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Klein R.,Medical Decision Modeling | Wielage R.,Medical Decision Modeling | Muehlenbein C.,Eli Lilly and Company | Liepa A.M.,Eli Lilly and Company | And 3 more authors.
Journal of Thoracic Oncology | Year: 2010

Introdution: The primary objective was to estimate the cost-effectiveness of maintenance therapy with pemetrexed (Pem) compared with observation, each with best supportive care, in patients with advanced non-small cell lung cancer (NSCLC) who have completed, without progression, at least four cycles of first-line platinum chemotherapy, particularly in those with nonsquamous cell histology. Secondary comparisons included Pem with erlotinib (Erl) or Pem with bevacizumab (Bev). Methods:A semi-Markov model was developed to compare the 3-year impact of Pem with three other alternatives for maintenance therapy from a United States payer perspective. Data from randomized controlled clinical trials provided clinical inputs. Medicare reimbursement rates were used to determine drug costs. A retrospective claims database analysis was used to obtain estimates of other direct NSCLC-related costs. Results: In the prespecified subset of patients with nonsquamous cell histology only, the incremental cost per life-year gained was $122,371 for Pem to observation and $150,260 for Pem to Erl, and Bev was dominated by Pem. In all patients with advanced NSCLC regardless of histologic subtype, using Pem as maintenance therapy led to an incremental cost per life-year gained of $205,597 compared with observation and $312,341 compared with Erl. Conclusions: Compared with observation and other agents used and/or reimbursed for maintenance therapy in advanced NSCLC, Pem may be considered cost-effective, particularly in patients with nonsquamous cell histology. This analysis is the first to evaluate the cost-effectiveness of maintenance therapy in advanced NSCLC and emphasizes the importance of histology in identifying the appropriate patient for Pem maintenance therapy. © 2010 by the International Association for the Study of Lung Cancer.

Schwartzberg L.S.,West Clinic | Whittaker S.,Amgen Inc. | Abella E.,Amgen Inc.
Supportive Care in Cancer | Year: 2014

Purpose: The objective of this study was to describe the incidence of grade 3/4 neutropenia, patterns of chemotherapy treatment, and granulocyte colony-stimulating factor (G-CSF) use patterns among patients with non-Hodgkin's lymphoma (NHL) <65 and ≥65 years. Methods: This retrospective, observational study included adult patients with NHL who received cyclophosphamide, doxorubicin, vincristine, and prednisone±rituximab (CHOP±R) from January 2006 to June 2010. Results: A total of 1,579 patients were included, with 54.1 % <65 years and 45.9 % ≥65 years. Most received CHOP-R on a Q3W schedule. Among patients <65 years, the incidence of grade 3/4 neutropenia was 52.3 %, the mean relative dose intensity (RDI) was 80.4 %, and the incidences of dose delays and reductions were 26.5 and 9.6 %, respectively. Among patients ≥65 years, the incidence of grade 3/4 neutropenia was 63.2 %, the mean RDI was 73.9 %, and the incidences of dose delays and reductions were 24.6 and 24.9 %, respectively. Most patients (86.9 %) received G-CSF. Among patients <65 years, 71.9, 17.4, and 10.7 % first received G-CSF as primary prophylaxis, secondary prophylaxis, or treatment, respectively. Among patients ≥65 years, 80.1, 11.6, and 8.3 % first received G-CSF as primary prophylaxis, secondary prophylaxis, or treatment, respectively. Conclusions: Chemotherapy regimens and schedules were similar among age groups. Grade 3/4 neutropenia, reduced RDI, and dose delays were common in both age groups, though patients ≥65 years had a higher incidence of dose reductions. In spite of these similarities, patients <65 years were less likely to receive primary prophylactic G-CSF. Thus, careful assessment of neutropenia risk factors is needed across age groups to determine appropriate G-CSF use and support planned chemotherapy. © 2014 Springer-Verlag.

Schwarzberg L.S.,West Clinic | Franco S.X.,Memorial Cancer Institute | Florance A.,Glaxosmithkline | O'Rourke L.,Glaxosmithkline | And 2 more authors.
Oncologist | Year: 2010

Objective. To evaluate the efficacy and tolerability of letrozole plus lapatinib versus letrozole plus placebo in women with hormone receptor (HR) + human epidermal growth factor receptor (HER)-2+ tumors receiving first-line therapy for metastatic breast cancer (MBC). Patients and Methods. Postmenopausal women (n = 1,286) with HR+ MBC were randomized to daily oral treatment with letrozole (2.5 mg) plus lapatinib (1,500 mg) versus letrozole (2.5 mg) plus placebo. Of the 1,286 patients enrolled in the phase III study, 219 had HER-2+ tumors. The primary endpoint was progression-free survival (PFS) in HER-2+ patients. Results. Results in the HR+ HER-2+ population (n = 219) are presented. The addition of lapatinib to letrozole resulted in a significantly lower risk for disease progression than with letrozole alone (hazard ratio, 0.71; 95% confidence interval, 0.53-0.96). The PFS time was 8.2 months, versus 3.0 months. The objective response rate (ORR) (28% versus 15%) and clinical benefit rate (CBR) (48% versus 29%) were also significantly greater in lapatinib-treated women. The most common adverse events in the lapatinib group were diarrhea (68%) and rash (46%), primarily grade 1 and 2. Conclusions. The addition of lapatinib to letrozole is well tolerated and leads to a significantly greater PFS time, ORR, and CBR than with letrozole alone in women with MBC who coexpress HR and HER-2. ©AlphaMed Press.

Schwartzberg L.,West Clinic | Barbour S.Y.,Duke University | Morrow G.R.,University of Rochester | Ballinari G.,Helsinn Healthcare SA | And 2 more authors.
Supportive Care in Cancer | Year: 2014

Purpose: Preventing chemotherapy-induced nausea and vomiting (CINV) is integral to treatment success in patients with cancer. This analysis was undertaken to assess the relative efficacy and safety of palonosetron versus older 5HT3 RAs in preventing CINVassociated withmoderately or highly emetogenic chemotherapy. Methods: Patient-level data from four randomized, double-blind, phase III trials comparing palonosetron 0.25 or 0.75 mg with ondansetron 32 mg, dolasetron 100 mg, or granisetron 40 μg/kg were analyzed. Endpoints included complete response (CR: no emesis and no rescue antiemetics) in the acute (0-24 h), delayed (>24-120 h), and overall (0-120 h) postchemotherapy periods (primary), complete control (CC: no emesis, no rescue antiemetics, and no more than mild nausea), number of emetic episodes, and nausea severity. Results: CR rates were significantly higher for palonosetron (n =1,787) versus older 5HT3 RAs (n =1,175) in the delayed (57 vs 45%, P <0.0001) and overall periods (51 vs 40%, P <0.0001); odds ratios (95% CI) in the acute, delayed, and overall periods were 1.15 (0.98-1.34), 1.62 (1.40-1.88), and 1.56 (1.34-1.81), respectively. Significant differences in CC rates and nausea severity were observed for the delayed and overall periods and in emetic episodes for all three periods. The incidence of treatment-related adverse events was similar with palonosetron (0.25 mg, 20.0%; 0.75 mg, 26.5%) and older 5HT3 RAs (27.5%). Conclusions: Palonosetron is more effective than older 5HT3 RAs for controlling CINV in the delayed and overall post-chemotherapy periods. © The Author(s) 2013.

Tabernero J.,Autonomous University of Barcelona | Yoshino T.,National Cancer Center Hospital East | Cohn A.L.,Rocky Mountain Cancer Center Us Oncology | Obermannova R.,Comprehensive Care | And 15 more authors.
The Lancet Oncology | Year: 2015

Background: Angiogenesis is an important therapeutic target in colorectal carcinoma. Ramucirumab is a human IgG-1 monoclonal antibody that targets the extracellular domain of VEGF receptor 2. We assessed the efficacy and safety of ramucirumab versus placebo in combination with second-line FOLFIRI (leucovorin, fluorouracil, and irinotecan) for metastatic colorectal cancer in patients with disease progression during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. Methods: Between Dec 14, 2010, and Aug 23, 2013, we enrolled patients into the multicentre, randomised, double-blind, phase 3 RAISE trial. Eligible patients had disease progression during or within 6 months of the last dose of first-line therapy. Patients were randomised (1:1) via a centralised, interactive voice-response system to receive 8 mg/kg intravenous ramucirumab plus FOLFIRI or matching placebo plus FOLFIRI every 2 weeks until disease progression, unacceptable toxic effects, or death. Randomisation was stratified by region, KRAS mutation status, and time to disease progression after starting first-line treatment. The primary endpoint was overall survival in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01183780.ld. Findings: We enrolled 1072 patients (536 in each group). Median overall survival was 13·3 months (95% CI 12·4-14·5) for patients in the ramucirumab group versus 11·7 months (10·8-12·7) for the placebo group (hazard ratio 0·844 95% CI 0·730-0·976; log-rank p=0·0219). Survival benefit was consistent across subgroups of patients who received ramucirumab plus FOLFIRI. Grade 3 or worse adverse events seen in more than 5% of patients were neutropenia (203 [38%] of 529 patients in the ramucirumab group vs 123 [23%] of 528 in the placebo group, with febrile neutropenia incidence of 18 [3%] vs 13 [2%]), hypertension (59 [11%] vs 15 [3%]), diarrhoea (57 [11%] vs 51 [10%]), and fatigue (61 [12%] vs 41 [8%]). Interpretation: Ramucirumab plus FOLFIRI significantly improved overall survival compared with placebo plus FOLFIRI as second-line treatment for patients with metastatic colorectal carcinoma. No unexpected adverse events were identified and toxic effects were manageable. Funding: Eli Lilly. © 2015 Elsevier Ltd.

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