[A randomized clinical study of Gefitinib and pemetrexed as second line therapy for advanced non-squamous non-small cell lung cancer].
OBJECTIVE
Gefitinib and Pemetrexed are drugs used as second-line therapy for advanced non-small cell lung cancer (NSCLC), although studies comparing the two drugs are limited. The aim of this study is to explore the effects, safety, and quality of life (QoL) of Gefitinib and Pemetrexed on patients with advanced non-squamous NSCLC.


METHODS
Forty-six advanced non-squamous NSCLC patients who failed to first-line therapy were randomly divided into two groups with 23 patients each, one using oral Gefitinib (Gefitinib group) and the other using intravenous injection Pemetrexed (Pemetrexed group). The effects, safety, and QoL were determined and analyzed.


RESULTS
For the Pemetrexed group, objective response rate (ORR) was 13.0% (3/23), disease control rate (DCR) was 30.4% (7/23), and median progression-free survival (mPFS) was 3.1 months. In the Gefitinib group, ORR was 17.3% (4/23), DCR was 39.1% (9/23), and mPFS was 4.4 months. Compared with the Pemetrexed group, the ORR, DCR, and mPFS in the Gefitinib group exhibited no statistical significance (P>0.05). Furthermore, the most common toxicities in the Pemetrexed group were neutropenia (n=9, 39.13%) and fatigue (n=8, 34.78%), whereas those in the in Gefitinib group were skin rash (n=8, 34.78%) and diarrhea (n=4, 17.39%). Compared with baseline, the QoL improved in both groups but to different degrees. Likewise, emotional, functional well-being, and QoL aspects specifically related to lung cancer were better improved in the Gefitinib group than in the Pemetrexed group (P<0.05).


CONCLUSIONS
The effects of Pemetrexed and Gefitinib as second line therapy were similar, although with different AEs. Both drugs could improve the QoL, but Gefitinib showed better overall results than Pemetrexed.
Department of Respiratory Medicine, Nanjing Chest Hospital, Nanjing 210029, China.
Hongyu
H
Dai
Ling
L
Xu
Chunwei
C
Xia
Wenping
W
Chen
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology*; D005260:Female; D000077156:Gefitinib; D005971:Glutamates / Q000009:adverse effects / Q000627:therapeutic use*; D006147:Guanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D000068437:Pemetrexed; D011788:Quality of Life; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D005971:Glutamates; D011799:Quinazolines; D000068437:Pemetrexed; D006147:Guanine; D000077156:Gefitinib