Citations

Background: Publication of the 2015 American Thyroid Association (ATA) management guidelines for adult patients with thyroid nodules and differentiated thyroid cancer was met with disagreement by the extended nuclear medicine community with regard to some of the recommendations related to the diagnostic and therapeutic use of radioiodine ( 131 I). Because of these concerns, the European Association of Nuclear Medicine and the Society of Nuclear Medicine and Molecular Imaging declined to endorse the ATA guidelines. As a result of these differences in opinion, patients and clinicians risk receiving conflicting advice with regard to several key thyroid cancer management issues. Summary: To address some of the differences in opinion and controversies associated with the therapeutic uses of 131 I in differentiated thyroid cancer constructively, the ATA, the European Association of Nuclear Medicine, the Society of Nuclear Medicine and Molecular Imaging, and the European Thyroid Association each sent senior leadership and subject-matter experts to a two-day interactive meeting. The goals of this first meeting were to (i) formalize the dialogue and activities between the four societies; (ii) discuss indications for 131 I adjuvant treatment; (iii) define the optimal prescribed activity of 131 I for adjuvant treatment; and (iv) clarify the definition and classification of 131 I-refractory thyroid cancer. Conclusion: By fostering an open, productive, and evidence-based discussion, the Martinique meeting restored trust, confidence, and a sense of collegiality between individuals and organizations that are committed to optimal thyroid disease management. The result of this first meeting is a set of nine principles (The Martinique Principles) that (i) describe a commitment to proactive, purposeful, and inclusive interdisciplinary cooperation; (ii) define the goals of 131 I therapy as remnant ablation, adjuvant treatment, or treatment of known disease; (iii) describe the importance of evaluating postoperative disease status and multiple other factors beyond clinicopathologic staging in 131 I therapy decision making; (iv) recognize that the optimal administered activity of 131 I adjuvant treatment cannot be definitely determined from the published literature; and (v) acknowledge that current definitions of 131 I-refractory disease are suboptimal and do not represent definitive criteria to mandate whether 131 I therapy should be recommended.

Abstract BACKGROUND Congenital disorders of glycosylation (CDG) represent 1 of the largest groups of metabolic disorders with >130 subtypes identified to date. The majority of CDG subtypes are disorders of N-linked glycosylation, in which carbohydrate residues, namely, N-glycans, are posttranslationally linked to asparagine molecules in peptides. To improve the diagnostic capability for CDG, we developed and validated a plasma N-glycan assay using flow injection–electrospray ionization–quadrupole time-of-flight mass spectrometry. METHODS After PNGase F digestion of plasma glycoproteins, N-glycans were linked to a quinolone using a transient amine group at the reducing end, isolated by a hydrophilic interaction chromatography column, and then identified by accurate mass and quantified using a stable isotope-labeled glycopeptide as the internal standard. RESULTS This assay differed from other N-glycan profiling methods because it was free of any contamination from circulating free glycans and was semiquantitative. The low end of the detection range tested was at 63 nmol/L for disialo-biantennary N-glycan. The majority of N-glycans in normal plasma had <1% abundance. Abnormal N-glycan profiles from 19 patients with known diagnoses of 11 different CDG subtypes were generated, some of which had previously been reported to have normal N-linked protein glycosylation by carbohydrate-deficient transferrin analysis. CONCLUSIONS The clinical specificity and sensitivity of N-glycan analysis was much improved with this method. Additional CDGs can be diagnosed that would be missed by carbohydrate-deficient transferrin analysis. The assay provides novel biomarkers with diagnostic and potentially therapeutic significance.

158 Background: There is limited research on methods for alerting clinicians to concerning patient-reported outcome (PRO) responses and how often PROs trigger alerts to nurses during cancer care. Methods: In two randomized trials, adults with advanced cancer receiving chemotherapy were enrolled. Participants were randomized to usual care vs. weekly PROs completed between visits (with automated feedback to nurses). PRO responses in the intervention arm triggered automated email alerts to nurses for frequent, severe, or worsening symptoms in the last 7 days. Alert thresholds for PROs were chosen a priori but were unique to each study. The “Symptom Tracking and Reporting” (STAR) trial was conducted at one academic medical center. The “PROs to Enhance Cancer Treatment” (PRO-TECT [AFT-39]) cluster-randomized trial is being conducted in > 30 community practices. Results: In STAR, 766 patients participated (58% female, 38% ages ≥65, 17% minority, 28% ≤high school). 441 participants were randomized to the intervention arm, where 1,431/84,212 items (2%) triggered a concerning symptom alert, during 1,070/8,498 weeks (13%). Frequent alerts were for fatigue (62%), pain (32%), and appetite (16%). In PRO-TECT (AFT-39), 300 patients have been enrolled (58% female, 49% ages ≥65, 8% minority, 47% ≤high school) out of 1,000. 146 participants have been randomized to the intervention arm, where 1,422/24,739 items (6%) triggered an alert, during 824/2249 weeks (37%). Common alerts were for pain (48%), physical function (35%), and diarrhea (15%). PRO-TECT provided clinical decision support with alerts. Conclusions: In two randomized trials in advanced cancer, PROs collected during care delivery enabled tailored treatment based on issues identified on PROs. Pain, physical function, appetite, and diarrhea commonly triggered alerts for concerning symptoms. Early PRO-TECT results are showing a trend for higher weekly alert rates for concerning symptoms (37% vs. 13% in STAR), which may indicate that the PRO intervention will be even more effective in community practices. Results assist in addressing logistical considerations for implementing PROs into routine care. Clinical trial information: NCT03249090.

Introduction This manuscript describes data from an original study, simulating a tele-glaucoma programme in an established clinic practice with an interdisciplinary team. This is a ‘real life’ trial of a telemedicine approach to see a follow-up patient. The goal is to evaluate the accuracy of such a programme to detect worsening and/or unstable disease. Such a programme is attractive since in-clinic time could be reduced for both the patient and provider. This study evaluates agreement between in-person and remote assessment of glaucoma progression. Methods A total of 200 adult glaucoma patients were enrolled at a single institution. The in-person assessment by an optometrist or glaucoma specialist at time of enrolment was used as the gold standard for defining progression. Collated clinical data were then reviewed by four masked providers who classified glaucoma as progression or non-progression in each eye by comparing data from enrolment visit to data from the visit immediately prior to enrolment. Agreement of glaucoma progression between the masked observer and the in-person assessment was determined using Kappa statistics. Intra-observer agreement was calculated using Kappa to compare in-person to remote assessment when both assessments were performed by the same provider ( n = 279 eyes). Results A total of 399 eyes in 200 subjects were analysed. Agreement between in-person versus remote assessment for the determination of glaucoma progression was 63%, 62%, 69% and 68% for each reader 1–4 (kappa values = 0.19, 0.20, 0.35 and 0.33, respectively). For intra-observer agreement, reader 1 agreed with their own in-person assessment for 65% of visits (kappa = 0.18). Discussion Intra-observer agreement was similar to the agreement for each provider who did not see the patient in person. This similarity suggests that telemedicine may be equally effective at identifying glaucomatous disease progression, regardless of whether the same provider performed both in-clinic and remote assessments. However, fair agreement levels highlight a limitation of using only telemedicine data to determine progression compared with clinical detail available during in-patient assessment.

e21681 Background: Maintaining quality of life with minimal symptoms is an important goal of cancer treatment. We surveyed patients undergoing cancer treatment about their preferences for information about the long-term symptom burden associated with their current treatment. Methods: Patients undergoing active cancer treatment were enrolled at two large cancer centers from 1/2014 to 7/2015. At the time of enrollment patients reported their household income, employment, performance status and their agreement with the statement, “It would be useful to know the percentage of patients having persistent symptoms more than a year after getting the same treatment I am getting.” Treatment intention (curative vs. palliative) was reported by the treating oncologist. Results: 196 patients completed the survey. The mean age was 55.7 (range 20-80); 54% were female, 69% were white, and 60% were receiving palliative treatment. The majority (83%) of patients either strongly agreed or somewhat agreed that it would be helpful to have information about future symptoms. In univariable analyses, this preference did not significantly differ based on patient-reported performance status, sex, age, treatment intent, race, or household income. Using a more stringent criterion to dichotomize the outcome, 59% of participants strongly agreed that it would be helpful to have information about future symptoms. Patients undergoing treatment with curative intent were significantly more likely to strongly agree (72% vs. 51%, p = 0.0035). In a multivariable analysis adjusting for age, sex, income level, employment status, and patient-reported performance status, participants undergoing curative versus palliative treatment had 3.1 times the odds (95% CI 1.47-6.65) of strongly agreeing. Conclusions: The majority of patients undergoing cancer treatment wanted to know what symptoms to expect in the future, and this was independent of patient demographics. Patients undergoing treatment with curative intent are significantly more likely to want this information than patients undergoing palliative treatment. Symptom data collected through research studies and registries should be summarized by treatment and other key predictors and made available to patients.

6523 Background: Treatment for most types of cancer results in work disruptions. The aim of this study is to identify risk factors for not working during cancer therapy using a patient-reported outcome tool. Methods: Patients of all cancer types, who were undergoing treatment with curative or palliative intent, were enrolled in a survey-based study at Memorial Sloan Kettering Cancer Center and the North Carolina Cancer Hospital from 1/2014 to 7/2015. All patients working full- or part- time at the time of cancer diagnosis were included in this analysis. Patient reported outcomes were collected using a survey tool at any time during active cancer treatment. The primary outcome of this analysis was self-reported work status at the time of survey completion. Results: Of 119 patients who were working before their cancer diagnosis, 68% were working at the time of survey completion. The mean age was 52.9 (range 20-80). Younger age was associated with working: 82% of patients age < 40 were working during treatment vs. 31% of patients age > 65 (p=0.01). The number of days patients reported being completely unable to work in the past month was significantly associated with work status; only 26% of patients who missed > 10 days continued to work compared to 69% who missed ≤ 10 days (p<0.01). Patients who report having a flexible work schedule were 23% more likely to continue to work during treatment (69% vs. 46%, p=0.01). In a multivariable model controlling for having an employer contingent health plan, and household income > 200% of the federal poverty level (fpl), only age, having a flexible work schedule, and inability to work > 10 days were independently associated with work status during treatment (Table). Conclusions: Having a flexible work schedule allowed for more work interruptions without job loss. Patients who are likely to miss more than 10 days of work and who have inflexible work schedules are at high risk of unemployment and should be targeted for employment retention initiatives. [Table: see text]

LBA2 The full, final text of this abstract will be available at abstracts.asco.org at 7:30 AM (EDT) on Sunday, June 4, 2017, and in the Annual Meeting Proceedings online supplement to the June 20, 2017, issue of the Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Sunday edition of ASCO Daily News.