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A phase II study of fixed-dose rate gemcitabine plus low-dose cisplatin followed by consolidative chemoradiation for locally advanced pancreatic cancer.
- Source :
-
International journal of radiation oncology, biology, physics [Int J Radiat Oncol Biol Phys] 2007 Jul 01; Vol. 68 (3), pp. 809-16. Date of Electronic Publication: 2007 Mar 23. - Publication Year :
- 2007
-
Abstract
- Purpose: The optimal strategy for treating locally advanced pancreatic cancer remains controversial, including the respective roles and timing of chemotherapy and radiation. We conducted a Phase II nonrandomized trial to evaluate sequential chemotherapy followed by chemoradiation in this patient population.<br />Methods and Materials: Chemotherapy naive patients with locally advanced pancreatic adenocarcinoma were treated with fixed-dose rate gemcitabine (1,000 mg/m(2) at 10 mg/m(2)/min) plus cisplatin 20 mg/m(2) on Days 1 and 15 of a 28-day cycle. Those without evidence of extrapancreatic metastases after six cycles of chemotherapy received radiation (5,040 cGy over 28 fractions) with concurrent capecitabine (800 mg/m(2) orally twice daily on the day of radiation) as a radiosensitizer.<br />Results: A total of 25 patients were enrolled with a median follow-up time of 656 days. Twelve patients (48%) successfully received all six cycles of chemotherapy plus chemoradiation. Eight patients (32%) progressed during chemotherapy, including 7 with extrapancreatic metastases. Grade 3/4 hematologic toxicities were uncommon. Two patients sustained myocardial infarctions during chemotherapy, and 4 were hospitalized for infectious complications, although none in the setting of neutropenia. Median time to progression was 10.5 months and median survival was 13.5 months, with an estimated 1-year survival rate of 62%. Patients receiving all components of therapy had a median survival of 17.0 months.<br />Conclusions: A strategy of initial fixed-dose rate gemcitabine-based chemotherapy, followed by chemoradiation, shows promising efficacy for treatment of locally advanced disease. A substantial proportion of patients will be identified early on as having extrapancreatic disease and spared the potential toxicities associated with radiation.
- Subjects :
- Adult
Aged
Aged, 80 and over
Antimetabolites, Antineoplastic administration & dosage
California epidemiology
Cisplatin administration & dosage
Comorbidity
Deoxycytidine administration & dosage
Deoxycytidine analogs & derivatives
Dose-Response Relationship, Drug
Female
Gastrointestinal Diseases epidemiology
Humans
Incidence
Male
Middle Aged
Neoplasm Recurrence, Local prevention & control
Pancreatic Neoplasms surgery
Prognosis
Radiation-Sensitizing Agents administration & dosage
Risk Assessment methods
Risk Factors
Survival Analysis
Survival Rate
Treatment Outcome
Gemcitabine
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Neoplasm Recurrence, Local mortality
Pancreatic Neoplasms mortality
Pancreatic Neoplasms therapy
Radiation Injuries epidemiology
Radiotherapy, Adjuvant mortality
Subjects
Details
- Language :
- English
- ISSN :
- 0360-3016
- Volume :
- 68
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- International journal of radiation oncology, biology, physics
- Publication Type :
- Academic Journal
- Accession number :
- 17363191
- Full Text :
- https://doi.org/10.1016/j.ijrobp.2007.01.005