In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 24, No. 18_suppl ( 2006-06-20), p. 4068-4068
Abstract:
4068 Background: Docetaxel is increasingly integrated into chemotherapy combination regimens against gastric cancer. Docetaxel and 5-FU were compared to ECF and appeared to be very active and well tolerated (Thuss-Patience et. al. JCO 2005). In the current study the dual combination capecitabine and docetaxel (CapDoc) is evaluated to develop a convenient out-patient regimen with minimal toxicity. Methods: Prospective multicenter phase II trial. Eligibility: Metastatic or locally advanced gastro-esophageal junction or gastric adenocarcinoma, ECOG PS 0–2, no prior palliative chemotherapy. Chemotherapy: Docetaxel 75 mg/m 2 d1, capecitabine 2000 mg/m 2 d1–14, q3w. For part I of the study (presented here) accrual is completed (40 pts). In part II we reduced the starting dose of docetaxel to 60 mg/m 2 and capecitabine to 1600 mg/m 2 to further improve tolerability (accrual ongoing, 8 pts included so far, presented at meeting). Results: 40 pts are included in this trial (part I). Age: 32–79 years (median 61), M/F 29/11, ECOG PS 0: 7 pts, 1: 27 pts, 2: 6 pts. Number of organs involved by metastases: 1: 9 pts, 2: 11 pts, 3: 16 pts, more than 3: 4 pts. Measurable disease (RECIST): 40 pts. 233 cycles of chemotherapy are administered so far. Toxicity: 40 pts are evaluable for toxicity (worst grade per patient; % of pts): Grade 1/2/3/4: Nausea: 53/10/3/- %, vomiting: 18/13/-/3 %, diarrhea: 23/20/13/- %, asthenia: 38/40/10/- %, stomatitis: 23/15/10/- %, alopecia: 25/53/-/- %, fever not neutropenic: 10/20/3/- %, neutropenic fever: -/-/10/3 %, nail changes: 33/28/-/- %, paresthesia: 18/18/5/- %, dizziness: 15/8/5/- %, hand-foot-syndrome: 25/18/18/- %, leuko-neutropenia: 8/13/25/28 %, thrombocytopenia: 18/-/-/- %, anemia: 40/15/5/- %, fluid retention: 13/5/-/-, pulmonary embolism or thrombosis: 3/5/3/5. Dose adjustments of docetaxel had to be made in 45% and of capecitabine in 55% of pts. Response: 26 of 37 pts with tumor related symptoms showed a subjective improvement of symptoms (70.3%). 38 pts are evaluable for objective response: CR 1 pt (2.6%), PR 20 pts (52.6%), NC 14 pts (36.8%), PD 3 pts (7.9%), (objective response rate: 55.3%). Median time to tumor progression 5.5 months, median survival 9.5 months. Conclusion: These data suggest that CapDoc is a well tolerated convenient out-patient combination with very promising efficacy. [Table: see text]
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2006.24.18_suppl.4068
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2006
detail.hit.zdb_id:
2005181-5
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