Introduction . Soft Tissue Sarcoma (STS) is a rare malignancy of mesodermal tissue, with international incidence estimates between 1.8 and 5 per 100,000 per year. Understanding quality of life (QoL) and the detrimental impact of disease progression is critical for long-term care and survival. Objectives . The primary objective was to explore the relationship between disease progression and health-related quality of life (HRQoL) using data from Eisai’s study (E7389-G000-309). Methods . This was a 1 : 1 randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin versus dacarbazine in patients with advanced STS. The QoL analysis was conducted for the baseline and progression populations using the European Organization for Research and Treatment of Cancer 30-item core QoL questionnaire (EORTC QLQ-C30). Results . There were no statistical differences between the two treatment arms at baseline for any domain (p>0.05; n=452). Of the 399 patients who experienced disease progression (unadjusted and adjusting for histology), dacarbazine patients had significantly lower Global Health Status, Physical Functioning scores, and significantly worse Nausea and Vomiting, Insomnia, and Appetite Loss (p<0.05). Conclusions . These results indicate differences in HRQoL overall and at progression between dacarbazine and eribulin patients, with increases in symptom severity observed among dacarbazine patients.
The aim of this study was to estimate the cost-of-illness associated with completely resected stage IIIB/IIIC melanoma with macroscopic lymph node involvement, overall and by disease phase, in France, Germany and the UK. This retrospective observational study included patients aged older than or equal to 18 years first diagnosed with stage IIIB/IIIC cutaneous melanoma between 1 January 2009 and 31 December 2011. Data were obtained from medical records and a patient survey. Direct costs, indirect costs and patient out-of-pocket expenses were estimated in euros (€) (and British pounds, £) by collecting resource use and multiplying by country-specific unit costs. National annual costs were estimated using national disease prevalence from the European cancer registry and other published data. Forty-nine centres provided data on 558 patients (58.2% aged <65 years, 53.6% stage IIIB disease at diagnosis). The mean follow-up duration was 27 months (France), 26 months (Germany) and 22 months (UK). The mean total direct cost per patient during follow-up was €23 582 in France, €32 058 in Germany and €37 970 (£31 123) in the UK. The largest cost drivers were melanoma drugs [mean €14 004, €21 269, €29 750 (£24 385), respectively] and hospitalization/emergency treatment [mean: €6634, €6950, €3449 (£2827), respectively]. The total mean indirect costs per patient were €129 (France), €4,441 (Germany) and €1712 (£1427) (UK). Estimates for annual national direct cost were €13.1 million (France), €30.2 million (Germany) and €27.8 (£22.8) million (UK). The economic burden of stage IIIB/IIIC melanoma with macroscopic lymph node involvement was substantial in all three countries. Total direct costs were the highest during the period with distant metastasis/terminal illness.
To inform health-technology assessments of new adjuvant treatments, we describe treatment patterns in patients with complete resection of stage IB-IIIA non-small cell lung cancer (NSCLC) in France, Germany, and the United Kingdom (UK).Data were collected via medical record abstraction. Patients were aged ≥18 years with completely resected stage IB-IIIA NSCLC, diagnosed between 01 January 2009 and 31 December 2011. Median follow-up was 26 months. Adjuvant treatment patterns and clinical outcomes were summarized descriptively.Among the 831 patients studied, 239 (29%) had stage IB disease, 179 (22%) had stage IIA disease, 165 (20%) had stage IIB disease, and 248 (30%) had stage IIIA disease. Adjuvant systemic therapy was received by 402 patients (48.4%), (France, 61.8%; Germany, 51.9%; UK, 33.4%). Use of adjuvant therapy increased with increasing stage of disease. Cisplatin/vinorelbine and carboplatin/vinorelbine were the most frequently prescribed adjuvant regimens. Median disease-free survival was 48.0 months (95% confidence interval [CI] 42.3-not estimable); the 25th percentile was 13.2 months (95% CI, 11.0-15.3). 204 patients (24%) died during the follow-up period. The median overall survival was not reached, the 25th percentile was 31.2 months (95% CI 26.8-36.0 months). 272 patients (33%) had disease recurrence during the follow-up period. For 86 of those patients, the first recurrence was local or regional with no distant metastasis and 14 had further progression to metastatic disease during the follow-up time. For the other 186 patients, the first recurrence involved distant metastases. A total of 200 patients had metastatic disease at any time during study follow-up.Less than half the patients with stage IB-IIIA NSCLC in this observational study received adjuvant systemic therapy. A high rate of first recurrence with distant metastatic disease was observed, emphasising the need for more effective systemic adjuvant therapies in this population.
Metastatic breast cancer (MBC) is associated with poor prognosis, particularly for those patients with human epidermal growth factor receptor (HER2)-negative tumor. Similar to the rest of the world, treatment options are limited in South Korea following first-line chemotherapy with anthracyclines and/or taxanes. This study examined the cost-effectiveness and cost-utility of eribulin in South Korean patients with HER2-negative MBC who have progressed after usage of at least one chemotherapeutic regimen for advanced disease (second-line therapy).A partition survival model was developed from the perspective of the South Korean health care system. The economic impact of introducing eribulin as second-line therapy for HER2-negative MBC was compared to that of capecitabine and vinorelbine. The analysis estimated incremental cost per life-year (LY), that is, cost-effectiveness, and cost per quality-adjusted life-year (QALY), that is, cost-utility, of eribulin for management of HER2-negative MBC in South Korea. The model accounted for overall survival, progression-free survival, drug costs, grade 3/4 adverse events, and health care utilization. Deterministic and probabilistic sensitivity analyses were performed to identify uncertainty in the results of the economic evaluation.Second-line eribulin was associated with greater benefits in terms of LY and QALY, compared to capecitabine and vinorelbine. The incremental cost-effectiveness ratio was ₩10.5M (approximately USD 9,200) per LY, and the incremental cost-utility ratio was ₩17M (approximately USD 14,800) per QALY in the basecase analysis. The incremental cost-utility ratio ranged from ₩12M (USD 10,461) to ₩27M (USD 23,538) per QALY in the deterministic sensitivity analysis. In the probabilistic sensitivity analysis, >99% of the simulations were below ₩50M (USD 42,300), and the lower and upper 95% confidence intervals were ₩3M (USD 2,600) and ₩24M (USD 20,900) per QALY, respectively.There currently exist a limited number of treatment choices for women with HER2-negative MBC. Eribulin is a cost-effective option for second-line therapy in South Korea and should be added to the current indications for reimbursement.
11015 Background: Soft tissue sarcoma (STS) is a rare group of heterogeneous mesenchymal cancers with an annual incidence of 2 to 3 diagnoses for every 100,000 persons. Median survival time in patients with metastatic STS is usually less than 12 months, with only a small subgroup of these patients achieving long-term survival. Understanding quality of life and the detrimental impact of disease progression is critical for long-term care and survival. Methods: The objective of this study was to better understand treatment related differences comparing Eribulin to dacarbazine (DTIC) in quality of life among patients who experienced disease progression. Health-related Quality of life (HRQoL) was determined using the European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30). Any change greater than 10-points was considered meaningful. Differences in HRQoL between treatment arms and histology type were compared using a multi-factor ANOVA. Statistically significant differences in QLQ-C30 scores between planned treatment arms were assessed using p-values reflecting the F-ratio statistic at alpha 0.05. Results: A total of 452 patients were randomized into this Phase 3 clinical trial. Of these, 400 patients with progressive disease were included in this evaluation (209 in the Eribulin arm and 191 in the DTIC arm). Baseline QOL scores were equivalent at baseline for the Eribulin and DTIC arms. Patients on DTIC had significantly lower global health status compared to those on Eribulin (56.1 vs 62.1; p=0.0083) and physical function (63.9 vs 73.3; p=0. 0022) as well as worse nausea/vomiting (p=0.0009) and appetite loss (p=0.001). Similar results were observed in the histology subpopulations (adipocytic and Leiomyosarcoma). Conclusions: Overall, results of this exploratory analysis indicate difference in HRQoL at time of disease progression between the DTIC and Eribulin treatment arms, with notable increases in symptom severity noted among DTIC patients relative to comparable patients in the Eribulin arm.
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