Sequential combination chemotherapy in patients with advanced nonsmall cell lung carcinoma: Carboplatin and gemcitabine followed by paclitaxel

Martin J. Edelman, David R Gandara, Derick H Lau, Primo N Lara, I. Jun Lauder, Deborah Tracy

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)146-152
Number of pages7
JournalCancer
Volume92
Issue number1
DOIs
StatePublished - Jul 1 2001

Fingerprint

gemcitabine
Carboplatin
Paclitaxel
Combination Drug Therapy
Carcinoma
Lung
Confidence Intervals
Survival
Survival Rate
Therapeutics
Drug Therapy
Poisons
Pleural Effusion
Neutropenia
Thrombocytopenia
Disease Progression

Keywords

  • Carboplatin
  • Chemotherapy
  • Gemcitabine
  • Nonsmall cell lung carcinoma
  • Sequential chemotherapy
  • Southwest Oncology Group

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Sequential combination chemotherapy in patients with advanced nonsmall cell lung carcinoma : Carboplatin and gemcitabine followed by paclitaxel. / Edelman, Martin J.; Gandara, David R; Lau, Derick H; Lara, Primo N; Jun Lauder, I.; Tracy, Deborah.

In: Cancer, Vol. 92, No. 1, 01.07.2001, p. 146-152.

Research output: Contribution to journalArticle

@article{7235e24488c4453ab9e10b94a3bb2a4e,
title = "Sequential combination chemotherapy in patients with advanced nonsmall cell lung carcinoma: Carboplatin and gemcitabine followed by paclitaxel",
abstract = "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.",
keywords = "Carboplatin, Chemotherapy, Gemcitabine, Nonsmall cell lung carcinoma, Sequential chemotherapy, Southwest Oncology Group",
author = "Edelman, {Martin J.} and Gandara, {David R} and Lau, {Derick H} and Lara, {Primo N} and {Jun Lauder}, I. and Deborah Tracy",
year = "2001",
month = "7",
day = "1",
doi = "10.1002/1097-0142(20010701)92:1<146::AID-CNCR1302>3.0.CO;2-N",
language = "English (US)",
volume = "92",
pages = "146--152",
journal = "Cancer",
issn = "0008-543X",
publisher = "John Wiley and Sons Inc.",
number = "1",

}

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, Derick H

AU - Lara, Primo N

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 - Carboplatin

KW - Chemotherapy

KW - Gemcitabine

KW - Nonsmall cell lung carcinoma

KW - Sequential chemotherapy

KW - Southwest Oncology Group

UR - http://www.scopus.com/inward/record.url?scp=0035397132&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0035397132&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

AN - SCOPUS:0035397132

VL - 92

SP - 146

EP - 152

JO - Cancer

JF - Cancer

SN - 0008-543X

IS - 1

ER -