A phase II study of single-agent gemcitabine as a second-line treatment in advanced non-small cell lung cancer.
OBJECTIVE
To evaluate the efficacy and safety of the single-agent gemcitabine in advanced non-small cell lung cancer (NSCLC) as second-line chemotherapy.


METHODS
Between February 2002 and November 2004, a total of 27 patients, who had previously been treated with paclitaxel and platinum as first line chemotherapy, were enrolled in the study. Patients were treated with gemcitabine (1000 mg/m(2)) on days 1, 8 and 15 in a 28 day cycle. The response was assessed every two cycles. Toxicities were evaluated according to common toxicity criteria (CTC).


RESULTS
The median age was 62 (range, 46-79) years old. Among the 27 patients, 26 were male. Twenty-three patients had an ECOG performance status of 0 or 1 and four patients had a status of 2. Pathologically, 24 patients had squamous cell carcinoma and 3 had adenocarcinoma. Partial responses were observed in 15 patients. All patients were evaluated for response and toxicity. The overall response rate was 18.5% (95% confidence interval, 5-33%) and the median response duration was 17 (range, 7.4 to 49+) weeks. The median time to progression was 10 (range, 7 to 34+) weeks. The median overall survival for all patients was 38 (range, 10 to 122+) weeks. During a total of 87 cycles, granulocytopenia greater than CTC grade 2 occurred in 7%, thrombocytopenia in 1% and anemia in 24% of case. Non-hematologic toxicities were minor and easily controlled.


CONCLUSIONS
This study confirms the activity and safety of the single-agent gemcitabine as a second-line therapy in pretreated patients with advanced NSCLC.
Cho
Keun-Hyok
KH
Department of Internal Medicine, Seoul Veterans Hospital, (134-791) 6-2 Dunchon-Dong, Kangdong-Gu, Seoul, Korea.
Song
Young-Bong
YB
Choi
Ik-Sung
IS
Cho
Eun-Hee
EH
Choi
Jae-Won
JW
Ahn
Young Mi
YM
Roh
Yong Ho
YH
Nam
Seung-Hyun
SH
Kim
Bong-Seog
BS
D000230:Adenocarcinoma / Q000188:drug therapy; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D011379:Prognosis; D012074:Remission Induction; D016019:Survival Analysis; D014840:Vomiting, Anticipatory / Q000209:etiology; D000093542:Gemcitabine
D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine