Intact

Carbo/Paclitaxel alone

Chemo + Gefitinib 250mg

Chemo + Gefitinib 500mg

1-year survival 42% 41% 37%

Median survival 9.9 months 9.8 months 8.7 months

1-year survival 42% 41% 37%

Median survival 9.9 months 9.8 months 8.7 months activity for gefitinib.26 More research is required to establish tumor phenotypes in responding versus nonresponding patients.27

Erlotinib (Tarceva) Erlotinib is an ErbB1 TKI that binds reversibly to the adenosine triphosphate (ATP) hydrophobic pocket. Table 5.3 summarizes data from recent Phase II trials in advanced NSCLC with erlotinib. A Phase II study in 56 patients with EGFR-positive NSCLC refractory to platinum-based therapy gave a response rate of 11% for erlotinib 150mg/day.28 Results of Phase III combination studies of erlotinib with carboplatin and paclitaxel (TRIBUTE) or gemcitabine and cisplatin (TALENT) in NSCLC demonstrated no significant survival benefit or differences in time to progression.29,30 However, the NCI Canadian BR21 placebo-controlled Phase III trial of erlotinib in NSCLC patients failing one or two prior chemotherapy regimens demonstrated prolonged survival in the erlotinib arm (6.7 versus 4.7 months).31 Ongoing trials are investigating the activity for the combination of two targeted therapies in NSCLC, erlotinib and the VEGF antibody beva-cizumab (avastin). Phase II data in other tumor types have revealed response rates in pretreated patients with ovary and head and neck tumors between 11% and 13%, although Phase II monotherapy trials in breast cancer have been relatively disappointing.32 Important activity in previously treated glioblastoma multiforme was demonstrated in a Phase II study (with 8 of 49 patients achieving a partial response).

Canertinib Dihydrochloride (CI-1033);

Lapatinib (GW 572016) Canertinib dihydrochloride (CI-1033) is a selective and irreversible pan-erbB inhibitor. Activity has been demonstrated in Phase I studies with an acceptable side-effect profile, and Phase II studies are under way in breast and renal cancer.33 Lapatinib (GW 572016) is a dual inhibitor of EGFR and HER234 that has shown responses in trastuzumab-resistant breast cancer patients.35 Further studies of lapatinib in combination with either endocrine or cytotoxic therapy are ongoing in breast cancer.

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