Association between quality of life and patient-reported complications from surgery and radioiodine in early-stage thyroid cancer survivors: A matched-pair analysis.

BACKGROUND: Remnant radioiodine ablation is discouraged in low-risk differentiated thyroid cancer because it confers no survival advantage. The impact of remnant radioiodine ablation on health-related quality of life in these patients is not well described. We hypothesized remnant radioiodine ablation is associated with lower health-related quality of life in early-stage differentiated thyroid cancer survivors. METHODS: A retrospective matched-pair analysis was conducted in stage I differentiated thyroid cancer survivors recruited from a thyroid cancer support group. Respondents self-reported via online survey. Dysphonia and dysphagia were reported via Likert scale. Health-related quality of life was evaluated using Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item profile. Respondents who received remnant radioiodine ablation were matched for age, sex, race, and years since diagnosis with respondents who did not receive remnant radioiodine ablation. PROMIS t-scores were compared between remnant radioiodine ablation and nonremnant radioiodine ablation groups, and among those with or without surgical complications. RESULTS: One hundred and twenty-two pairs were matched. There was no significant difference in incidence of self-reported hypocalcemia, infection, dysphonia, or dysphagia between remnant radioiodine ablation and no remnant radioiodine ablation groups. There was no significant difference in mean PROMIS t-scores. Of respondents reporting normal preoperative voice and swallowing, there were no significant differences in postprocedural outcomes or PROMIS scores. Regardless of remnant radioiodine ablation treatment, those with surgical complications of hypocalcemia, dysphonia, or dysphagia reported worse PROMIS scores across multiple domains. Remnant radioiodine ablation-associated xerostomia was associated with worse PROMIS scores across multiple domains. CONCLUSION: This is the first study to use PROMIS measures to evaluate the association between remnant radioiodine ablation and health-related quality of life in early-stage differentiated thyroid cancer survivors treated surgically. Surgical and remnant radioiodine ablation-associated complications were associated with significantly worse PROMIS scores across multiple domains.

Adverse Events During Hematopoietic Stem Cell Infusion: Analysis of the Infusion Product.

BACKGROUND: Stem cell transplantation is a treatment option for patients with cancer. However, a risk of adverse events might be associated with the infusion itself. An understanding of the types and grades of adverse events occurring during infusion and the patient and infusion characteristics that might be associated with these events could allow for interventions to minimize these complications. The risk factors associated with transplant-related adverse events are not well understood. MATERIALS AND METHODS: We retrospectively analyzed the adverse events occurring within 1 hour after infusion in 460 patients with cancer undergoing stem cell transplantation at the Northwestern University Robert H. Lurie Comprehensive Cancer Center from January 1, 2008 and May 1, 2011. Of the 460 patients, 382 received autologous transplants and 78 allogeneic transplants. The incidence, types, and National Cancer Institute Common Terminology Criteria grade of toxicity for adverse events were noted (primary objective). Univariate analyses were performed to study which patient and infusion characteristics might be associated with the occurrence of adverse events (secondary objectives). RESULTS: Of the 460 patients, 261 (56.7%) experienced adverse events (66.7% during allogeneic infusion and 54.7% during autologous infusion). Most events were cardiopulmonary. Univariate analysis of the infusion and patient characteristics revealed that a second transplant (P = .005) was associated with more adverse events for autologous transplant patients. For allogeneic transplant patients, a higher infusion red blood cell volume (P = .01) was associated with more adverse events. CONCLUSION: Adverse events are common during stem cell infusion and are generally cardiopulmonary.

Soy isoflavone supplementation for breast cancer risk reduction: a randomized phase II trial.

Soy isoflavone consumption may protect against breast cancer development. We conducted a phase IIB trial of soy isoflavone supplementation to examine its effect on breast epithelial proliferation and other biomarkers in the healthy high-risk breast. One hundred and twenty-six consented women underwent a random fine-needle aspiration (rFNA); those with 4,000 or more epithelial cells were randomized to a double-blind 6-month intervention of mixed soy isoflavones (PTIG-2535) or placebo, followed by repeat rFNA. Cells were examined for Ki-67 labeling index and atypia. Expression of 28 genes related to proliferation, apoptosis, and estrogenic effect was measured using quantitative reverse transcriptase PCR. Hormone and protein levels were measured in nipple aspirate fluid (NAF). All statistical tests were two-sided. Ninety-eight women were evaluable for Ki-67 labeling index. In 49 treated women, the median Ki-67 labeling index was 1.18 at entry and 1.12 post intervention, whereas in 49 placebo subjects, it was 0.97 and 0.92 (P for between-group change: 0.32). Menopausal stratification yielded similar results between groups, but within premenopausal soy-treated women, Ki-67 labeling index increased from 1.71 to 2.18 (P = 0.04). We saw no treatment effect on cytologic atypia or NAF parameters. There were significant increases in the expression of 14 of 28 genes within the soy, but not the control group, without significant between-group differences. Plasma genistein values showed excellent compliance. A 6-month intervention of mixed soy isoflavones in healthy, high-risk adult Western women did not reduce breast epithelial proliferation, suggesting a lack of efficacy for breast cancer prevention and a possible adverse effect in premenopausal women.