James A. Talcott

The Multinational Association for Supportive Care in Cancer Risk Index: A Multinational Scoring System for Identifying Low-Risk Febrile Neutropenic Cancer Patients

PURPOSE Febrile neutropenia remains a potentially life-threatening complication of anticancer chemotherapy, but some patients are at low risk for serious medical complications. The purpose of this study was to develop an internationally validated scoring system to identify these patients. MATERIALS AND METHODS Febrile neutropenic cancer patients were observed in a prospective multinational study. Independent factors assessable at fever onset, predicting low risk of complications, on a randomly selected derivation set, were assigned integer weights to develop a risk-index score, which was subsequently tested on a validation set. RESULTS On the derivation set (756 patients), predictive factors were a burden of illness indicating absence of symptoms or mild symptoms (weight, 5; odds ratio [OR], 8.21; 95% confidence interval [CI], 4.15 to 16.38) or moderate symptoms (weight, 3; OR, 3.70; 95% CI, 2.18 to 6.29); absence of hypotension (weight, 5; OR, 7.62; 95% CI, 2.91 to 19.89); absence of chronic obstructive pulmonary disease (weight, 4; OR, 5. 35; 95% CI, 1.86 to 15.46); presence of solid tumor or absence of previous fungal infection in patients with hematologic malignancies (weight, 4; OR, 5.07; 95% CI, 1.97 to 12.95); outpatient status (weight, 3; OR, 3.51; 95% CI, 2.02 to 6.04); absence of dehydration (weight, 3; OR, 3.81; 95% CI, 1.89 to 7.73); and age less than 60 years (weight, 2; OR, 2.45; 95% CI, 1.51 to 4.01). On the validation set, a Multinational Association for Supportive Care in Cancer risk-index score >/= 21 identified low-risk patients with a positive predictive value of 91%, specificity of 68%, and sensitivity of 71%. CONCLUSION The risk index accurately identifies patients at low risk for complications and may be used to select patients for testing therapeutic strategies that may be more convenient or cost-effective.

Risk assessment in cancer patients with fever and neutropenia: a prospective, two-center validation of a prediction rule.

PURPOSE The study was undertaken to validate a clinical model for predicting the medical risk of cancer patients with fever and neutropenia. PATIENTS AND METHODS A consecutive sample of 444 cancer patients with fever and neutropenia (granulocyte count less than 500/microL) at two hospitals, a specialized cancer referral center and a university-affiliated general medical hospital, was studied to identify clinical characteristics in the first 24 hours that predict subsequent serious medical complications during the hospital stay. To control for bias, major risk factors and complications were subject to blinded review. RESULTS Serious medical complications occurred in 34% of patients with risk factors identified in a prior study, including prior inpatient status (group I), outpatients with a serious independent comorbidity (group II), or uncontrolled cancer (group III), compared with 5% of the remaining patients (group IV) (P less than .000001). Two of the complications in group IV patients were transient asymptomatic hypotension, and the remaining three complications occurred after at least 1 week of progressive medical deterioration. These risk groups were independently significant in stepwise logistic regression analysis. Multiple complications (17%) and death (10%) were common among patients in groups I through III but did not occur in group IV patients. CONCLUSIONS This risk assessment model accurately stratified the medical risk of these patients using only clinical information available on the first day of their course. Low-risk patients are an appropriate population in which to study less intensive treatment strategies.

Sexuality after treatment for early prostate cancer: exploring the meanings of "erectile dysfunction".

AbstractOBJECTIVE: To explore perceptions of the impact of erectile dysfunction on men who had undergone definitive treatment for early nonmetastatic prostate cancer. DESIGN: Seven focus groups of men with early prostate cancer. The groups were semistructured to explore men’s experiences and quality-of-life concerns associated with prostate cancer and its treatment. SETTING: A staff model health maintenance organization, and a Veterans Affairs medical center. PATIENTS: Forty-eight men who had been treated for early prostate cancer 12 to 24 months previously. RESULTS: Men confirmed the substantial effect of sexual dysfunction on the quality of their lives. Four domains of quality of life related to men’s sexuality were identified: 1) the qualities of sexual intimacy; 2) everyday interactions with women; 3) sexual imagining and fantasy life; and 4) men’s perceptions of their masculinity. Erectile problems were found to affect men in both their intimate and nonintimate lives, including how they saw themselves as sexual beings. CONCLUSIONS: Erectile dysfunction, the most common side effect of treatment for early prostate cancer, has far-reaching effects upon men’s lives. Assessment of quality of life related to sexual dysfunction should address these broad impacts of erectile function on men’s lives. Physicians should consider these effects when advising men regarding treatment options. Physicians caring for patients who have undergone treatment should address these psychosocial issues when counseling men with erectile dysfunction.

Complications after treatment with external-beam irradiation in early-stage prostate cancer patients: a prospective multiinstitutional outcomes study.

PURPOSE To use data from a prospective quality-of-life study to assess differences in disease-specific and general health-related quality-of-life changes after treatment with different external-beam irradiation techniques for prostate cancer. PATIENTS AND METHODS Patients were divided into three groups based on their pretreatment field size and planning technique: whole pelvis, small field, or conformal. Measures of bowel, urinary, and sexual function and of global health-related quality-of-life parameters (from the Health Survey Short Form [SF-36] and the Profile of Mood States [POMS]) were obtained from self-report questionnaires completed before initiation of therapy and at 3 and 12 months after therapy. RESULTS Irritative gastrointestinal and genitourinary side effects were frequent 3 months after treatment, but were substantially improved at 12 months. Sexual dysfunction increased steadily over the study period. The POMS and the SF-36 did not demonstrate significant changes over time. Despite small patient numbers, we found trends in favor of conformal therapy across several symptom measures, including sexual function. In the fatigue, energy, and vigor subscales, patients who received whole-pelvis treatment fared significantly worse than those in the other two groups. CONCLUSION Prospective, detailed data from a feasibility study allowed us to assess the effect of technique on quality of life following external-beam irradiation. Although limited by the small planned sample size, these results suggest that smaller radiation fields limit treatment-related complications, including, unexpectedly, sexual dysfunction. However, confirmation in a larger study is necessary.

Long-term treatment related complications of brachytherapy for early prostate cancer : A survey of patients previously treated

PURPOSE We determined long-term symptoms in patients after brachytherapy (radioactive seed implantation) for early (nonmetastatic) prostate cancer. MATERIALS AND METHODS We performed a cross-sectional survey of 105 (80% of those contacted) men treated at least 2 years 9 months (median 5.2 years) previously with brachytherapy alone (72 patients) or brachytherapy plus external beam radiation therapy (33) at a pioneering referral center for ultrasound guided brachytherapy. RESULTS Median patient age was 70 years at treatment and 75 years when surveyed. Bowel symptoms were uncommon (range 4% to 9%) unless patient had also received external beam radiation therapy. Urinary incontinence occurred in 45% of men, although leakage of more than a few drops, daily leakage and wearing absorptive pads occurred in 11%, 11% and 16%, respectively. Men who underwent documented transurethral prostatic resection were much more likely to report incontinence (83% versus 39%, p = 0.005) and those who underwent implantation less than 5 years earlier were less likely (33% versus 53%, respectively, p = 0.04). Complete impotence was common (50%) but impaired erections were more so (73%). Patients who received combined radiation treatment had more frequent erectile dysfunction. CONCLUSIONS Long-term bowel symptoms are infrequent after brachytherapy alone. Urinary incontinence is common, although usually only a few drops and not daily. Erectile dysfunction, prevalent in populations of older men, was found in most men. However, because our study design precluded documenting baseline symptoms before treatment and subsequent clinical interventions, the contribution of factors other than brachytherapy is unclear. The morbidity of patients receiving more recent brachytherapy may be less.

Symptom indexes to assess outcomes of treatment for early prostate cancer.

Background.Patients’ perceptions of treatment outcomes are important in the management of early prostate cancer, but few studies have offered reliable and responsive measures to assess the likely side effects of the most common treatments. Objective.To develop indexes of urinary, bowel, and sexual function, and related distress. Research Design. Prospective cohort study of the outcomes of treatment for early prostate cancer, with self-administered questionnaires completed before treatment, and 3 and 12 months afterward. Hypothesized indexes, based on a clinical model of pathophysiological side effects of treatment, were defined and evaluated with respect to reliability and validity. Subjects.Patients (n = 184) undergoing radical prostatectomy or external beam radiotherapy for early prostate cancer. Measures.Urinary and bowel items pertained to frequency or intensity of symptoms of dysfunction; parallel items assessed symptom-related distress. Sexual dysfunction items assessed the quality of erections, orgasm, and ejaculation; distress was assessed by 2 items adapted from the MOS Sexual Problems (MOS-SP) scale. HRQoL was assessed by the SF-36 and Profile of Mood States. Results.Symptom and symptom-related distress indexes for urinary incontinence, urinary obstruction/irritation, bowel dysfunction, and sexual dysfunction were defined. Symptom and distress indexes in each domain were highly correlated. Responsiveness was substantial and varied by treatment in ways consistent with clinical experience. The indexes accounted for significant proportions of the variance in HRQoL measures. Conclusions.These indexes may be used in monitoring outcomes of treatment for early prostate cancer.

Outcomes and Cost of Outpatient or Inpatient Management of 712 Patients With Febrile Neutropenia

PURPOSE We retrospectively compared the outcomes and costs of outpatient and inpatient management of low-risk outpatients who presented to an emergency department with febrile neutropenia (FN). PATIENTS AND METHODS A single episode of FN was randomly chosen from each of 712 consecutive, low-risk solid tumor outpatients who had been treated prospectively on a clinical pathway (1997-2003). Their medical records were reviewed retrospectively for overall success (resolution of all signs and symptoms of infection without modification of antibiotics, major medical complications, or intensive care unit admission) and nine secondary outcomes. Outcomes were assessed by physician investigators who were blinded to management strategy. Outcomes and costs (payers perspective) in 529 low-risk outpatients were compared with 123 low-risk patients who were psychosocially ineligible for outpatient management (no access to caregiver, telephone, or transportation; residence > 30 minutes from treating center; poor compliance with previous outpatient therapy) using univariate statistical tests. RESULTS Overall success was 80% among low-risk outpatients and 79% among low-risk inpatients. Response to initial antibiotics was 81% among outpatients and 80% among inpatients (P = .94); 21% of those initially treated as outpatients subsequently required hospitalization. All patients ultimately responded to antibiotics; there were no deaths. Serious complications were rare (1%) and equally frequent between the groups. The mean cost of therapy among inpatients was double that of outpatients (

Measuring patients' perceptions of the outcomes of treatment for early prostate cancer.

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Changes in quality of life following treatment for early prostate cancer

7,772; P < .001). CONCLUSION Outpatient management of low-risk patients with FN is as safe and effective as inpatient management of low-risk patients and is significantly less costly.

Hidden barriers between knowledge and behavior: the North Carolina prostate cancer screening and treatment experience.

Background. Compared with careful attention to the physical (eg, urinary, bowel, sexual) dysfunction that may follow treatment, little attention has been given to the behavioral, emotional, and interpersonal changes that the diagnosis of early prostate cancer and subsequent physical dysfunction may bring. Objective. To construct patient‐centered measures of the outcomes of treatment for early prostate cancer. Research Design. Qualitative study followed by survey of early prostate cancer patients and group of comparable patients with no history of prostate cancer. Analysis of focus groups identified relevant domains of quality of life, which were represented by Likert scale items included in survey questionnaires. Psychometric analyses of survey data defined scales evaluated with respect to internal consistency and validity. Results. Qualitative analysis identified three domains: urinary control, sexuality, and uncertainty about the cancer and its treatment. Psychometric analysis defined 11 scales. Seven were generically relevant to most older men: urinary control (eg, embarrassment with leakage), sexual intimacy (eg, anxiety about completing intercourse), sexual confidence (eg, comfort with sexuality), marital affection (eg, emotional distance from spouse/partner), masculine self esteem (eg, feeling oneself a whole man), health worry (eg, apprehensiveness about health changes), and PSA concern (eg, closely attending to ones PSA). Four scales were specific to the treatment experience: perceived cancer control, quality of treatment decision making, regret of treatment choice, and cancer‐related outlook. Conclusion. The scales provide definition and metrics for patient‐centered research in this area. They complement measures of physical dysfunction and bring into resolution outcomes of treatment that have gone unnoticed in previous studies.