Phase II trial of preoperative irinotecan-cisplatin followed by concurrent irinotecan-cisplatin and radiotherapy for resectable locally advanced gastric and esophagogastric junction adenocarcinoma.
OBJECTIVE
To determine in a Phase II trial whether preoperative irinotecan-cisplatin (IC) followed by concurrent IC therapy and radiotherapy (IC/RT) improved outcome in patients with resectable, locally advanced gastric adenocarcinoma (GC) or esophagogastric junction cancer (EGJC).


METHODS
Patients with resectable Stage II-IV, M0 GC or EGJC made up the study population. The primary endpoint was pathologic complete response (pCR). Two courses of IC (irinotecan, 65 mg/m(2); cisplatin, 30 mg/m(2) on Days 1 and 8 every 21 days) were given. Patients without progression then received IC/RT, consisting of daily radiotherapy (45Gy) with concurrent IC (irinotecan, 65 mg/m(2); cisplatin, 30 mg/m(2) on Days 1, 8, 15, and 22). Surgical resection was performed, if feasible, 5-8 weeks after the end of radiotherapy.


RESULTS
Twenty-three patients were included in the study: 10 with EGJC and 13 with GC. Two patients (9%) achieved pCR. The incidences of Grade 3-4 toxicities were as follows: IC: neutropenia 35% (febrile 13%), anemia 22%, diarrhea 22%, emesis 8%; IC/RT: neutropenia 52% (febrile 5%), asthenia 19%, anemia 9%, emesis 9%, diarrhea 5%, cardiotoxicity 5%. No patients died during IC or IC/RT. R0 resection was achieved in 15 patients (65%). Median survival was 14.5 months, and the actuarial 2-year survival rate was 35%.


CONCLUSIONS
Preoperative IC followed by IC/RT resulted in moderate response and resection rates with mild toxicity in patients with GC and EGJC.
Rivera
Fernando
F
Department of Medical Oncology, Hospital Universitario Marqués de Valdecilla, Santander, Spain. oncrhf@humv.es
Galán
Maica
M
Tabernero
Josep
J
Cervantes
Andres
A
Vega-Villegas
M Eugenia
ME
Gallego
Javier
J
Laquente
Berta
B
Rodríguez
Edith
E
Carrato
Alfredo
A
Escudero
Pilar
P
Massutí
Bartomeu
B
Alonso-Orduña
Vicente
V
Cardenal
Adelaida
A
Sáenz
Alberto
A
Giralt
Jordi
J
Yuste
Ana Lucia
AL
Antón
Antonio
A
Aranda
Enrique
E
D000230:Adenocarcinoma / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D000465:Algorithms; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy / Q000009:adverse effects / Q000379:methods; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D004943:Esophagogastric Junction; D006801:Humans; D000077146:Irinotecan; D057234:Preoperative Period; D011446:Prospective Studies; D012074:Remission Induction; D013030:Spain; D013274:Stomach Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D015996:Survival Rate
D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin