Acceptability of patients with brain metastases for clinical trials of chemotherapy for metastatic non-small-cell lung cancer.
This study was conducted to determine whether patients with brain metastases from non-small-cell lung cancer (NSCLC) should be included in clinical trials of chemotherapy. Patients with metastatic NSCLC and good performance status were studied. The survival of patients with brain metastases was compared with that of patients without brain metastases. Of 100 eligible patients, 22 had brain metastases at diagnosis. The median survival time was poorer in patients with brain metastases than in other patients with metastatic NSCLC (96.5 vs. 181.5 days). However, the difference in survival was not significant on univariate analysis (p = 0.106). Multivariate analysis confirmed that the prognostic value of brain metastases was limited in this sample (p = 0.129). There was little difference in survival curves during the first 8 weeks. Patients with brain metastases who have good performance status and minimal neurologic symptoms can be observed for approximately 8 weeks in clinical trials to determine their response to chemotherapy. However, it is doubtful that patients with brain metastases would be eligible for phase III trials, in which survival is an endpoint.
Ando
Y
Y
First Department of Internal Medicine, Nagoya University School of Medicine, Japan.
Sugiura
S
S
Ando
M
M
Minami
H
H
Nomura
F
F
Sakai
S
S
Shimokata
K
K
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary*; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D018579:Patient Selection; D011379:Prognosis; D012189:Retrospective Studies; D015996:Survival Rate