Phase II trial of gemcitabine in refractory or relapsed small-cell lung cancer: Eastern Cooperative Oncology Group Trial 1597

Gregory A. Masters, Lieven Declerck, Charles Blanke, Alan Sandler, Russell DeVore, Kathy Miller, David Johnson

Research output: Contribution to journalArticle

95 Citations (Scopus)

Abstract

Purpose: Gemcitabine has shown a broad range of activity in solid tumors, including previously untreated small-cell lung cancer (SCLC). The objective of this phase II trial was to investigate the activity of gemcitabine in patients with relapsed SCLC. Patients and Methods: SCLC patients with measurable disease who had experienced treatment failure with one prior chemotherapy regimen were considered eligible. Patients were required to have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and adequate organ function; signed informed consent was also required. Treatment consisted of gemcitabine 1,000 mg/m2 on days 1, 8, and 15 of a 28-day cycle. Patients were stratified according to their previous response to first-line chemotherapy (primary refractory v primary sensitive disease). Results: Forty-six patients were enrolled onto this phase II trial (20 refractory and 26 sensitive patients). Forty-two of these patients were assessable for response and survival, and 44 were assessable for toxicity. Median patient age was 60 years, and median ECOG performance status was 1. Principal grade 3/4 hematologic toxicities included neutropenia (27%) and thrombocytopenia (27%). The main grade 3/4 nonhematologic toxicities were pulmonary (9%) and neurologic toxicity (14%). Objective responses occurred in 11.9% of patients overall, including one patient with refractory SCLC (5.6%) and four patients with sensitive SCLC (16.7%). Median survival for the overall group was 7.1 months. Survival was not significantly different for patients with refractory versus sensitive disease. Conclusion: Gemcitabine has modest activity in previously treated SCLC patients. The favorable toxicity profile warrants further investigation, either in combination chemotherapy regimens or with targeted biologic compounds.

Original languageEnglish (US)
Pages (from-to)1550-1555
Number of pages6
JournalJournal of Clinical Oncology
Volume21
Issue number8
DOIs
StatePublished - Apr 15 2003
Externally publishedYes

Fingerprint

gemcitabine
Small Cell Lung Carcinoma
Survival

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Phase II trial of gemcitabine in refractory or relapsed small-cell lung cancer : Eastern Cooperative Oncology Group Trial 1597. / Masters, Gregory A.; Declerck, Lieven; Blanke, Charles; Sandler, Alan; DeVore, Russell; Miller, Kathy; Johnson, David.

In: Journal of Clinical Oncology, Vol. 21, No. 8, 15.04.2003, p. 1550-1555.

Research output: Contribution to journalArticle

Masters, Gregory A. ; Declerck, Lieven ; Blanke, Charles ; Sandler, Alan ; DeVore, Russell ; Miller, Kathy ; Johnson, David. / Phase II trial of gemcitabine in refractory or relapsed small-cell lung cancer : Eastern Cooperative Oncology Group Trial 1597. In: Journal of Clinical Oncology. 2003 ; Vol. 21, No. 8. pp. 1550-1555.
@article{2cd6c0539eb94afa98010d2bce24d5e0,
title = "Phase II trial of gemcitabine in refractory or relapsed small-cell lung cancer: Eastern Cooperative Oncology Group Trial 1597",
abstract = "Purpose: Gemcitabine has shown a broad range of activity in solid tumors, including previously untreated small-cell lung cancer (SCLC). The objective of this phase II trial was to investigate the activity of gemcitabine in patients with relapsed SCLC. Patients and Methods: SCLC patients with measurable disease who had experienced treatment failure with one prior chemotherapy regimen were considered eligible. Patients were required to have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and adequate organ function; signed informed consent was also required. Treatment consisted of gemcitabine 1,000 mg/m2 on days 1, 8, and 15 of a 28-day cycle. Patients were stratified according to their previous response to first-line chemotherapy (primary refractory v primary sensitive disease). Results: Forty-six patients were enrolled onto this phase II trial (20 refractory and 26 sensitive patients). Forty-two of these patients were assessable for response and survival, and 44 were assessable for toxicity. Median patient age was 60 years, and median ECOG performance status was 1. Principal grade 3/4 hematologic toxicities included neutropenia (27{\%}) and thrombocytopenia (27{\%}). The main grade 3/4 nonhematologic toxicities were pulmonary (9{\%}) and neurologic toxicity (14{\%}). Objective responses occurred in 11.9{\%} of patients overall, including one patient with refractory SCLC (5.6{\%}) and four patients with sensitive SCLC (16.7{\%}). Median survival for the overall group was 7.1 months. Survival was not significantly different for patients with refractory versus sensitive disease. Conclusion: Gemcitabine has modest activity in previously treated SCLC patients. The favorable toxicity profile warrants further investigation, either in combination chemotherapy regimens or with targeted biologic compounds.",
author = "Masters, {Gregory A.} and Lieven Declerck and Charles Blanke and Alan Sandler and Russell DeVore and Kathy Miller and David Johnson",
year = "2003",
month = "4",
day = "15",
doi = "10.1200/JCO.2003.09.130",
language = "English (US)",
volume = "21",
pages = "1550--1555",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "8",

}

TY - JOUR

T1 - Phase II trial of gemcitabine in refractory or relapsed small-cell lung cancer

T2 - Eastern Cooperative Oncology Group Trial 1597

AU - Masters, Gregory A.

AU - Declerck, Lieven

AU - Blanke, Charles

AU - Sandler, Alan

AU - DeVore, Russell

AU - Miller, Kathy

AU - Johnson, David

PY - 2003/4/15

Y1 - 2003/4/15

N2 - Purpose: Gemcitabine has shown a broad range of activity in solid tumors, including previously untreated small-cell lung cancer (SCLC). The objective of this phase II trial was to investigate the activity of gemcitabine in patients with relapsed SCLC. Patients and Methods: SCLC patients with measurable disease who had experienced treatment failure with one prior chemotherapy regimen were considered eligible. Patients were required to have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and adequate organ function; signed informed consent was also required. Treatment consisted of gemcitabine 1,000 mg/m2 on days 1, 8, and 15 of a 28-day cycle. Patients were stratified according to their previous response to first-line chemotherapy (primary refractory v primary sensitive disease). Results: Forty-six patients were enrolled onto this phase II trial (20 refractory and 26 sensitive patients). Forty-two of these patients were assessable for response and survival, and 44 were assessable for toxicity. Median patient age was 60 years, and median ECOG performance status was 1. Principal grade 3/4 hematologic toxicities included neutropenia (27%) and thrombocytopenia (27%). The main grade 3/4 nonhematologic toxicities were pulmonary (9%) and neurologic toxicity (14%). Objective responses occurred in 11.9% of patients overall, including one patient with refractory SCLC (5.6%) and four patients with sensitive SCLC (16.7%). Median survival for the overall group was 7.1 months. Survival was not significantly different for patients with refractory versus sensitive disease. Conclusion: Gemcitabine has modest activity in previously treated SCLC patients. The favorable toxicity profile warrants further investigation, either in combination chemotherapy regimens or with targeted biologic compounds.

AB - Purpose: Gemcitabine has shown a broad range of activity in solid tumors, including previously untreated small-cell lung cancer (SCLC). The objective of this phase II trial was to investigate the activity of gemcitabine in patients with relapsed SCLC. Patients and Methods: SCLC patients with measurable disease who had experienced treatment failure with one prior chemotherapy regimen were considered eligible. Patients were required to have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and adequate organ function; signed informed consent was also required. Treatment consisted of gemcitabine 1,000 mg/m2 on days 1, 8, and 15 of a 28-day cycle. Patients were stratified according to their previous response to first-line chemotherapy (primary refractory v primary sensitive disease). Results: Forty-six patients were enrolled onto this phase II trial (20 refractory and 26 sensitive patients). Forty-two of these patients were assessable for response and survival, and 44 were assessable for toxicity. Median patient age was 60 years, and median ECOG performance status was 1. Principal grade 3/4 hematologic toxicities included neutropenia (27%) and thrombocytopenia (27%). The main grade 3/4 nonhematologic toxicities were pulmonary (9%) and neurologic toxicity (14%). Objective responses occurred in 11.9% of patients overall, including one patient with refractory SCLC (5.6%) and four patients with sensitive SCLC (16.7%). Median survival for the overall group was 7.1 months. Survival was not significantly different for patients with refractory versus sensitive disease. Conclusion: Gemcitabine has modest activity in previously treated SCLC patients. The favorable toxicity profile warrants further investigation, either in combination chemotherapy regimens or with targeted biologic compounds.

UR - http://www.scopus.com/inward/record.url?scp=0037504528&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0037504528&partnerID=8YFLogxK

U2 - 10.1200/JCO.2003.09.130

DO - 10.1200/JCO.2003.09.130

M3 - Article

C2 - 12697880

AN - SCOPUS:0037504528

VL - 21

SP - 1550

EP - 1555

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 8

ER -