Docetaxel (Taxotere®)-cisplatin (TC):: An effective drug combination in gastric carcinoma

被引:169
作者
Roth, AD
Maibach, R
Martinelli, G
Fazio, N
Aapro, MS
Pagani, O
Morant, R
Borner, MM
Herrmann, R
Honegger, H
Cavalli, F
Alberto, P
Castiglione, M
Goldhirsch, A
机构
[1] Hop Cantonal Univ Geneva, Dept Surg, Geneva, Switzerland
[2] SIAK Coordinating Ctr, Bern, Switzerland
[3] European Inst Oncol, Milan, Italy
[4] Osped San Giovanni, Div Oncol, Bellinzona, Switzerland
[5] Kantonsspital, Dept Med C, Div Oncol, St Gallen, Switzerland
[6] Univ Bern, Inselspital, Inst Med Oncol, CH-3010 Bern, Switzerland
[7] Kantonsspital, Dept Med, Div Oncol, CH-4031 Basel, Switzerland
[8] Stadtspital Triemli, Inst Oncol & Haematol, Zurich, Switzerland
[9] Hop Cantonal Univ Geneva, Dept Med, Div Oncol, Geneva, Switzerland
[10] Osped Civ, Div Oncol, Lugano, Switzerland
关键词
chemotherapy; docetaxel; gastric cancer;
D O I
10.1023/A:1008342013224
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: A multi-centric trial was performed to explore the clinical activity, in terms of response and toxicity (primary objectives), duration of response and survival (secondary objectives), of docetaxel with cisplatin in advanced gastric cancer (AGC). Patients and methods: Patients with measurable unresectable and/or metastatic gastric carcinoma, performance status less than or equal to 1, normal hematological, hepatic and renal functions and not pretreated for advanced disease by chemotherapy received up to eight cycles of TC (docetaxel 85 mg/m(2) d1, cisplatin 75 mg/m(2) d1) q3w. Dose escalation to 100 mg/m(2) was performed in five patients and was discontinued for excessive toxicity. Results: Forty-eight patients were accrued. A median of 5 cycles/patient was given. We observed 2 complete and 25 partial responses for an overall intent to treat response rate of 56% (95% CI: 41%-71%). Twelve patients had stable disease for greater than or equal to 9 weeks (3 cycles). The median time to progression and overall survival were 6.6 and 9 months, respectively. Grade greater than or equal to 3 toxicities were neutropenia 81%, anemia 32%, thrombocytopenia 4%, alopecia 36%, fatigue 9%, mucositis 9%, diarrhea 6%, nausea/vomiting 4%, neurologic 2%, and one anaphylaxis precluding treatment administration. We recorded nine episodes of non-fatal febrile neutropenia in eight patients, two of them with docetaxel at 100 mg/m(2). There were no direct treatment-related deaths. Conclusions: TC is active in AGC with a high response rate in a multicentric trial. Despite its hematotoxicity, this regimen is well tolerated and can be recycled as originally planned in 78% of the cases. These results may serve as basis for further developments of docetaxel containing regimens in this disease.
引用
收藏
页码:301 / 306
页数:6
相关论文
共 44 条
[1]  
Bamias A, 1996, CANCER, V77, P1978, DOI 10.1002/(SICI)1097-0142(19960515)77:10<1978::AID-CNCR3>3.0.CO
[2]  
2-D
[3]   Intensive weekly chemotherapy for advanced gastric cancer using fluorouracil, cisplatin, epi-doxorubicin, 6S-leucovorin, glutathione, and filgrastim: A report from the Italian group for the study of digestive tract cancer [J].
Cascinu, S ;
Labianca, R ;
Alessandroni, P ;
Marcellini, M ;
Silva, RR ;
Pancera, G ;
Testa, E ;
Martignoni, G ;
Barni, S ;
Frontini, L ;
Zaniboni, A ;
Luporini, G ;
Cellerino, R ;
Catalano, G .
JOURNAL OF CLINICAL ONCOLOGY, 1997, 15 (11) :3313-3319
[4]   DOCETAXEL (TAXOTERE(R)) - AN ACTIVE-DRUG FOR THE TREATMENT OF PATIENTS WITH ADVANCED SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK [J].
CATIMEL, G ;
VERWEIJ, J ;
MATTIJSSEN, V ;
HANAUSKE, A ;
PICCART, M ;
WANDERS, J ;
FRANKLIN, H ;
LEBAIL, N ;
CLAVEL, M ;
KAYE, SB .
ANNALS OF ONCOLOGY, 1994, 5 (06) :533-537
[5]   FLUOROURACIL, DOXORUBICIN, AND MITOMYCIN COMBINATION VERSUS PELF CHEMOTHERAPY IN ADVANCED GASTRIC-CANCER - A PROSPECTIVE RANDOMIZED TRIAL OF THE ITALIAN-ONCOLOGY-GROUP-FOR-CLINICAL-RESEARCH [J].
COCCONI, G ;
BELLA, M ;
ZIRONI, S ;
ALGERI, R ;
DICOSTANZO, F ;
DELISI, V ;
LUPPI, G ;
MAZZOCCHI, B ;
RODINO, C ;
SOLDANI, M ;
GILLI, G ;
FINARDI, C .
JOURNAL OF CLINICAL ONCOLOGY, 1994, 12 (12) :2687-2693
[6]   CONTROLLED EVALUATION OF 3 DRUG-COMBINATION REGIMENS VERSUS FLUOROURACIL ALONE FOR THE THERAPY OF ADVANCED GASTRIC-CANCER [J].
CULLINAN, SA ;
MOERTEL, CG ;
WIEAND, HS ;
OCONNELL, MJ ;
POON, MA ;
KROOK, JE ;
MAILLIARD, JA ;
TSCHETTER, LK .
JOURNAL OF CLINICAL ONCOLOGY, 1994, 12 (02) :412-416
[7]   Phase II trial of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy: The eastern cooperative oncology group (ECOG) results of protocol E1293 [J].
Einzig, AI ;
Neuberg, D ;
Remick, SC ;
Karp, DD ;
ODwyer, PJ ;
Stewart, JA ;
Benson, AB .
MEDICAL ONCOLOGY, 1996, 13 (02) :87-93
[8]   A PHASE-II STUDY IN ADVANCED GASTROESOPHAGEAL CANCER USING EPIRUBICIN AND CISPLATIN IN COMBINATION WITH CONTINUOUS-INFUSION 5-FLUOROURACIL (ECF) [J].
FINDLAY, M ;
CUNNINGHAM, D ;
NORMAN, A ;
MANSI, J ;
NICOLSON, M ;
HICKISH, T ;
NICOLSON, V ;
NASH, A ;
SACKS, N ;
FORD, H ;
CARTER, R ;
HILL, A .
ANNALS OF ONCOLOGY, 1994, 5 (07) :609-616
[9]   PHASE-II TRIAL OF DOCETAXEL IN PATIENTS WITH STAGE-III AND STAGE-IV NON-SMALL-CELL LUNG-CANCER [J].
FRANCIS, PA ;
RIGAS, JR ;
KRIS, MG ;
PISTERS, KMW ;
ORAZEM, JP ;
WOOLLEY, KJ ;
HEELAN, RT .
JOURNAL OF CLINICAL ONCOLOGY, 1994, 12 (06) :1232-1237
[10]   Chemotherapy for advanced gastric cancer: Where do we stand? [J].
Fuchs, CS .
JOURNAL OF CLINICAL ONCOLOGY, 1997, 15 (11) :3299-3300