Does paclitaxel improve the chemoradiotherapy of locoregionally advanced esophageal cancer? A nonrandomized comparison with fluorouracil-based therapy.
OBJECTIVE
A phase II trial of accelerated fractionation radiation with concurrent cisplatin and paclitaxel chemotherapy was performed to investigate the role of the paclitaxel, when substituted for fluorouracil (5-FU), in the chemoradiotherapy of esophageal cancer.


METHODS
Patients with an esophageal ultrasound stage of T(3) or N(1) or M(1) (nodal) esophageal cancer were treated with two courses of a cisplatin infusion (20 mg/m(2)/d for 4 days) and paclitaxel (175 mg/m(2) over 24 hours) concurrent with a split course of accelerated fractionation radiation (1.5 Gy bid to a total dose of 45 Gy). Surgical resection was performed 4 to 6 weeks later followed by a single identical postoperative course of chemoradiotherapy (24 Gy) in patients with significant residual tumor at surgery. Toxicity and results of this treatment were retrospectively compared with our previous 5-FU and cisplatin chemoradiotherapy experience.


RESULTS
Between September 1995 and July 1997, 40 patients were entered onto this study. Although dysphagia proved worse in our 5-FU-treated patients, profound leukopenia and a need for unplanned hospitalization were significantly more common in the paclitaxel group. Thirty-seven patients (93%) proved resectable for cure. The 3-year projected overall survival is 30%, locoregional control is 81%, and distant metastatic disease control is 44%. When compared with a similarly staged cohort of 5-FU-treated patients, there was no advantage for any survival function studied.


CONCLUSIONS
This paclitaxel-based treatment regimen for locoregionally advanced esophageal cancer produced increased toxicity with no improvement in results when compared with our previous 5-FU experience. Paclitaxel-based treatments must be carefully and prospectively studied before their incorporation into the standard management of esophageal cancer.
Adelstein
D J
DJ
Departments of Hematology and Medical Oncology, Thoracic and Cardiovascular Surgery, Biostatistics and Epidemiology, Radiation Oncology, and Gastroenterology, The Cleveland Clinic Foundation, Cleveland, OH 44195, USA. adelstd@ccf.org
Rice
T W
TW
Rybicki
L A
LA
Larto
M A
MA
Ciezki
J
J
Saxton
J
J
DeCamp
M
M
Vargo
J J
JJ
Dumot
J A
JA
Zuccaro
G
G
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D018450:Disease Progression; D019583:Dose Fractionation, Radiation; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D011379:Prognosis; D011838:Radiation-Sensitizing Agents / Q000627:therapeutic use*; D012189:Retrospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome
D011838:Radiation-Sensitizing Agents; D017239:Paclitaxel; D002945:Cisplatin; D005472:Fluorouracil