Abstract | OBJECTIVE: METHODS: We conducted a phase II study evaluating 3× weekly 2-hour intravenous 3-aminopyridine-2-carboxaldehyde thiosemicarbazone (3-AP, 25 mg/m(2)) co-administered with 1× weekly intravenous cisplatin (40 mg/m(2)) and daily pelvic radiation (45 Gy) in women with stage I(B2)-IV(B) cervical (n=22) or stage II-IV vaginal (n=3) cancers. Brachytherapy followed (40 Gy). Toxicity was monitored by common terminology criteria for adverse events (version 3.0). The primary end point of response was assessed by 3-month posttherapy 2-[(18)F] fluoro-2-deoxy-d-glucose positron emission tomography (PET/CT) and clinical examination. RESULTS: 3-AP radiochemotherapy achieved clinical responses in 24 (96% [95% confidence interval: 80-99%]) of 25 patients (median follow-up 20 months, range 2-35 months). 23 (96% [95% confidence interval: 80-99%]) of 24 patients had 3-month posttherapy PET/CT scans that recorded metabolic activity in the cervix or vagina equal or less than that of the cardiac blood pool, suggesting complete metabolic responses. The most frequent 3-AP radiochemotherapy-related adverse events included fatigue, nausea, diarrhea, and reversible hematological and electrolyte abnormalities. CONCLUSIONS:
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Authors | Charles A Kunos, Tomas Radivoyevitch, Steven Waggoner, Robert Debernardo, Kristine Zanotti, Kimberly Resnick, Nancy Fusco, Ramon Adams, Raymond Redline, Peter Faulhaber, Afshin Dowlati |
Journal | Gynecologic oncology
(Gynecol Oncol)
Vol. 130
Issue 1
Pg. 75-80
(Jul 2013)
ISSN: 1095-6859 [Electronic] United States |
PMID | 23603372
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural)
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Copyright | Copyright © 2013 Elsevier Inc. All rights reserved. |
Chemical References |
- Pyridines
- Thiosemicarbazones
- Fluorodeoxyglucose F18
- 3-aminopyridine-2-carboxaldehyde thiosemicarbazone
- Cisplatin
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Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, adverse effects)
- Brachytherapy
- Chemoradiotherapy
- Cisplatin
(administration & dosage, adverse effects)
- Drug Administration Schedule
- Female
- Fluorodeoxyglucose F18
- Humans
- Middle Aged
- Multimodal Imaging
(methods)
- Neoplasm Staging
- Positron-Emission Tomography
- Pyridines
(administration & dosage, adverse effects)
- Thiosemicarbazones
(administration & dosage, adverse effects)
- Tomography, X-Ray Computed
- Uterine Cervical Neoplasms
(diagnostic imaging, drug therapy, pathology, radiotherapy)
- Vaginal Neoplasms
(diagnostic imaging, drug therapy, pathology, radiotherapy)
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