학술논문

Phase I Trial of Carboplatin and Gemcitabine Chemotherapy and Stereotactic Ablative Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer
Document Type
article
Source
Frontiers in Oncology. 5(JUN)
Subject
Biomedical and Clinical Sciences
Clinical Sciences
Oncology and Carcinogenesis
Cancer
Patient Safety
Clinical Research
Orphan Drug
Clinical Trials and Supportive Activities
Rare Diseases
6.1 Pharmaceuticals
6.5 Radiotherapy and other non-invasive therapies
Evaluation of treatments and therapeutic interventions
stereotactic radiosurgery
radiation
carboplatin
gemcitabine
ovarian cancer
endometrial cancer
cervix cancer
Clinical sciences
Oncology and carcinogenesis
Language
Abstract
BackgroundWe conducted a phase I trial to determine the safety of systemic chemotherapy prior to abdominopelvic robotic stereotactic ablative radiotherapy (SABR) in women with persistent or recurrent gynecologic cancers.MethodsPatients were assigned to dose-finding cohorts of day 1 carboplatin (AUC 2 or 4) and gemcitabine (600 or 800 mg/m(2)) followed by day 2 to day 4 Cyberknife SABR (8 Gy × three consecutive daily doses). Toxicities were graded prospectively by common terminology criteria for adverse events, version 4.0. SABR target and best overall treatment responses were recorded according to response evaluation criteria in solid tumors, version 1.1.FindingsThe maximum tolerated dose of chemotherapy preceding SABR was carboplatin AUC 4 and gemcitabine 600 mg/m(2). One patient experienced manageable, dose-limiting grade 4 neutropenia, grade 4 hypokalemia, and grade 3 nausea attributed to study treatment. One patient had a late grade 3 rectovaginal fistula 16 months after trial therapy. Among 28 SABR targets, 22 (79%) showed a partial response and 6 (21%) remained stable.InterpretationSystemic chemotherapy may be given safely prior to abdominopelvic robotic SABR with further investigation warranted.