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  • Gilteritinib Patients with NSCLC experience symptoms that co

    2019-09-02

    Patients with NSCLC experience symptoms that Gilteritinib commonly include dyspnea, cough, fatigue, anorexia, and pain, which affect the physical as well as functional aspects of a patient’s QoL [[14], [15], [16]]. Symptom burden is significantly higher in patients with more advanced NSCLC [17] and in those receiving more advanced lines of treatment [18]. Thus, control of symptoms and maintenance of QoL for patients with advanced NSCLC are essential parts of the decision-making process regarding treatment options and provide crucial information for the assessment of disease, clinician-reported functional status, and treatment symptom burden as well as the effectiveness of treatment [13,19]. The potential prognostic value of patient symptoms and function for survival in cancer clinical trials has been previously noted [[20], [21], [22], [23]]. Specific to lung tumors, baseline patient-reported symptoms, as measured by the LCSS and the Average Symptom Burden Index (ASBI; average of the 6 symptom components of the LCSS) have demonstrated prognostic value for OS in post hoc analyses of both malignant mesothelioma and nonsquamous NSCLC [24,25]. Understanding the potential prognosis of patients can be important information when balancing the selection of new drug therapies based on risk, tolerability, and clinical benefit for any given patient.
    Materials and methods
    Results
    Discussion Regardless of treatment, patients from the REVEL study with patient-reported baseline LSB had significantly longer OS and PFS and higher ORR than patients who reported baseline HSB, reinforcing findings from previous research that symptom burden may be a useful prognostic factor for patients with advanced NSCLC. More patients with baseline HSB versus LSB were refractory to first-line chemotherapy or had a time to progression within 12 weeks on first-line treatment—known hallmarks of tumor aggressiveness. In fact, there was a significant association between the occurrence of baseline HSB and the occurrence of refractory or rapidly progressing disease in REVEL patients. The occurrence of REVEL patients with refractory disease was also significantly associated with that of patients with rapidly progressing disease (P < 0.001). The median PFS and OS results of patients who reported HSB at baseline were also consistent with other exploratory REVEL subgroups with aggressive disease (Supplementary Table 2) [7,8,11]. All of this reflects ASBI as a probable symptomatic manifestation of these clinical prognostic indicators of aggressive disease. These results suggest that patients with HSB or aggressive disease benefit from treatment with ramucirumab plus docetaxel versus docetaxel alone with an acceptable toxicity profile and overall QoL functioning. As with any post hoc exploratory analysis, there are limitations that will impact both generalizability and interpretation. First, these analyses were not powered to detect differences between the treatment arms nor were they powered to detect potential effect differences between LSB and HSB subgroups. Additionally, a baseline LCSS compliance of less than 80% may indicate that these analyses are not representative of the entire REVEL patient population as missing data may not be missing at random. Another limitation of this study was that the median cut-point for data analysis was derived based on the median ASBI score and not anchored to a more clinically relevant empirical determination. However, previous research has determined symptom burden defined as low and high by an ASBI score of 25 aligns with the “mild” category of the LCSS observer scale [25]. The observer scale contains the 6 ASBI symptoms and rates them using a 5-point categorical scale (none, mild, moderate, marked, and severe) [25]. In this study, the near-perfect agreement of the calculated statistical median ASBI score of 24.3 with the previously cited cut-point of 25 suggests a level of alignment for distinguishing a mild category of the LCSS observer scale.