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Comparative effectiveness of upfront treatment strategies in elderly women with ovarian cancer.

ABSTRACT: BACKGROUND:Observational studies comparing neoadjuvant chemotherapy to primary surgery for advanced-stage ovarian cancer are limited by strong selection bias. Multiple methods were used to control for confounding and selection bias to estimate the effect of primary treatment on survival for ovarian cancer. METHODS:The Surveillance, Epidemiology, and End Results (SEER)-Medicare database was used to identify women ? 65 years of age with stage II-IV epithelial ovarian cancer who survived > 6 months from the date of diagnosis and received treatment from 1991 through 2007. Traditional regression analysis, propensity score-based analysis, and an instrumental variable analysis (IVA) using geographic location as an instrument were used to compare survival between neoadjuvant chemotherapy and primary surgery. RESULTS:A total of 9587 patients with stage II-IV ovarian cancer were identified. Use of primary surgery decreased from 63.2% in 1991 to 49.5% by 2007, whereas primary chemotherapy increased from 19.7% in 1991 to 31.8% in 2007 (P < .0001). In the observational cohort survival (hazard ratio [HR] = 1.27; 95% confidence interval [CI] = 1.19-1.35) was inferior for patients treated with neoadjuvant chemotherapy; both median survival (15.8 versus 28.8 months) and 2-year survival (36% versus 56%) were lower in the neoadjuvant chemotherapy group compared to those who underwent surgery. In the IVA, primary treatment had minimal effect on overall survival (HR = 1.04; 95% CI = 0.67-1.60). The median survival for patients with a value of the instrument less than the median (24.0 months, 95% CI = 23.0-25.0) and greater than or equal to median value of the IV (24.0 months, 95% CI = 23.0-26.0) were similar. CONCLUSIONS:Use of neoadjuvant therapy has increased over time. Survival with neoadjuvant chemotherapy did not differ significantly from primary surgery in elderly women in the United States.

SUBMITTER: Wright JD

PROVIDER: S-EPMC4062652 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature

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Comparative effectiveness of upfront treatment strategies in elderly women with ovarian cancer.

Wright Jason D JD Ananth Cande V CV Tsui Jennifer J Glied Sherry A SA Burke William M WM Lu Yu-Shiang YS Neugut Alfred I AI Herzog Thomas J TJ Hershman Dawn L DL

Cancer 20140117 8

<h4>Background</h4>Observational studies comparing neoadjuvant chemotherapy to primary surgery for advanced-stage ovarian cancer are limited by strong selection bias. Multiple methods were used to control for confounding and selection bias to estimate the effect of primary treatment on survival for ovarian cancer.<h4>Methods</h4>The Surveillance, Epidemiology, and End Results (SEER)-Medicare database was used to identify women ≥ 65 years of age with stage II-IV epithelial ovarian cancer who surv ...[more]

PMID: 24443159

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Project description:The incidence of early-stage non-small cell lung cancer (NSCLC) among older adults is expected to increase because of demographic trends and computed tomography-based screening; yet, optimal treatment in the elderly remains controversial. Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare cohort spanning 2001-2007, we compared survival outcomes associated with 5 strategies used in contemporary practice: lobectomy, sublobar resection, conventional radiation therapy, stereotactic ablative radiation therapy (SABR), and observation.Treatment strategy and covariates were determined in 10,923 patients aged ? 66 years with stage IA-IB NSCLC. Cox regression, adjusted for patient and tumor factors, compared overall and disease-specific survival for the 5 strategies. In a second exploratory analysis, propensity-score matching was used for comparison of SABR with other options.The median age was 75 years, and 29% had moderate to severe comorbidities. Treatment distribution was lobectomy (59%), sublobar resection (11.7%), conventional radiation (14.8%), observation (12.6%), and SABR (1.1%). In Cox regression analysis with a median follow-up time of 3.2 years, SABR was associated with the lowest risk of death within 6 months of diagnosis (hazard ratio [HR] 0.48; 95% confidence interval [CI] 0.38-0.63; referent is lobectomy). After 6 months, lobectomy was associated with the best overall and disease-specific survival. In the propensity-score matched analysis, survival after SABR was similar to that after lobectomy (HR 0.71; 95% CI 0.45-1.12; referent is SABR). Conventional radiation and observation were associated with poor outcomes in all analyses.In this population-based experience, lobectomy was associated with the best long-term outcomes in fit elderly patients with early-stage NSCLC. Exploratory analysis of SABR early adopters suggests efficacy comparable with that of surgery in select populations. Evaluation of these therapies in randomized trials is urgently needed.

Project description:IntroductionThe optimal management of locally advanced recto-sigmoid cancer is unclear. Although some experts advocate for upfront surgery, others recommend neoadjuvant chemoradiation followed by surgery. We used the National Cancer Database to characterize patterns-of-care and overall survival (OS) associated with these treatment strategies.Patients and methodsPatients with clinical stage II or III recto-sigmoid cancer who underwent surgery with or without adjunctive chemotherapy and/or radiotherapy from 2006 to 2014 were identified, and dichotomized into: (1) upfront surgery, and (2) neoadjuvant chemoradiation cohorts. Patterns-of-care were assessed using multivariable logistic regression. The association between neoadjuvant chemoradiation use and OS was assessed using Cox proportional hazards analysis with propensity score-matching.ResultsOf 9313 identified patients, 6756 (73%) underwent upfront surgery and 2557 (27%) received neoadjuvant chemoradiation. Treatment at academic facilities and higher clinical T stage were predictors of neoadjuvant chemoradiation use. Compared with upfront surgery, neoadjuvant chemoradiation resulted in fewer positive circumferential resection margins (384 [11%] patients vs. 108 [8%] patients; P = .001), and 478 [18.7%] patients achieved a pathologic complete response at surgery. In propensity score-matched analysis, neoadjuvant chemoradiation use was associated with improved OS (hazard ratio, 0.79; 95% confidence interval, 0.69-0.90) compared with upfront surgery; 5-year estimated OS was 77.0% versus 72.0%, respectively. The improvement in OS persisted in landmark analysis of patients who survived at least 12 months.ConclusionOnly a small percentage of patients with locally advanced recto-sigmoid cancer receive neoadjuvant chemoradiation even though its use might result in improved OS relative to upfront surgery. Prospective research is warranted to validate and standardize therapeutic strategies in patients with recto-sigmoid cancer.

Project description:ImportanceThe neoadjuvant treatment options for ERBB2-positive (also known as HER2-positive) breast cancer are associated with different rates of pathologic complete response (pCR). The KATHERINE trial showed that adjuvant trastuzumab emtansine (T-DM1) can reduce recurrence in patients with residual disease compared with patients treated with trastuzumab; however, T-DM1 and other ERBB2-targeted agents are costly, and understanding the costs and health consequences of various combinations of neoadjuvant followed by adjuvant treatments in the United States is needed.ObjectiveTo examine the costs and disease outcomes associated with selection of various neoadjuvant followed by adjuvant treatment strategies for patients with ERBB2-positive breast cancer.Design, setting, and participantsIn this economic evaluation, a decision-analytic model was developed to evaluate various neoadjuvant followed by adjuvant treatment strategies for women with ERBB2-positive breast cancer from a health care payer perspective in the United States. The model was informed by the KATHERINE trial, other clinical trials with different regimens from the KATHERINE trial, the Flatiron Health Database, McKesson Corporation data, and other evidence in the published literature. Starting trial median age for KATHERINE patients was 49 years (range, 24-79 years in T-DM1 arm and 23-80 years in trastuzumab arm). The model simulated patients receiving 5 different neoadjuvant followed by adjuvant treatment strategies. Data analyses were performed from March 2019 to August 2020.ExposureThere were 4 neoadjuvant regimens: (1) HP: trastuzumab (H) plus pertuzumab (P), (2) THP: paclitaxel (T) plus H plus P, (3) DDAC-THP: dose-dense anthracycline/cyclophosphamide (DDAC) plus THP, (4) TCHP: docetaxel (T) plus carboplatin (C) plus HP. All patients with pCR, regardless of neoadjuvant regimen, received adjuvant H. Patients with residual disease received different adjuvant therapies depending on the neoadjuvant regimen according to the 5 following strategies: (1) neoadjuvant DDAC-THP followed by adjuvant H, (2) neoadjuvant DDAC-THP followed by adjuvant T-DM1, (3) neoadjuvant THP followed by adjuvant DDAC plus T-DM1, (4) neoadjuvant HP followed by adjuvant DDAC/THP plus T-DM1, or (5) neoadjuvant TCHP followed by adjuvant T-DM1.Main outcomes and measuresLifetime costs in 2020 US dollars and quality-adjusted life-years (QALYs) were estimated for each treatment strategy, and incremental cost-effectiveness ratios were estimated. A strategy was classified as dominated if it was associated with fewer QALYs at higher costs than the alternative.ResultsIn the base-case analysis, costs ranged from $415 833 (strategy 3) to $518 859 (strategy 4), and QALYs ranged from 9.67 (strategy 1) to 10.73 (strategy 3). Strategy 3 was associated with the highest health benefits (10.73 QALYs) and lowest costs ($415 833) and dominated all other strategies. Probabilistic analysis confirmed that this strategy had the highest probability of cost-effectiveness (>70% at willingness-to-pay thresholds of $0-200,000/QALY) and was associated with the highest net benefit.Conclusions and relevanceThese results suggest that neoadjuvant THP followed by adjuvant H for patients with pCR or followed by adjuvant DDAC plus T-DM1 for patients with residual disease was associated with the highest health benefits and lowest costs for women with ERBB2-positive breast cancer compared with other treatment strategies considered.

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Comparative effectiveness of upfront treatment strategies in elderly women with ovarian cancer.

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Comparative effectiveness of upfront treatment strategies in elderly women with ovarian cancer.

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