An observational study of a team management approach for first-line XELOX therapy in patients with advanced/recurrent colorectal cancer: The SMILE study (the study of metastatic colorectal cancer to investigate impact of learning effect).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 554-554
Author(s):  
Michio Nakamura ◽  
HIroshi Matsuoka ◽  
Yoshihisa Shibata ◽  
Yoshinori Munemoto ◽  
Hiroyuki Okuda ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Observational Study ◽  
Small Sample Size ◽  
Depression Scale ◽  
Dose Intensity ◽  
Small Sample ◽  
Management Approach ◽  
First Line ◽  
Fighting Spirit ◽  
Supportive Interventions

554 Background: Although oral chemotherapies such as XELOX are widely favored for convenience and flexibility, these have several disadvantages such as drug non-compliance and delayed discovery of adverse events. So we designed a multicenter, prospective, observational study to evaluate the efficacy of supportive interventions in first-line XELOX for colorectal cancer (CRC) patients (pts). Methods: CRC pts undergoing first-line XELOX (+Bevacizumab) therapy practicing one or more of supportive interventions as follows: 1) a telephone follow-up (TF), 2) instruction on dosage and administration by a pharmacist, 3) skin care instruction by a nurse, and 4) pts education by a doctor were eligible. The objective was to evaluate the incident rate of grade 2 or worse hand-foot syndrome (HFS), QoL, safety, and efficacy. QoL was assessed at baseline, 2, 4, 5 and 8 cycles after the treatment started, using the Hospital Anxiety and Depression Scale (HADS) and the Mental adjustment to cancer scale (MAC). Results: From April 2011 to September 2012, 80 pts were enrolled from 14 institutes. The characteristics were as follows: male/female: 46/34, age median: 63 (36-75), and supportive intervention 1)/2)/3)/4): 36/68/73/78. The incidence of grade 2 or worse HFS during 6 months were 11.1% (n=4) for those received TF (n=36), and 20.5% (n=9) for those received other intervention except TF (n=44). Relative dose intensity (RDI) was 75.7% (TF+/-: 77.7/74.3%) in oxaliplatin and 77.5% (TF+/-: 80.2/75.3%) in capecitabine, respectively. Although a tendency of the QoL score improvement about anxiety, fighting spirit and helplessness in a TF group was observed during the periods from start of therapy to 4 courses, there were no significant differences compared to other interventions except TF. Conclusions: We confirmed that HFS incidence was mitigated in a TF group. In regard to QoL, although we could not show the statistical differences due to some limitations of this study such as small sample size and non-randomized, it was indicated that TS had the potential to improve several QoL about anxiety, fighting spirit, and helplessness. Clinical trial information: UMIN000007185.

scholarly journals Colorectal Cancer Biomarkers in the Era of Personalized Medicine

2019 ◽  
Vol 9 (1) ◽  
pp. 3 ◽  
Author(s):  
Jai Patel ◽  
Mei Fong ◽  
Megan Jagosky
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Therapy Response ◽  
Dose Intensity ◽  
Cancer Biomarkers ◽  
Clinical Implications ◽  
Test Results ◽  
First Line ◽  
Genomic Markers ◽  
Generation Sequencing

The 5-year survival probability for patients with metastatic colorectal cancer has not drastically changed over the last several years, nor has the backbone chemotherapy in first-line disease. Nevertheless, newer targeted therapies and immunotherapies have been approved primarily in the refractory setting, which appears to benefit a small proportion of patients. Until recently, rat sarcoma (RAS) mutations remained the only genomic biomarker to assist with therapy selection in metastatic colorectal cancer. Next generation sequencing has unveiled many more potentially powerful predictive genomic markers of therapy response. Importantly, there are also clinical and physiologic predictive or prognostic biomarkers, such as tumor sidedness. Variations in germline pharmacogenomic biomarkers have demonstrated usefulness in determining response or risk of toxicity, which can be critical in defining dose intensity. This review outlines such biomarkers and summarizes their clinical implications on the treatment of colorectal cancer. It is critical that clinicians understand which biomarkers are clinically validated for use in practice and how to act on such test results.

Methylated DNA markers for monitoring palliative chemotherapy response in advanced colorectal cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e15511-e15511
Author(s):  
Mojun Zhu ◽  
Douglas W. Mahoney ◽  
Kelli Burger ◽  
Patrick H. Foote ◽  
Karen A. Doering ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Treatment Response ◽  
Systemic Therapy ◽  
Small Sample Size ◽  
High Sensitivity ◽  
Response Assessment ◽  
Small Sample ◽  
Chemotherapy Response ◽  
Continuous Variables ◽  
Methylated Dna

e15511 Background: Aberrantly methylated DNA marker (MDM) candidates are strongly associated with primary colorectal cancer (CRC) before treatment and detect CRC recurrence with high sensitivity when assayed from plasma. The relationship of these MDMs in association to chemotherapy treatment response is unknown. Methods: In a prospective cohort of patients receiving systemic therapy for advanced CRC, peripheral blood was collected serially during restaging visits. 15 patients were retrospectively identified to have partial response (PR), stable disease (SD) and progressive disease (PD) to treatment (n=5 for each group) based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Using paired samples from each patient before and after response assessment, we analyzed 11 MDMs ( GRIN2D, ZNF671, ANKRD13B, QKI, VAV3, JAM3, SFMBT2, CHST2, ZNF568, FER1L4 and CNNM1) to assess correlation with treatment response. Cell-free DNA was extracted and bisulfite treated before MDMs were quantified by target enrichment long-probe quantitative-amplified signal assay and normalized to a methylated sequence of B3GALT6. Continuous variables are summarized as a median with corresponding interquartile ranges (IQR) and comparisons between subgroups were based on the Wilcox Rank Sums test. Results: The median interval between pre- and post-response assessment visits was 69 days (IQR: 63-83 days) and the level of tumor burden at pre-assessment was similar across all response types (Table 1). Patients with PD had higher levels of methylated GRIN2D, ZNF671 and ANKRD13B than those with PR or SD at baseline and may offer additional prognostic value over CEA which was similar in the PR and PD groups before treatment (Table 1). Elevation of pre-assessment MDMs preceded radiographic evidence of disease progression by 82 days (IQR 69-83 days). Conclusions: Three MDMs, GRIN2D, ZNF671 and ANKRD13B, were found to reflect treatment response (PD vs. PR + SD) as shown in the table. Although this pilot study was limited by a small sample size, it demonstrated the feasibility of using plasma-based MDMs in monitoring treatment response to systemic therapy for advanced CRC and should be compared to CEA in a larger study.[Table: see text]

Implementation of Postpartum Depression Screening for Women Participating in the WIC Program

2021 ◽  
pp. 107839032110478
Author(s):  
Kelli Giron ◽  
Shelly Noe ◽  
Lori Saiki ◽  
Elizabeth Kuchler ◽  
Satyapriya Rao
Keyword(s):  
Postpartum Depression ◽  
Sample Size ◽  
Low Income ◽  
Small Sample Size ◽  
Depression Scale ◽  
Small Sample ◽  
National Average ◽  
High Risk Population ◽  
Community Resources ◽  
Wic Program

Introduction: The national average for the occurrence of postpartum depression (PPD) is 11.5%. Women enrolled in the Women, Infants, and Children (WIC) program are at an elevated risk for PPD symptoms due to risk factors such as a low income, unemployment, low education level, and younger maternal age. Objective: To implement screening for PPD symptoms using the Edinburgh Postnatal Depression Scale (EPDS) (1987) for women participating in the local WIC program with an infant <12 months old and compare results of positive screenings to the national average. The second goal was to provide community resources to those women with a positive score. Methods: Of 72 women screened, 69 scores were used in the comparison of the positive scores to the national Centers for Disease Control and Prevention average of 11.5%. Women were offered community resources after completion of the EPDS. Results: There were 13 positive scores out of the sample size of 69. The percentage of positive scores obtained from these data were 18.84% for the WIC population, which is higher than the national average of 11.5%. This was significant with p = .0494. One limitation of this project was a small sample size. Conclusion: It would be beneficial for the WIC program to screen women for PPD symptoms in this high-risk population, so that recommendations for follow-up care could be made and quality of life could be increased.

scholarly journals An observational study of bevacizumab combined with FOLFIRI as the first-line treatment in metastatic colorectal cancer

2012 ◽  
Vol 4 (4) ◽  
pp. 122-127 ◽  
Author(s):  
Meng-Lin Huang ◽  
Jung-Yu Kan ◽  
Cheng-Jen Ma ◽  
Ching-Wen Huang ◽  
Fang-Ming Chen ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Observational Study ◽  
Metastatic Colorectal Cancer ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

scholarly journals Observational study of first-line chemotherapy including cetuximab in patients with metastatic colorectal cancer: CORAL trial

2019 ◽  
Vol 49 (4) ◽  
pp. 339-346 ◽  
Author(s):  
Kei Muro ◽  
Michio Itabashi ◽  
Hiroki Hashida ◽  
Toshiki Masuishi ◽  
Hiroyuki Bando ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Observational Study ◽  
Metastatic Colorectal Cancer ◽  
First Line ◽  
Line Chemotherapy

First-line simplified GEMOX (D1-D1) versus classical GEMOX (D1-D2) in metastatic pancreatic adenocarcinoma (MPA). A GERCOR randomized phase II study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4592-4592
Author(s):  
T. Andre ◽  
P. Afchain ◽  
G. Lledo ◽  
S. Nguyen ◽  
J. Paitel ◽  
...  
Keyword(s):  
Response Rate ◽  
Phase Ii Study ◽  
Small Sample Size ◽  
Small Sample ◽  
High Rate ◽  
First Line ◽  
Pancreas Head ◽  
Randomized Phase Ii ◽  
Metastatic Pancreatic Adenocarcinoma ◽  
Poorly Differentiated

4592 Background: GEMOX was defined as a D1-D2 schedule, based on preclinical data. In order to improve convenience for patients, we evaluated a simplified D1-D1GEMOX regimen (S-GEMOX) in MPA. Methods: Patients (pts) with MPA were 2:1 randomly assigned for first-line treatment to S-GEMOX (arm A : gemcitabine 1,000mg/m2, 100 min infusion D1 immediately followed by oxaliplatin 100 mg/m2, 120 min infusion) or to GEMOX (arm B : gem D1 and ox D2). Treatment was repeated in each arm every 2 weeks until disease progression. Stratification was performed on centre and PS. Results: Fifty-seven pts were enrolled, A = 37 (PS 2 : 22%), B = 20 (PS 2 : 20%). Populations were well balanced for age (64.9 yrs vs 66.6), gender (57% male vs 65), location of primary tumor (pancreas head 49% vs 50), and metastasic sites (liver 76% vs 85; peritoneum 24% vs 20; lung 16% vs 10; lymph nodes 14% vs 15; other 5% vs 5). Tumor differentiation significantly differed among the 2 groups (A : 8% poorly differentiated vs B : 36%). Response rate was 27% (95% CI : 12–42) in arm A and 10% (95% CI : 0 - 23) in arm B. Median PFS was 4.0 and 2.5 months in arm A and B, respectively. Median OS was 7.6 and 3.2 months in arm A and B, respectively. S-GEMOX was more toxic than GEMOX for gr 3–4 neutropenia (20% vs 0%) and thrombocytopenia (16% vs 10%). Other toxicities were comparable. However, since more cycles were administered in arm A (8.5 (1–29) vs 5.8 (2–12)), gr 3 oxaliplatin- induced neuropathy was higher in arm A (21.6% vs 0%). Conclusions: S-GEMOX is active in MPA. This activity is in the same range as compared to our previous experiences of GEMOX. The very bad outcome of pts randomized in arm B could be in part explained by the high rate of poorly differentiated tumors. This study emphazises one more time the limit of studies with small sample size of pts in MPA. No significant financial relationships to disclose.

Bevacizumab (BEV) plus second-line taxane (TAX) or other chemotherapy (CT) for triple-negative breast cancer (TNBC): Subgroup analysis of RIBBON-2.

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 290-290
Author(s):  
A. Brufsky ◽  
V. Valero ◽  
B. Tiangco ◽  
S. R. Dakhil ◽  
A. Brize ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Primary Endpoint ◽  
Small Sample Size ◽  
Objective Response ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Small Sample ◽  
Second Line ◽  
First Line ◽  
Free Survival

290 Background: In three randomized trials in the first-line metastatic breast cancer (MBC) setting, combining BEV with CT significantly improved progression-free survival (PFS; primary endpoint) and objective response rate (ORR) vs. CT alone. BEV also showed a significant PFS benefit in the second-line MBC setting (RIBBON-2) when combined with TAX or other CT. We analyzed data from the subgroup of patients (pts) with TNBC in RIBBON-2. Methods: Eligible pts had MBC that had progressed on first-line CT without BEV. Second-line CT (TAX, gemcitabine, capecitabine, or vinorelbine) was chosen before 2:1 randomization to CT with either BEV (10 mg/kg q2w or 15 mg/kg q3w) or placebo (PLA). All pts could receive BEV at progression. The primary endpoint was PFS. Results: RIBBON-2 included 684 pts; 159 (23%) had TNBC and of these, 67 (42%) received TAX with BEV/PLA. Baseline characteristics were broadly similar in the two treatment arms. In an exploratory analysis of pts with TNBC, BEV + CT led to significantly improved PFS and ORR vs. CT alone, and a trend toward improved overall survival (OS). The magnitude of the effect was particularly pronounced in pts receiving TAX CT. Conclusions: Pts with TNBC derive significant ORR and PFS benefit from BEV combined with second-line CT. Despite the small sample size, there was a trend (HR 0.624; p = 0.0534) toward OS benefit in pts treated with BEV, especially with TAX CT. [Table: see text]

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