Cecelia H Boardman1, William E Brady2, Don S Dizon3, Charles A Kunos4, Kathleen N Moore5, Kristine M Zanotti6, Cara Matthews7, Jonathan A Cosin8, Carol Aghajanian9, Paula M Fracasso10. 1. VCU Health System, Gynecologic Oncology, HCA Henrico Doctors Hospital, Virginia Gynecologic Oncology, Richmond, VA 23229, USA. Electronic address: cecelia.boardman@hcahealthcare.com. 2. NRG Oncology Statistics and Data Management Center, Roswell Park Cancer Institute Buffalo, NY 14263, USA. Electronic address: bbrady@gogstats.org. 3. Massachusetts General Hospital Cancer Center, USA. Electronic address: ddizon@partners.org. 4. Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD 20892, USA. Electronic address: charles.kunos@nih.gov. 5. Oklahoma University Medical Center, USA. Electronic address: kathleen-moore@ouhsc.edu. 6. UH Cleveland Medical Center, Cleveland, OH 44106, USA. Electronic address: Kristin.Zanotti@UHhospitals.org. 7. Women & Infants Hospital, Providence, RI 02905, USA. Electronic address: cmathews@wihri.org. 8. Hospital of Central Connecticut, New Britain, CT 06050, USA. Electronic address: Jonathan.Cosin@hhchealth.org. 9. Weill Cornell Medical College, New York, NY 10065, USA. Electronic address: aghajanc@mskcc.org. 10. Department of Medicine and the UVA Cancer Center, University of Virginia, Charlottesville, VA, USA. Electronic address: PMF4V@hscmail.mcc.virginia.edu.
Abstract
BACKGROUND: Chemo-radiation (chemoRT) has improved the overall survival for locally advanced cervical cancer (LACC) though women whose disease involves the para-aortic nodes (PAN) experience recurrence rates and worse survival outcomes compared to those without PAN involvement. This Phase I study determined if additional cycles of systemic chemotherapy could be safely added to extended field chemoRT in this population of patients. METHODS: Women with LACC and documented positive PAN were eligible for treatment. All women were treated with extended field radiation and brachytherapy and concurrent cisplatin 40 mg/m2 weekly for six weeks. Four to six weeks after completion of chemoRT, patients were treated with four cycles of paclitaxel 135 mg/m2 and escalating doses of carboplatin (Dose Level (DL) 1 = AUC 4, DL2 = AUC 5). RESULTS: Eleven women were entered on study and 9 were evaluable for dose limiting toxicities (DLT). Two women (1 in each of 2 DLs) did not complete chemoRT and so were not evaluable for DLT. Three women completed all 10 cycles at DL 1 with no DLTs. Six women were then treated at DL 2. For the 10 patients evaluable for response, the ORR was 60% (CR + PR). PFS and OS at 12 months were 60% and 90%, respectively. The predominant grade 3 or 4 acute toxicities were hematologic. There were no grade 5 events. CONCLUSION: Extended field chemoRT followed by paclitaxel 135 mg/m2 and carboplatin AUC 5 is feasible in women with LACC and positive PAN.
BACKGROUND: Chemo-radiation (chemoRT) has improved the overall survival for locally advanced cervical cancer (LACC) though women whose disease involves the para-aortic nodes (PAN) experience recurrence rates and worse survival outcomes compared to those without PAN involvement. This Phase I study determined if additional cycles of systemic chemotherapy could be safely added to extended field chemoRT in this population of patients. METHODS:Women with LACC and documented positive PAN were eligible for treatment. All women were treated with extended field radiation and brachytherapy and concurrent cisplatin 40 mg/m2 weekly for six weeks. Four to six weeks after completion of chemoRT, patients were treated with four cycles of paclitaxel 135 mg/m2 and escalating doses of carboplatin (Dose Level (DL) 1 = AUC 4, DL2 = AUC 5). RESULTS: Eleven women were entered on study and 9 were evaluable for dose limiting toxicities (DLT). Two women (1 in each of 2 DLs) did not complete chemoRT and so were not evaluable for DLT. Three women completed all 10 cycles at DL 1 with no DLTs. Six women were then treated at DL 2. For the 10 patients evaluable for response, the ORR was 60% (CR + PR). PFS and OS at 12 months were 60% and 90%, respectively. The predominant grade 3 or 4 acute toxicities were hematologic. There were no grade 5 events. CONCLUSION: Extended field chemoRT followed by paclitaxel 135 mg/m2 and carboplatin AUC 5 is feasible in women with LACC and positive PAN.
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