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Neoadjuvant therapy with weekly docetaxel and cisplatin, 5-fluorouracil continuous infusion, and concurrent radiotherapy in patients with locally advanced esophageal cancer produced a high percentage of long-lasting pathological complete response
A phase 2 study
Article first published online: 16 NOV 2012
Copyright © 2012 American Cancer Society
Volume 119, Issue 5, pages 939–945, 1 March 2013
How to Cite
Pasini, F., de Manzoni, G., Zanoni, A., Grandinetti, A., Capirci, C., Pavarana, M., Tomezzoli, A., Rubello, D. and Cordiano, C. (2013), Neoadjuvant therapy with weekly docetaxel and cisplatin, 5-fluorouracil continuous infusion, and concurrent radiotherapy in patients with locally advanced esophageal cancer produced a high percentage of long-lasting pathological complete response. Cancer, 119: 939–945. doi: 10.1002/cncr.27822
- Issue published online: 19 FEB 2013
- Article first published online: 16 NOV 2012
- Manuscript Accepted: 13 AUG 2012
- Manuscript Revised: 17 JUL 2012
- Manuscript Received: 5 JUN 2012
- esophageal cancer;
- weekly chemotherapy;
This phase 2 study was aimed at defining the pathological response rate of a neoadjuvant schedule including weekly docetaxel and cisplatin, continuous infusion (c.i.) of 5-fluorouracil (5-FU) and concomitant radiotherapy (RT) in untreated stage II-III adenocarcinoma and squamous cell carcinoma of mid-distal thoracic esophagus.
The schedule consisted of a first phase of chemotherapy alone and of a second phase of concurrent chemoradiation. Doses were as follows: docetaxel 35 mg/m2 and cisplatin 25 mg/m2 on days 1, 8, 15, 29, 36, 43, 50, and 57 plus 5-FU c.i. (180 mg/m2 on days 1-21 and 150 mg/m2 on days 29-63); RT (50 Gy) started at day 29. Surgery was planned 6 to 8 weeks after the completion of chemoradiation.
A total of 74 patients were enrolled; pathological complete remission (pCR) was found in 47% (35 of 74) and near pCR (microfoci of tumor cells on the primary tumor without lymph nodal metastases) (pnCR) in 15% of the patients (11 of 74). Grade 3-4 neutropenia, nonhematological toxicity, and toxic deaths occurred in 13.5%, 32.4%, and 4% of the patients, respectively. Median follow-up was 55 months (range, 3-108 months). Median survival of all 74 patients was 55 months, whereas it was not reached in the pCR subset. The 3- and 5-year survival rates were, respectively, 83% and 77% for pCR, 73% and 44% for pnCR, and 21% and 14% for Residual Tumor subsets (P < .001).
This study shows that 1) this intensive weekly schedule produced a high pathological response rate, 2) responders had high and long-term durable survival rates. Cancer 2013. © 2012 American Cancer Society.