Irinotecan/gemcitabine combination chemotherapy in pancreatic cancer

Caio Max S Rocha Lima, Carol A. Sherman, Frank J. Brescia, Chris Y. Brunson, Mark R. Green

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Abstract

Gemcitabine (Gemzar) and irinotecan (CPT-11, Camptosar) are active cytotoxic drugs against pancreatic cancer. Preclinical data evaluating the combination of gemcitabine and irinotecan suggest dose-dependent synergistic interactions in SCOG small-cell lung cancer and MCF-7 breast cancer cell lines. Two phase I trials of this combination have been reported to date: the day land 8 every-3-week schedule (IrinoGem trial), and the day 1, 8, and 15 every-4-week schedule (MSKCC trial). Both trials aimed to determine the maximum tolerated dose of irinotecan when administered as a 90-minute IV infusion either immediately after (IrinoGem) or before or immediately after (MSKCC) gemcitabine at 1,000 mg/m2 by 30-minute IV infusion in patients with solid tumors. The achieved maximum tolerated dose of IrinoGem has a higher dose intensity of irinotecan (100 mg/m2 on days 1 and 8, every-3-week cycle) compared with the MSKCC schedule (60 mg/m2 on days 1, 8, and 15, every-4-week trial). In IrinoGem, two of three previously untreated metastatic pancreas cancer patients had durable radiologic partial responses. The third had stable disease with clinical benefit for eight cycles. In addition, a patient with metastatic adenocarcinoma of unknown primary - potentially pancreatic - has had a durable response and is alive more than 30 months after the diagnosis. Preliminary results of a 45-patient multicenter phase II trial with IrinoGem in advanced and metastatic pancreas cancer were recently reported. Toxicity was modest, with no toxic deaths or neutropenic fever. Radiologic response rate was 20% of patients (9 out of 45), and a CA 19-9 decrease of more than 50% from baseline values occurred in 32.5% of patients (13 out of 40). Median survival was 6 months (range: 0.9 to 12.2+ months) and median time to treatment failure was 2.9 months (range: 0.1 to 11.3+ months). A pivotal international multicenter phase III trial comparing IrinoGem to single-agent gemcitabine in advanced and metastatic pancreas cancer is ongoing.

Original languageEnglish
Pages (from-to)46-51
Number of pages6
JournalOncology
Volume15
Issue number3 SUPPL. 5
StatePublished - Dec 1 2001

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irinotecan
gemcitabine
Combination Drug Therapy
Pancreatic Neoplasms
Appointments and Schedules
Maximum Tolerated Dose
Poisons
Small Cell Lung Carcinoma
Treatment Failure
Adenocarcinoma
Fever

ASJC Scopus subject areas

  • Oncology

Cite this

Rocha Lima, C. M. S., Sherman, C. A., Brescia, F. J., Brunson, C. Y., & Green, M. R. (2001). Irinotecan/gemcitabine combination chemotherapy in pancreatic cancer. Oncology, 15(3 SUPPL. 5), 46-51.

Irinotecan/gemcitabine combination chemotherapy in pancreatic cancer. / Rocha Lima, Caio Max S; Sherman, Carol A.; Brescia, Frank J.; Brunson, Chris Y.; Green, Mark R.

In: Oncology, Vol. 15, No. 3 SUPPL. 5, 01.12.2001, p. 46-51.

Research output: Contribution to journalArticle

Rocha Lima, CMS, Sherman, CA, Brescia, FJ, Brunson, CY & Green, MR 2001, 'Irinotecan/gemcitabine combination chemotherapy in pancreatic cancer', Oncology, vol. 15, no. 3 SUPPL. 5, pp. 46-51.
Rocha Lima CMS, Sherman CA, Brescia FJ, Brunson CY, Green MR. Irinotecan/gemcitabine combination chemotherapy in pancreatic cancer. Oncology. 2001 Dec 1;15(3 SUPPL. 5):46-51.
Rocha Lima, Caio Max S ; Sherman, Carol A. ; Brescia, Frank J. ; Brunson, Chris Y. ; Green, Mark R. / Irinotecan/gemcitabine combination chemotherapy in pancreatic cancer. In: Oncology. 2001 ; Vol. 15, No. 3 SUPPL. 5. pp. 46-51.
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N2 - Gemcitabine (Gemzar) and irinotecan (CPT-11, Camptosar) are active cytotoxic drugs against pancreatic cancer. Preclinical data evaluating the combination of gemcitabine and irinotecan suggest dose-dependent synergistic interactions in SCOG small-cell lung cancer and MCF-7 breast cancer cell lines. Two phase I trials of this combination have been reported to date: the day land 8 every-3-week schedule (IrinoGem trial), and the day 1, 8, and 15 every-4-week schedule (MSKCC trial). Both trials aimed to determine the maximum tolerated dose of irinotecan when administered as a 90-minute IV infusion either immediately after (IrinoGem) or before or immediately after (MSKCC) gemcitabine at 1,000 mg/m2 by 30-minute IV infusion in patients with solid tumors. The achieved maximum tolerated dose of IrinoGem has a higher dose intensity of irinotecan (100 mg/m2 on days 1 and 8, every-3-week cycle) compared with the MSKCC schedule (60 mg/m2 on days 1, 8, and 15, every-4-week trial). In IrinoGem, two of three previously untreated metastatic pancreas cancer patients had durable radiologic partial responses. The third had stable disease with clinical benefit for eight cycles. In addition, a patient with metastatic adenocarcinoma of unknown primary - potentially pancreatic - has had a durable response and is alive more than 30 months after the diagnosis. Preliminary results of a 45-patient multicenter phase II trial with IrinoGem in advanced and metastatic pancreas cancer were recently reported. Toxicity was modest, with no toxic deaths or neutropenic fever. Radiologic response rate was 20% of patients (9 out of 45), and a CA 19-9 decrease of more than 50% from baseline values occurred in 32.5% of patients (13 out of 40). Median survival was 6 months (range: 0.9 to 12.2+ months) and median time to treatment failure was 2.9 months (range: 0.1 to 11.3+ months). A pivotal international multicenter phase III trial comparing IrinoGem to single-agent gemcitabine in advanced and metastatic pancreas cancer is ongoing.

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