Annals of Oncology Advance Access published online on October 8, 2009
Annals of Oncology, doi:10.1093/annonc/mdp401
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
1 Department of Respiratory Medicine, Tohoku University Hospital
2 Department of Respiratory Medicine, Sendai Kousei Hospital, Sendai
3 Department of Respiratory Medicine, Miyagi Cancer Center, Natori
4 Department of Respiratory Medicine, Fukushima Medical University Hospital, Fukushima
5 Department of Respiratory Medicine, Kanto Medical Center NTT EC, Shinagawa-ku, Tokyo
6 Department of Respiratory Medicine, Tohoku Kouseinenkin Hospital, Sendai
7 Department of Respiratory Medicine, Senseki Hospital, Higashimatsushima, Yamoto
8 Department of Respiratory Medicine, Saka General Hospital, Shiogama
9 Department of Medical Oncology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan
* Correspondence to: Dr T. Sakakibara, Department of Respiratory Medicine, Tohoku University Hospital, 1-1 Seiryomachi, Aoba-ku, Sendai 980-8574, Japan. Tel: +81-22-717-8539; Fax: +81-22-717-8549; E-mail: sakatomo{at}idac.tohoku.ac.jp
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.
Patients and methods: Elderly patients (age 
70 years) with advanced NSCLC were randomly assigned to either the weekly arm {70 mg/m2 paclitaxel on days 1, 8, and 15 and carboplatin [area under the curve (AUC) = 6] on day 1} or the standard arm [200 mg/m2 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.
elderly patients, non-small-cell lung cancer, weekly paclitaxel
Received for publication June 1, 2009. Revision received July 8, 2009. Accepted for publication July 9, 2009.