Dataset Information

Hospital-based health care use correlates with incidence of adverse events among elderly Medicare patients treated in adjuvant chemotherapy trials (Alliance 70802).

ABSTRACT:

Objective

Medicare claims can be useful in chemotherapy-related comparative effectiveness research (CER) estimating survival, but methods for estimating patients' treatment morbidity are currently lacking. We sought to determine if patients' health care use in the claims is a marker of treatment morbidity.

Materials and methods

For 249 elderly Medicare patients with breast or colon cancer who were treated in two adjuvant clinical trials, we merged patients' National Cancer Institute Common Toxicity Criteria for Adverse Events (CTC AEs) trial data with their contemporaneous Medicare claims. We estimated associations of patients' grade ≥3 CTC AE counts and their use of two types of hospital-based health care in claims (i.e., emergency room (ER) visits and hospitalizations).

Results

ER visits and hospitalizations were significantly positively associated with grade ≥3 CTC AE counts incurred by patients during the study. Eight percent of patients without any grade ≥3 CTC AEs had one or more hospitalizations during the observation period compared to 43% of patients with three or more grade ≥3 CTC AEs (p<0.01). Those who were hospitalized at least once had more than three times the rate of grade ≥3 CTC AEs (IRR 3.70, 95% CI: 2.53-5.40) compared to those who were not. With each hospitalization, the daily incidence rate of any grade ≥3 CTC AE more than doubled (IRR 2.10, 95% CI: 1.54-2.86).

Conclusions

Because hospitalization is strongly associated with clinically significant toxicity it may be a useful outcome for Medicare claim-based CER comparing treatment morbidity for elderly patients receiving different adjuvant chemotherapy regimens.

SUBMITTER: Lamont EB

PROVIDER: S-EPMC4119569 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

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Publications

Hospital-based health care use correlates with incidence of adverse events among elderly Medicare patients treated in adjuvant chemotherapy trials (Alliance 70802).

Lamont Elizabeth B EB Yu Menggang M He Yulei Y Saltz Leonard L Muss Hyman H Zaslavsky Alan M AM

Journal of geriatric oncology 20140301 3

<h4>Objective</h4>Medicare claims can be useful in chemotherapy-related comparative effectiveness research (CER) estimating survival, but methods for estimating patients' treatment morbidity are currently lacking. We sought to determine if patients' health care use in the claims is a marker of treatment morbidity.<h4>Materials and methods</h4>For 249 elderly Medicare patients with breast or colon cancer who were treated in two adjuvant clinical trials, we merged patients' National Cancer Institu ...[more]

PMID: 24594119

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Project description:ContextImmune checkpoint blockade is associated with endocrine-related adverse events. Thyroid dysfunction during pembrolizumab therapy, an anti-programmed cell death 1 (PD-1) receptor monoclonal antibody, remains to be fully characterized.ObjectiveTo assess the incidence and characteristics of pembrolizumab-associated thyroid dysfunction.Design and settingThyroid function was monitored prospectively in melanoma patients who initiated pembrolizumab within an expanded access program at a referral oncology center. 18Fluorodeoxyglucose uptake on positron emission tomography/computed tomography (18FDG-PET/CT) was reviewed in cases compatible with inflammatory thyroiditis.PatientsNinety-nine patients with advanced melanoma (age, 26.3-93.6 years; 63.6% females) who received at least one administration of pembrolizumab.Main outcome measuresPatient characteristics, thyroid function (TSH, free T4), thyroid autoantibodies, and 18FDG-PET/CT.ResultsEighteen adverse events of thyroid dysfunction were observed in 17 patients. Thyrotoxicosis occurred in 12 patients, of which nine evolved to hypothyroidism. Isolated hypothyroidism was present in six patients. Levothyroxine therapy was required in 10 of 15 hypothyroid patients. Thyroid autoantibodies were elevated during thyroid dysfunction in four of 10 cases. Diffuse increased 18FDG uptake by the thyroid gland was observed in all seven thyrotoxic patients who progressed to hypothyroidism.ConclusionsThyroid dysfunction is common in melanoma patients treated with pembrolizumab. Hypothyroidism and thyrotoxicosis related to inflammatory thyroiditis are the most frequent presentations. Serial measurements of thyroid function tests are indicated during anti-PD-1 monoclonal antibody therapy. Thyrotoxicosis compatible with inflammatory thyroiditis was associated with diffuse increased 18FDG uptake by the thyroid gland. The prospective role of thyroid autoantibodies should be further investigated, together with the histopathological correlates.

Project description:ImportanceDespite existing evidence of a benefit associated with cisplatin-based adjuvant chemotherapy (AC) after radical cystectomy (RC) for chemotherapy-naive patients with pT3/T4 and/or pN+ urothelial carcinoma of the bladder (UCB), to our knowledge, no studies have addressed the effectiveness of AC in those who received neoadjuvant chemotherapy (NAC) before surgery.ObjectiveTo assess the comparative effectiveness of AC vs observation for patients with pT3/T4 and/or pN+ UCB previously treated with NAC and RC.Design, setting, and participantsThis observational cohort study used the National Cancer Data Base (January 1, 2006, through December 31, 2012) to identify individuals who received NAC and RC followed by AC or observation for pT3/T4 and/or pN+ UCB.Main outcomes and measuresAfter multiple imputation was used to handle missing data, inverse probability of treatment weighting (IPTW)-adjusted Kaplan-Meier and Cox proportional hazards regression analyses were performed with a 6-month conditional landmark to compare overall survival (OS) among patients who received NAC and RC followed by AC vs observation. In addition, exploratory analyses were conducted to examine the heterogeneity of the treatment effect according to age (continuous), sex (female vs male), Charlson comorbidity index (≥1 vs 0), pT/N stage (pT3/T4N0 vs pTanyN+), and surgical margin status (positive vs negative) by testing interaction terms within the IPTW-adjusted Cox proportional hazards regression model.ResultsOf the 788 patients with pT3/T4 and/or pN+ UCB (mean [SD] age, 65.3 [9.4] years; 603 [76.5%] male and 185 [23.5%] female), 184 (23.4%) received NAC and RC followed by AC and 604 (76.6%) received NAC and RC followed by observation. The 6-month conditional landmark, IPTW-adjusted Kaplan-Meier curves showed that median OS was significantly longer for NAC and RC followed by AC (29.9 months; interquartile range, 15.1-85.4 months) vs NAC and RC followed by observation (24.2 months; interquartile range, 12.9-58.9 months) (P = .046). The 5-year IPTW-adjusted rates of OS were 36.8% for NAC and RC followed by AC vs 24.7% for NAC and RC followed by observation. In the IPTW-adjusted Cox proportional hazards regression analysis, NAC and RC followed by AC was associated with a significant OS benefit (hazard ratio, 0.78; 95% CI, 0.61-0.99; P = .046). Interaction term analyses indicated that the OS benefit of NAC and RC followed by AC decreased significantly with age (hazard ratio, 0.97; 95% CI, 0.95-0.99; P = .02), whereas no significant interaction was observed with sex (P = .82), Charlson comorbidity index (P = .51), pT/N stage (P = .95), and surgical margin status (P = .29).Conclusions and relevanceThis study found that AC after NAC and RC may be associated with an OS benefit for patients with pT3/T4 and/or pN+ UCB. The present findings should be considered as preliminary evidence to conduct a randomized clinical trial to address this association.

Dataset Information

Hospital-based health care use correlates with incidence of adverse events among elderly Medicare patients treated in adjuvant chemotherapy trials (Alliance 70802).

Objective

Materials and methods

Results

Conclusions

Publications

Hospital-based health care use correlates with incidence of adverse events among elderly Medicare patients treated in adjuvant chemotherapy trials (Alliance 70802).

Similar Datasets

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