Outcomes by tumor location in patients with metastatic colorectal cancer (mCRC) treated with regorafenib (REG): Final analysis from the prospective, observational CORRELATE study.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 539-539 ◽  
Author(s):  
Michel Ducreux ◽  
Lone Nørgård Petersen ◽  
Leopold Öhler ◽  
Francesca Bergamo ◽  
Jean-Philippe Metges ◽  
...  
Keyword(s):  
Observational Study ◽  
Progression Free Survival ◽  
Final Analysis ◽  
Tumor Location ◽  
Local Health Authority ◽  
Anatomical Location ◽  
Local Health ◽  
Primary Tumors ◽  
Kaplan Meier ◽  
Ecog Ps

539 Background: The anatomical location of the primary tumor has been associated with different prognosis and outcomes in mCRC. REG significantly improved overall survival (OS) versus placebo in patients with mCRC who progressed on standard therapies in phase 3 trials. We report the final results of outcomes in patients with mCRC with left-sided (L) or right-sided (R) primary tumors who were treated with REG in the real-world CORRELATE study. Methods: CORRELATE (NCT02042144) was a prospective, observational study designed to characterize the safety and effectiveness of REG in patients previously treated with approved therapies and for whom the decision to treat with REG was made by the treating physician according to the local health authority label. Patients with tumor location unknown or tumors in both regions were excluded (n = 62). OS was analyzed using the Kaplan–Meier method. Results: Overall, 975 patients were included in the analysis: L = 768 (79%) and R = 207 (21%). Most patients were ECOG PS 0–1 (L: 86%; R: 87%). Median time from initial diagnosis and from diagnosis of metastatic disease to REG treatment was slightly longer in L versus R tumors (34 vs 30 months and 27 vs 23 months, respectively). A higher proportion of patients with L versus R tumors, respectively, had prior radiotherapy (34% vs 15%) and a lower proportion had a partial colectomy (44% vs 75%). Both groups received a median of three prior regimens. REG treatment duration was similar in the two groups (median duration: L 2.6 months vs R 2.3 months), as was median progression-free survival (95% CI): 2.8 months (2.6, 2.9) for L tumors versus 2.7 months (2.5, 3.1) for R tumors. Median OS (95% CI) was 7.4 months (6.7, 8.0) for L tumors versus 8.2 months (6.6, 9.3) for R tumors; one-year OS rates were 32% versus 34%, respectively. Conclusions: Results from this observational study suggest that OS is similar in patients with L and R tumors treated with REG. Clinical trial information: NCT02042144.

Impact of tumor location on outcomes in patients with metastatic colorectal cancer (mCRC) treated with regorafenib (REG): An interim analysis from the prospective, observational CORRELATE study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3567-3567 ◽  
Author(s):  
Michel Ducreux ◽  
Leopold Öhler ◽  
Werner Scheithauer ◽  
Jean-Philippe Metges ◽  
Louis-Marie Dourthe ◽  
...  
Keyword(s):  
Observational Study ◽  
Primary Tumor ◽  
Tumor Location ◽  
Response To Treatment ◽  
Rank Test ◽  
Local Health Authority ◽  
Anatomical Location ◽  
Local Health ◽  
Duration Of Treatment ◽  
Primary Tumor Location

3567 Background: The anatomical location of the primary tumor has been associated with outcomes in mCRC, with left-sided (L) tumors having a better prognosis than right-sided (R) tumors and location predicting response to treatment. REG significantly improved overall survival (OS) vs placebo in patients with mCRC who progressed on available treatments in 2 randomized, phase 3 trials (CORRECT, CONCUR). This exploratory analysis evaluated outcomes by primary tumor location in patients with mCRC treated with REG in the CORRELATE study. Methods: CORRELATE is an observational study designed to characterize the safety and effectiveness of REG in unselected patients for whom the decision to treat with REG has been made by the treating physician according to the local health authority label. Primary L tumors were located in the rectum, splenic flexure, recto-sigmoid, descending, or sigmoid colon; R tumors were in the appendix, hepatic flexure, cecum, or ascending colon. OS was analyzed by the Kaplan–Meier method and comparisons were by a 2-sided log-rank test. Results: Primary tumor location was available for 474 patients (L, n = 375 [79%]; R, n = 99 [21%]). Median time from initial diagnosis and from diagnosis of metastatic disease to treatment was slightly longer in L vs R tumors (32 vs 28 months and 25 vs 22 months, respectively). A higher proportion of patients with L vs R tumors, respectively, had prior radiotherapy (34% vs 13%) and a lower proportion had a partial colectomy (40% vs 70%). Best response to prior systemic therapy (partial response + stable disease) was 72% for L tumors and 68% for R tumors with a median duration of treatment of 26 and 22 months, respectively. REG treatment duration was similar in the 2 groups. Median OS (95% CI) was 6.7 months (6.1, 7.7) for L tumors vs 6.3 months (4.9, 8.1) for R tumors (P = 0.3); median progression-free survival (95% CI) was 2.8 months (2.6, 3.0) vs 2.6 months (2.4, 3.0) (P = 0.5), respectively. Conclusions: Interim results from this observational study suggest that OS is similar in patients with R and L tumors treated with REG. Clinical trial information: NCT02042144.

scholarly journals Prognostic and clinicopathological significance of systemic immune-inflammation index in colorectal cancer: a meta-analysis

2020 ◽  
Vol 12 ◽  
pp. 175883592093742 ◽  
Author(s):  
Meilian Dong ◽  
Yonggang Shi ◽  
Jing Yang ◽  
Quanbo Zhou ◽  
Yugui Lian ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
Tumor Location ◽  
Cochrane Library ◽  
Hazard Ratios ◽  
Clinicopathological Significance ◽  
Immune Inflammation ◽  
Ecog Ps ◽  
The Cochrane Library

Background: Previous studies on the systemic immune-inflammation index (SII), which is based on platelet, neutrophil and lymphocyte counts, as a prognostic marker in patients with colorectal cancer (CRC) yielded inconsistent results. The aim of this study was to evaluate the prognostic and clinicopathological role of SII in CRC via meta-analysis. Methods: A comprehensive literature survey was performed on PubMed, Web of Science, Embase and the Cochrane Library databases to include studies published up to 6 April 2020. Pooled hazard ratios (HRs) and odds ratios (ORs) with 95% confidence intervals (CIs) were computed to estimate the prognostic and clinicopathological value of SII in CRC. Results: A total of 12 studies published between 2016 and 2019 were included in our meta-analysis. The combined analysis showed that high SII levels were significantly associated with worse overall survival (OS; HR = 1.61, 95% CI = 1.21–2.13, p = 0.001) and progression-free survival (HR = 1.74, 95% CI = 1.26–2.39, p = 0.001) in CRC. Moreover, elevated SII was also correlated with poor tumor differentiation (OR = 1.60, 95% CI = 1.27–2.02, p < 0.001), presence of distant metastasis (OR = 2.27, 95% CI = 1.10–4.67, p = 0.026), ECOG PS of 1–2 (OR = 1.98, 95% CI = 1.39–2.84, p < 0.001) and tumor size ⩾5 cm (OR = 1.49, 95% CI = 1.18–1.88, p = 0.001). However, high SII was not significantly associated with sex, tumor location, lymph node metastasis, or age in patients with CRC. Conclusion: Our meta-analysis indicated that high SII levels predicted poor prognosis in CRC. In addition, an elevated SII was also associated with clinical factors, implying higher malignancy of the disease.

Retrospective analysis of first-line chemotherapy in 132 patients with advanced small-bowel adenocarcinoma.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 260-260
Author(s):  
T. Tsushima ◽  
N. Boku ◽  
Y. Honma ◽  
H. Takahashi ◽  
S. Ueda ◽  
...  
Keyword(s):  
Small Bowel ◽  
Univariate Analysis ◽  
Objective Response ◽  
Progression Free Survival ◽  
Ampullary Carcinoma ◽  
Small Bowel Adenocarcinoma ◽  
Kaplan Meier ◽  
Group A ◽  
Group B ◽  
Ecog Ps

260 Background: No standard care has been established for advanced small-bowel adenocarcinoma (SBA). The aim of this study is to explore a most promising chemotherapy regimen for advanced SBA. Methods: All data were collected from medical records of patients with advanced or recurrent SBA who received chemotherapy between April 1999 and March 2009 at 41 hospitals in Japan. Selection criteria were as follows: 1) histologically proven SBA, excluding ampullary carcinoma, 2) no previous chemotherapy or radiotherapy, 3) ECOG PS 0-2, 4) adequate bone marrow, hepatic and renal functions, 5) no concomitant malignancy. Patients were divided into the five groups by regimens: group A, fluoropyrimidine alone; group B, fluoropyrimidine + cisplatin; group C, fluoropyrimidine + oxaliplatin; group D, fluoropyrimidine + irinotecan; group E, others. Progression-free survival (PFS) and overall survival (OS) were calculated by Kaplan-Meier method. Results: Demographics of selected 132 patients were: median age (range), 59 (23-78) years; male/female, 87/45; location of primary tumor, duodenum/jejunum/ileum/unknown, 80/32/17/3; advanced/recurrent disease, 91/41. The numbers of the patients in group A, B, C, D and E were 60, 17, 22, 11 and 22, and objective response rates (ORR) in the patients with target lesions were 20% (9/46), 38% (5/13), 42% (8/19), 25% (2/8), 21% (4/19), respectively. Median PFS and OS were 6.0 and 14.0 months for the whole population, and those in each group are shown in the Table.In comparison with fluoropyrimidine alone (A), oxaliplatin-combined regimens (C) associated with better PFS (HR=0.53 [0.31-0.93], p=0.03) and OS (HR=0.64 [0.33-1.25], p=0.19), while cisplatin-combined regimens (B) did not (HR=1.54 [0.88-2.68], p=0.13 for PFS and HR=1.67 [0.94-2.97], p=0.08 for OS) by univariate analysis. Conclusions: It is suggested that oxaliplatin-combined regimens might be the most promising regimen for advanced SBA. [Table: see text] No significant financial relationships to disclose.

Randomized phase III trial of irinotecan plus cisplatin versus irinotecan alone after S-1 based chemotherapy failure for patients with advanced and recurrent gastric cancer (AGC) (TCOG GI-0801).

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 61-61
Author(s):  
Ken Shimada ◽  
Katsuhiko Higuchi ◽  
Naoshi Hosaka ◽  
Eisaku Sasaki ◽  
Norisuke Nakayama ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Statistical Design ◽  
Progression Free Survival ◽  
Final Analysis ◽  
Phase Iii ◽  
Second Line ◽  
Second Line Chemotherapy ◽  
High Level ◽  
Ecog Ps ◽  
Line Chemotherapy

61 Background: S-1based chemotherapy is the standard first-line chemotherapy for AGC in Japan. Currently, there is no high level evidence established for second-line treatment. Irinotecan (CPT-11) plus cisplatin (CDDP) are active in AGC. The combination of these 2 agents is synergistic effect in preclinical and clinical studies. We conducted a phase III study of CPT-11 plus CDDP (CP) compared with CPT-11 alone (C) in patients with AGC refractory to S-1 based chemotherapy. Methods: Patients with previously treated with S-1-based chemotherapy for AGC, an ECOG PS of 0-1 and adequate organ functions were randomly assigned to receive either CPT-11 60 mg/m2 plus CDDP 30 mg/m2 on day 1 every 2 weeks or CPT-11 150mg/m2on day 1 every 2 weeks. The primary endpoint is progression free survival (PFS). The statistical design is based on superiority hypothesis; PFS is 110days in CP, 65days in C; two-sided α=0.05, 1-β=0.8; and planed accrual is 130 pts. Secondary endpoints include Overall Survival (OS), Time to Treatment Failure (TTF), Response Rate (RR), and safety. Results: From April 2008 to July 2011, 130 patients from 21 sites in Japan were randomized to CP (n=64) or C (n=66). Patient demographics were well balanced between the two groups. At the final analysis, total of 117 PFS events were observed. The primary endpoint was met. PFS for CP was superiority to C (median PFS, 4.17(95%CI 3.03-4.80) vs. 3.03(95%CI 2.20-3.33) months, respectively; HR=1.490(1.029-2.155), p=0.0324,). There were no significant differences in the TTF and RR (TTF was 3.4(95%CI 2.7-4.2) vs. 2.9(95%CI 2.2-3.3) months, RR was 21.9(95%CI 12.5-34.0) % vs. 16.4(95%CI 7.9-27.3) % with CP and C. OS is analyzing now. The most common grade 3/4 toxicities in CP/C (%) were neutropenia, 40.6/38.7; diarrhea, 1.6/7.9; anorexia, 4.7/11.1. Related adverse events were comparable with CP and C.Conclusions: CP has promising efficacy for the second-line chemotherapy compared with C for AGC.CP suggested to be one of the standard second-line chemotherapy regimen for AGC. Clinical trial information: 000001028.

A phase I/II study of ABT-888 in combination with 5-fluorouracil (5-FU) and oxaliplatin (Ox) in patients with metastatic pancreatic cancer (MPC).

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 147-147 ◽  
Author(s):  
Michael J. Pishvaian ◽  
Hongkun Wang ◽  
Tingting Zhuang ◽  
Aiwu Ruth He ◽  
Jimmy J. Hwang ◽  
...  
Keyword(s):  
Phase I ◽  
Parp Inhibitor ◽  
Gene Mutations ◽  
Brca2 Gene ◽  
Progression Free Survival ◽  
Final Analysis ◽  
Primary Objective ◽  
Repair Mechanisms ◽  
Recommended Phase Ii Dose ◽  
Ecog Ps

147 Background: The PARP inhibitor, ABT-888 is a potent sensitizing agent for, and has been safely combined with DNA-damaging chemotherapies. The sensitizing effects of ABT-888 are magnified when cancer cells harbor underlying defects in DNA repair mechanisms, such as BRCA2 mutations. Methods: We have initiated a Phase I/II trial, and we present here the data from the Phase I portion. Patients (pts) with MPC who had any number of prior therapies were eligible. A standard 3+3 dose escalation of ABT-888 was employed, in cohorts of 40, 60, 80, 100, 150, 200, 250, and 300mg orally twice a day, days 1-7 of a 14 day cycle. Pts also received 85mg/m2 of Ox, 400mg/m2 of 5-FU, and 400mg/m2 of leucovorin on Day 1, and 2400mg/m2 of 5-FU continuous infusion Days 1-3. Restaging studies were performed every 4 cycles. The primary objective was to determine the Recommended Phase II Dose (RP2D) of ABT-888 combined with 5-FU and Ox. Secondary clinical objectives included an assessment of the pharmacokinetics (PKs) of ABT-888 metabolism, as well as response rate (RR), progression-free survival (PFS), and overall survival (OS). Results: Between 01-2011 and 09-2012, 22 pts received treatment. 55% were male; median age = 64, most with an ECOG PS of 1. 55% were previously untreated. The first 6 pts experienced persistent ≤Grade 2 myelosuppression, primarily thrombocytopenia, prompting an amendment to drop the 5-FU bolus. In the latter 16 pts, the combination of ABT-888 plus 5-FU and Ox was well tolerated, with no DLTs. The RP2D is expected to be 300mg BID of ABT-888, with the final analysis including ABT-888 PKs to be presented. For the 22 pts, the RR was 14%, and the PFS and OS were 2.9 and 5.4 months, respectively. Of the 11 previously untreated pts, the RR was 18%, and the PFS and OS were 4.3 and 7.7 months, respectively. 2 pts with deleterious mutations in BRCA2 were included: Pt 6 had a PR and remains on study after 17 months; Pt 14 had a CR and a normalization of CA 19-9, and is still on treatment after 10 months. Conclusions: The combination of ABT-888, 5-FU, and Ox is safe and well tolerated. The combination has demonstrated promising efficacy in MPC, particularly in pts with BRCA2 gene mutations. Clinical trial information: NCT01489865.

Influence of tumor size and Eastern Cooperative Oncology Group performance status (ECOG PS) at baseline on patient (pt) outcomes in lenvatinib-treated radioiodine-refractory differentiated thyroid cancer (RR-DTC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6081-6081 ◽  
Author(s):  
Lori J. Wirth ◽  
Sophie Leboulleux ◽  
Naomi Kiyota ◽  
Makoto Tahara ◽  
Kei Muro ◽  
...  
Keyword(s):  
Tumor Size ◽  
Group Performance ◽  
Performance Status ◽  
Objective Response ◽  
Eastern Cooperative Oncology Group ◽  
Progression Free Survival ◽  
Disease Characteristics ◽  
Kaplan Meier ◽  
Ecog Ps ◽  
Post Hoc

6081 Background: In SELECT, lenvatinib significantly improved progression-free survival (PFS) of pts with RR-DTC versus placebo (18.3 v 3.6 months; hazard ratio [HR]: 0.21 [99% CI: 0.14, 0.31]; P<0.001). Here we examine the treatment of RR-DTC with lenvatinib in relation to tumor size (sum of all targeted lesions) and ECOG PS. Methods: In this post hoc analysis of SELECT with pts randomized to receive lenvatinib, Kaplan-Meier estimates of time to ECOG PS ≥2 were calculated for subgroups of pts according to baseline ECOG PS or tumor size. Objective response rate (ORR) and Kaplan-Meier estimates of overall survival (OS) and PFS according to ECOG PS (0 or 1) at baseline were calculated. Correlations between ECOG PS at baseline (0 or 1) and maximum tumor shrinkage were calculated using one-way analysis of variance. Results: Pts with ECOG PS 0 or 1 at baseline had similar demographic and disease characteristics. ORR was 78.5% and 51.0% for pts with ECOG PS 0 and 1 at baseline, respectively (odds ratio [95% CI]: 3.508 [2.018, 6.097]). Mean maximum percent decrease in tumor size was significantly greater in pts with baseline ECOG PS 0 (-46.13%) versus pts with ECOG PS 1 (-37.16%; P=0.0017). For pts with ECOG PS 1 at baseline, time to ECOG PS ≥2 was numerically shorter with tumor size >60 mm versus tumor size ≤60 mm (HR [95% CI]: 1.450 [0.708, 2.967]). Additional results are summarized in the table. Conclusions: Among pts with RR-DTC, PFS, OS, ORR, and time to ECOG ≥2 were generally better for patients with lower ECOG PS or smaller tumor size at baseline. These results may indicate that it is beneficial to start lenvatinib in pts with RR-DTC early, before ECOG PS worsens and tumor size increases. Clinical trial information: NCT01321554. [Table: see text]

Impact of previous nephrectomy on clinical outcome of metastatic renal carcinoma treated with immune-oncology (I-O):A real-world study on behalf of Meet-URO group (MeetUro-7b).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17088-e17088
Author(s):  
Marco Stellato ◽  
Daniele Santini ◽  
Ugo De Giorgi ◽  
Elena Verzoni ◽  
Chiara Casadei ◽  
...  
Keyword(s):  
Real World ◽  
Progression Free Survival ◽  
Outcome Data ◽  
Rank Test ◽  
Prognostic Impact ◽  
Curative Intent ◽  
Kaplan Meier ◽  
The Difference ◽  
Third Line ◽  
Ecog Ps

e17088 Background: Immuno-oncology (IO) treatment demonstrated to improve Overall Survival (OS) in metastatic renal cell carcinoma (mRCC). The prognostic impact of previous citoreductive nephrectomy (CN) and radical nephrectomy with curative intent in patients (pts) treated with IO is not well defined. Methods: 229 eligible pts, with a least one radiological assessment of response according to the RECIST 1:1 criteria, were retrospectively collected from 16 Italian referral centers. Baseline characteristics, outcome data including progression-free survival (PFS) and OS were collected. Kaplan-Meier method and log-rank test were performed to compare PFS and OS between groups. Results: 153(66.8%) pts received IO as second line, 61(26.6%) as third line and 15(6.6%) pts as further line. 54 pts (23.6%) were good risk, 144(62.9%) were intermediate and 31(13.5%) were poor risk according to IMDC score. 189(82.5%) pts underwent nephrectomy (of them 72(32.4%) pts had synchronous metastatic disease and underwent CN), while 40(17.4%) pts did not. Nephrectomy was performed before IO treatment. ECOG PS, at the beginning of IO, was 0 for 167 pts (72.9%), the other 62 (27.1%) had ECOG PS 1 or 2. At a median follow up time of 17.5 months (mo), 13 (5.7%) pts are still in treatment while 216 (94.3%) experienced progression. 81 (35.3%) pts were treated after IO progression with mTOR and VEGFR inhibitors. 63 (27.5%) pts continued IO beyond progression. G3-G4 iAE were reported in 46 pts (20%). Median IO-PFS was 4.5 months in pts who did not undergo nephrectomy and 2.9 mo in pts who did (HR log rank 0.713, 95%CI 0.4788 to 1.063; p= 0.0582). Median IO-OS was 18.4 mo in pts who underwent nephrectomy and 10.3 mo in pts who did not (HR log rank 1.915, 95%CI 1.118 to 3.281; p= 0.0024). The difference in OS was irrespective of the IMDC criteria and the lines of treatment. Conclusions: In our real world experience, in mRCC pts treated with IO, previous nephrectomy was associated with a better outcome in terms of OS with all the limitations of a retrospective collection.

Efficacy and safety of radiotherapy (RT) plus temozolomide (TMZ) in elderly patients (EP) with glioblastoma (GBM).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 2043-2043 ◽  
Author(s):  
Giuseppe Lombardi ◽  
Luisa Bellu ◽  
Franco Berti ◽  
Patrizia Farina ◽  
Sara Galuppo ◽  
...  
Keyword(s):  
Haematological Toxicity ◽  
Progression Free Survival ◽  
Severe Toxicity ◽  
Wild Type ◽  
Free Survival ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Grade 3 ◽  
Ecog Ps

2043 Background: the optimal management of EP with GBM remains controversial. The role of RT with TMZ for EP is unclear, and EP are often treated with RT alone, TMZ alone or palliative approaches. We describe our experience of combining RT with concurrent TMZ for treatment of EP with GBM Methods: medical records of patients ≥65 years old with newly GBM, histologically confirmed at Veneto Institute of Oncology – Padua, and treated with RT plus TMZ, were reviewed. Concomitant TMZ was 75mg/m2/die. The adjuvant treatment consisted of TMZ 150-200mg/m2/die for six cycles. Median progression-free survival(PFS) and overall survival(OS) were estimated with Kaplan-Meier method. Toxicity was scored according to CTCAE 4.0 Results: we analyzed 60 patients(PTS), 34 males and 26 females; the average age was 70 (range 65-82); ECOG PS was 0-1 in 35 PTS and 2 in 25 PTS; complete surgery was performed in 35 PTS, partial surgery in 25 PTS. 40 and 20 PTS received RT within 6 or more weeks (range 7-9) from surgery. MGMT and IDH1 were analyzed in 43 PTS: MGMT methylated in 20 PTS (46%), all PTS had wild-type IDH1. 34 PTS were treated with RT 40Gy in 15 fractions, 26 PTS with RT 60Gy in 30 fractions with no significant difference in ECOG PS, MGMT and type of surgery between the two subgroups. For all PTS, PFS and OS were 9.5 and 12.7 ms, respectively. OS was 13.7 and 12.4 ms (p=0.9) in PTS receiving RT within 6 or more weeks from surgery, respectively. 13% of PTS showed grade 3-4 haematological toxicity, 12% grade 3-4 asthenia, 3% nausea/vomiting. MGMT methylated and complete surgery was associated with a longer survival. PFS was 9 vs 10 months (p=0.4) and OS was 11.7 vs 13.7 ms (p=0.1), for PTS treated with 40Gy and 60Gy, respectively. Regarding toxicity: grade 3-4 haematological toxicity was 9% vs 23%, severe asthenia was 9% vs 15%, nausea/vomiting was 3% vs 4% of PTS receiving RT 40Gy and 60Gy, respectively. Conclusions: RT plus TMZ is effective and safe in EP with GBM and good ECOG PS. PFS and OS was not statistically different between PTS receiving RT 40Gy or 60Gy, although we showed a trend for longer OS with RT 60Gy; in contrast, severe toxicity was higher in PTS with RT 60Gy. OS was similar between PTS receiving RT within 6 or more weeks (7-9ws) from surgery.

Characteristics of long- versus short-surviving patients (Pts): An analysis of the ARIES Observational Cohort Study (OCS) of bevacizumab (BV)-treated pts with metastatic colorectal cancer (mCRC).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 702-702
Author(s):  
Mark Kozloff ◽  
Axel Grothey ◽  
Johanna C. Bendell ◽  
Allen Lee Cohn ◽  
Tanios S. Bekaii-Saab ◽  
...  
Keyword(s):  
Performance Status ◽  
Progression Free Survival ◽  
Treatment Patterns ◽  
Primary Tumors ◽  
Mutation Status ◽  
Free Survival ◽  
Disease Characteristics ◽  
Kaplan Meier ◽  
Observational Cohort

702 Background: Median overall survival (OS) in mCRC has significantly improved over the past 20 yrs, but the observed range of OS in pts remains wide; a large percentage of pts have OS <1 yr or >4 yrs. ARIES was a prospective OCS conducted from 2006–2012 that evaluated outcomes in pts receiving BV + chemotherapy (CT) for mCRC in general clinical practice. The objective of this analysis is to examine clinical characteristics of pts with long vs short OS. Methods: This analysis included 1,417/1,550 first-line (1L) BV-treated mCRC pts who died or had complete follow-up on study. Long OS was defined as OS within the upper quartile of the analysis population (range 42–67 mos); short OS was defined as OS within the lower quartile (range 0.3–12 mos). Progression-free survival (PFS) was estimated using Kaplan-Meier methods. Pt and disease characteristics and treatment patterns were described using summary statistics. Results: Pt and disease characteristics are shown in the Table. Median PFS was 22.3 mos (95% CI, 19.9–23.3) vs. 4.9 mos (95% CI, 4.6–5.4), in the long-OS vs. short-OS groups. More pts with long OS received any second-line (2L) therapy (71% vs. 46%), and were exposed to 5-fluorouracil, oxaliplatin, and irinotecan throughout the course of their disease (53% vs. 32%) compared with pts with short OS. KRAS/BRAF mutation status was not collected. Conclusions: Pts with long OS had better baseline performance status, primary tumors more likely to have been resected, and were more likely to have received 2L CT. Additional analyses of detailed treatment patterns and safety are ongoing. Clinical trial information: NCT00388206. [Table: see text]

Sequential treatment with sorafenib (SOR) followed by regorafenib (REG) in patients (pts) with unresectable hepatocellular carcinoma (HCC): Interim analysis of the observational REFINE study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16680-e16680
Author(s):  
Philippe Merle ◽  
Ho Yeong Lim ◽  
Richard S. Finn ◽  
Masafumi Ikeda ◽  
Masatoshi Kudo ◽  
...  
Keyword(s):  
Interim Analysis ◽  
Progression Free Survival ◽  
Local Health Authority ◽  
Local Health ◽  
Second Line ◽  
Secondary Endpoints ◽  
Prior Systemic Therapy ◽  
Third Line ◽  
Practice Methods ◽  
Dose Modifications

e16680 Background: REG is approved for the treatment of pts with HCC who previously received SOR, based on results of the phase 3 RESORCE trial. The REFINE study was designed to evaluate the safety and effectiveness of REG in pts with HCC in real-world practice. Methods: This prospective, observational study aims to recruit 1000 pts with unresectable HCC for whom a decision to treat with REG was made by the treating physician prior to enrollment according to the local health authority approved label. The primary endpoint is the incidence of treatment-emergent adverse events (TEAEs) and dose modifications due to TEAEs (NCI-CTCAE v4.03). Secondary endpoints include overall survival (OS) and progression-free survival (investigator assessed). This interim analysis includes the first 500 pts on study for ≥4 months. Results: Of 500 pts enrolled and observed for ≥4 months, 498 received REG and were evaluable (data cut-off: November 11, 2019). Pts were Child-Pugh A 67%, B 11%, C 1%, and missing/not evaluable 21%. Most pts (98%; n = 490) had received prior systemic therapy; 97% (n = 482) had received prior SOR. REG was second line treatment in 81% of pts (n = 403), third line or higher in 17% (n = 87), and first line in 2% (n = 8). Of the 403 pts who received REG second line, 398 (99%) received prior SOR. Among the 482 pts who received SOR in any prior line, the median duration of prior SOR was 4.8 months (interquartile range 2.5–9.6), 45% (n = 216) had a last daily SOR dose of 800 mg, and 8% (n = 40) had a TEAE leading to SOR discontinuation (SOR-intolerant). OS by treatment line is shown in the Table. Among all treated pts, the most frequent TEAEs (any grade) were hand–foot skin reaction (HFSR; 30%), diarrhea (21%), fatigue (16%), and decreased appetite (14%). In SOR-intolerant pts (n = 40), the most frequent TEAEs (any grade) were diarrhea (25%), HFSR (20%), abdominal pain (15%), and decreased appetite (13%). Conclusions: In this interim analysis of REFINE, most pts received REG second line after SOR versus other lines of therapy. Median OS in this subgroup was longer than OS in RESORCE, but the proportion of censored pts was high. The most common TEAEs were similar to those in RESORCE in both the overall cohort and in SOR-intolerant pts. Clinical trial information: NCT03289273 . [Table: see text]

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