TY - JOUR
T1 - Sequential combination chemotherapy in patients with advanced nonsmall cell lung carcinoma
T2 - Carboplatin and gemcitabine followed by paclitaxel
AU - Edelman, Martin J.
AU - Gandara, David R.
AU - Lau, Derrick H.M.
AU - Lara, Primo
AU - Jun Lauder, I.
AU - Tracy, Deborah
PY - 2001/7/1
Y1 - 2001/7/1
N2 - BACKGROUND. The objective of this Phase II study was to evaluate the concept of sequential chemotherapy in the treatment of patients with advanced nonsmall cell lung carcinoma (NSCLC) by the administration of carboplatin plus gemcitabine followed by of paclitaxel. METHODS. Patients with Stage IIIB (pleural effusion) or Stage IV NSCLC and a Southwest Oncology Group (SWOG) performance status (PS) of 0-2 were eligible. Therapy consisted of three cycles of carboplatin (area under the concentration-time curve = 5.5 mg/mL per minute) on Day 1 and gemcitabine 1000 mg/m2 on Days 1 and 8 every 21 days followed by three cycles of paclitaxel 225 mg/m2 every 21 days. RESULTS. Of the 37 eligible patients, 81% had Stage IV disease, and 27% had a PS of 2; all were assessable for survival and toxicity; 32 patients were assessable for response. After treatment with carboplatin plus gemcitabine, there were no complete responses (CRs) and eight partial responses (PRs) (response rate [RR], 25%; 95% confidence interval [95% CI], 11-43%). The best overall response was two CRs and eight PRs (RR, 31%; 95% CI, 16-50%). The median survival time was 9.5 months, the 1-year survival rate was 36% (95% CI, 26-44%), the 2-year survival rate was 11% (95% CI, 3-25%), and the median time to disease progression was 4.9 months. The median survivals were 11.2 months for patients with a PS of 0-1 and 6.4 months for patients with a PS of 2. Noncumulative, reversible thrombocytopenia was the principal toxicity with carboplatin/gemcitabine therapy. Paclitaxel therapy was well tolerated, and moderate (Grade 3) neutropenia was the primary toxic effect. One cardiac death occurred, possibly related to paclitaxel. CONCLUSIONS. This study is the first to evaluate planned sequential chemotherapy in patients with NSCLC. Carboplatin plus gemcitabine followed by paclitaxel was well tolerated and resulted in promising survival in this patient population. This pilot experience forms the basis for an ongoing SWOG trial.
AB - BACKGROUND. The objective of this Phase II study was to evaluate the concept of sequential chemotherapy in the treatment of patients with advanced nonsmall cell lung carcinoma (NSCLC) by the administration of carboplatin plus gemcitabine followed by of paclitaxel. METHODS. Patients with Stage IIIB (pleural effusion) or Stage IV NSCLC and a Southwest Oncology Group (SWOG) performance status (PS) of 0-2 were eligible. Therapy consisted of three cycles of carboplatin (area under the concentration-time curve = 5.5 mg/mL per minute) on Day 1 and gemcitabine 1000 mg/m2 on Days 1 and 8 every 21 days followed by three cycles of paclitaxel 225 mg/m2 every 21 days. RESULTS. Of the 37 eligible patients, 81% had Stage IV disease, and 27% had a PS of 2; all were assessable for survival and toxicity; 32 patients were assessable for response. After treatment with carboplatin plus gemcitabine, there were no complete responses (CRs) and eight partial responses (PRs) (response rate [RR], 25%; 95% confidence interval [95% CI], 11-43%). The best overall response was two CRs and eight PRs (RR, 31%; 95% CI, 16-50%). The median survival time was 9.5 months, the 1-year survival rate was 36% (95% CI, 26-44%), the 2-year survival rate was 11% (95% CI, 3-25%), and the median time to disease progression was 4.9 months. The median survivals were 11.2 months for patients with a PS of 0-1 and 6.4 months for patients with a PS of 2. Noncumulative, reversible thrombocytopenia was the principal toxicity with carboplatin/gemcitabine therapy. Paclitaxel therapy was well tolerated, and moderate (Grade 3) neutropenia was the primary toxic effect. One cardiac death occurred, possibly related to paclitaxel. CONCLUSIONS. This study is the first to evaluate planned sequential chemotherapy in patients with NSCLC. Carboplatin plus gemcitabine followed by paclitaxel was well tolerated and resulted in promising survival in this patient population. This pilot experience forms the basis for an ongoing SWOG trial.
KW - Aged
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
KW - Carboplatin/administration & dosage
KW - Carcinoma, Non-Small-Cell Lung/drug therapy
KW - Deoxycytidine/administration & dosage
KW - Female
KW - Gemcitabine
KW - Humans
KW - Lung Neoplasms/drug therapy
KW - Male
KW - Middle Aged
KW - Neoplasm Staging
KW - Paclitaxel/administration & dosage
KW - Pilot Projects
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=0037094092&partnerID=8YFLogxK
U2 - 10.1002/1097-0142(20010701)92:1<146::AID-CNCR1302>3.0.CO;2-N
DO - 10.1002/1097-0142(20010701)92:1<146::AID-CNCR1302>3.0.CO;2-N
M3 - Article
C2 - 11443620
SN - 0008-543X
VL - 92
SP - 146
EP - 152
JO - Cancer
JF - Cancer
IS - 1
ER -
