Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lime cancer

Nasser Hanna, Paul A. Bunn, Corey Langer, Lawrence Einhorn, Troy Guthrie, Thaddeus Beck, Rafat Ansari, Peter Ellis, Michael Byrne, Mark Morrison, Subramanian Hariharan, Benjamin Wang, Alan Sandler

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Abstract

Purpose: Etoposide and cisplatin (EP) has been a standard treatment for extensive-disease small-cell lung cancer (SCLC). An earlier phase III trial reported improved survival for patients receiving irinotecan plus cisplatin (IP) versus EP. Our trial was designed to determine if a modified weekly regimen of IP would provide superior survival with less toxicity than EP. Patients and Methods: The primary objective was to compare overall survival in extensive-disease SCLC patients randomly assigned to receive IP (n = 221) or EP (n = 110). Patients were randomly assigned in 2:1 ratio to cisplatin 30 mg/m2 intravenously (IV) + irinotecan 65 mg/m2 IV on days 1 and 8 every 21 days, or cisplatin 60 mg/m2 IV on day 1, and etoposide 120 mg/m2 IV on days 1 to 3 every 21 days for at least four cycles, until progressive disease, or until intolerable toxicity resulted. Results: Selected grade 3/4 toxicities for IP/EP were: neutropenia (36.2% v 86.5%; P < .01), febrile neutropenia (3.7% v 10.4%; P = .06), anemia (4.8% v 11.5%; P = .02), thrombocytopenia (4.3% v 19.2%; P < .01), vomiting (12.5% v 3.8%; P = .04), and diarrhea (21.3% v 0%; P < .01). There was no significant difference in response rates (48% v 43.6%), median time to progression (4.1 v 4.6 months), or overall survival (median survival time, 9.3 months v 10.2 months; P = .74). Conclusion: Treatment with this dose and schedule of IP did not result in improved survival when compared with EP. Fewer patients receiving IP had grade 3/4 anemia, thrombocytopenia, neutropenia, and febrile neutropenia compared with patients receiving EP, but more had grade 3/4 diarrhea and vomiting.

Original languageEnglish
Pages (from-to)2038-2043
Number of pages6
JournalJournal of Clinical Oncology
Volume24
Issue number13
DOIs
StatePublished - May 1 2006

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irinotecan
Etoposide
Cisplatin
Neoplasms
Survival
Febrile Neutropenia
Small Cell Lung Carcinoma
Neutropenia
Vomiting
Anemia
Diarrhea
lime

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lime cancer. / Hanna, Nasser; Bunn, Paul A.; Langer, Corey; Einhorn, Lawrence; Guthrie, Troy; Beck, Thaddeus; Ansari, Rafat; Ellis, Peter; Byrne, Michael; Morrison, Mark; Hariharan, Subramanian; Wang, Benjamin; Sandler, Alan.

In: Journal of Clinical Oncology, Vol. 24, No. 13, 01.05.2006, p. 2038-2043.

Research output: Contribution to journalArticle

Hanna, Nasser ; Bunn, Paul A. ; Langer, Corey ; Einhorn, Lawrence ; Guthrie, Troy ; Beck, Thaddeus ; Ansari, Rafat ; Ellis, Peter ; Byrne, Michael ; Morrison, Mark ; Hariharan, Subramanian ; Wang, Benjamin ; Sandler, Alan. / Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lime cancer. In: Journal of Clinical Oncology. 2006 ; Vol. 24, No. 13. pp. 2038-2043.
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abstract = "Purpose: Etoposide and cisplatin (EP) has been a standard treatment for extensive-disease small-cell lung cancer (SCLC). An earlier phase III trial reported improved survival for patients receiving irinotecan plus cisplatin (IP) versus EP. Our trial was designed to determine if a modified weekly regimen of IP would provide superior survival with less toxicity than EP. Patients and Methods: The primary objective was to compare overall survival in extensive-disease SCLC patients randomly assigned to receive IP (n = 221) or EP (n = 110). Patients were randomly assigned in 2:1 ratio to cisplatin 30 mg/m2 intravenously (IV) + irinotecan 65 mg/m2 IV on days 1 and 8 every 21 days, or cisplatin 60 mg/m2 IV on day 1, and etoposide 120 mg/m2 IV on days 1 to 3 every 21 days for at least four cycles, until progressive disease, or until intolerable toxicity resulted. Results: Selected grade 3/4 toxicities for IP/EP were: neutropenia (36.2{\%} v 86.5{\%}; P < .01), febrile neutropenia (3.7{\%} v 10.4{\%}; P = .06), anemia (4.8{\%} v 11.5{\%}; P = .02), thrombocytopenia (4.3{\%} v 19.2{\%}; P < .01), vomiting (12.5{\%} v 3.8{\%}; P = .04), and diarrhea (21.3{\%} v 0{\%}; P < .01). There was no significant difference in response rates (48{\%} v 43.6{\%}), median time to progression (4.1 v 4.6 months), or overall survival (median survival time, 9.3 months v 10.2 months; P = .74). Conclusion: Treatment with this dose and schedule of IP did not result in improved survival when compared with EP. Fewer patients receiving IP had grade 3/4 anemia, thrombocytopenia, neutropenia, and febrile neutropenia compared with patients receiving EP, but more had grade 3/4 diarrhea and vomiting.",
author = "Nasser Hanna and Bunn, {Paul A.} and Corey Langer and Lawrence Einhorn and Troy Guthrie and Thaddeus Beck and Rafat Ansari and Peter Ellis and Michael Byrne and Mark Morrison and Subramanian Hariharan and Benjamin Wang and Alan Sandler",
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T1 - Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lime cancer

AU - Hanna, Nasser

AU - Bunn, Paul A.

AU - Langer, Corey

AU - Einhorn, Lawrence

AU - Guthrie, Troy

AU - Beck, Thaddeus

AU - Ansari, Rafat

AU - Ellis, Peter

AU - Byrne, Michael

AU - Morrison, Mark

AU - Hariharan, Subramanian

AU - Wang, Benjamin

AU - Sandler, Alan

PY - 2006/5/1

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N2 - Purpose: Etoposide and cisplatin (EP) has been a standard treatment for extensive-disease small-cell lung cancer (SCLC). An earlier phase III trial reported improved survival for patients receiving irinotecan plus cisplatin (IP) versus EP. Our trial was designed to determine if a modified weekly regimen of IP would provide superior survival with less toxicity than EP. Patients and Methods: The primary objective was to compare overall survival in extensive-disease SCLC patients randomly assigned to receive IP (n = 221) or EP (n = 110). Patients were randomly assigned in 2:1 ratio to cisplatin 30 mg/m2 intravenously (IV) + irinotecan 65 mg/m2 IV on days 1 and 8 every 21 days, or cisplatin 60 mg/m2 IV on day 1, and etoposide 120 mg/m2 IV on days 1 to 3 every 21 days for at least four cycles, until progressive disease, or until intolerable toxicity resulted. Results: Selected grade 3/4 toxicities for IP/EP were: neutropenia (36.2% v 86.5%; P < .01), febrile neutropenia (3.7% v 10.4%; P = .06), anemia (4.8% v 11.5%; P = .02), thrombocytopenia (4.3% v 19.2%; P < .01), vomiting (12.5% v 3.8%; P = .04), and diarrhea (21.3% v 0%; P < .01). There was no significant difference in response rates (48% v 43.6%), median time to progression (4.1 v 4.6 months), or overall survival (median survival time, 9.3 months v 10.2 months; P = .74). Conclusion: Treatment with this dose and schedule of IP did not result in improved survival when compared with EP. Fewer patients receiving IP had grade 3/4 anemia, thrombocytopenia, neutropenia, and febrile neutropenia compared with patients receiving EP, but more had grade 3/4 diarrhea and vomiting.

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