A randomized phase III study of adjuvant platinum/docetaxel chemotherapy with or without radiation therapy in patients with gastric cancer.
Title | A randomized phase III study of adjuvant platinum/docetaxel chemotherapy with or without radiation therapy in patients with gastric cancer. |
Publication Type | Journal Article |
Year of Publication | 2010 |
Authors | Bamias, A., Karina M., Papakostas P., Kostopoulos I., Bobos M., Vourli G., Samantas E., Christodoulou C., Pentheroudakis G., Pectasides D., Dimopoulos M. A., & Fountzilas G. |
Journal | Cancer Chemother Pharmacol |
Volume | 65 |
Issue | 6 |
Pagination | 1009-21 |
Date Published | 2010 May |
ISSN | 1432-0843 |
Keywords | Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Carboplatin, Chemotherapy, Adjuvant, Cisplatin, Combined Modality Therapy, Diarrhea, Female, Humans, Immunohistochemistry, Kaplan-Meier Estimate, Male, Middle Aged, Neutropenia, Prognosis, Receptor, Epidermal Growth Factor, Receptor, ErbB-2, Stomach Neoplasms, Taxoids, Tissue Array Analysis, Treatment Outcome, Tumor Markers, Biological |
Abstract | The optimal adjuvant treatment for gastric cancer remains controversial. We compared the efficacy of a docetaxel and platinum adjuvant chemotherapy regimen, in patients with high-risk gastric cancer, with that of the same chemotherapy plus radiation therapy (RT). In addition, we evaluated the prognostic and/or predictive value of a panel of molecular markers. Patients with histologically proven, radically resected gastric cancer, stage > or =T3 and/or N+ were randomized to 6 cycles of docetaxel with cisplatin, both at 75 mg/m2 every 3 weeks (arm A) or the same treatment with RT (arm B; 45 Gy). Due to excessive nausea and vomiting, cisplatin was substituted by carboplatin at AUC (area under the curve) of 5 after the first 45 patients (22 group A, 23 group B). The prognostic value of EGFR, ERCC1, HER2, MET/HGFR, MAP-Tau, and PTEN expression was also studied in a subset of 67 patients using immunohistochemistry on tissue microarrays (TMAs). A total of 147 patients were randomized. After a median follow-up of 53.7 months, no differences in overall (OS) and disease-free survival (DFS) were found between the two arms. The most common grade 3/4 toxicities for arms A and B (excluding alopecia) were non-febrile neutropenia (11 and 17%, respectively), febrile neutropenia (9 and 7%) and diarrhea (7 and 4%, respectively). Patients with ERCC1 positive tumors had significantly longer median DFS (33.1 vs. 11.8 months, Wald P = 0.016) and OS (63.2 vs. 18.8 months, Wald P = 0.046). Our results indicate that the addition of RT to platinum/docetaxel adjuvant chemotherapy does not appear to improve survival in high-risk, radically resected gastric cancer. However, the possibility that a benefit by the addition of RT was not detected due to decreased power of the study should not be excluded. |
DOI | 10.1007/s00280-010-1256-6 |
Alternate Journal | Cancer Chemother. Pharmacol. |
PubMed ID | 20130877 |