Tallal Younis

Cost-utility of the 21-gene recurrence score assay in node-negative and node-positive breast cancer

The 21-gene recurrence score (Oncotype DX®: RS) appears to augment clinico-pathologic prognostication and is predictive of adjuvant chemotherapy benefit in node-negative (N−) and node-positive (N+), endocrine-sensitive breast cancer. RS is a costly assay that is associated with good ‘value for money’ in N− disease, while economic evaluations in N+ disease based on most recent data have not been conducted. We examined the cost-utility (CU) of a RS-guided adjuvant strategy, compared to current practice without RS in N− and N+, endocrine-sensitive, breast cancer from a Canadian health care system perspective. A generic state-transition model was developed to compute cumulative costs and quality-adjusted life years (QALYs) over a 25-year horizon. Patient outcomes with and without chemotherapy in RS-untested cohorts and in those with low, intermediate and high RS were examined based on the reported prognostic and predictive impact of RS in N− and N+ disease. Chemotherapy utilization (current vs. RS-guided), unit costs and utilities were derived from a Nova Scotia Canadian population-based cohort, local unit costs and the literature. Costs and outcomes were discounted at 3% annually, and costs were reported in 2011 Canadian dollars (

Primary G-CSF prophylaxis for adjuvant TC or FEC-D chemotherapy outside of clinical trial settings: a systematic review and meta-analysis

). Probabilistic and one-way sensitivity analyses were conducted for key model parameters. Compared to a non-RS-guided strategy, RS-guided adjuvant therapy was associated with

Waiting Times in Early-Stage Non-small Cell Lung Cancer (NSCLC)

2,585 and

Adjuvant Chemotherapy Uptake in Non-small Cell Lung Cancer

864 incremental costs, 0.27 and 0.06 QALY gains, and resultant CUs of

Adjuvant chemotherapy for breast cancer: a cost-utility analysis of FEC-D vs. FEC 100

9,591 and

The Cost-Utility of Sequential Adjuvant Trastuzumab in Women with Her2/Neu-Positive Breast Cancer: An Analysis Based On Updated Results from the HERA Trial

14,844 per QALY gained for N− and N+ disease, respectively. CU estimates were robust to key model parameters, and were most sensitive to chemo utilization proportions. RS-guided adjuvant therapy appears to be a cost-effective strategy in both N− and N+, endocrine-sensitive breast cancer with resultant CU ratios well below commonly quoted thresholds.

Comparison of elapsed times from breast cancer detection to first adjuvant therapy in Nova Scotia in 1999/2000 and 2003/04

BackgroundVariable febrile neutropenia (FN) rates reported with adjuvant TC (taxotere®, cyclophosphamide) and FEC-D (5-flurouracil, epirubicin, cyclophosphamide, docetaxel) outside of clinical trials have precluded definitive recommendations for primary G-CSF (granulocyte colony-stimulating factor) prophylaxis in most jurisdictions. A systematic review and meta-analysis was conducted to assess: (a) FN rates associated with TC and FEC-D without primary G-CSF prophylaxis outside of clinical trial settings, and (b) the potential impact of G-CSF prophylaxis on FN prevention.MethodsA MEDLINE search was conducted and major conference abstracts were reviewed up to June 15th 2011 to identify all relevant English-language studies. Random- and fixed-effects meta-analysis models were performed.ResultsNine hundred two patients treated with TC and 1342 with FEC-D from 13 to 9 studies, respectively, were included. The pooled random-effects meta-analysis estimates of FN rates for TC and FEC-D without G-CSF were 29% (95% CI 24–35%) and 31% (95% CI 27–35%), with a 76% (RR = 0.24, 95% CI 0.14–0.41) and 63% (RR = 0.37, 95% CI 0.11–1.24) relative risk reduction with G-CSF, respectively.ConclusionIn routine clinical practice, TC and FEC-D without G-CSF are associated with FN rates exceeding the 20% threshold for which primary G-CSF prophylaxis is commonly recommended, and are considerably higher than those reported in pivotal clinical trials.

Drug-induced subacute cutaneous lupus erythematosus associated with nab-paclitaxel therapy.

Introduction: Wait times in cancer care continue to be an important clinical, social, and political issue. This study examines wait times along the care path from suspicious imaging study (Detection) to adjuvant chemotherapy initiation (Chemotherapy) for patients with early-stage non-small cell lung cancer (NSCLC) who undergo surgical resection. Methods: A retrospective chart review of patients diagnosed in 2005 with NSCLC who underwent curative-intent surgery in Nova Scotia, Canada was conducted to abstract dates of care events (Detection, Surgery Consultation, Surgery, Medical Oncology [MO] Referral, MO Consultation and Chemotherapy) and patient characteristics. Multifactorial regression methods were used to identify statistically-significant cofactors associated with wait times at various resolutions of care intervals (low, intermediate, high). Results: A median wait time of 141 days elapsed between Detection-Chemotherapy; and a median 107 and 52 days elapsed between Detection-Surgery and Surgery-Chemotherapy, respectively. A number of demographic, clinical, epidemiological, and system resource dependant factors influenced wait times at different resolutions, and were best detailed utilizing high resolution analysis. Wait time between MO referral-MO Consultation was inversely related to that experienced in the preceding interval of Surgery-MO Referral. Conclusions: This study provides a first detailed examination of wait times experienced by NSCLC patients undergoing curative-intent surgery according to care interval definitions; demonstrates the value of high care interval resolution analysis to detect bottlenecks in access to care; and reports on the interdependence of elapsed times between care events along the care path for cancer patients.

Routine Cardiac Evaluation in Patients With Early-Stage Breast Cancer Before Adjuvant Chemotherapy

Introduction: Adjuvant chemotherapy in non-small cell lung cancer (NSCLC) has become a new standard of care. This study examines the uptake patterns for adjuvant chemotherapy outside of clinical trials. Methods: A retrospective study of all patients diagnosed with NSCLC in the year 2005 who underwent curative-intent surgery in Nova Scotia, Canada was conducted. Logistic regression models and discriminant function analyses were employed to identify cofactors associated with referral to medical oncology and/or utilization of adjuvant chemotherapy. Results: Of 540 patients with NSCLC, 108 underwent curative-intent surgery (67% lobectomy; 15% pneumonectomy; 19% wedge resection) for NSCLC (39% IA; 24% IB; 25% II; 14% III). Referral to medical oncology was observed in 44% (47 of 108) of all patients including 73% (30 of 41) of those with stage II–III. Adjuvant chemotherapy utilization was observed in 62% (29 of 47) of those referred including 73% (22 of 30) of those with stage II–III. Overall, 27% (29 of 108) of all patients received adjuvant chemotherapy, including 54% (22 of 41) of those with stage II–III. Higher uptake was significantly associated with age (younger versus older), stage (II/III versus I), and surgery type (pneumonectomy versus wedge). Weaker associations were observed with other cofactors including surgeon, health center, mean household income, and surgery-medical oncologist consult timeline. Conclusions: The uptake of adjuvant chemotherapy in patients with resected NSCLC outside of clinical trials is low overall, but is higher among younger patients and those with more advanced stages. These uptake patterns may allow future planning of health resource utilization and/or improvement of chemotherapy utilization rates.

Survivin and COX-2 expression in male breast carcinoma.

Background Adjuvant 5-flurouracil, epirubicin and cyclophosphamide–docetaxel (FEC-D) has been shown to improve disease-free and overall survival (DFS and OS), compared to FEC 100, for node-positive breast cancer. An economic evaluation was undertaken to examine the cost-utility (CU) of FEC-D relative to FEC 100 given possible differences in cost between the two regimens. Methods A Markov model was developed to calculate the cumulative costs and quality-adjusted life years (QALY) gained over a 10-year horizon for a hypothetical cohort of 1,000 women with node-positive breast cancer treated with FEC 100 or FEC-D. Event rates, costs, and utilities were derived from the literature. Efficacy outcomes were based primarily on the hazard ratio of DFS for all patients, but separate analyses were also conducted according to age and menopausal status as per the PACS 01 subgroup analysis results. The model took a third-party direct payer perspective and reports results in 2006 Canadian dollars (