BACKGROUNDBased on evidence that psychologic distress often goes unrecognized although it is common among cancer patients, clinical practice guidelines recommend routine screening for distress. For this study, the authors sought to determine whether the single‐item Distress Thermometer (DT) compared favorably with longer measures currently used to screen for distress.METHODSPatients (n = 380) who were recruited from 5 sites completed the DT and identified the presence or absence of 34 problems using a standardized list. Participants also completed the 14‐item Hospital Anxiety and Depression Scale (HADS) and an 18‐item version of the Brief Symptom Inventory (BSI‐18), both of which have established cutoff scores for identifying clinically significant distress.RESULTSReceiver operating characteristic (ROC) curve analyses of DT scores yielded area under the curve estimates relative to the HADS cutoff score (0.80) and the BSI‐18 cutoff scores (0.78) indicative of good overall accuracy. ROC analyses also showed that a DT cutoff score of 4 had optimal sensitivity and specificity relative to both the HADS and BSI‐18 cutoff scores. Additional analyses indicated that, compared with patients who had DT scores < 4, patients who had DT scores ≥ 4 were more likely to be women, have a poorer performance status, and report practical, family, emotional, and physical problems (P ≤ 0.05).CONCLUSIONSFindings confirm that the single‐item DT compares favorably with longer measures used to screen for distress. A DT cutoff score of 4 yielded optimal sensitivity and specificity in a general cancer population relative to established cutoff scores on longer measures. The use of this cutoff score identified patients with a range of problems that were likely to reflect psychologic distress. Cancer 2005. © 2005 American Cancer Society.

Objective Few intervention programs assist patients and their family caregivers to manage advanced cancer and maintain their quality of life (QOL). This study examined: 1) whether patient-caregiver dyads (i.e., pairs) randomly assigned to a Brief or Extensive dyadic intervention (the FOCUS Program) had better outcomes than dyads randomly assigned to usual care, and 2) if patients' risk for distress (RFD) and other factors moderated the effect of the Brief or Extensive Program on outcomes. Methods Advanced cancer patients and their caregivers (N=484 dyads) were stratified by patients' baseline risk for distress (high versus low), cancer type (lung, colorectal, breast, prostate), and research site, and then randomly assigned to a Brief (3-session) or Extensive (6-session) intervention or Control. The interventions offered dyads information and support. Intermediary outcomes were: appraisals (i.e., appraisal of illness/caregiving, uncertainty, hopelessness) and resources (i.e., coping, interpersonal relationships, and self-efficacy). The primary outcome was QOL. Data were collected prior to intervention and post-intervention (3 and 6 months from baseline). The final sample was 302 dyads. Repeated Measures MANOVA was used to evaluate outcomes. Results Significant Group by Time interactions showed there was improvement in dyads' coping (p<.05), self-efficacy (p<.05), and social QOL (p<.01), and in caregivers' emotional QOL (p<.05). Effects varied by intervention dose. Most effects were found at 3 months only. Risk for distress accounted for very few moderation effects. Conclusions Both Brief and Extensive programs had positive outcomes for patient-caregiver dyads, but few sustained effects. Patient-caregiver dyads benefit when viewed as the “unit of care.”

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Axitinib has antitumor activity in patients with mRCC refractory to prior VEGF-targeted therapy, including sorafenib. Toxicities were mild to moderate and were manageable. A randomized, phase III trial to compare axitinib with sorafenib in patients who have mRCC refractory to one prior first-line therapy regimen is underway.

PURPOSE The KRISTINE study compared neoadjuvant trastuzumab emtansine plus pertuzumab (T-DM1+P) with docetaxel, carboplatin, trastuzumab plus P (TCH+P) for the treatment human epidermal growth factor receptor 2–positive stage II to III breast cancer. T-DM1+P led to a lower pathologic complete response rate (44.4% v 55.7%; P = .016), but fewer grade 3 or greater and serious adverse events (AEs). Here, we present 3-year outcomes from KRISTINE. METHODS Patients were randomly assigned to neoadjuvant T-DM1+P or TCH+P every 3 weeks for six cycles. Patients who received T-DM1+P continued adjuvant T-DM1+P, and patients who received TCH+P received adjuvant trastuzumab plus pertuzumab. Secondary end points included event-free survival (EFS), overall survival, patient-reported outcomes (measured from random assignment), and invasive disease-free survival (IDFS; measured from surgery). RESULTS Of patients, 444 were randomly assigned (T-DM1+P, n = 223; TCH+P, n = 221). Median follow-up was 37 months. Risk of an EFS event was higher with TDM-1+P (hazard ratio [HR], 2.61 [95% CI, 1.36 to 4.98]) with more locoregional progression events before surgery (15 [6.7%] v 0). Risk of an IDFS event after surgery was similar between arms (HR, 1.11 [95% CI, 0.52 to 2.40]). Pathologic complete response was associated with a reduced risk of an IDFS event (HR, 0.24 [95% CI, 0.09 to 0.60]) regardless of treatment arm. Overall, grade 3 or greater AEs (31.8% v 67.7%) were less common with T-DM1+P. During adjuvant treatment, grade 3 or greater AEs (24.5% v 9.9%) and AEs leading to treatment discontinuation (18.4% v 3.8%) were more common with T-DM1+P. Patient-reported outcomes favored T-DM1+P during neoadjuvant treatment and were similar to trastuzumab plus pertuzumab during adjuvant treatment. CONCLUSION Compared with TCH+P, T-DM1+P resulted in a higher risk of an EFS event owing to locoregional progression events before surgery, a similar risk of an IDFS event, fewer grade 3 or greater AEs during neoadjuvant treatment, and more AEs leading to treatment discontinuation during adjuvant treatment.

This article presents preliminary results investigating the relationship between parental and adolescent adjustment and coping and their relationship to social support and family functioning in a sample of adolescents (ages 11-18) with cancer and one of their parents. Parents and adolescents from two pediatric oncology clinics completed measures of distress, coping, social support, and family cohesion/adaptability. Low levels of distress were reported by both children and their parents with positive correlations noted between parent and child adjustment. Adolescents reported that their parents and a close friend were the greatest sources of social support and described their families as having a high degree of cohesion and adaptability. Both adolescents and parents used more adaptive than maladaptive coping strategies, although distress was associated with reduced use of adaptive coping. Adolescents are able to adapt to cancer in the context of strong family and social supports. In addition, there is a relationship between parental and adolescents adjustment, and between greater use of adaptive coping styles and lower distress.

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