Comparison of survival and quality of life in advanced non-small-cell lung cancer patients treated with two dose levels of paclitaxel combined with cisplatin versus etoposide with cisplatin

Results of an eastern cooperative oncology group trial

Philip Bonomi, KyungMann Kim, Diane Fairclough, David Cella, John Kugler, Eric Rowinsky, Michael Jiroutek, David Johnson

Research output: Contribution to journalArticle

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Abstract

Purpose: Treatment with cisplatin-based chemotherapy provides a modest survival advantage over supportive care alone in advanced non-small-cell lung cancer (NSCLC). To determine whether a new agent, paclitaxel, would further improve survival in NSCLC, the Eastern Cooperative Oncology Group conducted a randomized trial comparing paclitaxel plus cisplatin to a standard chemotherapy regimen consisting of cisplatin and etoposide. Patients and Methods: The study was carried out by a multi-institutional cooperative group in chemotherapy-naive stage IIIB to IV NSCLC patients randomized to receive paclitaxel plus cisplatin or etoposide plus cisplatin. Paclitaxel was administered at two different dose levels (135 mg/m2 and 250 mg/m2), and etoposide was given at a dose of 100 mg/m2 daily on days 1 to 3. Each regimen was repeated every 21 days and each included cisplatin (75 mg/m2). Results: The characteristics of the 599 patients were well-balanced across the three treatment groups. Superior survival was observed with the combined paclitaxel regimens (median survival time, 9.9 months; 1-year survival rate, 38.9%) compared with etoposide plus cisplatin (median survival time, 7.6 months; 1-year survival rate, 31.8%; P = .048). Comparing survival for the two dose levels of paclitaxel revealed no significant difference. The median survival duration for the stage IIIB subgroup was 7.9 months for etoposide plus cisplatin patients versus 13.1 months for all paclitaxel patients (P =. 152). For the stage IV subgroup, the median survival time for etoposide plus cisplatin was 7.6 months compared with 8.9 months for paclitaxel (P = .246). With the exceptions of increased granulocytopenia on the low-dose paclitaxel regimen and increased myalgias, neurotoxicity, and, possibly, increased treatment-related cardiac events with high-dose paclitaxel, toxicity was similar across all three arms. Quality of life (QOL) declined significantly over the 6 months. However, QOL scores were not significantly different among the regimens. Conclusion: As a result of these observations, paclitaxel (135 mg/m2) combined with cisplatin has replaced etoposide plus cisplatin as the reference regimen in our recently completed phase III trial. (C) 2000 by American Society of Clinical Oncology.

Original languageEnglish (US)
Pages (from-to)623-631
Number of pages9
JournalJournal of Clinical Oncology
Volume18
Issue number3
StatePublished - Feb 2000

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Etoposide
Paclitaxel
Non-Small Cell Lung Carcinoma
Cisplatin
Quality of Life
Survival
Drug Therapy
Survival Rate
Agranulocytosis
Myalgia
Therapeutics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Comparison of survival and quality of life in advanced non-small-cell lung cancer patients treated with two dose levels of paclitaxel combined with cisplatin versus etoposide with cisplatin : Results of an eastern cooperative oncology group trial. / Bonomi, Philip; Kim, KyungMann; Fairclough, Diane; Cella, David; Kugler, John; Rowinsky, Eric; Jiroutek, Michael; Johnson, David.

In: Journal of Clinical Oncology, Vol. 18, No. 3, 02.2000, p. 623-631.

Research output: Contribution to journalArticle

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title = "Comparison of survival and quality of life in advanced non-small-cell lung cancer patients treated with two dose levels of paclitaxel combined with cisplatin versus etoposide with cisplatin: Results of an eastern cooperative oncology group trial",
abstract = "Purpose: Treatment with cisplatin-based chemotherapy provides a modest survival advantage over supportive care alone in advanced non-small-cell lung cancer (NSCLC). To determine whether a new agent, paclitaxel, would further improve survival in NSCLC, the Eastern Cooperative Oncology Group conducted a randomized trial comparing paclitaxel plus cisplatin to a standard chemotherapy regimen consisting of cisplatin and etoposide. Patients and Methods: The study was carried out by a multi-institutional cooperative group in chemotherapy-naive stage IIIB to IV NSCLC patients randomized to receive paclitaxel plus cisplatin or etoposide plus cisplatin. Paclitaxel was administered at two different dose levels (135 mg/m2 and 250 mg/m2), and etoposide was given at a dose of 100 mg/m2 daily on days 1 to 3. Each regimen was repeated every 21 days and each included cisplatin (75 mg/m2). Results: The characteristics of the 599 patients were well-balanced across the three treatment groups. Superior survival was observed with the combined paclitaxel regimens (median survival time, 9.9 months; 1-year survival rate, 38.9{\%}) compared with etoposide plus cisplatin (median survival time, 7.6 months; 1-year survival rate, 31.8{\%}; P = .048). Comparing survival for the two dose levels of paclitaxel revealed no significant difference. The median survival duration for the stage IIIB subgroup was 7.9 months for etoposide plus cisplatin patients versus 13.1 months for all paclitaxel patients (P =. 152). For the stage IV subgroup, the median survival time for etoposide plus cisplatin was 7.6 months compared with 8.9 months for paclitaxel (P = .246). With the exceptions of increased granulocytopenia on the low-dose paclitaxel regimen and increased myalgias, neurotoxicity, and, possibly, increased treatment-related cardiac events with high-dose paclitaxel, toxicity was similar across all three arms. Quality of life (QOL) declined significantly over the 6 months. However, QOL scores were not significantly different among the regimens. Conclusion: As a result of these observations, paclitaxel (135 mg/m2) combined with cisplatin has replaced etoposide plus cisplatin as the reference regimen in our recently completed phase III trial. (C) 2000 by American Society of Clinical Oncology.",
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T1 - Comparison of survival and quality of life in advanced non-small-cell lung cancer patients treated with two dose levels of paclitaxel combined with cisplatin versus etoposide with cisplatin

T2 - Results of an eastern cooperative oncology group trial

AU - Bonomi, Philip

AU - Kim, KyungMann

AU - Fairclough, Diane

AU - Cella, David

AU - Kugler, John

AU - Rowinsky, Eric

AU - Jiroutek, Michael

AU - Johnson, David

PY - 2000/2

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N2 - Purpose: Treatment with cisplatin-based chemotherapy provides a modest survival advantage over supportive care alone in advanced non-small-cell lung cancer (NSCLC). To determine whether a new agent, paclitaxel, would further improve survival in NSCLC, the Eastern Cooperative Oncology Group conducted a randomized trial comparing paclitaxel plus cisplatin to a standard chemotherapy regimen consisting of cisplatin and etoposide. Patients and Methods: The study was carried out by a multi-institutional cooperative group in chemotherapy-naive stage IIIB to IV NSCLC patients randomized to receive paclitaxel plus cisplatin or etoposide plus cisplatin. Paclitaxel was administered at two different dose levels (135 mg/m2 and 250 mg/m2), and etoposide was given at a dose of 100 mg/m2 daily on days 1 to 3. Each regimen was repeated every 21 days and each included cisplatin (75 mg/m2). Results: The characteristics of the 599 patients were well-balanced across the three treatment groups. Superior survival was observed with the combined paclitaxel regimens (median survival time, 9.9 months; 1-year survival rate, 38.9%) compared with etoposide plus cisplatin (median survival time, 7.6 months; 1-year survival rate, 31.8%; P = .048). Comparing survival for the two dose levels of paclitaxel revealed no significant difference. The median survival duration for the stage IIIB subgroup was 7.9 months for etoposide plus cisplatin patients versus 13.1 months for all paclitaxel patients (P =. 152). For the stage IV subgroup, the median survival time for etoposide plus cisplatin was 7.6 months compared with 8.9 months for paclitaxel (P = .246). With the exceptions of increased granulocytopenia on the low-dose paclitaxel regimen and increased myalgias, neurotoxicity, and, possibly, increased treatment-related cardiac events with high-dose paclitaxel, toxicity was similar across all three arms. Quality of life (QOL) declined significantly over the 6 months. However, QOL scores were not significantly different among the regimens. Conclusion: As a result of these observations, paclitaxel (135 mg/m2) combined with cisplatin has replaced etoposide plus cisplatin as the reference regimen in our recently completed phase III trial. (C) 2000 by American Society of Clinical Oncology.

AB - Purpose: Treatment with cisplatin-based chemotherapy provides a modest survival advantage over supportive care alone in advanced non-small-cell lung cancer (NSCLC). To determine whether a new agent, paclitaxel, would further improve survival in NSCLC, the Eastern Cooperative Oncology Group conducted a randomized trial comparing paclitaxel plus cisplatin to a standard chemotherapy regimen consisting of cisplatin and etoposide. Patients and Methods: The study was carried out by a multi-institutional cooperative group in chemotherapy-naive stage IIIB to IV NSCLC patients randomized to receive paclitaxel plus cisplatin or etoposide plus cisplatin. Paclitaxel was administered at two different dose levels (135 mg/m2 and 250 mg/m2), and etoposide was given at a dose of 100 mg/m2 daily on days 1 to 3. Each regimen was repeated every 21 days and each included cisplatin (75 mg/m2). Results: The characteristics of the 599 patients were well-balanced across the three treatment groups. Superior survival was observed with the combined paclitaxel regimens (median survival time, 9.9 months; 1-year survival rate, 38.9%) compared with etoposide plus cisplatin (median survival time, 7.6 months; 1-year survival rate, 31.8%; P = .048). Comparing survival for the two dose levels of paclitaxel revealed no significant difference. The median survival duration for the stage IIIB subgroup was 7.9 months for etoposide plus cisplatin patients versus 13.1 months for all paclitaxel patients (P =. 152). For the stage IV subgroup, the median survival time for etoposide plus cisplatin was 7.6 months compared with 8.9 months for paclitaxel (P = .246). With the exceptions of increased granulocytopenia on the low-dose paclitaxel regimen and increased myalgias, neurotoxicity, and, possibly, increased treatment-related cardiac events with high-dose paclitaxel, toxicity was similar across all three arms. Quality of life (QOL) declined significantly over the 6 months. However, QOL scores were not significantly different among the regimens. Conclusion: As a result of these observations, paclitaxel (135 mg/m2) combined with cisplatin has replaced etoposide plus cisplatin as the reference regimen in our recently completed phase III trial. (C) 2000 by American Society of Clinical Oncology.

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