRC and improves response rate, progression-free survival and overall survival compared with chemotherapy alone. This randomized non-comparative phase II trial evaluated the efficacy and safety of BEV in combination with either XELIRI or FOLFIRI as first-line therapy for mCRC. Methods: Patients were eligible for inclusion in this study if they had histologically proven measurable mCRC, were aged 18–75 years, and had an ECOG performance status (PS) of 0–2. Patients were treated with 8 cycles of XELIRI (irinotecan 200 mg/m2 on Day 1 and capecitabine 1000 mg/m2 bid on Days 1–14) + BEV 7.5 mg/kg on Day 1, every 3 weeks or 12 cycles of FOLFIRI (irinotecan 200 mg/m2 on Day 1 + 5-fluorouracil (5-FU) 400 mg/m2 + folinic acid 400 mg/m2 on day 1 followed by 5-FU 2400 mg/m2 via 46-h infusion) + BEV 5 mg/kg on day 1, every 2 weeks. BEV was continued to disease progression. Patients aged ≥65 years received a lower daily dose of capecitabine (800 mg/m2 bid). The primary endpoint was crude progression-free survival (PFS) at 6 months. Results: In total, 145 patients were entered in the study between March 2006 and January 2008; 72 patients received BEV + XELIRI and 73 patients received BEV + FOLFIRI (male 64%/48%; median age 61/61 years; 35/36% aged >65 years). Preliminary results from the first 6 months of follow-up are reported here. A total of 491/783 cycles was administered, 63%/67% receiving at least the initially planned number of cycles (8 cycles for BEV + XELIRI and 12 for BEV + FOLFIRI). Main results are given in the table . Conclusions: This randomized non-comparative study has shown that BEV + XELIRI and BEV + FOLFIRI are similarly effective treatments for patients with mCRC, with manageable toxicity profiles. Results with updated follow-up will be presented at the Meeting. [Table: see text] [Table: see text]

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