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Phase I study of twice-weekly gemcitabine and concomitant external-beam radiotherapy in patients with adenocarcinoma of the pancreas
- Source :
- International Journal of Radiation Oncology*Biology*Physics. 50:1317-1322
- Publication Year :
- 2001
- Publisher :
- Elsevier BV, 2001.
-
Abstract
- Purpose: To determine the maximum tolerated dose and dose-limiting toxicity associated with twice-weekly gemcitabine and concomitant external-beam radiotherapy in patients with adenocarcinoma of the pancreas. Methods and Materials: Twenty-one patients with biopsy-proven adenocarcinoma of the pancreas were treated with external-beam radiotherapy to a dose of 50.4 Gy in 28 fractions, concurrent with gemcitabine, infused over 30 min before irradiation on a Monday and Thursday schedule. The dose of gemcitabine was escalated in 5 cohorts of 3–6 patients each. Initial gemcitabine dose was 10 mg/m 2 , with dose escalation until dose-limiting toxicity was observed. Results: The maximum tolerated dose of gemcitabine was 50 mg/m 2 , when given in a twice-weekly schedule with radiation. Dose-limiting toxicity was seen in 2 patients at 60 mg/m 2 , and consisted of severe upper gastrointestinal bleeding approximately 1 month after completion of treatment. Six patients had radiographic evidence of response to treatment, and 5 of these underwent complete surgical resection. Three patients who underwent complete resection had been deemed to have unresectable tumors before enrollment on trial. Four patients are alive, including 2 without evidence of disease more than 1 year after resection. Conclusion: The combination of external-beam radiation and twice-weekly gemcitabine at a dose of 50 mg/m 2 is well tolerated and shows promising activity for the treatment of pancreatic cancer. Our data suggest a higher maximum tolerated dose and different dose-limiting toxicity than previously reported. Further investigation of this regimen is warranted.
- Subjects :
- Adult
Male
Antimetabolites, Antineoplastic
Cancer Research
medicine.medical_specialty
medicine.medical_treatment
Urology
Adenocarcinoma
Deoxycytidine
Disease-Free Survival
Drug Administration Schedule
Radiotherapy, High-Energy
Pancreatectomy
Pancreatic cancer
medicine
Humans
Radiology, Nuclear Medicine and imaging
External beam radiotherapy
Bone Marrow Diseases
Fatigue
Chemotherapy
Radiation
business.industry
Radiotherapy Planning, Computer-Assisted
Remission Induction
Nausea
Radiotherapy Dosage
Middle Aged
medicine.disease
Combined Modality Therapy
Survival Analysis
Gemcitabine
Surgery
Pancreatic Neoplasms
Radiation therapy
Regimen
Treatment Outcome
Oncology
Chemotherapy, Adjuvant
Concomitant
Female
Gastrointestinal Hemorrhage
business
Follow-Up Studies
medicine.drug
Subjects
Details
- ISSN :
- 03603016
- Volume :
- 50
- Database :
- OpenAIRE
- Journal :
- International Journal of Radiation Oncology*Biology*Physics
- Accession number :
- edsair.doi.dedup.....13ae8d762e53a31b398c85fcd4ad6868