Phase II trial of preoperative irinotecan-cisplatin followed by concurrent irinotecan-cisplatin and radiotherapy for resectable locally advanced gastric and esophagogastric junction adenocarcinoma.

Abstract

PURPOSE:

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).

PATIENTS AND 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.

• Authors: Fernando Rivera, Maica Galán, Josep Tabernero, Andres Cervantes, M Eugenia Vega-Villegas, Javier Gallego, Berta Laquente, Edith Rodríguez, Alfredo Carrato, Pilar Escudero, Bartomeu Massutí, Vicente Alonso-Orduña, Adelaida Cardenal, Alberto Sáenz, Jordi Giralt, Ana Lucia Yuste, Antonio Antón, Enrique Aranda, Spanish Cooperative Group for Digestive Tumor Therapy
• Journal: International journal of radiation oncology, biology, physics (Int J Radiat Oncol Biol Phys) Vol. 75 Issue 5 Pg. 1430-6 (Dec 01 2009) ISSN: 1879-355X [Electronic] United States
• PMID: 19540072 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Irinotecan
• Cisplatin
• Camptothecin

Topics

• Adenocarcinoma (drug therapy, pathology, radiotherapy, surgery)
• Algorithms
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Camptothecin (administration & dosage, adverse effects, analogs & derivatives)
• Cisplatin (administration & dosage, adverse effects)
• Combined Modality Therapy (adverse effects, methods)
• Drug Administration Schedule
• Esophageal Neoplasms (drug therapy, pathology, radiotherapy, surgery)
• Esophagogastric Junction
• Humans
• Irinotecan
• Preoperative Period
• Prospective Studies
• Remission Induction
• Spain
• Stomach Neoplasms (drug therapy, pathology, radiotherapy, surgery)
• Survival Rate