Irinotecan plus gemcitabine induces both radiographic and CA 19-9 tumor marker responses in patients with previously untreated advanced pancreatic cancer

Caio Max S Rocha Lima, Diane Savarese, Howard Bruckner, Arkadiusz Dudek, John Eckardt, John Hainsworth, Furhan Yunus, Eric Lester, William Miller, Wayne Saville, Gary L. Elfring, Paula K. Locker, Linda D. Compton, Langdon L. Miller, Mark R. Green

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Abstract

Purpose: This phase II, multicenter, open-label, single-arm study evaluated the efficacy and safety of irinotecan and gemcitabine as combination chemotherapy for previously untreated patients with unresectable or metastatic pancreatic cancer. Patients and Methods: Patients received repeated 21-day cycles at starting doses of gemcitabine 1,000 mg/m2 over 30 minutes followed immediately by irinotecan 100 mg/m2 over 90 minutes, both given intravenously on days 1 and 8. Patients were evaluated for objective tumor response, changes in the serum tumor marker CA 19-9, time to tumor progression (TTP), survival, and safety. Results: Forty-five patients were treated. Eleven patients (24%) had 50% or greater reductions in tumor area. These were confirmed one cycle later in nine patients (response rate, 20%; 95% confidence interval, 8% to 32%). Among 44 patients with baseline CA 19-9 determinations, CA 19-9 decreased during therapy in 22 patients (50%) and was reduced by 50% or more in 13 patients (30%). Median TTP was 2.8 months (range, 0.3 to 10.8 months). There were significant (P < .001) correlations between proportional changes in CA 19-9 and radiographic changes in tumor area with regard to extent of change (r = .67), timing of minimum on-study values (r = .85), and tumor progression (r = .89). Median survival was 5.7 months (range, 0.4 to 19.4+ months), and the 1-year survival rate was 27%. Severe toxicities were uncommon and primarily limited to grade 4 neutropenia (2%), grade 4 vomiting (2%), and grade 3 diarrhea (7%). Conclusion: Irinotecan/gemcitabine is a new combination that offers encouraging activity in terms of radiographic and CA 19-9 response and notable 1-year survival in pancreatic cancer. The regimen was well tolerated, with minimal grade 3 and 4 toxicities and excellent maintenance of planned dose-intensity.

Original languageEnglish
Pages (from-to)1182-1191
Number of pages10
JournalJournal of Clinical Oncology
Volume20
Issue number5
DOIs
StatePublished - Mar 1 2002

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irinotecan
gemcitabine
Tumor Biomarkers
Pancreatic Neoplasms
Neoplasms
Survival
Safety

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Irinotecan plus gemcitabine induces both radiographic and CA 19-9 tumor marker responses in patients with previously untreated advanced pancreatic cancer. / Rocha Lima, Caio Max S; Savarese, Diane; Bruckner, Howard; Dudek, Arkadiusz; Eckardt, John; Hainsworth, John; Yunus, Furhan; Lester, Eric; Miller, William; Saville, Wayne; Elfring, Gary L.; Locker, Paula K.; Compton, Linda D.; Miller, Langdon L.; Green, Mark R.

In: Journal of Clinical Oncology, Vol. 20, No. 5, 01.03.2002, p. 1182-1191.

Research output: Contribution to journalArticle

Rocha Lima, CMS, Savarese, D, Bruckner, H, Dudek, A, Eckardt, J, Hainsworth, J, Yunus, F, Lester, E, Miller, W, Saville, W, Elfring, GL, Locker, PK, Compton, LD, Miller, LL & Green, MR 2002, 'Irinotecan plus gemcitabine induces both radiographic and CA 19-9 tumor marker responses in patients with previously untreated advanced pancreatic cancer', Journal of Clinical Oncology, vol. 20, no. 5, pp. 1182-1191. https://doi.org/10.1200/JCO.20.5.1182
Rocha Lima, Caio Max S ; Savarese, Diane ; Bruckner, Howard ; Dudek, Arkadiusz ; Eckardt, John ; Hainsworth, John ; Yunus, Furhan ; Lester, Eric ; Miller, William ; Saville, Wayne ; Elfring, Gary L. ; Locker, Paula K. ; Compton, Linda D. ; Miller, Langdon L. ; Green, Mark R. / Irinotecan plus gemcitabine induces both radiographic and CA 19-9 tumor marker responses in patients with previously untreated advanced pancreatic cancer. In: Journal of Clinical Oncology. 2002 ; Vol. 20, No. 5. pp. 1182-1191.
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abstract = "Purpose: This phase II, multicenter, open-label, single-arm study evaluated the efficacy and safety of irinotecan and gemcitabine as combination chemotherapy for previously untreated patients with unresectable or metastatic pancreatic cancer. Patients and Methods: Patients received repeated 21-day cycles at starting doses of gemcitabine 1,000 mg/m2 over 30 minutes followed immediately by irinotecan 100 mg/m2 over 90 minutes, both given intravenously on days 1 and 8. Patients were evaluated for objective tumor response, changes in the serum tumor marker CA 19-9, time to tumor progression (TTP), survival, and safety. Results: Forty-five patients were treated. Eleven patients (24{\%}) had 50{\%} or greater reductions in tumor area. These were confirmed one cycle later in nine patients (response rate, 20{\%}; 95{\%} confidence interval, 8{\%} to 32{\%}). Among 44 patients with baseline CA 19-9 determinations, CA 19-9 decreased during therapy in 22 patients (50{\%}) and was reduced by 50{\%} or more in 13 patients (30{\%}). Median TTP was 2.8 months (range, 0.3 to 10.8 months). There were significant (P < .001) correlations between proportional changes in CA 19-9 and radiographic changes in tumor area with regard to extent of change (r = .67), timing of minimum on-study values (r = .85), and tumor progression (r = .89). Median survival was 5.7 months (range, 0.4 to 19.4+ months), and the 1-year survival rate was 27{\%}. Severe toxicities were uncommon and primarily limited to grade 4 neutropenia (2{\%}), grade 4 vomiting (2{\%}), and grade 3 diarrhea (7{\%}). Conclusion: Irinotecan/gemcitabine is a new combination that offers encouraging activity in terms of radiographic and CA 19-9 response and notable 1-year survival in pancreatic cancer. The regimen was well tolerated, with minimal grade 3 and 4 toxicities and excellent maintenance of planned dose-intensity.",
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T1 - Irinotecan plus gemcitabine induces both radiographic and CA 19-9 tumor marker responses in patients with previously untreated advanced pancreatic cancer

AU - Rocha Lima, Caio Max S

AU - Savarese, Diane

AU - Bruckner, Howard

AU - Dudek, Arkadiusz

AU - Eckardt, John

AU - Hainsworth, John

AU - Yunus, Furhan

AU - Lester, Eric

AU - Miller, William

AU - Saville, Wayne

AU - Elfring, Gary L.

AU - Locker, Paula K.

AU - Compton, Linda D.

AU - Miller, Langdon L.

AU - Green, Mark R.

PY - 2002/3/1

Y1 - 2002/3/1

N2 - Purpose: This phase II, multicenter, open-label, single-arm study evaluated the efficacy and safety of irinotecan and gemcitabine as combination chemotherapy for previously untreated patients with unresectable or metastatic pancreatic cancer. Patients and Methods: Patients received repeated 21-day cycles at starting doses of gemcitabine 1,000 mg/m2 over 30 minutes followed immediately by irinotecan 100 mg/m2 over 90 minutes, both given intravenously on days 1 and 8. Patients were evaluated for objective tumor response, changes in the serum tumor marker CA 19-9, time to tumor progression (TTP), survival, and safety. Results: Forty-five patients were treated. Eleven patients (24%) had 50% or greater reductions in tumor area. These were confirmed one cycle later in nine patients (response rate, 20%; 95% confidence interval, 8% to 32%). Among 44 patients with baseline CA 19-9 determinations, CA 19-9 decreased during therapy in 22 patients (50%) and was reduced by 50% or more in 13 patients (30%). Median TTP was 2.8 months (range, 0.3 to 10.8 months). There were significant (P < .001) correlations between proportional changes in CA 19-9 and radiographic changes in tumor area with regard to extent of change (r = .67), timing of minimum on-study values (r = .85), and tumor progression (r = .89). Median survival was 5.7 months (range, 0.4 to 19.4+ months), and the 1-year survival rate was 27%. Severe toxicities were uncommon and primarily limited to grade 4 neutropenia (2%), grade 4 vomiting (2%), and grade 3 diarrhea (7%). Conclusion: Irinotecan/gemcitabine is a new combination that offers encouraging activity in terms of radiographic and CA 19-9 response and notable 1-year survival in pancreatic cancer. The regimen was well tolerated, with minimal grade 3 and 4 toxicities and excellent maintenance of planned dose-intensity.

AB - Purpose: This phase II, multicenter, open-label, single-arm study evaluated the efficacy and safety of irinotecan and gemcitabine as combination chemotherapy for previously untreated patients with unresectable or metastatic pancreatic cancer. Patients and Methods: Patients received repeated 21-day cycles at starting doses of gemcitabine 1,000 mg/m2 over 30 minutes followed immediately by irinotecan 100 mg/m2 over 90 minutes, both given intravenously on days 1 and 8. Patients were evaluated for objective tumor response, changes in the serum tumor marker CA 19-9, time to tumor progression (TTP), survival, and safety. Results: Forty-five patients were treated. Eleven patients (24%) had 50% or greater reductions in tumor area. These were confirmed one cycle later in nine patients (response rate, 20%; 95% confidence interval, 8% to 32%). Among 44 patients with baseline CA 19-9 determinations, CA 19-9 decreased during therapy in 22 patients (50%) and was reduced by 50% or more in 13 patients (30%). Median TTP was 2.8 months (range, 0.3 to 10.8 months). There were significant (P < .001) correlations between proportional changes in CA 19-9 and radiographic changes in tumor area with regard to extent of change (r = .67), timing of minimum on-study values (r = .85), and tumor progression (r = .89). Median survival was 5.7 months (range, 0.4 to 19.4+ months), and the 1-year survival rate was 27%. Severe toxicities were uncommon and primarily limited to grade 4 neutropenia (2%), grade 4 vomiting (2%), and grade 3 diarrhea (7%). Conclusion: Irinotecan/gemcitabine is a new combination that offers encouraging activity in terms of radiographic and CA 19-9 response and notable 1-year survival in pancreatic cancer. The regimen was well tolerated, with minimal grade 3 and 4 toxicities and excellent maintenance of planned dose-intensity.

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