Children, despite presenting with more extensive PTC when compared to adults, have postoperative recurrences at similar frequency, typically coexist with DM and die of PTC less often. Since 1976, both children and adults with MACIS <6 PTC have a <1% chance at 30 years of CSM; adults with higher MACIS scores (6 or more) have a 30-year CSM rate of 30%.
Purpose Oxaliplatin and paclitaxel are commonly used chemotherapies associated with acute and chronic neuropathies. There is a need to better understand the similarities and differences of these clinical syndromes. Methods Neuropathy data were pooled from patients receiving adjuvant oxaliplatin and weekly paclitaxel or every 3 weeks of paclitaxel. Patients completed daily questionnaires after each chemotherapy dose and the European Organization for Research and Treatment of Cancer quality-of-life questionnaire for patients with chemotherapy-induced peripheral neuropathy before each chemotherapy cycle and for 12 months post-treatment. Results Acute neuropathy symptoms from both drugs peaked around day 3. Acute symptoms experienced in cycle 1 predicted occurrence in subsequent cycles. Paclitaxel-induced acute symptoms were similar in intensity in each cycle and largely resolved between cycles. Oxaliplatin-induced acute symptoms were about half as severe in the first cycle as in later cycles and did not resolve completely between cycles. Both drugs caused a predominantly sensory chronic neuropathy (with numbness and tingling being more common than pain). Oxaliplatin-induced neuropathy worsened after the completion of treatment and began to improve 3 months post-treatment. In contrast, paclitaxel-induced neuropathy began improving immediately after chemotherapy cessation. During treatment, the incidence of paclitaxel sensory symptoms was similar in the hands and feet; with oxaliplatin, the hands were affected more than the feet. Both paclitaxel- and oxaliplatin-induced acute neurotoxicity appeared to predict the severity of chronic neuropathy, more prominently with oxaliplatin. Conclusions Knowledge of the similarities and differences between neuropathy syndromes may provide insight into their underlying pathophysiology and inform future research to identify preventative treatment approaches.
Background/Aims The use of Patient Reported Outcomes (PROs) in clinical trials is a focal point for research and policy. Non-compliance with planned questionnaires and missing data can threaten both internal validity and generalizability. This retrospective analysis was conducted to determine the extent of, and characteristics associated with, missing PROs. Methods Study characteristics, patient characteristics and adverse events, and reasons for non-compliance were compiled from 14 closed Alliance for Clinical Trials in Oncology, Mayo Clinic Cancer Center, or Mayo Clinic Cancer Research Consortium clinical trials. Compliance rates were calculated for each patient using the number of booklets completed while the patient was on trial divided by the number of booklets the patient was expected to complete. Frequency counts and summary statistics were compiled. Logistic regression techniques were employed. Results The 1640 included patients had a median age of 58 years, were mostly white (90.8%) and female (73.8%). Compliance rates per study ranged from 84.7% to 97.2%. The primary endpoint of overall compliance rate was 93.1%. A total of 1267 patients were compliant. Those non-compliant were slightly older (mean 58.6 vs 57.5, p=0.03) and had different types of cancer (p<0.01). There were no differences in compliance according to tumor status (p=0.66), clinical stage (p=0.81), baseline quality of life (p=0.42 for ≥8 vs <8 and p=0.12 for ≥6 vs <6) or maximum adverse event grade incidence (p=0.33 for grade 2+ incidence and p=0.36 for grade 3+ incidence). Reasons for non-compliance included patient refusal (N=136), booklet not administered to patient (N=199), no clinic visit at the scheduled time for booklet completion (N=40), and at-home completed booklet not returned (N=224). Logistic regression indicates gender (p<0.01), race (p<0.01), performance score (p=0.02), dose delay status (p=0.01) and incidence of grade 3 or higher adverse event (p=0.03) were correlates of compliance. Conclusions PROs have successfully been implemented into Alliance and Mayo Clinic trials with high rates of patient compliance. Further improvement in compliance can be made with staff commitment and education. Patients are typically noncompliant only when the task at hand is burdensome, unclear or logistically challenging. Existing tracking systems used for the other trial outcomes should be utilized to ensure successful capture of PRO outcomes.
Objective: To determine whether radioiodine remnant ablation (RRA) reduces cause-specific mortality (CSM) or tumor recurrence (TR) rate after bilateral lobar resection (BLR). Patients and Methods: There were 2952 low-risk adult papillary thyroid cancer (LRAPTC) patients (with MACIS scores <6) who underwent potentially curative
Background Currently acceptable management options for patients with adult papillary thyroid microcarcinoma (APTM) range from immediate surgery, either unilateral lobectomy or bilateral lobar resection, to active surveillance (AS). An alternative minimally invasive approach, originally employed for eliminating neck nodal metastases, may be ultrasound-guided percutaneous ethanol ablation (EA). Here we present our experience of definitively treating with EA fifteen patients with APTM. Patients/Methods During 2010-2017 the fifteen cT1aN0M0 patients selected for EA, were aged 36-86 years (median 45 years). Tumor volumes (n=17), assessed by sonography, ranged from 25-375 mm 3 (median 109). 14/15 patients had two ethanol injections on successive days; total volume injected ranging from 0.45 -1.80 cc (median 1.1 cc). All ablated patients were followed with sonography and underwent recalculation of tumor volume and reassessment of tumor perfusion at each follow-up visit. Results The ablated patients have now been followed for 10-100 months (median 64). There were no complications and no ablated patient developed post-procedure recurrent laryngeal nerve dysfunction. All 17 ablated tumors shrunk (median 93%) and Doppler flow eliminated. Median tumor volume reduction in 9 identifiable avascular foci was 82% (range 26-93%). After EA, 8 tumors (47%) disappeared on sonography after a median of 10 months. During follow-up no new PTM foci and no nodal metastases have been identified. Conclusions Definitive treatment of APTM by EA is effective, safe and inexpensive. Our results suggest that, for APTM patients who do not wish neck surgery and are uncomfortable with AS, EA represents a well-tolerated and minimally invasive outpatient management option.
◥Over one million women in the United States receive biopsy diagnoses of benign breast disease (BBD) each year, which confer a 1.5-4.0-fold increase in breast cancer risk. Studies in the general population suggest that nonsteroidal anti-inflammatory agents (NSAID) lower breast cancer risk; however, associations among women with BBD are unknown. We assessed whether NSAID use among women diagnosed with BBD is associated with lower breast cancer risk. Participants included 3,080 women (mean age ¼ 50.3 AE 13.5 years) in the Mayo BBD surgical biopsy cohort diagnosed between January 1, 1992 and December 31, 2001 who completed breast cancer risk factor questionnaires that assessed NSAID use, and whose biopsies underwent detailed pathology review, masked to outcome. Women were followed from date of BBD biopsy to breast cancer diagnosis (main outcome) or censoring (death, prophylactic mastec-tomy, reduction mammoplasty, lobular carcinoma in situ or last contact). Median follow-up time was 16.4 AE 6.0 years. Incident breast cancer was diagnosed among 312 women over a median follow-up of 9.9 years. Regular non-aspirin NSAID use was associated with lower breast cancer risk [HR ¼ 0.63; 95% confidence interval (CI) ¼ 0.46-0.85; P ¼ 0.002] with trends of lower risk (highest tertiles of use vs. nonuse) for greater number of years used [HR ¼ 0.55; 95% CI ¼ 0.31-0.97; P trend ¼ 0.003), days used per month (HR ¼ 0.51; 95% CI ¼ 0.33-0.80; P trend ¼ 0.001) and lifetime number of doses taken (HR ¼ 0.53; 95% CI ¼ 0.31-0.89; P trend ¼ 0.003). We conclude that nonaspirin NSAID use is associated with statistically significant lower breast cancer risk after a BBD biopsy, including a dose-response effect, suggesting a potential role for NSAIDs in breast cancer prevention among patients with BBD.
Objective: To determine whether radioiodine remnant ablation (RRA) reduces cause-specific mortality (CSM) or tumor recurrence rates (TRR) after potentially curative bilateral thyroidectomy (BT) in low-risk adult papillary thyroid carcinoma (APTC) patients, we compared postoperative outcome in 1836 pTNM stage I APTC patients having BT alone with 832 having BT+RRA during two consecutive 25-year periods. Methods: The THEN cohort (consecutively managed during 1966-1990) comprised 809 patients (36% having BT+RRA). NOW cohort (1991-2015) comprised 1859 patients (29% BT+RRA). Analyses of difference in occurrence rates between BT alone and BT+RRA patients were performed with SAS software. Results: During 1966-1990, when RRA rates rose ten-fold, 20-year CSM after BT alone was 0.6% and after BT+RRA 1.2% (P=0.66); during 1991-2015, when RRA rates progressively fell, no PTC deaths occurred in 1859 patients. In the THEN cohort, RRA did not significantly improve TRR at local, regional or distant sites (P<0.1), when compared to BT alone. RRA in NOW cohort was administered to 49% of pN1 patients and 17% of pN0/NX patients (P<0.0001); TRR therefore examined separately for pN0/NX and pN1 patients. In 1157 pN0/NX cases, 20-yr locoregional TRR were 3.1% after BT and higher (p=.049) at 8.6% after BT+RRA. In four pN1 groups, stratified by metastatic nodal burden, RRA did not significantly reduce the locoregional TRR observed after BT with curative intent (P<0.5). Conclusion: In a 5-decade experience RRA administered postoperatively to stage I APTC patients did not reduce either CSM or TRR and should probably not be indicated when such patients undergo potentially curative BT.
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