3rd April 22:08
pretty good results with Irinotecan plus gemcitabine in panc cancer (cancer tumor neutropenia chemotherapy diarrhea)
J Clin Oncol. 2002 Mar 1;20(5):1182-91.
Irinotecan plus gemcitabine induces both radiographic and CA 19-9 tumor
marker responses in patients with previously untreated advanced pancreatic
H. Lee Moffitt Cancer Center, University of South Florida, Gastrointestinal
Program Office, Tampa, FL 33612, USA.
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/m(2) over 30 minutes followed immediately by
irinotecan 100 mg/m(2) 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
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 [time to progression] 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.