Randomized phase II trial of weekly paclitaxel combined with carboplatin versus standard paclitaxel combined with carboplatin for elderly patients with advanced non-small-cell lung cancer.
BACKGROUND
The optimal platinum doublet regimen in elderly patients with non-small-cell lung cancer (NSCLC) is still uncertain. We conducted a randomized phase II study to compare the efficacy and safety of weekly paclitaxel combined with carboplatin with those of the standard schedule.


METHODS
Elderly patients (age > or =70 years) with advanced NSCLC were randomly assigned to either the weekly arm {70 mg/m(2) paclitaxel on days 1, 8, and 15 and carboplatin [area under the curve (AUC) = 6] on day 1} or the standard arm [200 mg/m(2) paclitaxel and carboplatin (AUC = 6) on day 1]. The primary end point was the overall response rate (ORR).


RESULTS
Eighty-two patients were enrolled. The ORR and median progression-free survival were 55% and 6.0 months for the weekly arm and 53% and 5.6 months for the standard arm. Grade 3/4 neutropenia and peripheral neuropathy were observed in 41% and 0% of the patients in the weekly arm and in 88% and 25% in the standard arm, respectively.


CONCLUSIONS
This is the first randomized study that compares the platinum doublet designed specifically for the elderly. Regarding the safety, the weekly regimen was less toxic than the standard regimen and seems to be preferable for elderly patients with advanced NSCLC.
Sakakibara
T
T
Department of Respiratory Medicine, Tohoku University Hospital. Electronic address: sakatomo@idac.tohoku.ac.jp.
Inoue
A
A
Department of Respiratory Medicine, Tohoku University Hospital.
Sugawara
S
S
Department of Respiratory Medicine, Sendai Kousei Hospital, Sendai.
Maemondo
M
M
Department of Respiratory Medicine, Miyagi Cancer Center, Natori.
Ishida
T
T
Department of Respiratory Medicine, Fukushima Medical University Hospital, Fukushima.
Usui
K
K
Department of Respiratory Medicine, Kanto Medical Center NTT EC, Shinagawa-ku, Tokyo.
Abe
T
T
Department of Respiratory Medicine, Tohoku Kouseinenkin Hospital, Sendai.
Kanbe
M
M
Department of Respiratory Medicine, Senseki Hospital, Higashimatsushima, Yamoto.
Watanabe
H
H
Department of Respiratory Medicine, Saka General Hospital, Shiogama.
Saijo
Y
Y
Department of Medical Oncology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Nukiwa
T
T
Department of Respiratory Medicine, Tohoku University Hospital.
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018450:Disease Progression; D004304:Dosage Forms / Q000592:standards; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects / Q000592:standards; D016019:Survival Analysis; D016896:Treatment Outcome
D004304:Dosage Forms; D016190:Carboplatin; D017239:Paclitaxel