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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
Author(s) -
Pasini Felice,
de Manzoni Giovanni,
Zai Andrea,
Grandinetti Antonio,
Capirci Carlo,
Pavarana Michele,
Tomezzoli Anna,
Rubello Domenico,
Cordiano Claudio
Publication year - 2012
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.27822
Subject(s) - medicine , docetaxel , fluorouracil , cisplatin , neutropenia , esophagus , radiation therapy , chemotherapy , phases of clinical research , esophageal cancer , neoadjuvant therapy , gastroenterology , adenocarcinoma , chemoradiotherapy , cancer , concomitant , surgery , breast cancer
BACKGROUND: 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.METHODS: 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/m 2 and cisplatin 25 mg/m 2 on days 1, 8, 15, 29, 36, 43, 50, and 57 plus 5‐FU c.i. (180 mg/m 2 on days 1‐21 and 150 mg/m 2 on days 29‐63); RT (50 Gy) started at day 29. Surgery was planned 6 to 8 weeks after the completion of chemoradiation.RESULTS: 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).CONCLUSIONS: 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.