Multicenter phase II trial of preoperative induction chemotherapy followed by chemoradiation with docetaxel and cisplatin for locally advanced esophageal carcinoma (SAKK 75/02).
BACKGROUND
This multicenter phase II study investigated the efficacy and feasibility of preoperative induction chemotherapy followed by chemoradiation and surgery in patients with esophageal carcinoma.


METHODS
Patients with locally advanced resectable squamous cell carcinoma or adenocarcinoma of the esophagus received induction chemotherapy with cisplatin 75 mg/m(2) and docetaxel (Taxotere) 75 mg/m(2) on days 1 and 22, followed by radiotherapy of 45 Gy (25 x 1.8 Gy) and concurrent chemotherapy comprising cisplatin 25 mg/m(2) and docetaxel 20 mg/m(2) weekly for 5 weeks, followed by surgery.


RESULTS
Sixty-six patients were enrolled at eleven centers and 57 underwent surgery. R0 resection was achieved in 52 patients. Fifteen patients showed complete, 16 patients nearly complete and 26 patients poor pathological remission. Median overall survival was 36.5 months and median event-free survival was 22.8 months. Squamous cell carcinoma and good pathologically documented response were associated with longer survival. Eighty-two percent of all included patients completed neoadjuvant therapy and survived for 30 days after surgery. Dysphagia and mucositis grade 3/4 were infrequent (<9%) during chemoradiation. Five patients (9%) died due to surgical complications.


CONCLUSIONS
This neoadjuvant, taxane-containing regimen was efficacious and feasible in patients with locally advanced esophageal cancer in a multicenter, community-based setting and represents a suitable backbone for further investigation.
Ruhstaller
T
T
Department of Oncology and Hematology, Kantonsspital, St Gallen, St Gallen. Electronic address: thomas.ruhstaller@kssg.ch.
Widmer
L
L
Department of Oncology, Triemlispital Zurich, Zurich.
Schuller
J C
JC
Coordination Center, SAKK Bern, Bern.
Roth
A
A
Oncosurgery, Department of Surgery, University Hospital of Geneva, Geneva.
Hess
V
V
Division of Medical Oncology, Department of Internal Medicine, University Hospital of Basel, Basel.
Mingrone
W
W
Department of Oncology and Hematology, Kantonsspital Aarau, Aarau.
von Moos
R
R
Department of Medical Oncology and Hematology, Kantonsspital Graubünden, Chur.
Borner
M
M
Institute of Medical Oncology, Inselspital Bern, Bern.
Pestalozzi
B C
BC
Department of Oncology, University Hospital of Zurich, Zurich.
BalmerMajno
S
S
Department of Radiation Oncology, University Hospital of Geneva, Geneva.
Köberle
D
D
Department of Oncology and Hematology, Kantonsspital, St Gallen, St Gallen.
Terraciano
L
L
Institute of Pathology, University Hospital of Basel, Basel.
Schnider
A
A
Department of Surgery, Triemlispital Zurich, Zurich.
Bodis
S
S
Institute for Radio-Oncology, Kantonsspital Aarau, Aarau.
Popescu
R
R
Tumor Center, Hirslanden Clinic Aarau, Aarau, Switzerland.
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002277:Carcinoma / Q000401:mortality / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D013505:Digestive System Surgical Procedures; D000077143:Docetaxel; D004938:Esophageal Neoplasms / Q000401:mortality / Q000628:therapy*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D011878:Radiotherapy; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin