Efficacy and safety of first-line erlotinib in elderly patients with advanced non-small cell lung cancer

Abstract

Abstract. TaRceva LUng cancer Survival Treatment (TRUST)was an open-label, phase IV study of advanced non-small cell lung cancer (NSCLC). Patients failing or unsuitable for chemotherapy or radiotherapy received erlotinib 150 mg/day until progression. We examined a subpopulation of elderly patients (≥70 years) receiving first-line erlotinib (n=485) in TRUST. In this subpopulation, disease control rate (n=356 with best response data available) was 79% (vs. 69% for the overall TRUST population; P<0.0001); median progressionfree survival (PFS) was 4.57 months [95% confidence interval (CI), 3.68-5.22]; median overall survival (OS) was 7.29 months (95% CI, 6.27-8.67); and one-year survival, was 36.6%. PFS and OS were significantly longer in patients developing rash, compared to those without, and in those with good performance status (PS; 0/1), compared to poor PS (≥2). Eighty-seven subpopulation patients (18%) had an erlotinib-related AE; other than the protocol-defined frequent adverse events (AEs); 4% had a grade ≥3 erlotinib-related AE, 7% had an erlotinibrelated serious AE. In the subpopulation, dose reductions were required in 27%, most (97%) were reductions to 100 mg/ day; treatment was discontinued in 10%, and one death was associated with treatment-related toxicity (<1%). Erlotinib was effective and well-tolerated and may be considered for elderly patients with advanced NSCLC who are unsuitable for standard first-line chemotherapy or radiotherapy. IntroductionThe incidence of non-small cell lung cancer (NSCLC) increases with age, with 60% of cases arising in patients over 60 years of age, and 30-40% in patients of 70 years or older (1,2). In developed countries the median age of diagnosis for advanced disease is 68 years (3), but this has increased notably over the last 3 decades. Consequently, the age of the patient is often a major factor for physicians considering treatment options for patients with advanced NSCLC. Elderly patients are often denied therapy, prematurely discontinued and excluded from clinical trials because of the perception that they are less able to tolerate cytotoxic chemotherapy than younger patients, and are more likely to suffer toxic effects that adversely affect their quality of life (4). Physicians may be concerned that age-related impairment in renal or hepatic function could exacerbate the toxic effects of chemotherapy, and that the presence of comorbidities could reduce the capacity of their elderly patients to tolerate such effects. While it is true that the incidence of age-related organ dysfunction and the development of comorbid conditions increase abruptly between 70 and 75 years of age (5), the clinical significance of the relationship between age and comorbid conditions is complex in patients with cancer (6) and it has been suggested that chronological age is not a valid criterion on which to base treatment decisions in NSCLC (7). Clinical trials that have investigated the effects of cytotoxic chemotherapy in unselected elderly patients have reported modest improvements i...

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Epidermal growth factor receptor (EGFR) mutation and personalized therapy in advanced nonsmall cell lung cancer (NSCLC)

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Erlotinib treatment after platinum-based therapy in elderly patients with non-small-cell lung cancer in routine clinical practice – results from the ElderTac study

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