Feasibility and validity of the Patient Neurotoxicity Questionnaire during taxane chemotherapy in a phase III randomized trial in patients with breast cancer: N-SAS BC 02

Goals

The aim of the study was to determine the feasibility and validity of a newly developed patient-based instrument—the Patient Neurotoxicity Questionnaire (PNQ)—for grading chemotherapy-induced peripheral neuropathy (CIPN).

Patients and methods

We prospectively collected data from 300 female patients who were treated with taxane chemotherapy for primary breast cancer as part of a national multicenter phase III randomized trial (N-SAS BC 02). We evaluated patient compliance with the PNQ and several validation parameters, including concordance between CIPN grades noted by physicians (National Cancer Institute Common Toxicity Criteria) and patients (PNQ), and the concurrent validity and responsiveness of the PNQ versus the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) utilizing data at pre-treatment and before three, five, and seven treatment cycles.

Main results

The questionnaire completion rate was >90% at all assessments. Evaluation by physicians always resulted in lower neuropathy assessment scores compared with those reported directly by patients (weighted kappa coefficients, 0.02–0.06). Both PNQ sensory and motor scores were significantly correlated with the FACT/GOG-Ntx (r?=?0.66 and 0.51, respectively). In the repeated measures analysis of variance model, PNQ grades increased considerably as treatment continued, indicating progressively worsening CIPN over time.

Conclusions

The PNQ has an applicable degree of feasibility and validity, useful for the diagnosis of CIPN as well as for clinical treatment decision-making, where the development of CIPN is a potential treatment-limiting consideration. Physicians underreport and underestimate the severity of CIPN symptoms compared with patients, thereby supporting the importance of assessing patient-reported outcomes using the PNQ.     

A phase III randomized,placebo-controlled study of topical amitriptyline and ketamine for chemotherapy-induced peripheral neuropathy (CIPN): a University of Rochester CCOP study of 462 cancer survivors

Purpose

Chemotherapy-induced peripheral neuropathy (CIPN) occurs in as high as 70 % of patients receiving certain types of chemotherapy agents. The FDA has yet to approve a therapy for CIPN. The aim of this multicenter, phase III, randomized, double-blind, placebo-controlled trial was to investigate the efficacy of 2 % ketamine plus 4 % amitriptyline (KA) cream for reducing CIPN.

Methods

Cancer survivors who completed chemotherapy at least 1 month prior and had CIPN (>4 out of 10) were enrolled (N?=?462). CIPN was assessed using average scores from a 7-day daily diary that asks patients to rate the average “pain, numbness, or tingling in [their] hands and feet over the past 24 h” on an 11-point numeric rating scale at baseline and 6 weeks post intervention. ANCOVA was used to measure differences in 6-week CIPN with effects including baseline CIPN, KA treatment arm, and previous taxane therapy (Y/N).

Results

The KA treatment showed no effect on 6-week CIPN scores (adjusted mean difference?=??0.17, p?=?0.363).

Conclusions

This study suggests that KA cream does not decrease CIPN symptoms in cancer survivors.     

Chemotherapy-induced neuropathy in multiple myeloma: influence on quality of life and development of a questionnaire to compose common toxicity criteria grading for use in daily clinical practice

Purpose

Chemotherapy-induced peripheral neuropathy (CIPN) may negatively influence multiple myeloma (MM) patients’ health-related quality of life (HRQOL). Dose modification is the only way to minimize CIPN. To measure CIPN in daily practice, the Indication for Common Toxicity Criteria (CTC) Grading of Peripheral Neuropathy Questionnaire (ICPNQ) was developed which can be completed within five minutes by the patient. The aims of this study were to (1) perform a psychometric evaluation of the ICPNQ and (2) examine the prevalence of CIPN and its influence on HRQOL in population-based MM patients.

Methods

One hundred fifty-six MM patients, diagnosed between 2000 and 2014, completed the ICPNQ, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20), and EORTC QLQ-C30 (65 % response).

Results

The psychometric analyses showed a Cronbach’s alpha of 0.84, 0.74, and 0.61 for, respectively, the sensory, motoric, and autonomic subscales of the ICPNQ. Test-retest reliability and construct validity were good for all subscales. Overall, 65 % of patients reported grade 2–3 neuropathy according to the ICPNQ. Patients with the highest CTC grades (grade 2 with neuropathic pain and grade 3 (38 %)) according to the ICPNQ reported significantly worse scores on all EORTC QLQ-CIPN20 subscales compared to patients with lower CTC grades (p ≤ 0.002). In addition, they reported statistically significant and clinically relevant worse HRQOL scores on almost all EORTC QLQ-C30 subscales.

Conclusions

CIPN is a common side effect in MM patients, which has a negative impact on HRQOL. The ICPNQ is a valid instrument to distinguish the highest CIPN CTC grades from the lower CTC grades necessary to decide on dose modifications of chemotherapy in daily clinical practice.

     

Similarities in the Neuropathy Phenotype of Cancer Survivors Who Received Different Classes of Chemotherapy Drugs

With the advent of platinum and taxane compounds used as single agents or in combination regimens, survival rates for some of the most common cancers have improved substantially. However, information on differences in the chemotherapy-induced peripheral neuropathy (CIPN) phenotype among single and combination regimens is limited. Study's purposes were to evaluate for differences in demographic and clinical characteristics; subjective and objective measures of CIPN; as well as the severity of common symptoms and quality of life among survivors who received platinum- (n = 95), taxane- (n = 200), or platinum and taxane-containing (n = 131) regimens. Patients completed self-report questionnaires (ie, duration of CIPN, pain intensity, pain qualities, pain interference) and underwent a physical examination that evaluated light touch, pain, and cold sensations and balance. For most of the subjective and objective measures of CIPN, as well as symptom severity and quality of life scores, no differences were found among the 3 chemotherapy groups. In all 3 chemotherapy treatment groups, CIPN was a painful, small fiber, and length dependent neuropathy. These findings support the hypothesis that CIPN induced by different classes of chemotherapy, as single agents or in combination, produce a similar CIPN phenotype which raises the possibility that CIPN induced by diverse chemotherapy protocols has the same underlying mechanism.PerspectiveIn this study, that compared patients who received only platinum, only taxane, or both platinum and taxane containing regimens, no differences were found among the 3 groups in the CIPN phenotype. Findings raise the possibility that CIPN induced by diverse chemotherapy protocols has the same underlying mechanism.     

Prospective assessment of chemotherapy-induced peripheral neuropathy due to weekly paclitaxel in patients with advanced or metastatic breast cancer (CSP-HOR 02 study)

Goals of work  The aim of this study was to prospectively evaluate chemotherapy-induced peripheral neuropathy (CIPN) using a patient-based instrument, the Patient Neurotoxicity Questionnaire (PNQ) and a physician-based instrument, the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) in patients with advanced or metastatic breast cancer who were treated with weekly paclitaxel. Materials and methods  CIPN symptoms were prospectively assessed in 35 patients using the PNQ, NCI-CTC, and the Functional Assessment of Cancer Therapy (FACT)-Taxane including neurotoxicity component (Ntx) at the baseline, and 8 and 16 weeks after starting chemotherapy. Results  For sensory neuropathy symptoms, the reported incidence of CIPN was significantly increased during active treatment in terms of both the PNQ and NCI-CTC assessments. In contrast, there was a notable increase of patient motor neuropathy symptoms that were elucidated only by the PNQ. The PNQ grades of CIPN were widely distributed in the patient population as compared with the NCI-CTC grades for both sensory and motor neuropathy. The sensory PNQ grade was correlated with sensory NCI-CTC grade (r = 0.58) and Ntx (r = 0.51), and the motor PNQ grade was correlated with Ntx (r = 0.57). Conclusions  The PNQ appears to be more sensitive and responsive than the NCI-CTC for CIPN; the PNQ appears to have diagnostic validity for evaluating CIPN in patients who are receiving neurotoxic chemotherapy.     

Falls and functional impairments in cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN): a University of Rochester CCOP study

Purpose

This study was conducted in order to characterize the prevalence of falls and functional impairments (FIs) and their association with chemotherapy-induced peripheral neuropathy (CIPN) in cancer survivors.

Methods

We analyzed baseline assessments from a phase III RCT in cancer survivors with self-reported CIPN scores of >4 out of 10. Patients completed the EORTC QLQ-CIPN-20 for neuropathy and reported falls in the previous 3 months. FIs were defined using the Activities of Daily Living subsection of the Vulnerable Elder’s Scale. Associations of baseline characteristics and CIPN with falls and FIs were examined using logistic regression.

Results

Of 421 patients, 11.9 % experienced recent falls and 26.6 % reported FIs. Motor neuropathy was the only factor associated with falls (OR?=?1.127, p?=?0.01). Factors associated with FIs included non-white race (OR?=?0.335 white relative to non-white, 0.781, p?=?0.01) and greater motor neuropathy scores (OR?=?1.262, p?<?0.0001).

Conclusion

CIPN, primarily motor, is associated with falls and FIs. Future prospective research should investigate the ability of motor neuropathy severity to predict falls.     

Association of health-related quality of life with gender in patients with B-cell chronic lymphocytic leukemia

Purpose

This analysis examined associations between gender and health-related quality of life (HRQOL) in patients with B-cell chronic lymphocytic leukemia (CLL) as they initiate therapy for CLL outside the clinical trial setting.

Methods

Baseline data were collected as part of Connect® CLL Registry, a prospective observational study initiated in community, academic, and government centers. Patient demographics and clinical characteristics were provided by clinicians. Patients reported HRQOL using the Brief Fatigue Inventory (BFI), EQ-5D, and Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu). Mean scores were analyzed, with statistical significance of differences determined by ANOVA. Multivariate analysis also considered age and line of therapy.

Results

Baseline HRQOL data were available for 1,140 patients: 710 (62 %) men and 430 (38 %) women from 161 centers. Patients were predominantly white (89 %) with mean age 69?±?11 years. Women reported significantly worse global fatigue (P <0.0001), fatigue severity (P <0.0001), and fatigue-related interference (P?=?0.0005) versus men (BFI). Pain/discomfort (P?=?0.0077), usual activities (P?=?0.0015), and anxiety/depression (P?=?0.0117) were significantly worse in women than in men (EQ-5D). With women reporting a better social/family score (P?=?0.0238) and men reporting a better physical score (P?=?0.0002), the mean FACT-G total score did not differ by gender. However, the mean FACT-Leu total score was better among men versus women (P?=?0.0223), primarily because the mean leukemia subscale score was significantly better among men (P <0.0001). Multivariate analysis qualitatively confirmed these findings.

Conclusions

Connect® CLL Registry results indicate that significant differences exist in certain HRQOL domains, as women reported greater levels of fatigue and worse functioning in physical domains.     

Longitudinal prospective assessment of sleep quality: before, during, and after adjuvant chemotherapy for breast cancer

Purpose

Cross-sectional data suggest that many individuals with breast cancer experience significant sleep disturbance across the continuum of care. Understanding the longitudinal trajectory of sleep disturbance may help identify factors associated with its onset, severity, or influence on health-related quality of life (HRQL). Study objectives were to observe sleep quality in breast cancer patients prior to, during, and after completion of adjuvant chemotherapy, evaluate its relationship with HRQL and explore correlates over time.

Methods

Participants were administered patient-reported outcome measures including the Pittsburgh Sleep Quality Index (PSQI) and the Functional Assessment of Cancer Therapy—General (FACT-G), which assesses HRQL. Data were collected prospectively 3–14 days prior to beginning chemotherapy, cycle 4 day 1 of chemotherapy, and 6 months following initiation of chemotherapy.

Results

Participants (n?=?80) were primarily women (97.5 %) with stage II (69.0 %) breast cancer. Total FACT-G scores were negatively correlated with global PSQI scores at each time point (rho?=??0.46, ?0.41, ?0.45; all p?<?0.001). Poor sleep quality (PSQI ≥ 5) was prevalent at all time points (48.5–65.8 %); however, there were no significant changes within participants over time. Correlates with sleep quality varied across time points. Participants with poor sleep quality reported worse overall HRQL, fatigue, depression, and vasomotor/endocrine symptoms.

Conclusions

These findings suggest that early identification of sleep disturbance and ongoing assessment and treatment of contributing factors over the course of care may minimize symptom burden associated with chemotherapy and prevent chronic insomnia in survivorship.     

Acupuncture for the treatment of post-chemotherapy chronic fatigue: a randomized, blinded, sham-controlled trial

Purpose

Many cancer patients experience persistent fatigue after the completion of chemotherapy. A previous single-arm study provided evidence for an effect of acupuncture in this population. We conducted a randomized controlled trial to determine whether acupuncture reduces post-chemotherapy chronic fatigue more effectively than sham acupuncture.

Methods

Cancer patients reporting significant fatigue persisting for at least 2 months following the completion of chemotherapy were randomized to receive once weekly true or sham acupuncture for 6 weeks. Fatigue was evaluated before and after treatment using the Brief Fatigue Inventory (BFI, the primary endpoint). Secondary endpoints included the Hospital Anxiety and Depression Scale (HADS) and Functional Assessment of Cancer Treatment-General (FACT-G) scores.

Results

One hundred one patients were randomized with 74 (34 true acupuncture; 40 sham control) evaluated for the primary endpoint. BFI scores fell by about one point between baseline and follow-up in both groups with no statistically significant difference between groups. HADS and FACT-G scores also improved in both groups, but there was no significant difference between groups. Patients in the sham acupuncture group crossed over to receive true acupuncture in week 7. No long-term reduction of fatigue scores was observed at the 6-month evaluation.

Conclusions

True acupuncture as provided in this study did not reduce post-chemotherapy chronic fatigue more than did sham acupuncture. The study is limited by the number of patients lost to follow-up. We also cannot exclude the possibility that a more intensive treatment regimen may be more effective.     

Psychometric validation of the functional assessment of cancer therapy—brain (FACT-Br) for assessing quality of life in patients with brain metastases

Objective

This study aimed to test the reliability, psychometric, and clinical validity of the use of the Functional Assessment of Cancer Therapy—Brain (FACT-Br) in patients with brain metastases.

Methods

Patients with brain metastases were interviewed using the FACT-Br (including the FACT-general) 1 week prior to treatment. All patients completed a follow-up assessment 1 month post-treatment. Patients with a good performance status and receiving stereotactic radiosurgery completed an additional 1 week follow-up assessment after the initial baseline interview to assess test–retest reliability.

Results

Forty patients had complete 1 month follow-up data. Ten of these patients also completed the 1 week follow-up assessment from baseline. The median Karnofsky performance status of patients was 80 and the median age was 64 years. All subscales of the FACT-Br were found to be conceptually related (except for two correlations) using the following subscales: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), FACT-G total score, brain cancer subscale (BrC), and the FACT-Br total score. All FACT-Br scores demonstrated excellent reliability, except for the SWB scale which revealed good reliability. The FACT-Br scores showed no significant change in the quality of life (QoL) of patients from baseline to 1 month follow-up.

Conclusion

The use of the combined FACT-G and FACT-Br Subscale to assess QoL specifically in patients with brain metastases has successfully undergone psychometric validation. Future clinical trials should use the FACT-G and FACT-Br Subscale to assess QoL in this patient population.     

Chemotherapy-induced peripheral neuropathy and its association with quality of life: a systematic review

Background

The objective of this study was to systematically review all available literature concerning chemotherapy-induced peripheral neuropathy (CIPN) and quality of life (QOL) among cancer patients.

Methods

A computerized search of the literature was performed in December 2013. Articles were included if they investigated CIPN and QOL among cancer patients. Twenty-five articles were selected and were subjected to a 13-item quality checklist independently by two investigators.

Results

The methodological quality of the majority of the selected studies was adequate to high. The included studies differed tremendously with respect to study design (19 prospective studies, 5 cross-sectional, 1 both cross-sectional and prospective), patient population (lung, colorectal, ovarian, endometrial, cervical or breast cancer, lymphoma, acute lymphoblastic leukemia, or a mixed population), number of included patients (ranging from 14 to 1643), and ways to assess CIPN (objectively, subjectively, or both). Of the 25 included studies, 11 assessed the association of CIPN on patients’ QOL. While three of these studies did not find an association between CIPN and QOL, the others concluded that more CIPN was associated with a lower QOL.

Implications for cancer survivors

Although the included studies in this systematic review were very diverse, which impedes drawing firm conclusions on this topic, CIPN is likely to have a negative association with QOL. The variety of the studied patient populations and chemotherapeutic agents in the existing studies calls for further studies on this topic. These studies are preferably prospective in nature, include a large number of patients, and assess QOL and CIPN with validated questionnaires.     

A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA

Background

Chemotherapy-induced peripheral neuropathy (CIPN) is a troublesome chronic symptom that has no proven pharmacologic treatment. The purpose of this double-blind randomized placebo-controlled trial was to evaluate a novel compounded topical gel for this problem.

Methods

Patients with CIPN were randomized to baclofen 10?mg, amitriptyline HCL 40?mg, and ketamine 20?mg in a pluronic lecithin organogel (BAK-PLO) versus placebo (PLO) to determine its effect on numbness, tingling, pain, and function. The primary endpoint was the baseline-adjusted sensory subscale of the EORTC QLQ-CIPN20, at 4?weeks.

Results

Data in 208 patients reveal a trend for improvement that is greater in the BAK-PLO arm over placebo in both the sensory (p?=?0.053) and motor subscales (p?=?0.021). The greatest improvements were related to the symptoms of tingling, cramping, and shooting/burning pain in the hands as well as difficulty in holding a pen. There were no undesirable toxicities associated with the BAK-PLO and no evidence of systemic toxicity.

Conclusion

Topical treatment with BAK-PLO appears to somewhat improve symptoms of CIPN. This topical gel was well tolerated, without evident systemic toxicity. Further research is needed with increased doses to better clarify the clinical role of this treatment in CIPN.     

Does gender influence outcomes from a multidisciplinary intervention for quality of life designed for patients with advanced cancer?

Purpose

Cancer treatment can profoundly impact the patient’s quality of life (QOL). It has been well documented that there are gender differences in the symptoms associated with cancer treatment. This study explores the impact of gender on QOL for patients with newly diagnosed advanced cancer.

Methods

A randomized, controlled clinical trial in patients receiving radiotherapy for advanced cancer demonstrated maintenance of QOL with a six session multidisciplinary structured intervention compared to controls. This current study reports the gender differences in that trial. Outcome measures included the functional assessment of cancer therapy-general (FACT-G), linear analog self-assessment (LASA), and profile of mood states (POMS) at baseline and weeks 4, 27, and 52. Kruskal–Wallis was used to compare QOL scores.

Results

One hundred thirty-one patients (45 women and 86 men, mean age 58.7) participated in the clinical trial. At week 4 postintervention, women in the intervention group had statistically significant improvement in their FACT-G score, FACT-G physical well-being subscale, LASA fatigue, POMS total score, POMS fatigue–inertia subscale, and POMS confusion–bewilderment subscale (p?<?0.05). Men receiving the intervention had a smaller decrease in FACT-G score compared to controls (p?=?0.048) and also worsened on the LASA financial (p?=?0.02). At week 27, the only gender difference was that intervention group men had more POMS anger–hostility (p?=?0.009). By week 52, there were no statistically significant gender differences in any of the QOL measures.

Conclusions

Gender-based differences appear to play a role in the early, but not late, response to a multidisciplinary intervention to improve QOL for patients with advanced cancer, suggesting that early interventions can be tailored for each gender.     

Evaluation of the Semmes–Weinstein filaments and a questionnaire to assess chemotherapy-induced peripheral neuropathy

Objective

This study aims to assess the use of Semmes–Weinstein monofilaments (SWMs) and of the Chemotherapy-Induced Neurotoxicity Questionnaire (CINQ) in the detection of chemotherapy-induced peripheral neuropathy (CIPN).

Method

It is a comparative and cross-sectional study performed in a philanthropic general hospital, located in the state of Minas Gerais, Brazil. One hundred seventeen individuals have participated in this study; they were divided into two groups: patients (n?=?87) treated with oxaliplatin, paclitaxel, or docetaxel and controls (n?=?30) without malignant disease.

Results

There were statistically significant differences between groups for all symptoms assessed by means of the CINQ. Lower limbs were more severely affected. Patients had increased frequency and severity of changes in all points assessed with SWM compared with controls. In the analyses of concordance between CINQ and SWM, kappa?=?0.320 (p?ρ?=?0.357; p?Conclusion CINQ and SWM may be valid tools for diagnosing CIPN in oncology practice. SWM may identify subclinical CIPN.     

Chemotherapy-induced peripheral neuropathy after neoadjuvant or adjuvant treatment of breast cancer: a prospective cohort study

Purpose

The purposes of this study were to estimate the incidence of chemotherapy-induced peripheral neuropathy (CIPN) and to identify its main determinants and impact in patient-reported outcomes.

Methods

We performed a prospective cohort study including 296 patients with incident breast cancer submitted to chemotherapy, followed for 1 year. Patients with incident CIPN were reevaluated 6 months after this diagnosis. Relative risks (RR) with 95 % confidence intervals (95 % CI) were computed to quantify the relation between different clinical characteristics and the occurrence of CIPN, using Poisson regression. The variation of patient-reported outcomes between baseline and 1-year follow-up assessments was compared between patients with and without CIPN.

Results

The cumulative incidence of CIPN in the first year after diagnosis was 28.7 % (95 % CI 23.8–34.1), and more than 80 % of the patients were still symptomatic after 6 months. Among the latter, there was a significant decrease in the median total neuropathy score, clinical version (7 versus 4) between the two periods. In multivariable analysis, the risk of CIPN was higher for treatment with docetaxel (cumulative doses ≤300 mg/m², RR?=?6.96, 95 % CI 2.53–19.10; >300 mg/m², RR?=?13.32; 95 % CI 4.11–43.14). Alcohol consumption and diabetes were not significantly associated with CIPN. There were no significant differences in the variation of patient-reported outcomes between the baseline and 1-year follow-up evaluations.

Conclusions

CIPN was frequent in this contemporary cohort of early-stage breast cancer patients and was strongly associated with docetaxel-based regimens. Symptoms persisted for at least 6 months in most patients, but severity was low and CIPN had no impact on patient-reported outcomes.

     

Nurse-led follow-up care for head and neck cancer patients: a quasi-experimental prospective trial

Purpose

The aim of this study was to compare conventional medical follow-up with follow-up containing additional nursing consultations regarding the psychosocial adjustment and health-related quality of life (HRQOL) of head and neck cancer patients.

Methods

Using a quasi-experimental design, patients were enrolled consecutively into two groups. Experimental care covered six 30-min bimonthly nursing follow-up consultations during the first year posttreatment. Data were collected at posttreatment months 1 (baseline), 6, and 12 for both groups.

Results

The intervention group was significantly worse at baseline, based on two of the seven adjustment scales and on the majority of HRQOL scales. However, their outcome at 6 and 12 months was consistent with that of the group which received conventional follow-up. Thus, the intervention group had a larger improvement in scores, and this was significant for one of the seven adjustment scales and 19 of the 33 HRQOL scales at 6 and 12 months, respectively. Most of the differences in HRQOL scales were clinically relevant at 6 months.

Conclusion

These results suggest that nurse-led consultations for patients with head and neck cancer have a positive effect, primarily with respect to HRQOL. Nurse-led follow-up leads to a similar psychosocial adjustment as conventional follow-up, even among patients who showed worse performance at the start of follow-up. Thus, nurse-led follow-up may be a cost-effective way to improve follow-up care for this patient group.     

Long-term mortality and quality of life after septic shock: a follow-up observational study

Purpose

In septic shock, short-term outcomes are frequently reported, while long-term outcomes are not. The aim of this study was to evaluate mortality and health-related quality of life (HRQOL) in survivors 6 months after an episode of septic shock.

Methods

This single-centre observational study was conducted in an intensive care unit in a university hospital. All patients with septic shock were included. Mortality was assessed 6 months after the onset of septic shock, and a comparison between patients who survived and those who died was performed. HRQOL was assessed using the MOS SF-36 questionnaire prior to hospital admission (baseline) and at 6 months in survivors. HRQOL at baseline and at 6 months were compared to the general French population, and HRQOL at baseline was compared to 6-month HRQOL.

Results

Ninety-six patients were included. Six-month mortality was 45 %. Survivors were significantly younger, had significantly lower lactate levels and SAPS II scores, required less renal support, received less frequent administration of corticosteroids, and had a longer length of hospital stay. At baseline (n = 39) and 6 months (n = 46), all of the components of the SF-36 questionnaire were significantly lower than those in the general population. Compared to baseline (n = 23), the Physical Component Score (CS) improved significantly at 6 months, the Mental CS did not differ.

Conclusions

Mortality 6 months after septic shock was high. HRQOL at baseline was impaired when compared to that of the general population. Although improvements were noted at 6 months, HRQOL remained lower than that in the general population.     

Evaluation of chemotherapy-induced peripheral neuropathy using current perception threshold and clinical evaluations

Purpose

Chemotherapy-induced peripheral neuropathy (CIPN) is increasing with introduction of new and combination cancer pharmacotherapies. This study evaluated associations between clinical and self-report measurements and current perception threshold (CPT), a neuroselective measure of sensory nerve function that may detect asymptomatic CIPN damage.

Methods

Data for this secondary analysis were from a prospective, observational study using CPT to evaluate CIPN. Bivariate mixed models, accounting for the intraclass correlation between repeated patient assessments, were used to assess the relationship between CPT at each frequency (5, 250, and 2,000 Hz) and each subjective measure (Neuropathic Pain Scale, FACT-GOGntx) and objective measurement (quantitative sensory testing, deep tendon reflexes, and grip strength).

Results

A total of 29 chemotherapy-naïve subjects with various cancer types had a mean age of 56.7 (SD 10.4); nine subjects developed CIPN grade >1 using NCI CTC-AE criteria. Cold detection thresholds were inversely associated with CPT 5 [b(95 % CI)?=??2.5(?4.5, ?0.5)] and CPT 2,000 [?7.5(?11.8, ?3.3)] frequencies. FACT GOG-ntx quality of life (QoL) scale and neurotoxicity and function subscales were inversely associated with CPT 2,000 [?1.8 (?3.5, ?0.05), ?2.2 (?4.2, ?0.2), and ?5.4 (?9.8, ?0.9), respectively], indicating worsening QoL, impairment, and function as hypoesthesia increases.

Conclusions

CPT 2,000 may identify impending worsening of patient-reported outcomes such as QoL.