Quality of life and outcome of patients with metastatic pancreatic cancer receiving first-line chemotherapy with nab-paclitaxel and gemcitabine: Real-life results from the prospective QOLIXANE trial of the Platform for Outcome, Quality of Life and Translational Research on Pancreatic Cancer registry.

Few data exist on health-related quality of life (QoL) in patients with metastatic pancreatic cancer (mPC) receiving first-line chemotherapy (Awad L ZE, Mesbah M Boston, MA. Applying survival data methodology to analyze quality of life data, in Mesbah M, Cole BF, Ting Lee M-L (eds): Statistical Methods for Quality of Life Studies: Design, Measurements and Analysis. Kluwer Academic Publishers 2002). The QOLIXANE study is a prospective, noninterventional, multicenter substudy of the Platform for Outcome, Quality of Life and Translational Research on Pancreatic Cancer (PARAGON) registry, which evaluated QoL in patients with mPC receiving first-line gemcitabine and nab-paclitaxel chemotherapy in real-life setting. QoL was prospectively measured via EORTC QLQ-C30 questionnaires at baseline and every month thereafter. Therapy and efficacy parameters were prospectively collected. Main objectives were the rate of patients without deterioration of Global Health Status/QoL (GHS/QoL) at 3 and 6 months. Six hundred patients were enrolled in 95 German study sites. Median progression-free survival was 5.9 months (95% confidence interval [CI], 5.2-6.3). Median overall survival (OS) was 8.9 months (95% CI, 7.9-10.2), while median time to deterioration of GHS/QoL was 4.7 months (95% CI, 4.0-5.6). With a baseline GHS/QoL score of 46 (SD, 22.8), baseline QoL of the patients was severely impaired, in most cases due to loss in role functioning and fatigue. In the Kaplan-Meier analysis, 61% and 41% of patients had maintained GHS/QoL after 3 and 6 months, respectively. However, in the QoL response analysis, 35% and 19% of patients had maintained (improved or stable) GHS/QoL after 3 and 6 months, respectively, while 14% and 9% had deteriorated GHS/QoL with the remaining patients being nonevaluable. In the Cox regression analysis, GHS/QoL scores strongly predicted survival with a hazard ratio of 0.86 (P < .0001). Patients with mPC have poor QoL at baseline that deteriorates within a median of 4.7 months. Treatment with gemcitabine and nab-paclitaxel is associated with maintained QoL in relevant proportions of patients. However, overall, results remain poor, reflecting the aggressive nature of the disease.

Palliative treatment of colorectal cancer in Germany: cost of care and quality of life.

INTRODUCTION: To estimate the costs of palliative care for colorectal cancer (CRC) from the perspective of German statutory health insurance and to measure the patients' quality of life (QoL) for a 2-year time period. METHODS: A prospective observational multicentre study was carried out to estimate the direct costs of care over a 2-year period. Case report forms, medical records, and claims data were all applied to document medical and resource usage data in real-world settings. QoL was measured by using the Short Form-12 Health Survey. RESULTS: In total 101 patients (mean age 67.09 ± 11.13 years, 68 % male) from 12 different settings were included. The mean costs per patient during the 1st and 2nd years were calculated to be 42,361€ and 32,023€, respectively. Highest mean costs were calculated for the second quarter, which reached an amount of 12,900€ (95 % CI: 11,127€-14,673€). Mean physical summary scores and mean mental summary scores were 41.8 and 49.7, respectively. DISCUSSION: This is the first study assessing the costs of palliative care and the quality of life of patients with CRC in real-world health-care delivery in Germany. It could be shown that CRC treatment represents an enormous economic burden to the German health-care system. Increased efforts in promoting effective and efficient treatment options, or performance-based medication reimbursement schemes, might be helpful in reducing the costs.

A case of chronic myeloproliferative syndrome followed by precursor T-cell acute lymphoblastic leukemia.

Interlineage switch from myeloid to lymphatic malignancies is a rare phenomenon. Progression from a BCR-ABL negative chronic myeloproliferative disorder (CMPD) to acute lymphoblastic leukemia (ALL) has been reported in very few cases. We describe the case of a 62-year-old man who developed precursor T-cell (pre-T) ALL 18 months after the diagnosis of an unclassifiable chronic myeloproliferative syndrome (CMPD, U), which had been treated with hydroxyurea (HU) over 12 months. The transformation from CMPD to pre-T-ALL was accompanied by clonal evolution from normal to a high hyperdiploid karyotype with an i(17q): 52,XY,+X,+2,+13,+14,+15,i(17)(q10),+19. Diverse pathways should be considered in this transformation process: although therapeutic induction of ALL is extremely rare and no MLL/11q23 rearrangement was detected by chromosome banding analyses and interphase fluorescence in situ hybridization (FISH), T-lineage ALL might have been caused by HU therapy for the CMPD. Chance coincidence of both disorders seems improbable, given the short interval from the diagnosis of the CMPD to the development of the pre-T-ALL, but nonetheless must be considered. A third explanation might be provided by a spontaneous interlineage switch, which would give further support to the theory that the CMPDs are disorders of a pluripotent stem cell. Interlineage switch might result from an aberrant differentiation of the malignant clone or from selection within a mixed population.