Einat Shacham-Shmueli

SIRFLOX: Randomized Phase III Trial Comparing First-Line mFOLFOX6 (Plus or Minus Bevacizumab) Versus mFOLFOX6 (Plus or Minus Bevacizumab) Plus Selective Internal Radiation Therapy in Patients With Metastatic Colorectal Cancer

PURPOSE SIRFLOX was a randomized, multicenter trial designed to assess the efficacy and safety of adding selective internal radiation therapy (SIRT) using yttrium-90 resin microspheres to standard fluorouracil, leucovorin, and oxaliplatin (FOLFOX)-based chemotherapy in patients with previously untreated metastatic colorectal cancer. PATIENTS AND METHODS Chemotherapy-naïve patients with liver metastases plus or minus limited extrahepatic metastases were randomly assigned to receive either modified FOLFOX (mFOLFOX6; control) or mFOLFOX6 plus SIRT (SIRT) plus or minus bevacizumab. The primary end point was progression-free survival (PFS) at any site as assessed by independent centralized radiology review blinded to study arm. RESULTS Between October 2006 and April 2013, 530 patients were randomly assigned to treatment (control, 263; SIRT, 267). Median PFS at any site was 10.2 v 10.7 months in control versus SIRT (hazard ratio, 0.93; 95% CI, 0.77 to 1.12; P = .43). Median PFS in the liver by competing risk analysis was 12.6 v 20.5 months in control versus SIRT (hazard ratio, 0.69; 95% CI, 0.55 to 0.90; P = .002). Objective response rates (ORRs) at any site were similar (68.1% v 76.4% in control v SIRT; P = .113). ORR in the liver was improved with the addition of SIRT (68.8% v 78.7% in control v SIRT; P = .042). Grade ≥ 3 adverse events, including recognized SIRT-related effects, were reported in 73.4% and 85.4% of patients in control versus SIRT. CONCLUSION The addition of SIRT to FOLFOX-based first-line chemotherapy in patients with liver-dominant or liver-only metastatic colorectal cancer did not improve PFS at any site but significantly delayed disease progression in the liver. The safety profile was as expected and was consistent with previous studies.

Impact of the 12-Gene Colon Cancer Assay on Clinical Decision Making for Adjuvant Therapy in Stage II Colon Cancer Patients

OBJECTIVES To evaluate the impact of the 12-gene Colon Cancer Recurrence Score Assay-a clinically validated prognosticator in stage II colon cancer after surgical resection-on adjuvant treatment decisions in T3 mismatch repair proficient (MMR-P) stage II colon cancer in clinical practice. METHODS This retrospective analysis included all patients with T3 MMR-P stage II colon cancer (Clalit Health Services members) with Recurrence Score results (time frame January 2011 to May 2012). Treatment recommendations pretesting were compared with the treatments received. Changes were categorized as decreased (to observation alone/removing oxaliplatin from the therapy) or increased (from observation alone/adding oxaliplatin to the therapy) intensity. RESULTS The analysis included 269 patients; 58%, 32%, and 10% of the values were in the low (<30), intermediate (30-40), and high (≥41) score groups, respectively. In 102 patients (38%), treatment changed post-testing (decreased/increased intensity 76/26 patients). The overall impact was decreased chemotherapy use (45.0% to 27.9%; P < 0.001). Treatment changes occurred in all score groups, but more frequently in the high (change rate 63.0%; 95% confidence interval [CI] 42.3%-80.6%) than in the intermediate (30.6%; 95% CI 21.0%-41.5%) and low (37.6%; 95% CI 30.0%-45.7%) score groups. The direction of the change was consistent with the assay result, with increased intensity more common in higher score values and decreased intensity more common in lower score values. CONCLUSIONS Testing significantly affected adjuvant treatment in T3 MMR-P stage II colon cancer in clinical practice. The study is limited by its design, which compared treatment recommendations pretesting to actual treatments received post-testing, lack of a control group, and nonassessment of confounding factors that may have affected treatment decisions.

Self-concealment among couples who cope with chronic illness: development and preliminary validation of the Couples Illness Self-Concealment (CISC) questionnaire

PurposeThe aim of this study was to develop and assess the psychometric characteristics of a new brief self-report measure, which evaluates self-concealment behavior in the context of couples coping with chronic illness.MethodsThe Couples Illness Self-Concealment (CISC) scale was developed, emphasizing the active process involved in self-concealment. It was then tested among 56 cancer patients and partners of cancer patients. Correlations and multiple regression analysis were used to assess the internal consistency reliability and validity of the scale.ResultsPsychometric evaluation of the CISC final version, which includes 13 items, provides evidence that the scale has high internal consistency reliability. The findings support the construct validity of the scale, examined by both convergent validity and between group differences (patients vs. spouses).ConclusionsThe CISC scale has acceptable psychometric qualities, internal consistency reliability and validity. The use of CISC may assist in revealing important aspects of couple’s illness communication patterns, and enable examination of possible links between self-concealment behavior in the context of illness, and psychological outcome. It may also contribute to the assessment of interventions aimed at enhancing communication between partners coping with chronic illness.

Correlates of concealment behavior among couples coping with cancer: Actor partner model

Contextual self‐concealment in the psychooncology literature has been found to be associated with elevated distress. The current study aimed to understand the dyadic relationships of an individuals perception of spousal support and dispositional perspective‐taking with own and partners levels of self‐concealment behavior, among couples coping with cancer.

Abstract LB-A17: Hospital volume determines mortality amongst neutropenic cancer patients within the United States

Introduction: Hospital Volume is associated with improved outcomes in cancer surgery, and some aspects of cancer care. The influence of hospital volume on outcomes in neutropenic patients is unknown. Neutropenia secondary to bone-marrow suppression is a common, and dangerous complication of cancer treatment. Known factors associated with increased mortality include age, race and co-morbidities. We hypothesized that large-volume hospitals would have reduced mortality rates for neutropenic patients compared with small-volume institutions. Methods: We utilized the NIS database of the Healthcare Cost and Utilization Project, focusing on the years 2000-2006. Only inpatient episodes with a diagnosis of both neutropenia and cancer were included in the study. Hospital volume was defined as the number of neutropenic cancer episodes listed for each institution per year. Mortality was defined as death during admission. Results: 155,512 hospitalizations were included in the study, from 3049 different institutions. Median age was 60 years. The overall inpatient mortality was 7.1%. Mortality increased with patient age, for instance amongst those aged 30-39 years it was 4.3% compared to 10.7% for those aged 70-79 years. The average number of “neutropenic” inpatient episodes in each institution per year ranged from less than one to 225 (median 22.7). The population was split into four equal groups based upon hospital volume. Mortality was 8.5%, 7.7%, 7.0% and 5.2% for each group (from lowest to highest volume), likewise% discharged home was 77.3%, 82.4%, 85.2% and 90.1% (for both p Conclusion: Neutropenic patients hospitalized in large-volume institutions have a substantially lower mortality and a higher likelihood of returning home compared to those hospitalized at low-volume institutions. Our findings have implications for the setting in which phase I/II clinical trials of combination treatments with new biological agents and cytotoxic therapies be performed. Citation Format: Yaacov Richard Lawrence, Damian Urban, Tal Sella, Jair Bar, Raanan Berger, Jeffrey Goldstein, Einat Shacham-Shmueli, Zvi Symon, Talia Golan. Hospital volume determines mortality amongst neutropenic cancer patients within the United States. [abstract]. In: Proceedings of the AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics; 2015 Nov 5-9; Boston, MA. Philadelphia (PA): AACR; Mol Cancer Ther 2015;14(12 Suppl 2):Abstract nr LB-A17.