Single-agent gemcitabine and gemcitabine/irinotecan combination (IrimoGem) in non-small cell lung cancer

C. M S Rocha Lima, J. R. Eckardt, S. S. Leong, C. A. Sherman, J. A. Perkel, T. Putman, A. R. Safa, H. R. Bahadori, M. R. Green

Research output: Contribution to journalArticle

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Abstract

Gemcitabine is a fluoridated pyrimidine related to cytosine arabinoside that has significant activity in solid tumor models. Irinotecan is camptothecin analog with an active metabolite, SN-38, which inhibits topoisomerase I activity by stabilizing the topoisomerase I-DNA cleavable complex. Gemcitabine studies in non-small cell lung cancer conducted in the United States, as well as an international collaboration and clinical trials from Europe and Japan, found overall response rates of 20% to 26%, a median duration of response between 5 to 9 months, and a median duration of survival ranging from 7 to 12.3 months. Gemcitabine also has been shown to be more effective than best supportive care in non-small cell lung cancer. In a phase I trial of irinotecan (50, 75, 100, and 115 mg/m2) in combination with 1,000 mg/m2 gemcitabine, three patients had documented partial responses: one with pancreas cancer at irinotecan 100 mg/m2, one with pancreas cancer, and one with metastatic carcinoma of unknown primary at irinotecan 115 mg/m2. Three of five non-small cell lung cancer patients had stable disease for four or more cycles at irinotecan doses of 50, 75, and 100 mg/m2; no non-small cell lung cancer patients were treated at irinotecan 115 mg/m2. We recommend that a combination of gemcitabine 1,000 mg/m2 and irinotecan 100 mg/m2 given on days 1 and 8 every 3 weeks be used as the starting dose in future phase II studies. Furthermore, based on the absence of severe nonhematologic toxicity or grade IV hematologic toxicity in the majority of patients treated at the highest dose, escalation of irinotecan to 115 mg/m2 may be considered for subsequent cycles in patients who do not experience ≥grade I hematologic or nonhematologic toxicity during the first cycle of gemcitabine/irinotecan combination chemotherapy.

Original languageEnglish
Pages (from-to)43-50
Number of pages8
JournalSeminars in Oncology
Volume26
Issue number5 SUPPL. 16
StatePublished - Dec 14 1999

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irinotecan
gemcitabine
Non-Small Cell Lung Carcinoma
Type I DNA Topoisomerase
Pancreatic Neoplasms
Camptothecin

ASJC Scopus subject areas

  • Oncology

Cite this

Rocha Lima, C. M. S., Eckardt, J. R., Leong, S. S., Sherman, C. A., Perkel, J. A., Putman, T., ... Green, M. R. (1999). Single-agent gemcitabine and gemcitabine/irinotecan combination (IrimoGem) in non-small cell lung cancer. Seminars in Oncology, 26(5 SUPPL. 16), 43-50.

Single-agent gemcitabine and gemcitabine/irinotecan combination (IrimoGem) in non-small cell lung cancer. / Rocha Lima, C. M S; Eckardt, J. R.; Leong, S. S.; Sherman, C. A.; Perkel, J. A.; Putman, T.; Safa, A. R.; Bahadori, H. R.; Green, M. R.

In: Seminars in Oncology, Vol. 26, No. 5 SUPPL. 16, 14.12.1999, p. 43-50.

Research output: Contribution to journalArticle

Rocha Lima, CMS, Eckardt, JR, Leong, SS, Sherman, CA, Perkel, JA, Putman, T, Safa, AR, Bahadori, HR & Green, MR 1999, 'Single-agent gemcitabine and gemcitabine/irinotecan combination (IrimoGem) in non-small cell lung cancer', Seminars in Oncology, vol. 26, no. 5 SUPPL. 16, pp. 43-50.
Rocha Lima CMS, Eckardt JR, Leong SS, Sherman CA, Perkel JA, Putman T et al. Single-agent gemcitabine and gemcitabine/irinotecan combination (IrimoGem) in non-small cell lung cancer. Seminars in Oncology. 1999 Dec 14;26(5 SUPPL. 16):43-50.
Rocha Lima, C. M S ; Eckardt, J. R. ; Leong, S. S. ; Sherman, C. A. ; Perkel, J. A. ; Putman, T. ; Safa, A. R. ; Bahadori, H. R. ; Green, M. R. / Single-agent gemcitabine and gemcitabine/irinotecan combination (IrimoGem) in non-small cell lung cancer. In: Seminars in Oncology. 1999 ; Vol. 26, No. 5 SUPPL. 16. pp. 43-50.
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abstract = "Gemcitabine is a fluoridated pyrimidine related to cytosine arabinoside that has significant activity in solid tumor models. Irinotecan is camptothecin analog with an active metabolite, SN-38, which inhibits topoisomerase I activity by stabilizing the topoisomerase I-DNA cleavable complex. Gemcitabine studies in non-small cell lung cancer conducted in the United States, as well as an international collaboration and clinical trials from Europe and Japan, found overall response rates of 20{\%} to 26{\%}, a median duration of response between 5 to 9 months, and a median duration of survival ranging from 7 to 12.3 months. Gemcitabine also has been shown to be more effective than best supportive care in non-small cell lung cancer. In a phase I trial of irinotecan (50, 75, 100, and 115 mg/m2) in combination with 1,000 mg/m2 gemcitabine, three patients had documented partial responses: one with pancreas cancer at irinotecan 100 mg/m2, one with pancreas cancer, and one with metastatic carcinoma of unknown primary at irinotecan 115 mg/m2. Three of five non-small cell lung cancer patients had stable disease for four or more cycles at irinotecan doses of 50, 75, and 100 mg/m2; no non-small cell lung cancer patients were treated at irinotecan 115 mg/m2. We recommend that a combination of gemcitabine 1,000 mg/m2 and irinotecan 100 mg/m2 given on days 1 and 8 every 3 weeks be used as the starting dose in future phase II studies. Furthermore, based on the absence of severe nonhematologic toxicity or grade IV hematologic toxicity in the majority of patients treated at the highest dose, escalation of irinotecan to 115 mg/m2 may be considered for subsequent cycles in patients who do not experience ≥grade I hematologic or nonhematologic toxicity during the first cycle of gemcitabine/irinotecan combination chemotherapy.",
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