Adjuvant chemotherapy for resected adenocarcinoma of the esophagus, gastro-esophageal junction, and cardia: Phase II trial (E8296) of the Eastern Cooperative Oncology Group

被引:44
作者
Armanios, M
Xu, RH
Forastiere, AA
Haller, DG
Kugler, JW
Benson, AB
机构
[1] Johns Hopkins Univ, Baltimore, MD 21205 USA
[2] Dana Farber Canc Inst, Boston, MA 02115 USA
[3] Univ Penn, Philadelphia, PA 19104 USA
[4] Illinois Oncol Res Assoc, Peoria, IL USA
[5] Northwestern Univ, Chicago, IL 60611 USA
关键词
D O I
10.1200/JCO.2004.06.533
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose To evaluate the effect of postoperative paclitaxel and cisplatin on 2-year survival in patients with completely resected adenocarcinoma of the distal esophagus, gastro-esophageal (GE) junction, and cardia. Patients and Methods We conducted a multicenter phase II trial. Patients had pathologically staged T2 node-positive to T3-4, any node status adenocarcinoma of the distal esophagus, GE junction, or gastric cardia with negative margins (R0). Treatment consisted of four cycles of paclitaxel 175 mg/m(2) intravenously (IV) over 3 hours followed by cisplatin 75 mg/m(2) IV every 21 days. A positive outcome was considered to be an improvement in 2-year survival rate by greater than or equal to20% compared to historic controls. Results Fifty-nine patients were recruited from 20 centers. Of 55 eligible patients, 49 (89%) had lymph node involvement. Forty-six patients (84%) completed all four cycles. Of the total 59 patients, 31 (56%) developed grade 3 or 4 toxicity with leukopenia/neutropenia, nausea/vomiting, and metabolic toxicities were most common. The median follow-up for surviving patients was 4 years. At 2 years, 33 patients were alive and 22 were dead, with a survival rate of 60% (95% CI, 46% to 73%; one-sided P = .0008 compared with the historic controls). Conclusion Our data suggest that adjuvant paclitaxel and cisplatin may improve survival in R0 resected patients with locally advanced adenocarcinoma of the distal esophagus, GE junction, and cardia. These results warrant further testing in randomized trials. (C) 2004 by American Society of Clinical Oncology.
引用
收藏
页码:4495 / 4499
页数:5
相关论文
共 25 条
[1]   ACTIVITY OF TAXOL IN PATIENTS WITH SQUAMOUS-CELL CARCINOMA AND ADENOCARCINOMA OF THE ESOPHAGUS [J].
AJANI, JA ;
ILSON, DH ;
DAUGHERTY, K ;
PAZDUR, R ;
LYNCH, PM ;
KELSEN, DP .
JOURNAL OF THE NATIONAL CANCER INSTITUTE, 1994, 86 (14) :1086-1091
[2]  
Ajani Jaffer A, 2003, Oncology (Williston Park), V17, P20
[3]  
*AM JOINT COMM CAN, 1997, ES GASTR
[4]   Surgery plus chemotherapy compared with surgery alone for localized squamous cell carcinoma of the thoracic esophagus: A Japan Clinical Oncology Group Study - JCOG9204 [J].
Ando, N ;
Iizuka, T ;
Ide, H ;
Ishida, K ;
Shinoda, M ;
Nishimaki, T ;
Takiyama, W ;
Watanabe, H ;
Isono, K ;
Aoyama, N ;
Makuuchi, H ;
Tanaka, O ;
Yamana, H ;
Ikeuchi, S ;
Kabuto, T ;
Nagai, K ;
Shimoda, Y ;
Kinjo, Y .
JOURNAL OF CLINICAL ONCOLOGY, 2003, 21 (24) :4592-4596
[5]  
Bancewicz J, 2002, LANCET, V359, P1727
[6]   Chemoradiotherapy followed by surgery compared with surgery alone in squamous-cell cancer of the esophagus [J].
Bosset, JF ;
Gignoux, M ;
Triboulet, JP ;
Tiret, E ;
Mantion, G ;
Elias, D ;
Lozach, P ;
Ollier, JC ;
Pavy, JJ ;
Mercier, M ;
Sahmoud, T .
NEW ENGLAND JOURNAL OF MEDICINE, 1997, 337 (03) :161-167
[7]   Combined-modality therapy for esophageal cancer: Are we making progress? [J].
Gibson, MK ;
Forastiere, AA .
CANCER JOURNAL, 2003, 9 (04) :238-240
[8]   Phase II evaluation of preoperative chemoradiation and postoperative adjuvant chemotherapy for squamous cell and adenocarcinoma of the esophagus [J].
Heath, EI ;
Burtness, BA ;
Heitmiller, RF ;
Salem, R ;
Kleinberg, L ;
Knisely, JPS ;
Yang, SC ;
Talamini, MA ;
Kaufman, HS ;
Canto, MI ;
Topazian, M ;
Wu, TT ;
Olukayode, K ;
Forastiere, AA .
JOURNAL OF CLINICAL ONCOLOGY, 2000, 18 (04) :868-876
[9]  
Ilson DH, 2000, CANCER J, V6, P316
[10]  
KELSEN D, 1994, SEMIN ONCOL, V21, P44