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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. What's new?: In metastatic pancreatic cancer (mPC), chemotherapy with nab‐paclitaxel plus gemcitabine has shown significant survival benefits. However, less attention has been paid to quality of life (QoL) for these patients. In this prospective study, the authors found that, due to the aggressive nature of mPC, QoL declined rapidly for most patients. But surprisingly, as many as 41% of patients were able to maintain their baseline QoL at six months. Thus, while overall results remain poor, it does appear possible to stabilize QoL for a subset of patients receiving this first‐line combination chemotherapy. [ABSTRACT FROM AUTHOR]

Purpose: To determine whether irinotecan plus oxaliplatin (mIROX) is superior to irinotecan plus infusional 5-fluorouracil, leucovorin (FUFIRI) as first-line therapy of patients with metastatic colorectal cancer (mCRC). Patients and methods: A phase III, randomised, open-label multicentre study compared standard treatment with FUFIRI (irinotecan 80mg/m2, 5-fluorouracil 2000mg/m2, folinic acid 500mg/m2 weekly times 6) to mIROX using an identical schedule of irinotecan plus oxaliplatin 85mg/m2 applied on days 1, 15 and 29 of a 7-week cycle. The primary end-point was progression-free survival (PFS). Results: A total of 479 eligible patients were randomly assigned. Progression-free survival was 7.2months in the mIROX arm and 8.2months in the FUFIRI arm [hazard ratio=1.14; 95% confidence interval (CI) 0.94–1.37; P =0.178]. Comparable results were also obtained for overall survival time with 19months in the mIROX-arm and 22months in the FUFIRI-arm (hazard ratio=1.08, P =0.276). Both regimens induced an identical objective response rate (ORR) of 41%, but disease control rate (ORR plus stable disease) was significantly greater in the FUFIRI group (81% versus 68%, P =0.001). Most frequent grades 1–4 side-effects of mIROX and FUFIRI treatment were nausea (80% versus 73%) and delayed diarrhoea (79% versus 68%). Grades 3–4 toxicities were generally below 10%, except for diarrhoea which was more frequent in the mIROX-arm compared to the FUFIRI-arm (19% versus 30%, P =0.006) Conclusion: mIROX failed to show superior activity compared to high-dose 5-FU/folinic acid plus irinotecan. Due to better tolerability the combination of high-dose 5-FU/folinic acid and irinotecan remains a standard of care in first-line treatment of metastatic colorectal cancer. [Copyright &y& Elsevier]