Feasibility of sequential therapy with FOLFIRI followed by docetaxel/cisplatin in patients with radically resected gastric adenocarcinoma. A randomized phase III trial.
OBJECTIVE
Combination therapies of fluorouracil (FU) with irinotecan (CPT-11) and docetaxel plus cisplatin have been proven to be active in metastatic gastric cancer. In this paper, we present the results of a phase III trial in which these two combinations given sequentially were compared to mitomycin C (MMC) monochemotherapy in an adjuvant setting.


METHODS
169 patients with radically resected gastric cancer were randomized to receive CPT-11 (180 mg/m2 day 1), leucovorin (100 mg/m2 days 1-2), FU (400-600 mg/m2 days 1-2, q 14; for four cycles; FOLFIRI regimen), followed by docetaxel (85 mg/m2 day 1), cisplatin (75 mg/m2 day 1, q 21; for three cycles; arm A), or MMC (8 mg/m2 days 1-2 as 2-hour infusion, q 42; for four cycles; arm B). All patients had histologically confirmed gastric carcinoma with nodal positivity or pT3/4. A total of 166 patients (85 in arm A and 81 in arm B) were treated. Adjuvant treatment was completed in 76% of the patients in arm A and in 70% of the patients in arm B. The main grade 3/4 side effects recorded were neutropenia in 35%, with only 1 febrile patient, and diarrhea in 11% in arm A, and thrombocytopenia in 10% and neutropenia in 7% in arm B. The FOLFIRI regimen and docetaxel/cisplatin given in sequence was well tolerated and feasible in adjuvant setting. This sequence treatment currently represents the experimental arm of an ongoing multicenter trial.
Di Bartolomeo
Maria
M
Medical Oncology Unit 2, Fondazione IRCCS, Istituto Nazionale dei Tumori of Milano, Milano, Italia.
Buzzoni
Roberto
R
Mariani
Luigi
L
Ferrario
Erminia
E
Katia
Dotti
D
Gevorgyan
Arpine
A
Zilembo
Nicoletta
N
Bordonaro
Roberto
R
Bochicchio
Anna Maria
AM
Massidda
Bruno
B
Ardizzoia
Antonio
A
Ardizzoni
Antonio
A
Marini
Giovanni
G
Aitini
Enrico
E
Schieppati
Giuseppe
G
Comella
Giuseppe
G
Pinotti
Graziella
G
Palazzo
Salvatore
S
Cicero
Giovanni
G
Bajetta
Emilio
E
Villa
Eugenio
E
Fagnani
Daniele
D
Reguzzoni
Giorgio
G
Agostana
Biagio
B
Oliani
Cristina
C
Kildani
Basem
B
Duro
Maria
M
Botta
Mario
M
Mozzana
Ruggiero
R
Mantovani
Giovanni
G
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000601:surgery*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects / Q000379:methods; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003967:Diarrhea / Q000139:chemically induced; D013505:Digestive System Surgical Procedures; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D009503:Neutropenia / Q000139:chemically induced; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000601:surgery*; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
D043823:Taxoids; D000077143:Docetaxel; D016685:Mitomycin; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin