A phase II study of weekly gemcitabine and paclitaxel in patients with previously untreated stage IIIb and IV non-small cell lung cancer

Sumeet Bhatia, Nasser Hanna, Rafat Ansari, William Pletcher, Lawrence Einhorn, Elizabeth Ng, Alan Sandler

Research output: Contribution to journalArticle

34 Citations (Scopus)

Abstract

Platinum-based combination chemotherapy has become the standard treatment for good performance patients with stage IIIb and IV non-small cell lung cancer (NSCLC). However, newer agents such as gemcitabine and paclitaxel appear to have superior single agent activity and are more easily tolerated in comparison to the older platinum compounds. Therefore, we conducted this phase II study to evaluate the activity and toxicity of the combination paclitaxel and gemcitabine in advanced NSCLC. Gemcitabine was given at 1000 mg/m2 intravenously over 30 min followed by paclitaxel at 110 mg/m2 intravenously over 1 h on days 1, 8 and 15 every 28 days for a maximum of 6 cycles. Between April 1998 and June 1999, 40 of 42 patients entered were eligible and received chemotherapy. Data was available on 39 patients. Toxicities included Grade 3/4 neutropenia in 43% of patients, while thrombocytopenia (13%) and anemia (7%) were less frequent. Five (12.5%) patients developed neutropenic fever. Four (10%) patients developed bilateral interstitial shadows with hypoxia suggestive of a drug-induced pneumonitis. There were 4 treatment-related deaths (1 from pneumonitis, 3 from neutropenic complications). Five patients were not evaluable due to early death. Therefore, 34 patients were evaluable with 12 (35.3%) achieving a partial remission and 1 achieving a complete remission for an overall response rate of 38.2% (32.5% on an intention-to-treat basis). The median progression free survival was 107 days (range, 14-391), median survival was 148 days (range, 12-495) and 1-year survival was 26%. In conclusion, weekly gemcitabine with paclitaxel in patients with advanced NSCLC is an active regimen; however, toxicity and poor survival precludes the use of this regimen as an experimental arm on a future phase III study.

Original languageEnglish
Pages (from-to)73-77
Number of pages5
JournalLung Cancer
Volume38
Issue number1
DOIs
StatePublished - Oct 1 2002

Fingerprint

gemcitabine
Paclitaxel
Non-Small Cell Lung Carcinoma
Survival
Pneumonia
Platinum Compounds
Combination Drug Therapy
Neutropenia
Platinum
Thrombocytopenia

Keywords

  • Gemcitabine
  • Non-small cell lung cancer
  • Paclitaxel

ASJC Scopus subject areas

  • Oncology

Cite this

A phase II study of weekly gemcitabine and paclitaxel in patients with previously untreated stage IIIb and IV non-small cell lung cancer. / Bhatia, Sumeet; Hanna, Nasser; Ansari, Rafat; Pletcher, William; Einhorn, Lawrence; Ng, Elizabeth; Sandler, Alan.

In: Lung Cancer, Vol. 38, No. 1, 01.10.2002, p. 73-77.

Research output: Contribution to journalArticle

Bhatia, Sumeet ; Hanna, Nasser ; Ansari, Rafat ; Pletcher, William ; Einhorn, Lawrence ; Ng, Elizabeth ; Sandler, Alan. / A phase II study of weekly gemcitabine and paclitaxel in patients with previously untreated stage IIIb and IV non-small cell lung cancer. In: Lung Cancer. 2002 ; Vol. 38, No. 1. pp. 73-77.
@article{5ac43dcaf53e45948c808fd08be7c53c,
title = "A phase II study of weekly gemcitabine and paclitaxel in patients with previously untreated stage IIIb and IV non-small cell lung cancer",
abstract = "Platinum-based combination chemotherapy has become the standard treatment for good performance patients with stage IIIb and IV non-small cell lung cancer (NSCLC). However, newer agents such as gemcitabine and paclitaxel appear to have superior single agent activity and are more easily tolerated in comparison to the older platinum compounds. Therefore, we conducted this phase II study to evaluate the activity and toxicity of the combination paclitaxel and gemcitabine in advanced NSCLC. Gemcitabine was given at 1000 mg/m2 intravenously over 30 min followed by paclitaxel at 110 mg/m2 intravenously over 1 h on days 1, 8 and 15 every 28 days for a maximum of 6 cycles. Between April 1998 and June 1999, 40 of 42 patients entered were eligible and received chemotherapy. Data was available on 39 patients. Toxicities included Grade 3/4 neutropenia in 43{\%} of patients, while thrombocytopenia (13{\%}) and anemia (7{\%}) were less frequent. Five (12.5{\%}) patients developed neutropenic fever. Four (10{\%}) patients developed bilateral interstitial shadows with hypoxia suggestive of a drug-induced pneumonitis. There were 4 treatment-related deaths (1 from pneumonitis, 3 from neutropenic complications). Five patients were not evaluable due to early death. Therefore, 34 patients were evaluable with 12 (35.3{\%}) achieving a partial remission and 1 achieving a complete remission for an overall response rate of 38.2{\%} (32.5{\%} on an intention-to-treat basis). The median progression free survival was 107 days (range, 14-391), median survival was 148 days (range, 12-495) and 1-year survival was 26{\%}. In conclusion, weekly gemcitabine with paclitaxel in patients with advanced NSCLC is an active regimen; however, toxicity and poor survival precludes the use of this regimen as an experimental arm on a future phase III study.",
keywords = "Gemcitabine, Non-small cell lung cancer, Paclitaxel",
author = "Sumeet Bhatia and Nasser Hanna and Rafat Ansari and William Pletcher and Lawrence Einhorn and Elizabeth Ng and Alan Sandler",
year = "2002",
month = "10",
day = "1",
doi = "10.1016/S0169-5002(02)00145-9",
language = "English",
volume = "38",
pages = "73--77",
journal = "Lung Cancer",
issn = "0169-5002",
publisher = "Elsevier Ireland Ltd",
number = "1",

}

TY - JOUR

T1 - A phase II study of weekly gemcitabine and paclitaxel in patients with previously untreated stage IIIb and IV non-small cell lung cancer

AU - Bhatia, Sumeet

AU - Hanna, Nasser

AU - Ansari, Rafat

AU - Pletcher, William

AU - Einhorn, Lawrence

AU - Ng, Elizabeth

AU - Sandler, Alan

PY - 2002/10/1

Y1 - 2002/10/1

N2 - Platinum-based combination chemotherapy has become the standard treatment for good performance patients with stage IIIb and IV non-small cell lung cancer (NSCLC). However, newer agents such as gemcitabine and paclitaxel appear to have superior single agent activity and are more easily tolerated in comparison to the older platinum compounds. Therefore, we conducted this phase II study to evaluate the activity and toxicity of the combination paclitaxel and gemcitabine in advanced NSCLC. Gemcitabine was given at 1000 mg/m2 intravenously over 30 min followed by paclitaxel at 110 mg/m2 intravenously over 1 h on days 1, 8 and 15 every 28 days for a maximum of 6 cycles. Between April 1998 and June 1999, 40 of 42 patients entered were eligible and received chemotherapy. Data was available on 39 patients. Toxicities included Grade 3/4 neutropenia in 43% of patients, while thrombocytopenia (13%) and anemia (7%) were less frequent. Five (12.5%) patients developed neutropenic fever. Four (10%) patients developed bilateral interstitial shadows with hypoxia suggestive of a drug-induced pneumonitis. There were 4 treatment-related deaths (1 from pneumonitis, 3 from neutropenic complications). Five patients were not evaluable due to early death. Therefore, 34 patients were evaluable with 12 (35.3%) achieving a partial remission and 1 achieving a complete remission for an overall response rate of 38.2% (32.5% on an intention-to-treat basis). The median progression free survival was 107 days (range, 14-391), median survival was 148 days (range, 12-495) and 1-year survival was 26%. In conclusion, weekly gemcitabine with paclitaxel in patients with advanced NSCLC is an active regimen; however, toxicity and poor survival precludes the use of this regimen as an experimental arm on a future phase III study.

AB - Platinum-based combination chemotherapy has become the standard treatment for good performance patients with stage IIIb and IV non-small cell lung cancer (NSCLC). However, newer agents such as gemcitabine and paclitaxel appear to have superior single agent activity and are more easily tolerated in comparison to the older platinum compounds. Therefore, we conducted this phase II study to evaluate the activity and toxicity of the combination paclitaxel and gemcitabine in advanced NSCLC. Gemcitabine was given at 1000 mg/m2 intravenously over 30 min followed by paclitaxel at 110 mg/m2 intravenously over 1 h on days 1, 8 and 15 every 28 days for a maximum of 6 cycles. Between April 1998 and June 1999, 40 of 42 patients entered were eligible and received chemotherapy. Data was available on 39 patients. Toxicities included Grade 3/4 neutropenia in 43% of patients, while thrombocytopenia (13%) and anemia (7%) were less frequent. Five (12.5%) patients developed neutropenic fever. Four (10%) patients developed bilateral interstitial shadows with hypoxia suggestive of a drug-induced pneumonitis. There were 4 treatment-related deaths (1 from pneumonitis, 3 from neutropenic complications). Five patients were not evaluable due to early death. Therefore, 34 patients were evaluable with 12 (35.3%) achieving a partial remission and 1 achieving a complete remission for an overall response rate of 38.2% (32.5% on an intention-to-treat basis). The median progression free survival was 107 days (range, 14-391), median survival was 148 days (range, 12-495) and 1-year survival was 26%. In conclusion, weekly gemcitabine with paclitaxel in patients with advanced NSCLC is an active regimen; however, toxicity and poor survival precludes the use of this regimen as an experimental arm on a future phase III study.

KW - Gemcitabine

KW - Non-small cell lung cancer

KW - Paclitaxel

UR - http://www.scopus.com/inward/record.url?scp=0036806170&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0036806170&partnerID=8YFLogxK

U2 - 10.1016/S0169-5002(02)00145-9

DO - 10.1016/S0169-5002(02)00145-9

M3 - Article

VL - 38

SP - 73

EP - 77

JO - Lung Cancer

JF - Lung Cancer

SN - 0169-5002

IS - 1

ER -