Mean survival in cancer trials can be estimated with statistical techniques to extrapolate study survival curves. This methodology was applied to data from the VELOUR trial, where use of the novel ...biologic aflibercept (ziv-aflibercept in the United States) in combination with fluorouracil+leucovorin+irinotecan (FOLFIRI), had significantly increased median overall survival (OS) by 1.44 months, vs placebo plus FOLFIRI in patients with metastatic colorectal cancer (mCRC) resistant to, or that had progressed following, an oxaliplatin-containing regimen.
Parametric survival analyses were used to identify distributions with the best fit to the empirical VELOUR data. Mean OS for the two treatment groups (and pre-defined subgroups) was calculated from the fitted curves over a 15-year survival period.
Overall, the log-logistic distribution was the best-fitting for both treatment arms and, with it, the estimated difference in mean OS over 15 years between aflibercept+FOLFIRI and placebo+FOLFIRI was 4.7 months. In addition, the survival advantage with aflibercept was at least 3 months for the ITT population, whichever distribution was used to extrapolate survival.
Extrapolation of survival curves suggests the mean OS difference for aflibercept in the VELOUR trial is at least 3 months in the ITT population and selected subgroups.
Purpose
This study aimed to elicit EuroQol Quality of Life 5-Dimensions (EQ-5D) utility values from patients with second-line metastatic colorectal cancer (mCRC) pre- and post-progression.
Methods
A ...cross-sectional study was conducted in five hospitals in the Netherlands and the UK. Patients with mCRC were eligible if prescribed a second or subsequent line of therapy or best supportive care (BSC), received prior oxaliplatin in first-line therapy, and had Eastern Cooperative Oncology Group (ECOG) performance status scores of 0–2 at second-line initiation. Patients completed the EuroQol Quality of Life 5-Dimensions 3-levels (EQ-5D-3L) questionnaire and were categorized as pre- or post-progression. Chart data including patient demographics, clinical history, prior/current treatments and serious adverse events (SAEs) were collected. Mean utilities were estimated; uni- and multivariate analyses were conducted.
Results
Seventy-five patients were enrolled; 42 were pre-progression defined as second line or third line following an AE on second line and 33 were post-progression defined as third or subsequent therapy lines or BSC. Patient/disease characteristics and number of SAEs were similar between cohorts. Mean utility scores were 0.741 (SD = 0.230) and 0.731 (SD = 0.292) for pre- and post-progression cohorts, respectively. Compared to pre-progression, more patients reported increased anxiety/depression (36 vs. 12 %) and fewer problems with daily activities (64 vs. 38 %) post-progression. More patients pre-progression were on active treatment at enrolment (83 vs. 42 %) compared to post-progression.
Conclusions
This is the first real-world study to collect utilities for patients with second-line mCRC pre- and post-disease progression. Utility values were similar pre- and post-progression. To further explore the effect of radiological progression on utilities, longitudinal research is required that includes patients in palliative care centres.
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•All fiber coupled QEPAS sensor without free space optics.•Mid-IR ICLs fiber coupled using indium fluoride glass fibers.•Plug and play connection to sensing module for extreme ...versatility.•Greenhouse gases detection (CH4, CO2, and NO) with multiple ICLs and a single ADM.•Sub-ppm detection limits for real time detection: suitable for on-field monitoring.
Infrared laser-based gas sensors are mature to take the leap from laboratory prototype to outdoor operation. Considering the demand of high robustness and compactness, the reliability of the optical alignment in a sensor is the top priority. This paper proposes a solution designing an optical system embedded within a sealed metallic cylinder containing an aspheric micro-lens to couple a single-mode interband cascade laser with an indium fluoride glass fiber. The fiber output is plug & play connected to an acoustic detection module of a quartz-enhanced photoacoustic sensor (QEPAS) equipped with a fiber port, avoiding the use of any free-space optics, from the source to the detection module. To demonstrate the operability, three all-fiber-coupled QEPAS sensors were realized for detection of CH4, CO2 and NO reaching sub-ppm ultimate detection limits with a signal integration time of 100 ms.
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