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

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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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