Premium
Sequential combination chemotherapy in patients with advanced nonsmall cell lung carcinoma
Author(s) -
Edelman Martin J.,
Gandara David R.,
Lau Derrick H. M.,
Lara Primo,
Lauder I. Jun,
Tracy Deborah
Publication year - 2001
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(20010701)92:1<146::aid-cncr1302>3.0.co;2-n
Subject(s) - medicine , carboplatin , gemcitabine , chemotherapy , gastroenterology , survival rate , progressive disease , lung cancer , carcinoma , malignant pleural effusion , surgery , pleural effusion , stage (stratigraphy) , cisplatin , paleontology , biology
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/m 2 on Days 1 and 8 every 21 days followed by three cycles of paclitaxel 225 mg/m 2 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. Cancer 2001;92:146–52. Published 2001 American Cancer Society.