A phase II feasibility study of weekly paclitaxel in heavily pretreated advanced gastric cancer patients with poor performance status.
OBJECTIVE
We investigated the efficacy and safety of weekly paclitaxel monotherapy in previously treated patients with advanced gastric cancer (AGC) and poor performance status (PS) according to the Eastern Cooperative Oncology Group (ECOG).


METHODS
Patients with evaluable disease who failed at least one previous chemotherapy and had a PS of 2-3, received paclitaxel 70 mg/m(2) on days 1, 8 and 15 every 4 weeks.


RESULTS
The median overall survival (OS) was 5.5 months (95% confidence interval, CI, 3.3-7.8) and progression-free survival was 2.1 months (95% CI, 1.2-3.0). The overall response rate was 3.8% and the disease control rate was 25.0%. Treatment-related toxicities were tolerable. OS was 7.1 (95% CI, 5.4-9.5) and 3.7 months (95% CI, 2.1-5.3) for patients with PS-ECOG 2 and 3, respectively (p < 0.001). When evaluated according to the previous treatment, OS was 5.1 (95% CI, 3.3-7.0) and 6.5 months (95% CI, 3.8-9.3) for patients receiving two and three or more lines of treatment, respectively (p = 0.815). With multivariate analysis, PS was a significant factor for OS.


CONCLUSIONS
Survival in patients treated with weekly paclitaxel monotherapy was comparable to other second- or third-line chemotherapies for AGC, with acceptable toxicities in previously treated patients with poor PS.
Im
Chong Kun
CK
Department of Internal Medicine, Yonsei Cancer Center, Cancer Metastasis Research Center, Yonsei University College of Medicine, Seoul, Korea.
Rha
Sun Young
SY
Jeung
Hei-Cheul
HC
Jeong
Jaeheon
J
Lee
Soo Hyeon
SH
Noh
Sung Hoon
SH
Roh
Jae Kyung
JK
Chung
Hyun Cheol
HC
D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D011379:Prognosis; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality
D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel