TITLE:
Phase II Study of Carboplatin and Pemetrexed Followed by Gefitinib for Patients with Advanced Non-Small Cell Lung Cancer Harboring Sensitive EGFR Mutation
AUTHORS:
Saki Manabe, Fumihiro Oshita, Shuji Murakami, Tetsuro Kondo, Haruhiro Saito, Takeshi Kaneko, Kouzo Yamada
KEYWORDS:
Pemetrexed, Gefitinib, EGFR Mutation, Non-Small Cell Lung Cancer, Chemotherapy
JOURNAL NAME:
Journal of Cancer Therapy,
Vol.6 No.15,
December
14,
2015
ABSTRACT: We conducted a phase II study of combination chemotherapy with
carboplatin (Cb) and pemetrexed (Pem) followed by gefitinib (Gef) to determine
the effects and toxicities in patients with non-small cell lung cancer (NSCLC)
harboring sensitive EGFR mutation. Eligible patients received four courses of
Cb at a dose corresponding to a target area under the curve equal to 6 mg/mL·min and 500 mg/m2 Pem on day 1 every
three to four weeks followed by sequential Gef 250 mg once a day until tumor
progression. Sixteen of registered 28 patients responded to Cb and Pem
combination. Twenty-seven patients received sequential Gef and 8 non-responders
to Cb and Pem achieved PR. The overall response rate was 85.7%. Among the major
toxicities, grade 3 SGPT elevation, nausea and thrombosis were observed in 3, 3
and 1 patients, respectively, who received Cb and Pem, and grade 3 SGPT
elevation and dry skin were observed in 5 and 1 patients, respectively, who
received Gef. There was no febrile neutropenia and no treatment-related death.
The median progression-free survival time was 19.1 months. Among 21 patients
who were followed up for more than 2 years, 14 survived during that time. Cb
and Pem followed by Gef maintenance are recommended for further evaluation for
patients with metastatic NSCLC harboring sensitive EGFR mutation.