A phase I/II trial of etoposide and cisplatin in extensive small cell lung cancer. A cancer and Leukemia Group B study

Edith P. Mitchell; Michael C. Perry; Sharon D. Luikart; Constance T. Cirrincione; David A. Van Echo; James E. Herndon; L. Herbert Maurer; Gerald Clamon; Mark R. Green

doi:10.1016/0169-5002(95)00585-4

A phase I/II trial of etoposide and cisplatin in extensive small cell lung cancer. A cancer and Leukemia Group B study

Edith P. Mitchell, Michael C. Perry, Sharon D. Luikart, Constance T. Cirrincione, David A. Van Echo, James E. Herndon, L. Herbert Maurer, Gerald Clamon, Mark R. Green

Medicine - Veteran's Administration Medical Center

Research output: Contribution to journal › Article › peer-review

5 Scopus citations

Abstract

Patients with untreated extensive small cell lung cancer (SCLC) with CALGB performance scores 0-2 were treated with etoposide 200 mg/m²/day on days 1-3 and cisplatin doses of 20, 30, or 35 mg/m²/day days 1-3 in a Phase I/II format. Of the nine patients treated at the 35 mg/m²/day cisplatin dose in the Phase I portion of the study, Grade 4 leukopenia occurred in five patients and Grade 4 thrombocytopenia in four. There were two deaths due to myelosuppression and sepsis. This dose was thus considered the maximum tolerated dose (MTD), and a Phase II trial was then conducted using this treatment program. In the Phase II trial of 39 patients, the objective response rate was 67% (95% confidence interval, 50-81%) with 21% complete responses (CI 9-36%). Median survival was 10.5 months. Grade 4-5 leukopenia was seen in 57% and Grade 4-5 thrombocytopenia in 56%. The MTD defined by this Phase I trial represents a 67-100% increase in etoposide and a 33-42% increase in cisplatin dosage compared to prior studies. The observed objective response rates with this regimen are comparable to studies using conventional doses, but hematological toxicity was higher.

Original language	English (US)
Pages (from-to)	215-223
Number of pages	9
Journal	Lung Cancer
Volume	15
Issue number	2
DOIs	https://doi.org/10.1016/0169-5002(95)00585-4
State	Published - Sep 1996

Bibliographical note

Funding Information:
EPM and MCP were supported by CA12046; SDL was supported by CA16450; DAVE was supported by CA31983; JEH and CTC were supported by CA33601; LHM was supported by CA04326; GC was supported by CA47692; MRG was supported by CA1 1789; The following institutions participated in the study: Univ. of Minnesota; Dartmouth; Columbia University; Massachusetts General Hospital; Univ. of Missouri; Univ. of Iowa Hospitals; New York Hospital; SUNY-Syracuse; Univ. of Maryland Cancer Center; McGill; Walter Reed Army Medical Center; Univ. of California-San Diego; Univ. of Alabama; Mt. Sinai; SUNY-Maimonides; Univ. of North Carolina-Chapel Hill; Univ. of Massachusetts; Rhode Island Hosp.

Funding Information:
This study 8631 was conducted by Cancer and Leukemia Group B (0. Ross McIntyre, Chairman) and was supported by Public Health Service grants (CA) from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services and by a grant from the T.J. Martell Foundation.

Keywords

Cisplatin
Dose intensity
Etoposide
Small cell lung cancer

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Publisher link

10.1016/0169-5002(95)00585-4

Find It

Find It at U of M Libraries

Cite this

@article{8b6501688e124ff1b33d08463bcaf8d2,

title = "A phase I/II trial of etoposide and cisplatin in extensive small cell lung cancer. A cancer and Leukemia Group B study",

abstract = "Patients with untreated extensive small cell lung cancer (SCLC) with CALGB performance scores 0-2 were treated with etoposide 200 mg/m2/day on days 1-3 and cisplatin doses of 20, 30, or 35 mg/m2/day days 1-3 in a Phase I/II format. Of the nine patients treated at the 35 mg/m2/day cisplatin dose in the Phase I portion of the study, Grade 4 leukopenia occurred in five patients and Grade 4 thrombocytopenia in four. There were two deaths due to myelosuppression and sepsis. This dose was thus considered the maximum tolerated dose (MTD), and a Phase II trial was then conducted using this treatment program. In the Phase II trial of 39 patients, the objective response rate was 67% (95% confidence interval, 50-81%) with 21% complete responses (CI 9-36%). Median survival was 10.5 months. Grade 4-5 leukopenia was seen in 57% and Grade 4-5 thrombocytopenia in 56%. The MTD defined by this Phase I trial represents a 67-100% increase in etoposide and a 33-42% increase in cisplatin dosage compared to prior studies. The observed objective response rates with this regimen are comparable to studies using conventional doses, but hematological toxicity was higher.",

keywords = "Cisplatin, Dose intensity, Etoposide, Small cell lung cancer",

author = "Mitchell, {Edith P.} and Perry, {Michael C.} and Luikart, {Sharon D.} and Cirrincione, {Constance T.} and {Van Echo}, {David A.} and Herndon, {James E.} and Maurer, {L. Herbert} and Gerald Clamon and Green, {Mark R.}",

note = "Funding Information: EPM and MCP were supported by CA12046; SDL was supported by CA16450; DAVE was supported by CA31983; JEH and CTC were supported by CA33601; LHM was supported by CA04326; GC was supported by CA47692; MRG was supported by CA1 1789; The following institutions participated in the study: Univ. of Minnesota; Dartmouth; Columbia University; Massachusetts General Hospital; Univ. of Missouri; Univ. of Iowa Hospitals; New York Hospital; SUNY-Syracuse; Univ. of Maryland Cancer Center; McGill; Walter Reed Army Medical Center; Univ. of California-San Diego; Univ. of Alabama; Mt. Sinai; SUNY-Maimonides; Univ. of North Carolina-Chapel Hill; Univ. of Massachusetts; Rhode Island Hosp. Funding Information: This study 8631 was conducted by Cancer and Leukemia Group B (0. Ross McIntyre, Chairman) and was supported by Public Health Service grants (CA) from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services and by a grant from the T.J. Martell Foundation.",

year = "1996",

month = sep,

doi = "10.1016/0169-5002(95)00585-4",

language = "English (US)",

volume = "15",

pages = "215--223",

journal = "Lung Cancer",

issn = "0169-5002",

publisher = "Elsevier Ireland Ltd",

number = "2",

}

TY - JOUR

T1 - A phase I/II trial of etoposide and cisplatin in extensive small cell lung cancer. A cancer and Leukemia Group B study

AU - Mitchell, Edith P.

AU - Perry, Michael C.

AU - Luikart, Sharon D.

AU - Cirrincione, Constance T.

AU - Van Echo, David A.

AU - Herndon, James E.

AU - Maurer, L. Herbert

AU - Clamon, Gerald

AU - Green, Mark R.

N1 - Funding Information: EPM and MCP were supported by CA12046; SDL was supported by CA16450; DAVE was supported by CA31983; JEH and CTC were supported by CA33601; LHM was supported by CA04326; GC was supported by CA47692; MRG was supported by CA1 1789; The following institutions participated in the study: Univ. of Minnesota; Dartmouth; Columbia University; Massachusetts General Hospital; Univ. of Missouri; Univ. of Iowa Hospitals; New York Hospital; SUNY-Syracuse; Univ. of Maryland Cancer Center; McGill; Walter Reed Army Medical Center; Univ. of California-San Diego; Univ. of Alabama; Mt. Sinai; SUNY-Maimonides; Univ. of North Carolina-Chapel Hill; Univ. of Massachusetts; Rhode Island Hosp. Funding Information: This study 8631 was conducted by Cancer and Leukemia Group B (0. Ross McIntyre, Chairman) and was supported by Public Health Service grants (CA) from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services and by a grant from the T.J. Martell Foundation.

PY - 1996/9

Y1 - 1996/9

N2 - Patients with untreated extensive small cell lung cancer (SCLC) with CALGB performance scores 0-2 were treated with etoposide 200 mg/m2/day on days 1-3 and cisplatin doses of 20, 30, or 35 mg/m2/day days 1-3 in a Phase I/II format. Of the nine patients treated at the 35 mg/m2/day cisplatin dose in the Phase I portion of the study, Grade 4 leukopenia occurred in five patients and Grade 4 thrombocytopenia in four. There were two deaths due to myelosuppression and sepsis. This dose was thus considered the maximum tolerated dose (MTD), and a Phase II trial was then conducted using this treatment program. In the Phase II trial of 39 patients, the objective response rate was 67% (95% confidence interval, 50-81%) with 21% complete responses (CI 9-36%). Median survival was 10.5 months. Grade 4-5 leukopenia was seen in 57% and Grade 4-5 thrombocytopenia in 56%. The MTD defined by this Phase I trial represents a 67-100% increase in etoposide and a 33-42% increase in cisplatin dosage compared to prior studies. The observed objective response rates with this regimen are comparable to studies using conventional doses, but hematological toxicity was higher.

AB - Patients with untreated extensive small cell lung cancer (SCLC) with CALGB performance scores 0-2 were treated with etoposide 200 mg/m2/day on days 1-3 and cisplatin doses of 20, 30, or 35 mg/m2/day days 1-3 in a Phase I/II format. Of the nine patients treated at the 35 mg/m2/day cisplatin dose in the Phase I portion of the study, Grade 4 leukopenia occurred in five patients and Grade 4 thrombocytopenia in four. There were two deaths due to myelosuppression and sepsis. This dose was thus considered the maximum tolerated dose (MTD), and a Phase II trial was then conducted using this treatment program. In the Phase II trial of 39 patients, the objective response rate was 67% (95% confidence interval, 50-81%) with 21% complete responses (CI 9-36%). Median survival was 10.5 months. Grade 4-5 leukopenia was seen in 57% and Grade 4-5 thrombocytopenia in 56%. The MTD defined by this Phase I trial represents a 67-100% increase in etoposide and a 33-42% increase in cisplatin dosage compared to prior studies. The observed objective response rates with this regimen are comparable to studies using conventional doses, but hematological toxicity was higher.

KW - Cisplatin

KW - Dose intensity

KW - Etoposide

KW - Small cell lung cancer

UR - http://www.scopus.com/inward/record.url?scp=0030249649&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0030249649&partnerID=8YFLogxK

U2 - 10.1016/0169-5002(95)00585-4

DO - 10.1016/0169-5002(95)00585-4

M3 - Article

C2 - 8882988

AN - SCOPUS:0030249649

SN - 0169-5002

VL - 15

SP - 215

EP - 223

JO - Lung Cancer

JF - Lung Cancer

IS - 2

ER -

A phase I/II trial of etoposide and cisplatin in extensive small cell lung cancer. A cancer and Leukemia Group B study

Abstract

Bibliographical note

Keywords

UN SDGs

Publisher link

Find It

Other files and links

Fingerprint

Cite this