In sufferers with EGFR immunohistochemistry-positive tumours, chemotherapy did not signifi cantly prolong PFS compared with erlotinib (p=0?066; fi gure 5B). PFS in patients with EGFR immunohistochemistry-negative tumours was related across the therapy groups (p=0?94). In sufferers with EGFR FISH-positive tumours, PFS was comparable (p=0?72). Nonetheless, in individuals with EGFR FISH-negative tumours, the risk of condition progression kinase inhibitors of signaling pathways was increased while in the erlotinib group than in the chemotherapy group (p=0?045). The diff erence during the danger of progression was not signifi cant involving therapy groups for patients with KRAS mutation-positive tumours (p=0?092) or for patients with KRAS wild-type tumours (p=0?98). Nevertheless, the quantity of sufferers within the KRAS mutation subgroup was too little to help any conclusions. From your EGFR wild-type population, 68 (91%) of 75 patients within the erlotinib group had a PFS occasion compared with 59 (80%) of 74 within the chemotherapy group (HR 1?25, 95% CI 0?88?1?78 p=0?20). Having said that, there were too few patients with EGFR-activating mutations to interpret any effi cacy information and draw worthwhile conclusions (fi gure 5B). 409 sufferers had been incorporated while in the security population: 196 in the erlotinib group and 213 in the chemotherapy group.
46 (23%) of 196 sufferers inside the erlotinib group have been handled for 0?30 days, 76 (39%) for 31?60 days, 24 (12%) for 61?90 days, and 51 (26%) for more than 90 days. The median variety of 3-weekly cycles for that two chemotherapy drugs was two for docetaxel (array one?15) and three (range one?24) for pemetrexed. The most frequently kinase inhibitor reported treatment-related adverse occasions with erlotinib were rash and diarrhoea, which were uncommon in patients who received chemotherapy (table 2).
For individuals who obtained chemotherapy, the most common treatment-related adverse occasion was alopecia, which did not come about in patients who received erlotinib (table 2). Fewer patients within the erlotinib group than inside the chemotherapy group skilled critical adverse occasions (table 3), which includes significant haematological occasions such as anaemia (none vs 4 [2%]), neutropenia (none vs two [1%]), and febrile neutropenia (none vs two [1%]). There was a greater incidence of pulmonary embolism while in the erlotinib group (four [2%]) than the chemotherapy group (none). Two (10%) from the twenty really serious adverse occasions within the erlotinib group and 19 (49%) of 39 serious adverse events in the chemotherapy arm were classed as relevant to treatment. Patients who received erlotinib have been extra likely to undergo dose modifi cation or interruption than those who received chemotherapy (table three) and had been less prone to have at the least one adverse event major to withdrawal or death (table 3). 20 patients (10%) while in the erlotinib group had a dose reduction to 100 mg erlotinib and one patient had a dose reduction to 50 mg.