Preoperative versus postoperative docetaxel–cisplatin–fluorouracil (TCF) chemotherapy in locally advanced resectable gastric carcinoma: 10-year follow-up of the SAKK 43/99 phase III trial
| Autor: | Giuseppe Renne, Sandra Thierstein, Ugo Pace, S. Cenciarelli, M.G. Zampino, Bruno Andreoni, M. Matter, Simonetta Pozzi, Arnaud Roth, F. de Braud, S. Mura, A. Goldhirsch, Olivier Huber, S. Boselli, Cristiano Crosta, G. Di Meglio, Juerg Bernhard, Roger Stupp, Stefanie Hayoz, Rudolf Maibach, Christian Dittrich, Peter Brauchli, Fabrizio Luca, M. Richter, Nicola Fazio, S. Monfardini, Antonio Chiappa, Rudolf Morant, Davide Ravizza, Emilio Bertani, Roberto Biffi, M. Häfner, K. Lorizzo, M. Clemens |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
0301 basic medicine medicine.medical_specialty Adolescent medicine.medical_treatment Docetaxel Adenocarcinoma Disease-Free Survival 03 medical and health sciences 0302 clinical medicine Gastrectomy Stomach Neoplasms Antineoplastic Combined Chemotherapy Protocols medicine Humans Postoperative Period Perioperative Period Neoadjuvant therapy Aged Chemotherapy Taxane business.industry Hematology Perioperative Middle Aged Chemotherapy regimen Neoadjuvant Therapy Surgery Regimen Treatment Outcome 030104 developmental biology Oncology Fluorouracil 030220 oncology & carcinogenesis Taxoids Cisplatin business medicine.drug |
| Zdroj: | Annals of Oncology. 27:668-673 |
| ISSN: | 0923-7534 |
| Popis: | Background Fluorouracil-based adjuvant chemotherapy in gastric cancer has been reported to be effective by several meta-analyses. Perioperative chemotherapy in locally advanced resectable gastric cancer (RGC) has been reported improving survival by two large randomized trials and recent meta-analyses but the role of neoadjuvant chemotherapy and optimal regimen remains to be determined. We compared a neoadjuvant with adjuvant docetaxel-based regimen in a prospective randomized phase III trial, of which we present the 10-year follow-up data. Patients and methods Patients with cT3–4 anyN M0 or anyT cN1–3 M0 gastric carcinoma, staged with endoscopic ultrasound, computed tomography, bone scan, and laparoscopy, were assigned to receive four 21-day/cycles of docetaxel 75 mg/m2 day 1, cisplatin 75 mg/m2 day 1, and fluorouracil 300 mg/m2/day over days 1–14, either before (arm A) or after (arm B) gastrectomy. Event-free survival was the primary end point, whereas secondary end points included overall survival, toxicity, down-staging, pathological response, quality of life, and feasibility of adjuvant chemotherapy. Results This trial was activated in November 1999 and closed in November 2005 due to insufficient accrual. Of the 70 enrolled patients, 69 were randomized, 34 to arm A and 35 to arm B. No difference in EFS (2.5 years in both arms) or OS (4.3 versus 3.7 years, in arms A and B, respectively) was found. A higher dose intensity of chemotherapy was observed in arm A and more frequent chemotherapy-related serious adverse events occurred in arm B. Surgery was safe after preoperative chemotherapy. A 12% pathological complete response was observed in arm A. Conclusion Docetaxel/cisplatin/fluorouracil chemotherapy is promising in preoperative setting of locally advanced RGC. The early stopping could mask the real effectiveness of neoadjuvant treatment. However, the complete pathological tumour responses, feasibility, and safe surgery warrant further investigation of a taxane-based regimen in the preoperative setting. |
| Databáze: | OpenAIRE |
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