Phase II trial of irinotecan and carboplatin for extensive or relapsed small-cell lung cancer

Derick H Lau, Gigi Chen, Minh Huynh, Lou Fehrenbacher, Howard West, Primo N Lara, Leonid L. Yavorkovsky, Michael Russin, Desiree Goldstein, David R Gandara

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Abstract

Purpose The regimens of weekly irinotecan with platinum have been used for treatment of metastatic small-cell lung cancer (SCLC). We conducted a multi-institution phase II trial to evaluate a novel 21-day schedule of irinotecan and carboplatin in patients with relapsed or extensive SCLC. Patients and Methods Eighty patients were enrolled with the following characteristics: 39 male patients, 41 female patients; median age, 65 years; and Zubrod performance status, 0 to 1 in 85% and 2 in 15% of patients. Dosing schemas were based on the maximum-tolerated dose derived in a previous phase I study. Chemotherapy-naive patients with extensive SCLC were treated with irinotecan 200 mg/m2 and carboplatin area under the curve (AUC) of 5 (arm A). Patients, who had previously been treated with chemotherapy and had relapsed disease received irinotecan 150 mg/m2 and carboplatin AUC of 5 (arm B). In each study arm, the treatment was given every 21 days for up to six cycles. Results The most common grade 3 to 4 toxicities included neutropenia (54%), thrombocytopenia (22%), anemia (13%), diarrhea (22%), and nausea/emesis (11%) in both study arms. There were three treatment-related deaths owing to neutropenic sepsis. Among 72 assessable patients, response rates of 65% and 50% were observed, respectively, for arm A and arm B. The median survival for both study arms was identical at 10 months (95% CI, 6 to 14 months). A response rate of 65% was observed in the intracranial disease of 14 patients with known brain metastases. Conclusion This 21-day regimen of irinotecan and carboplatin seems promising for the treatment of relapsed SCLC.

Original languageEnglish (US)
Pages (from-to)1401-1404
Number of pages4
JournalJournal of Clinical Oncology
Volume27
Issue number9
DOIs
StatePublished - Mar 20 2009

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irinotecan
Carboplatin
Small Cell Lung Carcinoma
Area Under Curve
Drug Therapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

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Phase II trial of irinotecan and carboplatin for extensive or relapsed small-cell lung cancer. / Lau, Derick H; Chen, Gigi; Huynh, Minh; Fehrenbacher, Lou; West, Howard; Lara, Primo N; Yavorkovsky, Leonid L.; Russin, Michael; Goldstein, Desiree; Gandara, David R.

In: Journal of Clinical Oncology, Vol. 27, No. 9, 20.03.2009, p. 1401-1404.

Research output: Contribution to journalArticle

Lau, DH, Chen, G, Huynh, M, Fehrenbacher, L, West, H, Lara, PN, Yavorkovsky, LL, Russin, M, Goldstein, D & Gandara, DR 2009, 'Phase II trial of irinotecan and carboplatin for extensive or relapsed small-cell lung cancer', Journal of Clinical Oncology, vol. 27, no. 9, pp. 1401-1404. https://doi.org/10.1200/JCO.2008.20.2127
Lau, Derick H ; Chen, Gigi ; Huynh, Minh ; Fehrenbacher, Lou ; West, Howard ; Lara, Primo N ; Yavorkovsky, Leonid L. ; Russin, Michael ; Goldstein, Desiree ; Gandara, David R. / Phase II trial of irinotecan and carboplatin for extensive or relapsed small-cell lung cancer. In: Journal of Clinical Oncology. 2009 ; Vol. 27, No. 9. pp. 1401-1404.
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abstract = "Purpose The regimens of weekly irinotecan with platinum have been used for treatment of metastatic small-cell lung cancer (SCLC). We conducted a multi-institution phase II trial to evaluate a novel 21-day schedule of irinotecan and carboplatin in patients with relapsed or extensive SCLC. Patients and Methods Eighty patients were enrolled with the following characteristics: 39 male patients, 41 female patients; median age, 65 years; and Zubrod performance status, 0 to 1 in 85{\%} and 2 in 15{\%} of patients. Dosing schemas were based on the maximum-tolerated dose derived in a previous phase I study. Chemotherapy-naive patients with extensive SCLC were treated with irinotecan 200 mg/m2 and carboplatin area under the curve (AUC) of 5 (arm A). Patients, who had previously been treated with chemotherapy and had relapsed disease received irinotecan 150 mg/m2 and carboplatin AUC of 5 (arm B). In each study arm, the treatment was given every 21 days for up to six cycles. Results The most common grade 3 to 4 toxicities included neutropenia (54{\%}), thrombocytopenia (22{\%}), anemia (13{\%}), diarrhea (22{\%}), and nausea/emesis (11{\%}) in both study arms. There were three treatment-related deaths owing to neutropenic sepsis. Among 72 assessable patients, response rates of 65{\%} and 50{\%} were observed, respectively, for arm A and arm B. The median survival for both study arms was identical at 10 months (95{\%} CI, 6 to 14 months). A response rate of 65{\%} was observed in the intracranial disease of 14 patients with known brain metastases. Conclusion This 21-day regimen of irinotecan and carboplatin seems promising for the treatment of relapsed SCLC.",
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T1 - Phase II trial of irinotecan and carboplatin for extensive or relapsed small-cell lung cancer

AU - Lau, Derick H

AU - Chen, Gigi

AU - Huynh, Minh

AU - Fehrenbacher, Lou

AU - West, Howard

AU - Lara, Primo N

AU - Yavorkovsky, Leonid L.

AU - Russin, Michael

AU - Goldstein, Desiree

AU - Gandara, David R

PY - 2009/3/20

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N2 - Purpose The regimens of weekly irinotecan with platinum have been used for treatment of metastatic small-cell lung cancer (SCLC). We conducted a multi-institution phase II trial to evaluate a novel 21-day schedule of irinotecan and carboplatin in patients with relapsed or extensive SCLC. Patients and Methods Eighty patients were enrolled with the following characteristics: 39 male patients, 41 female patients; median age, 65 years; and Zubrod performance status, 0 to 1 in 85% and 2 in 15% of patients. Dosing schemas were based on the maximum-tolerated dose derived in a previous phase I study. Chemotherapy-naive patients with extensive SCLC were treated with irinotecan 200 mg/m2 and carboplatin area under the curve (AUC) of 5 (arm A). Patients, who had previously been treated with chemotherapy and had relapsed disease received irinotecan 150 mg/m2 and carboplatin AUC of 5 (arm B). In each study arm, the treatment was given every 21 days for up to six cycles. Results The most common grade 3 to 4 toxicities included neutropenia (54%), thrombocytopenia (22%), anemia (13%), diarrhea (22%), and nausea/emesis (11%) in both study arms. There were three treatment-related deaths owing to neutropenic sepsis. Among 72 assessable patients, response rates of 65% and 50% were observed, respectively, for arm A and arm B. The median survival for both study arms was identical at 10 months (95% CI, 6 to 14 months). A response rate of 65% was observed in the intracranial disease of 14 patients with known brain metastases. Conclusion This 21-day regimen of irinotecan and carboplatin seems promising for the treatment of relapsed SCLC.

AB - Purpose The regimens of weekly irinotecan with platinum have been used for treatment of metastatic small-cell lung cancer (SCLC). We conducted a multi-institution phase II trial to evaluate a novel 21-day schedule of irinotecan and carboplatin in patients with relapsed or extensive SCLC. Patients and Methods Eighty patients were enrolled with the following characteristics: 39 male patients, 41 female patients; median age, 65 years; and Zubrod performance status, 0 to 1 in 85% and 2 in 15% of patients. Dosing schemas were based on the maximum-tolerated dose derived in a previous phase I study. Chemotherapy-naive patients with extensive SCLC were treated with irinotecan 200 mg/m2 and carboplatin area under the curve (AUC) of 5 (arm A). Patients, who had previously been treated with chemotherapy and had relapsed disease received irinotecan 150 mg/m2 and carboplatin AUC of 5 (arm B). In each study arm, the treatment was given every 21 days for up to six cycles. Results The most common grade 3 to 4 toxicities included neutropenia (54%), thrombocytopenia (22%), anemia (13%), diarrhea (22%), and nausea/emesis (11%) in both study arms. There were three treatment-related deaths owing to neutropenic sepsis. Among 72 assessable patients, response rates of 65% and 50% were observed, respectively, for arm A and arm B. The median survival for both study arms was identical at 10 months (95% CI, 6 to 14 months). A response rate of 65% was observed in the intracranial disease of 14 patients with known brain metastases. Conclusion This 21-day regimen of irinotecan and carboplatin seems promising for the treatment of relapsed SCLC.

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