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Author Goody, Rebecca B. ♦ MacKay, Helen ♦ Pitcher, Bethany ♦ Oza, Amit ♦ Siu, Lillian L. ♦ Kim, John ♦ Wong, Rebecca K. S. ♦ Chen, Eric ♦ Swallow, Carol ♦ Knox, Jennifer ♦ Kassam, Zahra ♦ Cummings, Bernard ♦ Feld, Ron ♦ Hedley, David ♦ Liu, Geoffrey ♦ Krzyzanowska, Monika K. ♦ Dinniwell, Robert ♦ Brade, Anthony M. ♦ Dawson, Laura A. ♦ Pintilie, Melania
Source United States Department of Energy Office of Scientific and Technical Information
Content type Text
Language English
Subject Keyword RADIOLOGY AND NUCLEAR MEDICINE ♦ CHEMOTHERAPY ♦ FLUORINE COMPOUNDS ♦ GY RANGE 10-100 ♦ IMAGES ♦ MAGNESIUM 40 ♦ NEOPLASMS ♦ PATIENTS ♦ RADIATION DOSES ♦ RADIOTHERAPY ♦ TOXICITY
Abstract Purpose: Locoregional recurrence is common after surgery for gastric cancer. Adjuvant therapy improves outcomes but with toxicity. This phase 1/2 study investigated infusional 5-fluorouracil (5-FU) in combination with biweekly cisplatin delivered concurrently with image guided high-precision radiation therapy. Methods and Materials: Eligible patients had completely resected stage IB to IV (Union for International Cancer Control TNM 6th edition) nonmetastatic gastric adenocarcinoma. Treatment constituted 12 weeks of infusional 5-FU (200 mg/m{sup 2}/day) with cisplatin added in a standard 3 + 3 dose escalation protocol (0, 20, 30, and 40 mg/m{sup 2}) during weeks 1, 3, 5, and 7, and an additional week 9 dose in the final cohort. Radiation therapy (45 Gy in 25 fractions) was delivered during weeks 3 to 7. Maximum tolerated dose (MTD) was determined in phase 1 and confirmed in phase 2. Results: Among the 55 patients (median age, 54 years; range 28-77 years; 55% male), the median follow-up time was 3.0 years (range, 0.3-5.3 years). Five patients in phase 1 experienced dose-limiting toxicity, and MTD was determined as 4 cycles of 40 mg/m{sup 2} cisplatin. Twenty-seven patients were treated at MTD. Acute grade 3 to 4 toxicity rate was 37.0% at MTD and 29.1% across all dose levels. No treatment-related deaths occurred. Fourteen patients experienced recurrent disease. The 2-year overall survival (OS) and relapse-free survival were 85% and 74%, respectively. Median OS has not been reached. Quality of life (QOL) was impaired during treatment, but most scores recovered by 4 weeks. Conclusion: Cisplatin can be safely delivered with 5-FU–based chemoradiation therapy. Acute toxicity was acceptable, and patient-reported QOL showed the regimen was tolerable. Outcomes are encouraging and justify further study of this regimen.
ISSN 03603016
Educational Use Research
Learning Resource Type Article
Publisher Date 2016-12-01
Publisher Place United States
Journal International Journal of Radiation Oncology, Biology and Physics
Volume Number 96
Issue Number 5


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