Treatment persistence of interleukin-17 inhibitor class drugs among patients with psoriasis in Japan: a retrospective database study.

BACKGROUND AND OBJECTIVE: Real-world evidence on persistence of interleukin-17 inhibitors (IL-17i) as a drug class among Japanese patients with psoriasis is lacking. Hence, we aimed to describe persistence rates of IL-17is among patients with psoriasis including psoriasis vulgaris (PsO), psoriatic arthritis (PsA), and generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP) in Japan. METHODS: We analyzed claims data from the Medical Data Vision database. Patients ≥15 years old with a psoriasis diagnosis and an IL-17i prescription between November 2016 and August 2020 were included and followed through August 2021. Persistence rates of the IL-17i class among patients with psoriasis and its subtypes (PsO, PsA, and GPP or EP), and persistence rates of ixekizumab, secukinumab, or brodalumab among patients with PsO or PsA were analyzed using Kaplan-Meier method. Analyses were conducted in the bio-naïve and bio-experienced subgroups. RESULTS: The IL-17i class had >50% persistence rates up to 36 months among patients with psoriasis and its subtypes (PsO, PsA, and GPP or EP). 36-Month persistence rates for ixekizumab, secukinumab, and brodalumab were 46.2% to 57.7% in patients with PsO and 43.0% to 48.4% in patients with PsA. Across analyses, bio-naïve patients demonstrated similar or greater persistence rates than bio-experienced patients. CONCLUSION: IL-17is' persistence rates over 36 months were >50% among patients with psoriasis and its subtypes (PsO, PsA, and GPP or EP) in Japan.

Impact of Patient and Physician Disconnect on Satisfaction with Treatment for Atopic Dermatitis in Japan.

INTRODUCTION: Atopic dermatitis (AD) is an inflammatory disease causing severe skin itching. Data on patient-physician disconnect on treatment satisfaction in patients with AD in Japan are limited. We investigated patient-physician disconnect on treatment satisfaction in AD and if it influences treatment patterns, clinical characteristics, and patient-reported outcomes (PROs). METHODS: Data were drawn from the Adelphi AD Disease Specific Programme (DSP), a real-world, point-in-time survey of physicians and patients with AD conducted in Japan from April to July 2019. Patients and physicians were grouped according to level of treatment satisfaction ("extremely satisfied" to "extremely dissatisfied"); with any level of dissatisfaction recorded as "less than satisfied." Data were collected on treatment patterns, clinical characteristics, and PROs including the Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), EQ-5D-3L questionnaire, and Work Productivity and Activity Impairment (WPAI) questionnaire. RESULTS: Data were provided by 184 patients with AD and 56 physicians; 72.8% of patient-physician pairs reported a fair (kappa coefficient: 0.40) level of agreement on treatment satisfaction, 51.6% of patient-physician pairs were both satisfied, and 21.2% were both less than satisfied. Satisfied physicians prescribed a mean 1.2 fewer treatments than dissatisfied physicians (p < 0.05). Cases where both physician and patient were less than satisfied or where patients were less satisfied than their physicians reported the worst PROs, DLQI (both less than satisfied: mean 10.7 versus patient less satisfied than physician: 10.6 versus overall: 7.9), POEM (19.5 versus 17.3 versus 17.0), EQ-5D-3L (0.82 versus 0.81 versus 0.87) (all, p < 0.05). Work impairment was highest when both patient and physician were less than satisfied (p < 0.05). Physicians cited treatment efficacy and patients cited efficacy and usability as main reasons for dissatisfaction. CONCLUSION: Overall, 12.0% of patients were less satisfied with their AD treatment than the physician, demonstrating some of the worst PROs, suggesting unmet need that could be improved by better patient-physician communication.

Prevalence of alopecia areata in Japan: Estimates from a nationally representative sample.

Data on the prevalence of alopecia areata (AA) in Japan is limited and the epidemiology of the disease there is not well understood; therefore, it is critical to examine the prevalence and severity of AA in Japan to inform the need for future treatments and research. A cross-sectional, web-based survey was conducted in Japan from January through March 2021. A total of 45 006 participants were identified through general population survey panels and asked about their experience with AA and hair loss. The Alopecia Assessment Tool and the Scalp Hair Assessment PROTM were adopted to screen for history of AA and assess disease severity, respectively. Eligible participants submitted photos of their scalp, which were reviewed by three board-certified dermatologists to evaluate the presence and severity of AA. Prevalence and severity estimates were calculated using participants' self-reported data and verified through the dermatologists' assessments. The participant-reported point prevalence of AA was 2.18%. The adjusted point prevalence following physician adjudication using participant-submitted photos was 1.45%. Topical corticosteroids were the most commonly used treatments, with 34.6% of participants diagnosed with AA reported having ever used them. Participants also reported negative impacts on their mood (70.2%), self-esteem (55.8%), and social interactions (48.9%). Despite the social and emotional impact of hair loss, more than one third of those reporting a physician diagnosis of AA were not currently seeking treatment. The current study identified an estimated prevalence of AA in Japan between 1.45% and 2.18% based on the survey results and physician-adjudication of those findings. Considering the impactful psychological burden of AA, the survey results showing that 38.90% of surveyed patients do not currently seek treatment may indicate an unmet need for remedies.

Patient and physician perspectives on alopecia areata: A real-world assessment of severity and burden in Japan.

The criteria used by physicians to assess alopecia areata severity and its associated burden from the patients' point of view are not well understood. We aimed to understand physician-assessed determinants of disease severity, factors associated with severity, patient-physician concordance, and patient-reported burden by severity. Data were drawn from the Adelphi Alopecia Areata Disease Specific Programme™, a point-in-time survey of dermatologists and their alopecia areata patients in real-world practice in Japan conducted between January and March 2021. Patients were categorized into three groups by current disease severity according to physician subjective assessment: mild, moderate, or severe. Demographics, clinical characteristics, and outcomes were described within and compared between the three patient groups. Our study of 97 dermatologists and 587 patients found overall scalp hair loss was the most important factor considered by physicians in determining disease severity. More severe disease was associated with loss of eyebrow hair, eyelashes, and hair loss from other body areas. Agreement on disease severity between physicians and patients was moderate. From the patient perspective, greater severity of alopecia areata was associated with greater anxiety and depression, with lower work productivity and worse quality of life. Our study provides insights into which factors physicians use to determine alopecia areata severity, how physician and patient severity assessments compare, and the burden of alopecia areata on patients.

Current status of shared decision making for rheumatoid arthritis treatment in Japan: a web-based survey on physicians and patients.

OBJECTIVE: To assess the current status of shared decision making (SDM) in rheumatoid arthritis (RA) clinical practice in Japan from the perspectives of physicians and patients. METHODS: A web-based survey was conducted to recruit patients with RA who were prescribed, for the first time, a conventional synthetic disease-modifying antirheumatic drug (csDMARD) or a biological drug/Janus kinase (JAK) inhibitor, and physicians who prescribed these treatments to patients with RA. The SDM Questionnaire-Physician version (SDM-Q-Doc) and the 9-item SDM Questionnaire (SDM-Q-9) were used to assess the SDM levels of physicians and patients, respectively. The scale ranged from 0 to 100, and higher scores indicated better SDM status. RESULTS: The responses from 107 physicians who treat patients with RA, 107 patients prescribed a csDMARD, and 110 patients prescribed a biological drug/JAK inhibitor were collected. The mean SDM score for SDM-Q-Doc was 74.5 when physicians decided to prescribe a csDMARD and 77.2 when they decided to prescribe a biological drug/JAK inhibitor. However, the mean SDM score for SDM-Q-9 was 62.3 when patients were prescribed csDMARDs and 72.6 when they were prescribed biological drugs/JAK inhibitors. CONCLUSIONS: The results showed differences in SDM level between patients and physicians and, from the patient perspective, between treatment types.

Rheumatoid arthritis (RA) is a long-term disease that causes swelling and pain, mainly in the joints of the hands and feet. Because RA cannot be cured, treatment usually continues for a long time. Shared decision making (SDM) involves people and their doctors deciding on the best treatment together. This study was done to understand how SDM is used for RA treatment in Japan. We sent one survey to 107 doctors who treat RA and a different survey to 217 people with RA. Each survey asked the doctors or the people with RA to score, on a scale of 0 to 100, how involved the person with RA was in making the decision on what treatment to use. A higher score meant more involvement in SDM. Doctors gave higher SDM scores than people with RA did, which meant doctors thought there was more SDM than what people with RA thought. This was true whether the person started treatment with a conventional RA drug or a newer RA drug (biological/JAK inhibitor). However, for both doctors and people with RA, the SDM scores were higher when a newer drug was used than when a conventional drug was used. This may be because the newer drugs are often prescribed for people with more severe RA or because there are more treatment types available. This was the first study to look at SDM in RA treatment in Japan. Increasing SDM will help improve treatment satisfaction in people with RA and increase patient-centered medical care.[Figure: see text].

Evaluation of treatment satisfaction misalignment between Japanese psoriasis patients and their physicians - Japanese psoriasis patients and their physicians do not share the same treatment satisfaction levels.

OBJECTIVES: High treatment satisfaction in both patients and physicians is an important factor in improving quality of life in psoriasis patients. This study aimed to evaluate treatment satisfaction alignment between psoriasis patients and physicians and to identify factors associated with satisfaction misalignment, especially "physician-predominant" misalignment. METHODS: This is a nationwide multicenter cross-sectional study. Subjects were paired moderate to severe psoriasis outpatients and their physicians. Treatment satisfaction was evaluated on a scale from 0 to 10. Subjects were defined as "misaligned" when the difference in treatment satisfaction was over ±1 between the patient-physician pair. RESULTS: A total of 425 pairs were collected from 54 facilities in Japan. The mean patient age and disease duration were 56.5 years and 18.7 years, respectively. The mean physician age was 50.6 years and 69.6% of physicians specialized in psoriasis. Treatment satisfaction misalignment was found in 49.9% of the patient-physician pairs. Among misaligned pairs, 43.6% were "physician-predominant" pairs. In the multivariate logistic regression analyses, "treatment is effective" was the most important reason for treatment satisfaction (odds ratio [OR]: 35.5; 95% confidence interval [CI]: 5.43, 231.78). Symptoms in the genital area (OR: 10.2; 95% CI: 2.55, 40.93) and lack of understanding of treatment options by patients (OR: 7.5; 95% CI: 2.19, 25.94) were key factors leading to "physician-predominant" status. CONCLUSIONS: The results suggest that genital psoriasis plays an important role in treatment satisfaction from the patient perspective, and illustrate the importance of communication between patients and physicians which potentially resolves these factors and improves misalignment.

Glucagon-Like Peptide-1 Receptor Agonist Utilization in Type 2 Diabetes in Japan: A Retrospective Database Analysis (JDDM 57).

INTRODUCTION: There are limited real-world data on the prescribing of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) for patients with type 2 diabetes mellitus (T2DM). METHODS: This was a retrospective analysis of the CoDiC® database of the Japan Diabetes Clinical Data Management Study Group (JDDM). Demographic and clinical characteristics, concomitant treatment patterns, and GLP-1 RA treatment persistence or modification in patients with T2DM initiating GLP-1 RA therapy were evaluated. RESULTS: The analysis included 932 eligible patients with T2DM who had their first GLP-1 RA prescription (index date) between September 2016 and July 2018. Mean age was 63.8 years and 56.0% were male. Most patients had an index GLP-1 RA of dulaglutide (65.7%) or liraglutide (29.1%). Common comorbidities were obesity (58.7%), hypertension (54.7%), dyslipidemia (52.0%), retinopathy (11.3%), and nephropathy (10.2%). Mean hemoglobin A1c (HbA1c) levels decreased from 8.3 to 7.8% over 6 months after GLP-1 RA initiation, and the proportion of patients achieving HbA1c < 7.0% increased from 14.4% at index date to 22.9% at 6 months. Reductions occurred in mean body weight, body mass index, triglycerides, total cholesterol, low-density lipoprotein cholesterol, and adjusted urinary albumin over 6 months. Antidiabetic medication use decreased after GLP-1 RA initiation, whereas non-antidiabetic medication prescribing showed little change. Index GLP-1 RA persistence rates were 80.5%, 66.2%, and 51.6% at 6, 12, and 18 months post-index, respectively, with a median persistence until discontinuation or switch of 600 days. Persistence rates at 6, 12, and 18 months post-index, respectively, were 81.9%, 70.7%, and 65.4% for dulaglutide and 79.7%, 60.0%, and 30.4% for liraglutide. CONCLUSION: The study shows real-world benefits of GLP-1 RA therapy for T2DM, including improvements in HbA1c, body weight, and blood lipid profile, and supports the high rates of long-term persistence previously reported with dulaglutide, the GLP-1 RA most commonly prescribed for T2DM in Japanese clinical practice.

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are drugs that patients with type 2 diabetes mellitus (T2DM) take to help control their blood sugar levels. In Japan, the GLP-1 RAs that doctors can prescribe are dulaglutide, exenatide, liraglutide, and lixisenatide as of May 2020. We conducted a study of how GLP-1 RAs are used to treat patients with T2DM in Japanese real-world clinical practice. We used a large database of anonymous information from hospitals and clinics in Japan. Over 900 adult patients started their first GLP-1 RA treatment for T2DM between September 2016 and July 2018. Before these patients started GLP-1 RA treatment, many were overweight, had high blood pressure, and had abnormal levels of lipids in their blood. Six months after starting GLP-1 RA treatment, on average these patients had lower hemoglobin A1c (a measure of average blood sugar levels), lower body weight, and better blood lipid levels than before they started GLP-1 RA treatment. Dulaglutide was the most common GLP-1 RA prescribed, then liraglutide. After 6 months, most patients (four-fifths) continued to use their GLP-1 RA treatment without stopping or changing to another treatment. After 18 months, half of the patients were still using their GLP-1 RA. Two-thirds of patients on dulaglutide and one-third of patients on liraglutide continued the treatment after 18 months. This study shows that GLP-1 RAs can benefit patients with T2DM in real-world clinical practice. It also shows that patients may be able to take long-term dulaglutide treatment.

Comparative study of dulaglutide single-use pen Ateos versus insulin degludec FlexTouch on learning and mock administration time in Japanese patients with type 2 diabetes mellitus - a post-hoc analysis.

Aims: Clinical data have shown that patients with diabetes require shorter training time to use Ateos versus FlexTouch. Using data acquired from a previous study, self-administration procedures that necessitated more time and repetition during mock injection were evaluated.Methods: In this open-label task- and interview-based crossover study, 48 self-injection naïve participants with type 2 diabetes mellitus (T2DM) were randomized to 1 of 2 sequences to perform a mock injection of Ateos and FlexTouch into a rubber pad after receiving training. Time needed to conduct mock injection steps (preparation, pre-injection set-up, injection, clean-up), and the number and time needed for repeated steps due to procedural errors, were measured as post-hoc analyses.Results: Mean time for preparation, injection, and clean-up was shorter for Ateos (13, 15, 9 s) versus FlexTouch (96, 53, 36 s). Overall time for administration including repeated steps was 75 s for Ateos and 288 s for FlexTouch. Nine participants repeated procedures due to errors when using Ateos (preparation: 6; pre-injection set-up: 2; injection: 1), and 7 participants when using FlexTouch (preparation: 2; pre-injection set-up: 2; injection: 5). There was 1 repeat per person for Ateos injections versus multiple repeats for FlexTouch injections.Conclusions:Post-hoc analysis demonstrates the time needed for overall administration was shorter for Ateos than FlexTouch, and time for each procedure was shorter or similar for Ateos versus FlexTouch. Ateos was easy for participants with T2DM to learn with fewer repeated steps due to procedural errors, and easy for healthcare professionals to introduce to their patients.

Cross-sectional survey in patients with type 1 and type 2 diabetes to understand mealtime insulin unmet needs in Japan: The MINUTES-J study.

AIMS: This study was conducted to evaluate existing burden and unmet needs related to mealtime insulin (MTI) injection timing among adult Japanese patients with type 1 (T1D) and type 2 (T2D) diabetes. It also aimed to evaluate if a novel MTI could reduce this burden. METHODS: This study comprised of a qualitative pilot study facilitating development of an online survey; followed by an online quantitative survey involving T1D, young T2D (yT2D) and elderly T2D (eT2D) patients to assess burden of current MTI timings in Japan. RESULTS: Overall, 38% patients (amongst T1D, yT2D and eT2D groups) reported injecting MTI just before start or during meal in the past month. Experiencing lower glucose level/hypoglycemic condition before the meal and forgetting were the main reasons for injecting during/after meal in T1D and T2D patients respectively. Patients reported moderate-to-severe burden in multiple aspects of their lives, associated with current MTI timing. Most patients perceived that this burden would remain the same if a faster acting MTI was available. CONCLUSIONS: Substantial burden reported by Japanese patients regarding the current MTI timings suggests the need for new MTI products that could achieve optimal post-prandial glucose control at different timings to meet patients' needs in Japan.

Usability of Nasal Glucagon Device: Partially Randomized Caregiver and Third-Party User Experience Trial with Simulated Administration at a Japanese Site.

INTRODUCTION: Glucagon is the only approved medicine for severe hypoglycemia available for caregivers of people with diabetes. Nasal glucagon (NG) was recently approved in the USA as a needle-free, ready-to-use alternative to injectable glucagon. This simulated user experience study in Japan compared NG and intramuscular glucagon (IMG) administration by caregivers, and NG administration by untrained third parties. METHODS: This was an open-label, single-center, partially randomized crossover, simulated user experience trial conducted in Japan (October 2018 to December 2018). Caregivers who live with and care for a relative with diabetes were randomized (1:1, stratified by patient diabetes type 1 or 2) to one of two simulated administration sequences (group 1: NG then IMG; group 2: IMG then NG). Caregivers received training on each device 2 weeks before simulated administration of the device. Third parties received no training and only conducted simulated NG administration. Outcome measures included the percentage of successful administrations (based on critical step completion and dose; primary outcome), time to complete administration, and user satisfaction/preferences. RESULTS: In caregivers (N = 19), the percentage of successful administrations was greater (89.5% vs 26.3%, P < 0.001) and mean time to complete administration was shorter (23.9 vs 207.3 s, P < 0.001) with NG than with IMG. In third parties (N = 20), 95% of NG administration attempts were successful (mean time to complete administration, 55.5 s). All caregivers and 80% of third parties reported that the NG device was easy to use. All caregivers and 70% of third parties were confident and willing to use the device in a real emergency, and more than 80% of caregivers preferred the NG device to IMG. CONCLUSION: This simulated user experience study confirmed that glucagon administration using a nasal delivery device was quicker, easier, and had a higher success rate than intramuscular administration in Japan, where the glucagon injection kit is not available. FUNDING: Eli Lilly. Plain language summary available for this article.

Comparative usability study of the dulaglutide single-use pen versus the insulin degludec FlexTouch® among self-injection-naïve patients with type 2 diabetes mellitus in Japan.

OBJECTIVE: This study assessed training time with the dulaglutide single-use pen (SUP) and the insulin degludec disposable prefilled pen (FlexTouch®) in self-injection-naïve patients with type 2 diabetes mellitus (T2DM) in Japan. METHODS: This multi-center, open-label, comparative, crossover study measured training time with the dulaglutide SUP vs FlexTouch®. Participants learned how to use both devices in a randomly assigned order. Healthcare providers (HCP) conducted the training. The primary end-point was the time required to train self-injection-naïve T2DM participants to self-inject correctly using each device. Secondary end-points included performance measures, such as success and error rates, patient perceptions related to ease-of-use, and factors associated with training time and performance. RESULTS: Overall, 48 participants were randomized and completed the study. The mean training time to achieve correct administration was significantly shorter with the dulaglutide SUP vs FlexTouch® (7.4 min vs 19.7 min, p < .001). The proportions of participants who successfully completed the mock injection without error were similar for both devices. Ninety-two percent (44/48) of participants reported that the dulaglutide SUP was easier to use than FlexTouch®. CONCLUSIONS: In this study, participants required a shorter training time to achieve correct administration with the dulaglutide SUP, and had a higher preference for the dulaglutide SUP, when compared to FlexTouch®. These data suggest that the dulaglutide SUP is easy-to-use, which may decrease the burden on HCPs to train diabetic patients how to administer injection therapy and reduce patient injection hurdles, such as needle fear.

Taxane-induced peripheral neuropathy and health-related quality of life in postoperative breast cancer patients undergoing adjuvant chemotherapy: N-SAS BC 02, a randomized clinical trial.

PURPOSE: To elucidate whether adjuvant taxane monotherapy is a feasible and tolerable for postoperative breast cancer patients, we evaluated the severity of chemotherapy-induced peripheral neuropathy (CIPN) and the relative tolerability of regimens by health-related quality of life (HRQOL) assessment in node-positive breast cancer patients treated with taxane-containing regimens. METHODS: We evaluated CIPN and HRQOL in the first 300 patients enrolled in a larger (1,060 total) multicenter phase III trial randomized to one of four adjuvant regimens: (1) anthracycline-cyclophosphamide followed by paclitaxel (ACP), (2) AC followed by docetaxel (ACD), (3) paclitaxel alone (PTX), or (4) docetaxel alone (DTX). CIPN was assessed by the Patient Neurotoxicity Questionnaire (PNQ) and the National Cancer Institute Common Toxicity Criteria, and HRQOL by Functional Assessment of Cancer Therapy-General (FACT-G). CIPN and HRQOL scores were compared between ACP and ACD vs. PTX and DTX, and ACP and PTX vs. ACD and DTX. RESULTS: PNQ sensory scores were significantly higher in patients treated with taxane monotherapy compared to treatment with AC followed by taxane (P = .003). No significant differences in PNQ sensory scores were observed between the ACP and PTX vs. ACD and DTX regimens (P = .669). Regardless of taxane regimen, PNQ severity scores for CIPN appear to be largely reversible within 1 year of adjuvant treatment. No significant difference in FACT-G scores was observed between any regimens during the study treatments. CONCLUSIONS: Patient-reported CIPN was significantly more severe with single-agent adjuvant taxane compared to AC followed by taxane treatment; however, the HRQOL findings support that single-agent taxane treatment is tolerable.

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.

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.

A questionnaire survey of physicians' perspectives regarding the assessment of chemotherapy-induced peripheral neuropathy in patients with breast cancer.

OBJECTIVE: Since there is now growing interest in the incorporation of patient-reported outcome measures in cancer clinical trials, a patient-based questionnaire, the Patient Neurotoxicity Questionnaire (PNQ) was developed to quantify the symptoms and severity of chemotherapy-induced peripheral neuropathy (CIPN). The aim of this study was to evaluate the physicians' perspectives regarding the utility and diagnostic value of PNQ. METHODS: A questionnaire was sent to 61 physicians who participated in a Phase III randomized trial of adjuvant chemotherapy in breast cancer (AC followed by taxane versus taxane alone) that used the PNQ to assess CIPN. RESULTS: Forty-seven out of 61 physicians (77%) responded. The majority considered neurosensory symptoms the diagnostic hallmark for CIPN and most regarded interference with activities of daily living (ADLs) as definite justification for treatment modifications. For neurosensory disturbance, the majority of physicians indicated that Grade D severity (moderate to severe symptoms interfering with ADLs) should result in treatment postponement and Grade E severity (severe symptoms preventing most ADLs) should result in treatment discontinuation. Similarly, for neuromotor disturbance, over half of the physicians replied that Grade C (moderate symptoms not interfering with ADLs), D and E severity should result in dose reduction, treatment postponement and treatment discontinuation, respectively. Eighty-four percentage of the physicians reported that the use of the PNQ was helpful in the diagnosis and assessment of patients at risk of CIPN. CONCLUSIONS: The PNQ appears to be a useful instrument for the diagnosis and grading of CIPN, as well as for clinical decision-making regarding treatment modifications secondary to CIPN.