Phase II study of ifosfamide, carboplatin, and oral etoposide chemotherapy for extensive-disease small-cell lung cancer

An Eastern Cooperative Oncology Group pilot study

Antonio C. Wolff, David S. Ettinger, Donna Neuberg, Robert L. Comis, John C. Ruckdeschel, Phillip D. Bonomi, David H. Johnson

Research output: Contribution to journalArticle

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Abstract

Purpose: A phase II study of ifosfamide, carboplatin, and prolonged oral administration of etoposide (ICE) in patients with untreated extensive- disease (ED) small-cell lung cancer (SCLC) was conducted to assess toxicities, response, and median survival. Patients and Methods: Between July 1990 and August 1992, 35 patients were treated. ICE doses were ifosfamide 5 g/m2 by 24-hour continuous intravenous (CIV) infusion with mesna on day 1, carboplatin 300 mg/m2 intravenously (IV) on day 1, and etoposide 50 mg/m2 orally on days 1 to 21 every 4 weeks for up to six to eight cycles (schedule I). Because of severe hematologic toxicity in the first 18 patients, the last 17 patients received ifosfamide 3.75 mg/m2 IV on day 1, carboplatin 300 mg/m2 IV on day 1, and etoposide 50 mg orally on days 1 to 14 (schedule II). Results: Nine of 18 patients (50%) on schedule I had 13 episodes of severe hematologic toxicity (one death), and only two (11%) received full doses on cycle 2. However, with schedule II, only four of 17 patients (24%) developed severe hematologic toxicity, and eight (47%) received full doses on cycle 2. Objective responses were observed in 29 of 35 patients (83%) (schedule I, 16 of 18 patients [89%]; schedule II, 13 of 17 patients [76%]). There were eight (23%) complete responses (CRs) and 21 (60%) partial responses (PRs). The median survival duration was 8.3 months, and 1- and 2-year survival rates were 37% and 14%, respectively. Conclusion: ICE with oral etoposide has comparable activity with other regimens in ED SCLC. However, the 2-year survival rate may be higher and ICE with the lower doses of schedule II could be given safely with acceptable toxicity. Further studies of ICE compared with standard two-drug regimens are warranted.

Original languageEnglish (US)
Pages (from-to)1615-1622
Number of pages8
JournalJournal of Clinical Oncology
Volume13
Issue number7
StatePublished - Jul 1995

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Ifosfamide
Carboplatin
Small Cell Lung Carcinoma
Etoposide
Appointments and Schedules
Drug Therapy
Survival Rate
Mesna
Survival
Intravenous Infusions
Oral Administration

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase II study of ifosfamide, carboplatin, and oral etoposide chemotherapy for extensive-disease small-cell lung cancer : An Eastern Cooperative Oncology Group pilot study. / Wolff, Antonio C.; Ettinger, David S.; Neuberg, Donna; Comis, Robert L.; Ruckdeschel, John C.; Bonomi, Phillip D.; Johnson, David H.

In: Journal of Clinical Oncology, Vol. 13, No. 7, 07.1995, p. 1615-1622.

Research output: Contribution to journalArticle

Wolff, Antonio C. ; Ettinger, David S. ; Neuberg, Donna ; Comis, Robert L. ; Ruckdeschel, John C. ; Bonomi, Phillip D. ; Johnson, David H. / Phase II study of ifosfamide, carboplatin, and oral etoposide chemotherapy for extensive-disease small-cell lung cancer : An Eastern Cooperative Oncology Group pilot study. In: Journal of Clinical Oncology. 1995 ; Vol. 13, No. 7. pp. 1615-1622.
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title = "Phase II study of ifosfamide, carboplatin, and oral etoposide chemotherapy for extensive-disease small-cell lung cancer: An Eastern Cooperative Oncology Group pilot study",
abstract = "Purpose: A phase II study of ifosfamide, carboplatin, and prolonged oral administration of etoposide (ICE) in patients with untreated extensive- disease (ED) small-cell lung cancer (SCLC) was conducted to assess toxicities, response, and median survival. Patients and Methods: Between July 1990 and August 1992, 35 patients were treated. ICE doses were ifosfamide 5 g/m2 by 24-hour continuous intravenous (CIV) infusion with mesna on day 1, carboplatin 300 mg/m2 intravenously (IV) on day 1, and etoposide 50 mg/m2 orally on days 1 to 21 every 4 weeks for up to six to eight cycles (schedule I). Because of severe hematologic toxicity in the first 18 patients, the last 17 patients received ifosfamide 3.75 mg/m2 IV on day 1, carboplatin 300 mg/m2 IV on day 1, and etoposide 50 mg orally on days 1 to 14 (schedule II). Results: Nine of 18 patients (50{\%}) on schedule I had 13 episodes of severe hematologic toxicity (one death), and only two (11{\%}) received full doses on cycle 2. However, with schedule II, only four of 17 patients (24{\%}) developed severe hematologic toxicity, and eight (47{\%}) received full doses on cycle 2. Objective responses were observed in 29 of 35 patients (83{\%}) (schedule I, 16 of 18 patients [89{\%}]; schedule II, 13 of 17 patients [76{\%}]). There were eight (23{\%}) complete responses (CRs) and 21 (60{\%}) partial responses (PRs). The median survival duration was 8.3 months, and 1- and 2-year survival rates were 37{\%} and 14{\%}, respectively. Conclusion: ICE with oral etoposide has comparable activity with other regimens in ED SCLC. However, the 2-year survival rate may be higher and ICE with the lower doses of schedule II could be given safely with acceptable toxicity. Further studies of ICE compared with standard two-drug regimens are warranted.",
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T1 - Phase II study of ifosfamide, carboplatin, and oral etoposide chemotherapy for extensive-disease small-cell lung cancer

T2 - An Eastern Cooperative Oncology Group pilot study

AU - Wolff, Antonio C.

AU - Ettinger, David S.

AU - Neuberg, Donna

AU - Comis, Robert L.

AU - Ruckdeschel, John C.

AU - Bonomi, Phillip D.

AU - Johnson, David H.

PY - 1995/7

Y1 - 1995/7

N2 - Purpose: A phase II study of ifosfamide, carboplatin, and prolonged oral administration of etoposide (ICE) in patients with untreated extensive- disease (ED) small-cell lung cancer (SCLC) was conducted to assess toxicities, response, and median survival. Patients and Methods: Between July 1990 and August 1992, 35 patients were treated. ICE doses were ifosfamide 5 g/m2 by 24-hour continuous intravenous (CIV) infusion with mesna on day 1, carboplatin 300 mg/m2 intravenously (IV) on day 1, and etoposide 50 mg/m2 orally on days 1 to 21 every 4 weeks for up to six to eight cycles (schedule I). Because of severe hematologic toxicity in the first 18 patients, the last 17 patients received ifosfamide 3.75 mg/m2 IV on day 1, carboplatin 300 mg/m2 IV on day 1, and etoposide 50 mg orally on days 1 to 14 (schedule II). Results: Nine of 18 patients (50%) on schedule I had 13 episodes of severe hematologic toxicity (one death), and only two (11%) received full doses on cycle 2. However, with schedule II, only four of 17 patients (24%) developed severe hematologic toxicity, and eight (47%) received full doses on cycle 2. Objective responses were observed in 29 of 35 patients (83%) (schedule I, 16 of 18 patients [89%]; schedule II, 13 of 17 patients [76%]). There were eight (23%) complete responses (CRs) and 21 (60%) partial responses (PRs). The median survival duration was 8.3 months, and 1- and 2-year survival rates were 37% and 14%, respectively. Conclusion: ICE with oral etoposide has comparable activity with other regimens in ED SCLC. However, the 2-year survival rate may be higher and ICE with the lower doses of schedule II could be given safely with acceptable toxicity. Further studies of ICE compared with standard two-drug regimens are warranted.

AB - Purpose: A phase II study of ifosfamide, carboplatin, and prolonged oral administration of etoposide (ICE) in patients with untreated extensive- disease (ED) small-cell lung cancer (SCLC) was conducted to assess toxicities, response, and median survival. Patients and Methods: Between July 1990 and August 1992, 35 patients were treated. ICE doses were ifosfamide 5 g/m2 by 24-hour continuous intravenous (CIV) infusion with mesna on day 1, carboplatin 300 mg/m2 intravenously (IV) on day 1, and etoposide 50 mg/m2 orally on days 1 to 21 every 4 weeks for up to six to eight cycles (schedule I). Because of severe hematologic toxicity in the first 18 patients, the last 17 patients received ifosfamide 3.75 mg/m2 IV on day 1, carboplatin 300 mg/m2 IV on day 1, and etoposide 50 mg orally on days 1 to 14 (schedule II). Results: Nine of 18 patients (50%) on schedule I had 13 episodes of severe hematologic toxicity (one death), and only two (11%) received full doses on cycle 2. However, with schedule II, only four of 17 patients (24%) developed severe hematologic toxicity, and eight (47%) received full doses on cycle 2. Objective responses were observed in 29 of 35 patients (83%) (schedule I, 16 of 18 patients [89%]; schedule II, 13 of 17 patients [76%]). There were eight (23%) complete responses (CRs) and 21 (60%) partial responses (PRs). The median survival duration was 8.3 months, and 1- and 2-year survival rates were 37% and 14%, respectively. Conclusion: ICE with oral etoposide has comparable activity with other regimens in ED SCLC. However, the 2-year survival rate may be higher and ICE with the lower doses of schedule II could be given safely with acceptable toxicity. Further studies of ICE compared with standard two-drug regimens are warranted.

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