TY - JOUR
T1 - Gemcitabine, paclitaxel, and cisplatin as induction chemotherapy for patients with biopsy-proven stage IIIA(N2) nonsmall cell lung carcinoma
T2 - A phase II multicenter study
AU - De Marinis, Filippo
AU - Nelli, Fabrizio
AU - Migliorino, Maria Rita
AU - Martelli, Olga
AU - Cortesi, Enrico
AU - Treggiari, Stefano
AU - Portalone, Luigi
AU - Crispino, Carlo
AU - Brancaccio, Luigi
AU - Gridelli, Cesare
PY - 2003/10/15
Y1 - 2003/10/15
N2 - BACKGROUND. The objective of the current study was to define the activity and tolerability, as well as the influence on resectability, of the combination of gemcitabine, paclitaxel, and cisplatin (GTP) as induction chemotherapy for patients with Stage IIIA(N2) nonsmall cell lung carcinoma (NSCLC). METHODS. Forty-nine chemotherapy-naïve patients (median age, 61 years; World Health Organization performance status, 0-1) with biopsy-proven Stage IIIA(N2) disease received 1000 mg/m2 gemcitabine, 125 mg/m2 paclitaxel, and 50 mg/m2 cisplatin on Days 1 and 8 of every 3 weeks until reevaluation for surgery or definitive radiotherapy. RESULTS. Grade 3-4 neutropenia was the most common hematologic toxicity, occurring in 32.7% of patients; however, only 1 case of febrile neutropenia was reported. Grade 3-4 thrombocytopenia occurred in 12.2% of patients but was not associated with bleeding. Severe nonhematologic toxicities were uncommon; the only Grade 4 nonhematologic toxicity was diarrhea, which occurred in 4% of patients. One patient died after the first course of therapy, but this event was found to be unrelated to treatment. Thirty-six patients (73.5%) achieved an objective response, and an additional 4 patients had stable disease with clearance of mediastinal lymph nodes. Overall, 29 patients underwent thoracotomy and 27 (55%) underwent complete resection. Mediastinal nodes were free of tumor in 35% of all cases, and 8 pathologic complete responses (16%) were reported. Median survival was 23 months, with a 1-year survival rate of 85%. CONCLUSIONS. GTP is highly active as an induction chemotherapy regimen for Stage IIIA(N2) NSCLC and yields good toxicity results. The use of GTP in combination with radiotherapy and new biologic drugs should be explored.
AB - BACKGROUND. The objective of the current study was to define the activity and tolerability, as well as the influence on resectability, of the combination of gemcitabine, paclitaxel, and cisplatin (GTP) as induction chemotherapy for patients with Stage IIIA(N2) nonsmall cell lung carcinoma (NSCLC). METHODS. Forty-nine chemotherapy-naïve patients (median age, 61 years; World Health Organization performance status, 0-1) with biopsy-proven Stage IIIA(N2) disease received 1000 mg/m2 gemcitabine, 125 mg/m2 paclitaxel, and 50 mg/m2 cisplatin on Days 1 and 8 of every 3 weeks until reevaluation for surgery or definitive radiotherapy. RESULTS. Grade 3-4 neutropenia was the most common hematologic toxicity, occurring in 32.7% of patients; however, only 1 case of febrile neutropenia was reported. Grade 3-4 thrombocytopenia occurred in 12.2% of patients but was not associated with bleeding. Severe nonhematologic toxicities were uncommon; the only Grade 4 nonhematologic toxicity was diarrhea, which occurred in 4% of patients. One patient died after the first course of therapy, but this event was found to be unrelated to treatment. Thirty-six patients (73.5%) achieved an objective response, and an additional 4 patients had stable disease with clearance of mediastinal lymph nodes. Overall, 29 patients underwent thoracotomy and 27 (55%) underwent complete resection. Mediastinal nodes were free of tumor in 35% of all cases, and 8 pathologic complete responses (16%) were reported. Median survival was 23 months, with a 1-year survival rate of 85%. CONCLUSIONS. GTP is highly active as an induction chemotherapy regimen for Stage IIIA(N2) NSCLC and yields good toxicity results. The use of GTP in combination with radiotherapy and new biologic drugs should be explored.
KW - Cisplatin
KW - Gemcitabine
KW - Induction chemotherapy
KW - Nonsmall cell lung carcinoma
KW - Paclitaxel
KW - Stage IIIA(N2)
UR - http://www.scopus.com/inward/record.url?scp=0141923858&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0141923858&partnerID=8YFLogxK
U2 - 10.1002/cncr.11662
DO - 10.1002/cncr.11662
M3 - Article
C2 - 14534888
AN - SCOPUS:0141923858
VL - 98
SP - 1707
EP - 1715
JO - Cancer
JF - Cancer
SN - 0008-543X
IS - 8
ER -