The humanistic burden of non-small cell lung cancer (NSCLC) is high, with patients experiencing debilitating symptoms such as dyspnoea, cough, pain, loss of appetite and haemoptysis. Because
current treatments for locally advanced or metastatic NSCLC are not curative, their impact on quality of life (QoL) is an important consideration in a patient population whose QoL is already
The SATURN study compared the effects of maintenance therapy with the tyrosine kinase inhibitor, erlotinib, or placebo on progression-free survival (PFS) in 889 patients with stage IIIB or IV
NSCLC. The study also included the secondary endpoints: symptomatic progression, and time to deterioration in Trial Outcome Index (TOI) and QoL.
QoL was assessed until progression of disease or withdrawal using the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire. The impact of erlotinib on the time to appearance of three
key symptoms (pain, cough and dyspnoea) was explored. TOI, defined as the sum of the scores of the physical and functional wellbeing and lung cancer subscales of the FACT-L instrument, was designed
to measure the physical functioning of patients with NSCLC.
Overall, erlotinib improved PFS by 41% compared with placebo. In patients receiving erlotinib, QoL was not negatively impacted compared with those receiving placebo, with no differences in time to
symptomatic progression (HR=0.91 [0.74-1.12]), time to deterioration in TOI (HR=1.06 [0.87-1.31]) or QoL (HR=0.96 [0.79-1.16]).
Time to pain and analgesics was significantly delayed in patients receiving erlotinib compared with placebo (HR=0.61 [0.42-0.88] and HR=0.66 [0.46-0.94], respectively), with a non-significant trend
towards delayed time to appearance of cough ((HR=0.77, [0.49-1.21]) and dyspnoea (HR=0.75 [0.48-1.17]). Outcomes were similar in patients with stable disease prior to erlotinib therapy.
The benefits in survival seen with erlotinib first-line maintenance therapy in NSCLC are achieved with no negative impact on QoL until progression of disease, thereby allowing patients to spend
more time with their families, and to remain active and contributing members of their communities for longer.