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Randomized Controlled Trial
. 2010 Feb 21;16(7):868-74.
doi: 10.3748/wjg.v16.i7.868.

Surgical outcome after docetaxel-based neoadjuvant chemotherapy in locally-advanced gastric cancer

Affiliations
Randomized Controlled Trial

Surgical outcome after docetaxel-based neoadjuvant chemotherapy in locally-advanced gastric cancer

Roberto Biffi et al. World J Gastroenterol. .

Abstract

Aim: To investigate feasibility, morbidity and surgical mortality of a docetaxel-based chemotherapy regimen randomly administered before or after gastrectomy in patients suffering from locally-advanced resectable gastric cancer.

Methods: Patients suffering from locally-advanced (T3-4 any N M0 or any T N1-3 M0) gastric carcinoma, staged with endoscopic ultrasound, bone scan, computed tomography, and laparoscopy, were assigned to receive four 21 d/cycles of TCF (docetaxel 75 mg/m(2) day 1, cisplatin 75 mg/m(2) day 1, and fluorouracil 300 mg/m(2) per day for days 1-14), either before (Arm A) or after (Arm B) gastrectomy. Operative morbidity, overall mortality, and severe adverse events were compared by intention-to-treat analysis.

Results: From November 1999 to November 2005, 70 patients were treated. After preoperative TCF (Arm A), thirty-two (94%) resections were performed, 85% of which were R0. Pathological response was complete in 4 patients (11.7%), and partial in 18 (55%). No surgical mortality and 28.5% morbidity rate were observed, similar to those of immediate surgery arm (P = 0.86). Serious chemotherapy adverse events tended to be more frequent in arm B (23% vs 11%, P = 0.07), with a single death per arm.

Conclusion: Surgery following docetaxel-based chemotherapy was safe and with similar morbidity to immediate surgery in patients with locally-advanced resectable gastric carcinoma.

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Figure 1
Trial profile conforming to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.

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