Table 2.
Clinical, pathologic, demographic, molecular characteristics, response to therapy, and progression-free survival in the studied patients
| Clinical, Pathologic and Molecular Characteristics | Efficacy | Toxicity (grade -CTCAE) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| patient | age (years) | sex | Smoking history | histology | EGFR mutation | daily dose erlotinib (line of therapy) | response (RECIST) | PFS (months) | rash | diarrhea | other |
| 1 | 55 | M | former (60 py) | adenocarcinoma | delE746_A750 | 25 mg (1st line) | PR | 6 | none (0) | none (0) | none |
| 2 | 64 | F | never | adenocarcinoma | delE746_A750 | 25 mg (1st line) | PR | 8+ | none (0) | none (0) | none |
| 3 | 65 | F | former (30 py) | adenocarcinoma | delL747_T751 + R776S | 25 mg (1st line) ## | PR | 11+ | none (0) | none (0) | LFT (2) |
| 4 | 46 | M | former (30 py) | NSCLC, poorly differentiated | L858R | 25 mg (2nd line) | SD | 4 | yes (1) | none (0) | none |
| 5 | 67 | F | current (1.5 py) | adenocarcinoma | exon 19 deletion * | 25 mg (1st line) | PR | 10 | yes (1) | none (0) | none |
| 6 | 69 | F | former (0.5 py) | adenocarcinoma | exon 19 deletion * | 25 mg (2nd line) | SD | 17 | none (0) | none (0) | none |
| 7 | 86 | F | former (30 py) | adenocarcinoma | L858R | 25 mg # (1st line) | PR | 35 | none (0) | none (0) | none |
EGFR, epidermal growth factor receptor; NSCLC, non-small-cell lung cancer; PFS, progression-free survival; py, pack-years; CTCAE, common terminology criteria for adverse events v3.0; M, male; F, female; RECIST, response evaluation criteria in solid tumors v1.0; PR, partial response; SD, stable disease;
ongoing response; LFT, liver function test abnormalities;
exon 19 deletions were detected using length analysis of fluorescently labeled PCR in patients 5 and 6 and no further characterization of the mutation by sequencing was performed;
patient 6 had her dose of erlotinib increased to 50 mg/day after initial response to erlotinib 25 mg/day;
patient 3 had her dose of erlotinib reduced to 25 mg every other day after LFT abnormalities were noted. All other patients remained on erlotinib 25 mg/day until disease progression. Patients 1-4 were followed at BIDMC and patients 5-7 at MSKCC.