Malek B. Hannouf

Withholding stereotactic radiotherapy in elderly patients with stage I non-small cell lung cancer and co-existing COPD is not justified: Outcomes of a markov model analysis

BACKGROUND AND PURPOSE To model outcomes of SBRT versus best supportive care (BSC) in elderly COPD patients with stage I NSCLC. MATERIAL AND METHODS A Markov model was constructed to simulate the quality-adjusted and overall survival (OS) in patients ⩾75years undergoing either SBRT or BSC for a five-year timeframe. SBRT rates of local, regional and distant recurrences were obtained from 247 patients treated at the VUMC, Amsterdam. Recurrence rates were converted into transition probabilities and stratified into four groups according to T stage (1, 2) and COPD GOLD score (I-II, III-IV). Data for untreated patients were obtained from the California Cancer Registry. Tumor stage and GOLD score utilities were adapted from the literature. RESULTS Our model correlated closely with the source OS data for SBRT treated and untreated patients. After SBRT, our model predicted for 6.8-47.2% five-year OS and 14.9-27.4 quality adjusted life months (QALMs). The model predicted for 9.0% and 2.8% five-year OS, and 10.1 and 6.1 QALMs for untreated T1 and T2 patients, respectively. The benefit of SBRT was the least for T2, GOLD III-IV patients. CONCLUSION Our model indicates that SBRT should be considered in elderly stage I NSCLC patients with COPD.

Cost-effectiveness of adding cetuximab to platinum-based chemotherapy for first-line treatment of recurrent or metastatic head and neck cancer.

Purpose To assess the cost effectiveness of adding cetuximab to platinum-based chemotherapy in first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) from the perspective of the Canadian public healthcare system. Methods We developed a Markov state transition model to project the lifetime clinical and economic consequences of recurrent or metastatic HNSCC. Transition probabilities were derived from a phase III trial of cetuximab in patients with recurrent or metastatic HNSCC. Cost estimates were obtained from London Health Sciences Centre and the Ontario Case Costing Initiative, and expressed in 2011 CAD. A three year time horizon was used. Future costs and health benefits were discounted at 5%. Results In the base case, cetuximab plus platinum-based chemotherapy compared to platinum-based chemotherapy alone led to an increase of 0.093 QALY and an increase in cost of

Cost-effectiveness of a 21-gene recurrence score assay versus Canadian clinical practice in women with early-stage estrogen- or progesterone-receptor-positive, axillary lymph-node negative breast cancer

36,000 per person, resulting in an incremental cost effectiveness ratio (ICER) of

Evaluating the efficacy of current clinical practice of adjuvant chemotherapy in postmenopausal women with early-stage, estrogen or progesterone receptor–positive, one-to-three positive axillary lymph node, breast cancer

386,000 per QALY gained. The cost effectiveness ratio was most sensitive to the cost per mg of cetuximab and the absolute risk of progression among patients receiving cetuximab. Conclusion The addition of cetuximab to standard platinum-based chemotherapy in first-line treatment of patients with recurrent or metastatic HNSCC has an ICER that exceeds

Cost-effectiveness of using a gene expression profiling test to aid in identifying the primary tumour in patients with cancer of unknown primary.

100,000 per QALY gained. Cetuximab can only be economically attractive in this patient population if the cost of cetuximab is substantially reduced or if future research can identify predictive markers to select patients most likely to benefit from the addition of cetuximab to chemotherapy.

Cost-Effectiveness Analysis Using Registry and Administrative Data

BackgroundA 21-gene recurrence score (RS) assay may inform adjuvant systematic treatment decisions in women with early stage breast cancer. We sought to investigate the cost effectiveness of using the RS-assay versus current clinical practice (CCP) in women with early-stage estrogen- or progesterone-receptor-positive, axilliary lymph-node negative breast cancer (ER+/ PR + LN- ESBC) from the perspective of the Canadian public healthcare system.MethodsWe developed a Markov model to project the lifetime clinical and economic consequences of ESBC. We evaluated adjuvant therapy separately in post- and pre-menopausal women with ER+/ PR + LN- ESBC. We assumed that the RS-assay would reclassify pre- and post-menopausal women among risk levels (low, intermediate and high) and guide adjuvant systematic treatment decisions. The model was parameterized using 7 year follow up data from the Manitoba Cancer Registry, cost data from Manitoba administrative databases, and secondary sources. Costs are presented in 2010 CAD. Future costs and benefits were discounted at 5%.ResultsThe RS-assay compared to CCP generated cost-savings in pre-menopausal women and had an ICER of

A review of the value of human epidermal growth factor receptor 2 (HER2)-targeted therapies in breast cancer ☆

60,000 per QALY gained in post-menopausal women. The cost effectiveness was most sensitive to the proportion of women classified as intermediate risk by the RS-assay who receive adjuvant chemotherapy and the risk of relapse in the RS-assay model.ConclusionsThe RS-assay is likely to be cost effective in the Canadian healthcare system and should be considered for adoption in women with ER+/ PR + LN- ESBC. However, ongoing assessment and validation of the assay in real-world clinical practice is warranted.

The Clinical Significance of Occult Gastrointestinal Primary Tumours in Metastatic Cancer: A Population Retrospective Cohort Study

PURPOSE We evaluated the benefit of the current clinical practice of adjuvant chemotherapy for postmenopausal women with early-stage, estrogen- or progesterone-receptor-positive (er/pr+), one-to-three positive axillary lymph node (1-3 ln+), breast cancer (esbc). METHODS Using the Manitoba Cancer Registry, we identified all postmenopausal women diagnosed with er/pr+ 1-3 ln+ esbc during the periods 1995-1997, 2000-2002, and 2003-2005 (n = 156, 161, and 171 respectively). Treatment data were obtained from the Manitoba Cancer Registry and by linkage with Manitoba administrative databases. Seven-year survival data were available for the 1995-1997 and 2000-2002 populations. Using Cox regression, we assessed the independent effect of the clinical practice of adjuvant chemotherapy on disease-free (dfs) and overall survival (os). RESULTS Clinical breast cancer treatments did not differ significantly between the 2000-2002 and 2003-2005 populations. Adjuvant chemotherapy was administered in 103 patients in the 2000-2002 population (64%) and in 44 patients in the 1995-1997 population [28.2%; mean difference: 36%; 95% confidence interval (ci): 31% to 40%; p < 0.0001]. Compared with 1995-1997, 2000-2002 was not significantly associated with an incremental dfs benefit for patients over a period of 7 years (2000-2002 vs. 1995-1997; adjusted hazard ratio: 0.98; 95% ci: 0.64 to 1.4). CONCLUSIONS The treatment standard of adjuvant chemotherapy in addition to endocrine therapy may not be effective for all women with er/pr+ 1-3 ln+ esbc. There could be a subgroup of those women who do not benefit from adjuvant chemotherapy as expected and who are therefore being overtreated. Further studies with a larger sample size are warranted to confirm our results.

Identification and survival outcomes of a cohort of patients with cancer of unknown primary in Ontario, Canada

We aimed to investigate the cost-effectiveness of a 2000-gene-expression profiling (GEP) test to help identify the primary tumor site when clinicopathological diagnostic evaluation was inconclusive in patients with cancer of unknown primary (CUP). We built a decision-analytic-model to project the lifetime clinical and economic consequences of different clinical management strategies for CUP. The model was parameterized using follow-up data from the Manitoba Cancer Registry, cost data from Manitoba Health administrative databases and secondary sources. The 2000-GEP-based strategy compared to current clinical practice resulted in an incremental cost-effectiveness ratio (ICER) of

Abstract P3-12-01: Value-based approach to treatment of HER2-positive breast cancer: Examining the evidence

44,151 per quality-adjusted life years (QALY) gained. The total annual-budget impact was