ColotypeR gene signature predicts response to cetuximab in colorectal cancer metastases.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 599-599
Author(s):  
Steven Allen Buechler ◽  
Yesim Gokmen-Polar ◽  
Sunil S. Badve
Keyword(s):  
Colorectal Cancer ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Progression Free Survival ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
Cox Proportional Hazards Model ◽  
Response To Treatment ◽  
Molecular Characteristics ◽  
Wild Type

599 Background: The consensus molecular subtypes (CMS1-4) partition primary colorectal cancer (CRC) into subgroups with distinct molecular characteristics. We previously reported a 20-genes ColotypeR-CMS signature that accurately defines CMS subtypes for primary CRC tumor samples. The utility of CMS subtyping in defining response to treatment of CRC metastases remains to be established. Here, we report the ability of ColotypeR scores to predict differential response to cetuximab among CMS subtypes in CRC metastases. Methods: The role of ColotypeR-CMS signature scores was assessed in CRC metastasis samples (GSE5851, N = 68, Affymetrix microarray) in predicting response to cetuximab. Progression-free survival (PFS) was the primary endpoint. The predictive significance of ColotypeR-CMS scores relative to KRAS mutation status was also studied using multivariate Cox proportional hazards models. Results: ColotypeR-CMS scores were computed in GSE5851 using the algorithm developed in primary tumor samples. Higher values of ColotypeR-CMS CMS2 score were significantly predictive of longer PFS (p = 5 x 10-5for the score test in Cox proportional hazards model; hazard ratio 0.20 (95%CI 0.09-0.44) in CRC metastases samples (GSE5851, N = 68) treated with cetuximab. PFS was independent of CMS1,3, 4 scores. KRAS wild type tumors had significantly longer PFS (p = 0.01; hazard ratio 0.49 (95%CI 0.28-0.86). In multivariate survival analysis, ColotypeR-CMS CMS2 score added to the significance of KRAS status (p = 0.012) and ColotypeR-CMS CMS2 score was predictive of longer PFS in KRAS wild type tumors (p = 0.009; hazard ratio 0.20 (95%CI 0.06-0.69)). Conclusions: We showed that in CRC metastasis samples, the ColotypeR CMS2 score was highly predictive of sensitivity to cetuximab treatment, while no increase in PFS was observed for higher values of CMS1, 3, 4 scores.

Plasma VEGF-A (pVEGF-A) level in efficacy analysis of metastatic colorectal cancer patients (mCRC) treated with mFOLFOX6/XELOX plus bevacizumab (BV) (WJOG7612GTR).

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 699-699
Author(s):  
Wataru Okamoto ◽  
Akitaka Makiyama ◽  
Yoshiyuki Yamamoto ◽  
Kohei Shitara ◽  
Tadamichi Denda ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Progression Free Survival ◽  
Predictive Marker ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Enzyme Linked Immunosorbent Assay ◽  
Negative Results

699 Background: Plasma levels of VEGF-A short isoforms (VEGF-A110 and -A121) measured by immunological multiparametric chip technique (IMPACT) were reported to be associated with clinical benefits from bevacizumab (BV) in advanced gastric and pancreatic cancer but not in metastatic colorectal cancer (mCRC). Negative results in mCRC studies might be caused by different sample handling: citrate instead of EDTA and repetition of freeze/thaw. Methods: Blood samples were collected in EDTA before the first-line treatment with BV+mFOLFOX6 or +XELOX for mCRC. Plasma samples were analyzed at Roche Diagnostics Ltd. (Penzberg, Germany) using IMPACT-2 (Roche proprietary multiplex enzyme-linked immunosorbent assay platform). A median value of pVEGF-A was used as a cut-off point to categorize patients (pts) into the low and high pVEGF-A groups. Progression free survival (PFS) and overall survival (OS) between the low and high pVEGF-A groups were compared, using Cox proportional hazards model. We hypothesized that BV-containing treatment extend shorter PFS of pts with high pVEGF-A to that with low pVEGF-A, and estimated a threshold hazard ratio (HR) between them as below 1.15. Results: Among 102 pts enrolled between January 2014 and April 2015, 100 (53 BV+mFOLFOX6 and 47 BV+XELOX) were eligible. Median PFS was 11.4 months [95% CI, 9.5-13.0] and response rate was 64.6 % [range, 53.3-74.9]. pVEGF-A was measured in 97 pts and the median value was 36.8 pg/ml [range, 6.5- 262.2]. The hazard ratios of PFS and OS between the high and low pVEGF-A groups were 1.23 [95%CI, 0.76-1.97, p = 0.40] and 2.47 [95%CI, 1.14-5.36, p = 0.02], respectively. Conclusions: mCRC pts with high pVEGF-A showed shorter PFS than those with low pVEGF-A beyond the predefined threshold (HR 1.15) in BV-containing chemotherapy, suggesting that pVEGF-A could not be a predictive marker for BV efficacy. Clinical trial information: UMIN000012442.

scholarly journals Pre-Existing Disability and Its Risk of Fragility Hip Fracture in Older Adults

2019 ◽  
Vol 16 (7) ◽  
pp. 1237
Author(s):  
Jayeun Kim ◽  
Soong-Nang Jang ◽  
Jae-Young Lim
Keyword(s):  
Older Adults ◽  
Hip Fracture ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
Cox Proportional Hazards Model ◽  
Mental Disabilities ◽  
Term Care ◽  
Fragility Hip Fracture

Background: Hip fracture is one of the significant public concerns in terms of long-term care in aging society. We aimed to investigate the risk for the incidence of hip fracture focusing on disability among older adults. Methods: This was a population-based retrospective cohort study, focusing on adults aged 65 years or over who were included in the Korean National Health Insurance Service–National Sample from 2004 to 2013 (N = 90,802). Hazard ratios with 95% confidence interval (CIs) were calculated using the Cox proportional hazards model according to disability adjusted for age, household income, underlying chronic diseases, and comorbidity index. Results: The incidence of hip fracture was higher among older adults with brain disability (6.3%) and mental disability (7.5%) than among those with other types of disability, as observed during the follow-up period. Risk of hip fracture was higher among those who were mildly to severely disabled (hazard ratio for severe disability = 1.59; 95% CI, 1.33–1.89; mild = 1.68; 95% CI, 1.49–1.88) compared to those who were not disabled. Older men with mental disabilities experienced an incidence of hip fracture that was almost five times higher (hazard ratio, 4.98; 95% CI, 1.86–13.31) versus those that were not disabled. Conclusions: Older adults with mental disabilities and brain disability should be closely monitored and assessed for risk of hip fracture.

Prognostic indicators of secondary progression in a paediatric-onset multiple sclerosis cohort in Kuwait

2015 ◽  
Vol 22 (8) ◽  
pp. 1086-1093 ◽  
Author(s):  
Saeed Akhtar ◽  
Raed Alroughani ◽  
Samar F Ahmed ◽  
Jasem Y Al-Hashel
Keyword(s):  
Multiple Sclerosis ◽  
Confidence Interval ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
Cox Proportional Hazards Model ◽  
Adjusted Hazard Ratio ◽  
Secondary Progressive ◽  
Hazards Model

Background: The frequency of paediatric-onset multiple sclerosis (POMS) and the precise risk of secondary progression of disease are largely unknown in the Middle East. This cross-sectional cohort study assessed the risk and examined prognostic factors for time to onset of secondary progressive multiple sclerosis (SPMS) in a cohort of POMS patients. Methods: The Kuwait National MS Registry database was used to identify a cohort of POMS cases (diagnosed at age <18 years) from 1994 to 2013. Data were abstracted from patients’ records. A Cox proportional hazards model was used to evaluate the prognostic significance of the variables considered. Results: Of 808 multiple sclerosis (MS) patients, 127 (15.7%) were POMS cases. The median age (years) at disease onset was 16.0 (range 6.5–17.9). Of 127 POMS cases, 20 (15.8%) developed SPMS. A multivariable Cox proportional hazards model showed that at MS onset, brainstem involvement (adjusted hazard ratio 5.71; 95% confidence interval 1.53–21.30; P=0.010), and POMS patient age at MS onset (adjusted hazard ratio 1.38; 95% confidence interval 1.01–1.88; P=0.042) were significantly associated with the increased risk of a secondary progressive disease course. Conclusions: This study showed that POMS patients with brainstem/cerebellar presentation and a relatively higher age at MS onset had disposition for SPMS and warrant an aggressive therapeutic approach.

Use and impact of perioperative chemotherapy in patients with resectable colorectal cancer metastases.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 159-159
Author(s):  
Amy Body ◽  
Margaret Lee ◽  
Hui-Li Wong ◽  
Alun Pope ◽  
Azim Jalali ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
De Novo ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Biologic Agent ◽  
Separate Analysis ◽  
Perioperative Chemotherapy ◽  
Variable Approach

159 Background: There is conflicting evidence regarding benefit of perioperative chemotherapy (p-chemo) for metastatic colorectal cancer (mCRC) patients (pts) undergoing resection of metastases (mets). Aims: To describe use of and outcomes from p-chemo in mCRC pts who underwent resection of isolated liver or lung mets. Methods: Pts were identified from the TRACC (Treatment of Recurrent and Advanced Colorectal Cancer) database, a multi-centre registry of mCRC pts. P-chemo was defined as chemotherapy within 12 weeks of surgery. Multivariate (MV) analysis using a Cox proportional hazards model was undertaken. Results: 371 pts were identified. Median age was 64 (27 – 90), 169 (45%) had de novo stage IV disease, 96% were ECOG 0-1. 284 (77%) had liver-only and 87 (23%) lung-only mets. 242 (65%) pts received p-chemo (58 pre-op alone, 134 post-op alone, 50 both). 62 (19%) pts also received a biologic agent (47/62 pre-op). Median age was 68 and 61 years in no p-chemo and p-chemo groups, respectively (p<0.0001). 53% of no p-chemo pts and 23% of p-chemo pts had had prior adjuvant chemotherapy (p<0.001). On MV analysis, p-chemo was a significant predictor of survival (HR 0.52, 95% CI 0.32-0.88, p=0.014). The other significant predictor of improved survival was ECOG PS of 0 (HR 0.58, p=0.019). Predictors of worse survival were rectal primary (HR 1.98 p=0.009), male gender (HR 1.69 p=0.03) and de-novo metastatic disease (HR 2.63, p=0.006). Prior adjuvant chemo, age, liver vs lung mets, use of perioperative biologics, BRAF and RAS status had no significant impact. In an exploratory analysis, the group considered “resectable” upfront (n=281) was analysed separately, perioperative chemotherapy was not a significant predictor of survival in this subgroup (HR 0.69, p=0.26). Conclusions: In routine care there is a variable approach to the use of p-chemo in pts with potentially resectable liver or lung mets. P-chemo is associated with improved survival in this analysis, although this was not confirmed in the separate analysis of the “resectable” subgroup. Due to the retrospective nature of the study confounding by unmeasurable factors is possible. This study supports ongoing consideration of P-chemo in pts with resectable mets.

scholarly journals Prediagnosis plasma concentrations of enterolactone and survival after colorectal cancer: the Danish Diet, Cancer and Health cohort

2018 ◽  
Vol 122 (5) ◽  
pp. 552-563 ◽  
Author(s):  
Cecilie Kyrø ◽  
Kirsten Frederiksen ◽  
Marianne Holm ◽  
Natalja P. Nørskov ◽  
Knud E. B. Knudsen ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Plasma Concentrations ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Limited Attention ◽  
Hazards Model ◽  
Specific Mortality ◽  
Cancer Specific Mortality

AbstractThe association between lifestyle and survival after colorectal cancer has received limited attention. The female sex hormone, oestrogen, has been associated with lower colorectal cancer risk and mortality after colorectal cancer. Phyto-oestrogens are plant compounds with structure similar to oestrogen, and the main sources in Western populations are plant lignans. We investigated the association between the main lignan metabolite, enterolactone and survival after colorectal cancer among participants in the Danish Diet, Cancer and Health cohort. Prediagnosis plasma samples and lifestyle data, and clinical data from time of diagnosis from 416 women and 537 men diagnosed with colorectal cancer were used. Enterolactone was measured in plasma using a liquid chromatography–tandem mass spectrometry (LC–MS/MS) method. Participants were followed from date of diagnosis until death or end of follow-up. During this time, 210 women and 325 men died (170 women and 215 men died due to colorectal cancer). The Cox proportional hazards model was used to estimate hazard ratios (HR) and 95 % CI. Enterolactone concentrations were associated with lower colorectal cancer-specific mortality among women (HRper doubling: 0·88, 95 % CI 0·80, 0·97, P=0·0123). For men, on the contrary, enterolactone concentrations were associated with higher colorectal cancer-specific mortality (HRper doubling: 1·10, 95 % CI 1·01, 1·21, P=0·0379). The use of antibiotics affects enterolactone production, and the associations between higher enterolactone and lower colorectal cancer-specific mortality were more pronounced among women who did not use antibiotics (analysis on a subset). Our results suggest that enterolactone is associated with lower risk of mortality among women, but the opposite association was found among men.

scholarly journals Alcohol Use Disorders and Increased Risk of Adverse Birth Complications and Outcomes: An 11-Year Nationwide Cohort Study

2020 ◽  
Vol 17 (22) ◽  
pp. 8515
Author(s):  
Sarah Soyeon Oh ◽  
Yongho Jee ◽  
Eun-Cheol Park ◽  
Young Ju Kim
Keyword(s):  
Alcohol Use ◽  
Alcohol Dependence ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Alcohol Use Disorders ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
Cox Proportional Hazards Model ◽  
Birth Complications ◽  
Increased Risk

For women who suffer from Alcohol Use Disorders (AUDs), the use of alcohol before and/or during pregnancy may result in various birth complications, including miscarriage, stillbirth, or preterm delivery. Thus, this study aimed to explore whether Alcohol Use Disorders (AUDs) are associated with increased risk of adverse birth complications and outcomes. A total of 76,799 deliveries between 2003 and 2013 in the Korean National Health Insurance Service National Sample Cohort (NHIS-NSC) were analyzed. Women with an AUD diagnosis preceding delivery were identified as individuals with alcohol dependence. A multivariate Cox proportional hazards model was used to estimate the hazard ratio of adverse birth complications and outcomes associated with alcohol dependence. Diagnosis of an AUD was associated with increased risk of adverse birth complications (Hazard Ratio [HR]: 1.15, 95% CI: 1.01–1.31, p = 0.0302). This was especially the case for women whose AUD diagnosis was in the same year as their delivery (HR: 1.53, 95% CI: 1.24–1.88, p < 0.0001). AUDs were associated with increased risk of adverse birth outcomes, especially when prevalent in the same year as a woman’s delivery. Our study confirms that the monitoring of expecting women with a diagnosis of alcohol-related problems may be useful in preventing adverse birth complications.

Prognostic factors for overall survival with sunitinib as first-line therapy in patients with metastatic renal cell carcinoma (mRCC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5042-5042
Author(s):  
S. Patil ◽  
R. A. Figlin ◽  
T. E. Hutson ◽  
M. D. Michaelson ◽  
S. Négrier ◽  
...  
Keyword(s):  
Overall Survival ◽  
Prognostic Factors ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Progression Free Survival ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Rank Test ◽  
Type I ◽  
First Line

5042 Background: Sunitinib demonstrated superior progression-free survival (PFS; the primary endpoint) over interferon-alfa (IFN-α) as first-line mRCC therapy (NEJM 2007;356:115). Median overall survival (OS) with sunitinib compared to IFN-α was: 26.4 vs. 21.8 months (HR=0.821; P=0.051 by unstratified log-rank test; Proc ASCO 2008;26, May 20 suppl; abstr 5024). An analysis of prognostic factors for OS was performed on data from this trial. Methods: 750 treatment-naïve mRCC patients were randomized 1:1 to receive sunitinib or IFN-α. By Cox proportional hazards model, selected pretreatment variables were evaluated univariately and in a multivariate model for each treatment arm. Multivariate models for each treatment arm were based on a stepwise algorithm with a type I error of 0.25 for entry and 0.15 for elimination. Further elimination was applied to identify variables significant at P<0.05. Results: In multivariate analysis of sunitinib patients, factors associated with longer OS include: interval from diagnosis to treatment ≥1 yr, ECOG PS of 0, lower corrected calcium, absence of bone metastases, lower lactic dehydrogenase (LDH), and higher hemoglobin (Hgb) ( table ). For the IFN-α treatment arm, male gender, absence of bone or lymph node metastases, lower LDH, higher Hgb, lower corrected calcium, higher neutrophil count, and interval from diagnosis to treatment ≥1 yr were associated with longer OS. Conclusions: For patients in the sunitinib treatment arm, prognostic factors identified were similar to the factors previously identified in the MSKCC risk groups (J Clin Oncol 2002;20:289). Additional prognostic factors were identified for the IFN-α arm. Further studies are warranted to independently validate these findings as well as to identify tumor-specific prognostic factors. [Table: see text] [Table: see text]

Gender disparities in hepatocellular cancer survival

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15517-e15517
Author(s):  
A. E. Hendifar ◽  
D. Yang ◽  
S. Iqbal ◽  
H. Lenz ◽  
A. El-Khoueiry
Keyword(s):  
Overall Survival ◽  
Cancer Survival ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Premenopausal Women ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Response To Treatment ◽  
Cancer Specific Survival ◽  
Asian Ethnicity

e15517 Background: Recent reports suggest that estrogen mediated inhibition of IL-6 protects against the development of HCC and may explain the decreased risk of liver cancer in women. We investigated the relation-hip between gender, age, and survival for patients with localized HCC. Methods: We identified 11,097 patients with localized, histologically defined HCC, from 1988- 2003, using the Surveillance, Epidemiology, and End Results (SEER) registry. Age at diagnosis, sex, ethnicity, and overall survival were evaluated using Cox proportional hazards model. The models were adjusted for treatment modality, tumor differentiation, tumor size, lymph node involvement, and number of lesions; they were stratified by year of diagnosis and SEER registry site. Results: 8,111 (73%) patients were men and 2,986 (27%) were women. In univariate and multivariate analyses, female gender, young age (< 55 yo), and Asian ethnicity were all associated with improved overall survival (p<0.001). In patients less than 55 yo, women had a superior OS and cancer specific survival (CSS) when compared to men (OS: 18 months vs. 9, CSS: 31 months vs. 14, p<0.001). Conversely, in patients older than 55, there were no gender differences (OS: 8 months vs. 8, CSS 13 months vs. 11, p = 0.08). Local therapies, including, ablation (HR = 0.47 [0.43–0.53]), hepatectomy (HR = 0.40 [0.36–0.44]), radiation (HR = 0.67 [0.57–0.78]) and transplantation (HR = 0.17 [0.15–0.20]) were also associated with improved survival. There were no interactions identified between gender and treatment use. Conclusions: To our knowledge, this is the first report to highlight the superior outcome of premenopausal women with HCC compared to men. We postulate a potential role for estrogen in influencing the biology of HCC and the response to treatment. These observations are consistent with ones made in other gastrointestinal cancers and with reported preclinical data suggesting a protective role for estrogen. Further studies that confirm these observations and elucidate the biology of estrogen's influence on HCC are needed. [Table: see text] No significant financial relationships to disclose.

Circulating mir-21 and mir-378 are predictive of progression-free survival (PFS) in patients treated with everolimus in metastatic renal cell cancer (mRCC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4617-4617
Author(s):  
James Lin Chen ◽  
Kimryn Rathmell ◽  
David F. McDermott ◽  
Walter Michael Stadler
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Clear Cell ◽  
Standard Dose ◽  
Cell Cancer ◽  
Predictive Biomarkers ◽  
Progression Free Survival ◽  
Negative Control ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model

4617 Background: The oral mTOR inhibitor, everolimus, affects tumor growth by targeting cellular metabolic proliferation pathways and modestly delays RCC progression. We hypothesized that circulating microRNAs, which have been associated with renal cancer and inflammation, may serve as predictive biomarkers to help better define a population more sensitive to treatment. Methods: Plasma from mRCC pts refractory to VEGF inhibition were obtained prior to treatment with standard dose everolimus as part of a clinical trial examining FDG-PET as a potential predictive biomarker. As we were specifically interested in tumor response to drug, only pts who died, remained on trial, or had radiographic progression by RECIST criteria were profiled. Pts who were unable to tolerate drug were excluded. MicroRNAs were extracted and profiled without pre-amplification using Exiqon LNA PCR panels. Crossing point (Cp) values within 5 of the negative control were removed. MicroRNAs must have been present in >90% of samples and varied at least p > 0.10 from mean to be further analyzed. Cox-proportional hazards model and Kaplan-Meier analyses were performed. Results: 28 patients had available plasma and met criteria for profiling. Pt characteristics included: 20 (71%) clear cell histology, median age 57.7 (43 – 76), median number of prior systemic therapies 2 (1 – 3). 103 microRNAs were expressed in at least 90% of all samples. Mir-21 and mir-378 were independently correlated with PFS (FDR: 0.02 and 0.06, respectively). Low circulating plasma mir-21 and mir-378 levels resulted in a median PFS prolongation of 370d vs. 101d (p=0.027) and 368d vs. 106d (p=0.001). Analysis of the clear cell cohort for mir-21 and mir-378 also demonstrated a significant median PFS difference of 350d vs. 173d (p=0.045) and 345d vs. 147d (p=0.004). Conclusions: Elevated levels of circulating mir-21 and mir-378 have been associated with systemic inflammatory states, and in our study are correlated with decreased PFS in mRCC pts undergoing everolimus therapy. Further prospective studies will be required to validate these exploratory results for their potential role as prognostic or predictive biomarkers.

Association of morphologic response with progression free survival in patients with metastatic colorectal cancer treated with bevacizumab-based chemotherapy: HGCSG0802.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 743-743
Author(s):  
Satoshi Yuki ◽  
Hiroshi Nakatsumi ◽  
Hideyuki Hayashi ◽  
Hiraku Fukushima ◽  
Takashi Kato ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Progression Free Survival ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Rank Test ◽  
First Line ◽  
Free Survival ◽  
Contrast Enhanced Ct ◽  
Morphologic Response

743 Background: It was reported that an optimal morphologic response to preoperative chemotherapy was associated with better overall survival (OS) in patients (pts) with colorectal liver metastases (CLM). We investigated association of morphologic response with progression free survival (PFS) in pts with unresectable CLM from HGCSG0802 observational cohort study in pts with mCRC treated with first-line bevacizumab (BV)-based chemotherapy. Methods: The objective of HGCSG0802 was to evaluate PFS, OS, time to treatment failure (TTF), response rate (RR), safety, etc. The key eligibility criteria were evaluable lesions, older than 20 years old, ECOG PS 0-2. Pts with CLM underwent contrast-enhanced CT at the start and every 8-weeks of BV-based chemotherapy. In this analysis, three blinded, independent radiologists evaluated images for morphologic response, based on metastases changing from heterogeneous masses with ill-defined margins into homogeneous hypoattenuating lesions with sharp borders. Association of morphologic response and pts characteristics, RR, and PFS were evaluated. PFS was analyzed with Kaplan-Meier method, log-rank test, and Cox proportional hazards model. Results: Of 108 pts (the full analysis set), 73 pts with CLM were evaluable for morphologic criteria. Eighteen pts (24.7%) had optimal morphologic response (OR), 31 (42.5%) had incomplete (IR), and 24 (32.9%) had no response (NR). The pts characteristics between those with OR, IR and NR were generally balanced. The median TTF was 7.2 months in NR versus 7.2 months in IR versus 6.8 months in OR (HR (OR/NR) = 0.91, HR (OR/IR) = 0.90; p = 0.93). RR was 77.8% in OR versus 64.5% in IR and 58.3% in NR (p = 0.528). The median PFS was 8.3 months in NR versus 8.5 months in IR versus 9.1 months in OR (HR (OR/NR) = 0.72, HR (OR/IR) = 1.04; p = 0.420). Conclusions: In this analysis, morphologic response might not be a prognostic marker in first-line BV-based chemotherapy in pts with CLM.

Sign in / Sign up

Export Citation Format

Share Document