Abstract
4118 Background: Patients (pts) with metastatic pancreatic adenocarcinoma (PCa) treated with GEM using a FDRI have a longer survival than with 30 min infusion schedules1. Over 40% of metastatic PCa’s overexpress EGFR2. This study aimed to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of GEM using a FDRI in combination with gefitinib, an EGFR TK inhibitor in pts with PCa. Methods: Pts with advanced pancreatic cancer were given GEM at the FDRI of 10 mg/m2/min IV on days 1, 8, and 15 of a 28 day cycle. Dose levels of 1000, 1200 and 1500 mg/m2 were evaluated. Oral gefitinib 250 mg was given daily. DLTs were defined as two instances of grade III hematologic or IV non-hematologic toxicity or any grade IV hematologic toxicity. Four pts were treated at each dose level. Dose level escalation occurred in the absence of DLTs. Results: Four women and 8 men were enrolled. Median age was 61. All pts were PS 0 or 1 and had metastatic disease (83.3% liver; 16.6% lungs). Three pts received prior chemoradiation for pancreatic cancer, and one chemotherapy for lung cancer. Median cycles were 3 per pt. The MTD was 1200 mg/m2. Toxicity was predominantly hematologic. At 1500mg/m2, all 4 pts required dose reduction because of grade 3 granulocytopenia, and 1 pt had grade 3 anemia. One pt had grade 3 granulocytopenia at a dose of 1200mg/m2. Acneform rashes were mild with grade 1 in 6 pts (50%) and grade 2 in 2 pts (16.6%). One pt had grade 3 vomiting; no significant diarrhea or liver toxicity was seen. Median time to progression and overall survival were 3.6 months and 4.8 months, respectively. Conclusions: Combining FDRI gemcitabine with gefitinib is feasible and tolerable. Recommended phase II dose for GEM is 1200mg/m2 at FDRI of 10 mg/m2/min with gefitinib 250mg PO daily. 1 Tempero, M. Journal of Clinical Oncology 21(18):3402–8, 2003. 2 Uegaki, K. Anticancer Research 17:3841–7, 1997. Supported by a grant from AstraZeneca Pharmaceuticals Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AstraZeneca AstraZeneca
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
