A multicenter phase II study of carboplatin and paclitaxel for advanced thymic carcinoma: WJOG4207L.
BACKGROUND
Thymic carcinoma (TC) is an exceptionally rare tumor, which has a very poor prognosis differing from thymoma. Till date, there has been no report of any results of clinical trials focusing on TC. The role of non-anthracycline-based chemotherapy has not been elucidated since the previous studies included a relatively small number of TC patients. This single-arm study evaluated carboplatin and paclitaxel (CbP) in chemotherapy-naive patients with advanced TC.


METHODS
The study treatment consisted of carboplatin (area under the curve 6) and paclitaxel (200 mg/m(2)) every 3 weeks for a maximum of six cycles. The primary end point was objective response rate (ORR) by independent review. The secondary end points included overall survival (OS), progression-free survival (PFS), and safety. Based on the SWOG 2-stage design, the planned sample size of 40 patients was determined to reject the ORR of 20% under the expectation of 40% with a power of 0.85 and a type I error of 0.05.


RESULTS
Forty patients from 21 centers were enrolled for this study from May 2008 to November 2010. Of the 39 patients evaluable for analysis, 36 were pathologically diagnosed by independent review, and 97% patients were eventually TC. There was 1/13 complete/partial responses with an ORR of 36% (95% confidence interval 21%-53%; P = 0.031). The median PFS was 7.5 (6.2-12.3) months, while OS did not reach the median value. Major adverse event was grade 3-4 neutropenia in 34 patients (87%). There was no treatment-related death.


CONCLUSIONS
In this largest trial with TC, CbP showed promising efficacy in advanced TC when compared with anthracycline-based chemotherapy, which is the current standard treatment of thymic neoplasm. Our results established that CbP, one of the standard treatments for non-small-cell lung cancer, might be an option as a chemotherapy regimen for TC.
Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka.
F
F
Hirai
Department of Biostatistics, Yokohama City University, Yokohama.
T
T
Yamanaka
Department of Pathology, National Kyushu Cancer Center, Fukuoka.
K
K
Taguchi
Department of Clinical Oncology, Osaka City General Hospital, Osaka.
H
H
Daga
Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka.
A
A
Ono
Department of Medical Oncology, Kinki University Faculty of Medicine, Osaka.
K
K
Tanaka
Department of Respiratory Medicine, National Hospital Organization, Nagoya Medical Center, Nagoya.
Y
Y
Kogure
Department of Thoracic Oncology, Aichi Cancer Center Hospital, Nagoya.
J
J
Shimizu
Department of Respiratory Medicine, Graduate School of Medicine, Osaka City University, Osaka.
T
T
Kimura
Department of Pathology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki.
J
J
Fukuoka
Department of Medical Oncology, Hiroshima City Hospital, Hiroshima.
Y
Y
Iwamoto
Department of Oncology, Immunology and Surgery, Nagoya City University Graduate School of Medical Sciences, Nagoya, Aichi.
H
H
Sasaki
Department of Clinical Oncology, Osaka City General Hospital, Osaka.
K
K
Takeda
Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka tseto@nk-cc.go.jp.
T
T
Seto
Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka.
Y
Y
Ichinose
Department of Medical Oncology, Kinki University Faculty of Medicine, Osaka.
K
K
Nakagawa
Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Y
Y
Nakanishi
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D013945:Thymoma / Q000188:drug therapy* / Q000401:mortality; D013953:Thymus Neoplasms / Q000188:drug therapy* / Q000401:mortality
D016190:Carboplatin; D017239:Paclitaxel
advanced thymic carcinoma; carboplatin; paclitaxel; the standard treatments for non-small-cell lung cancer