A feasibility study of postoperative adjuvant therapy of carboplatin and weekly paclitaxel for completely resected non-small cell lung cancer.
BACKGROUND
Recent clinical trials have shown significant survival benefits from postoperative adjuvant therapy for respectable nonsmall cell lung cancer (NSCLC). However, evaluation of adjuvant chemotherapy with carboplatin combination is still uncertain. The purpose of the study was to test the feasibility of adjuvant chemotherapy with carboplatin and separate weekly paclitaxel after complete resection of pStage IB, II, IIIA NSCLC in a multicenter study.


METHODS
The study was conducted from 2001 to 2006 in the outpatient setting. A total of 61 patients were enrolled. Patients received adjuvant chemotherapy with 4 cycles of carboplatin (AUC 5) on day 1 and paclitaxel (70 mg/m) on day 1, 8, and 15 every 4 weeks. Primary endpoints were toxicity and chemotherapy compliance. Secondary endpoints were disease-free survival and overall survival.


RESULTS
More than 65% of eligible patients had pStage IIIA. The median number of chemotherapy cycles was 4 (range 1-4). Grade 3 or 4 toxicities of neutropenia were 34% (grade 4: 2%). Other hematologic adverse effects were extremely less frequent. Regarding the nonhematologic adverse effect, hair loss was frequent; however, peripheral neuralgia was less frequent. Treatment-related death was not registered. During median follow-up of 21 months, 24 patients developed recurrent disease. Estimated disease-free survival and overall survival at 2 years was 51.2% and 84.6%, respectively.


CONCLUSIONS
Postoperative carboplatin and weekly paclitaxel showed favorable feasibility and acceptable toxicity in comparison with the cisplatin-containing regimen. Consequently, it is desirable that this regimen would be validated in a phase III clinical trial for NSCLC after curative resection.
Yamashita
Yoshinori
Y
Department of Surgery, Hiroshima City Asa Hospital, Hiroshima, Japan. yosy.811kob@k3.dion.ne.jp
Kataoka
Kazuhiko
K
Ishida
Teruyoshi
T
Matsuura
Motoki
M
Seno
Noritomo
N
Mukaida
Hidenori
H
Miyahara
Eiji
E
Miyata
Yoshihiro
Y
Okita
Riki
R
Shimizu
Katsuhiko
K
Watari
Masanobu
M
Okumichi
Tsuneo
T
Okada
Morihito
M
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use*; D011013:Pneumonectomy / Q000379:methods*; D011182:Postoperative Care / Q000379:methods*; D011446:Prospective Studies; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D016190:Carboplatin; D017239:Paclitaxel