A Highly Active and Tolerable Neoadjuvant Regimen Combining Paclitaxel, Carboplatin, 5-FU, and Radiation Therapy in Patients with Stage II and III Esophageal Cancer

Abstract

Background: The present phase II study aimed to assess the feasibility and efficacy of a new paclitaxel-based neoadjuvant chemoradiation regimen followed by surgery in patients with stage II-III esophageal cancer.Methods: From January 2002 to November 2004, 50 patients with a potentially resectable stage II-III esophageal cancer received chemotherapy with paclitaxel, carboplatin, and 5-FU in combination with radiotherapy 45 Gy in 25 fractions. Surgery followed 6-8 weeks after completion of neoadjuvant treatment.Results: Patient characteristics: male/female: 44/6, median age 60 years (34-75), median WHO 1 (0-2), adenocarcinoma (n = 42), squamous cell carcinoma (n = 8). Toxicity was mild, and 84 % of the patients completed the whole regimen. Forty-seven patients underwent surgery with a curative intention (transhiatal n = 44, transthoracic n = 3). Pathologic complete tumor regression was achieved in 18 of 47 operated patients (38%). R0 resection was achieved in 45 of 47 operated patients (96%). There were four postoperative deaths (8.5). Postoperative complications were comparable with other studies. After a median follow-up of 41.5 months (21-59) estimated 3-and 5-year survival on an intention-to-treat basis was 56 and 48%. Estimated 3-year survival in responders was 61%, in nonresponders 33%.Conclusion: This novel neoadjuvant chemoradiation regimen for treatment of patients with stage II-III esophageal cancer is feasible. Results are encouraging with a high pathologic complete tumor regression and R0 resection rate and an acceptable morbidity and mortality. Preliminary survival data are very promising.

A Phase II Study of Concurrent Chemoradiotherapy With Paclitaxel and Cisplatin for Inoperable Esophageal Squamous Cell Carcinoma

“…[7][8][9][10][11][12][13][14] However, few studies revealing valid data on PTX involvement in definitive chemoradiation for locoregionally advanced esophageal cancer have yet been published. Thus, we carried out the study to observe the efficacy and toxicity of concurrent chemoradiation with PTX and DDP (TP regimen) in unresectable or inoperative local advanced esophageal cancer.…”

Improvement in survival for patients with synchronous metastatic esophageal cancer in the south of the Netherlands from 1994 to 2013

“…Since 2004 the use of chemoradiotherapy has increased [2]. In the past decade, several studies demonstrated that chemoradiotherapy in nonmetastatic disease resulted in a survival benefit and an impressive downsizing of the primary tumor [11,13,14]. In 2004 the Dutch CROSS trial started investigating the role of preoperative chemoradiotherapy with weekly administration of carboplatin (AUC 2) and paclitaxel (50 mg/m 2 ) during five weeks with concurrent radiotherapy (41.4 Gy, in 23 fractions, 5 days per week) [15].…”

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

“…20 In phase 2 studies using concomitant chemoradiotherapy with conventional schedule of paclitaxel, the pCR rate was mostly lower than 30% (range, 8%-41%). [21][22][23][24][25][26][27] Recent phase 1/2 and phase 2 studies tested the hypothesis that outcome and toxicity could be improved using innovative schedules based on weekly taxane administration and concomitant radiation [28][29][30][31][32][33] (Table 6).…”