A Phase I Evaluation of Extended Field Radiation Therapy With Concomitant Cisplatin Chemotherapy Followed by Paclitaxel and Carboplatin Chemotherapy in Women With Cervical Carcinoma Metastatic to the Para-aortic Lymph Nodes: An NRG Oncology/Gynecologic Oncology Group Study.

Autor: Boardman CH; VCU Health System, Gynecologic Oncology, HCA Henrico Doctors Hospital, Virginia Gynecologic Oncology, Richmond, VA 23229, USA. Electronic address: cecelia.boardman@hcahealthcare.com., Brady WE; NRG Oncology Statistics and Data Management Center, Roswell Park Cancer Institute Buffalo, NY 14263, USA. Electronic address: bbrady@gogstats.org., Dizon DS; Massachusetts General Hospital Cancer Center, USA. Electronic address: ddizon@partners.org., Kunos CA; Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD 20892, USA. Electronic address: charles.kunos@nih.gov., Moore KN; Oklahoma University Medical Center, USA. Electronic address: kathleen-moore@ouhsc.edu., Zanotti KM; UH Cleveland Medical Center, Cleveland, OH 44106, USA. Electronic address: Kristin.Zanotti@UHhospitals.org., Matthews C; Women & Infants Hospital, Providence, RI 02905, USA. Electronic address: cmathews@wihri.org., Cosin JA; Hospital of Central Connecticut, New Britain, CT 06050, USA. Electronic address: Jonathan.Cosin@hhchealth.org., Aghajanian C; Weill Cornell Medical College, New York, NY 10065, USA. Electronic address: aghajanc@mskcc.org., Fracasso PM; Department of Medicine and the UVA Cancer Center, University of Virginia, Charlottesville, VA, USA. Electronic address: PMF4V@hscmail.mcc.virginia.edu.
Jazyk: angličtina
Zdroj: Gynecologic oncology [Gynecol Oncol] 2018 Nov; Vol. 151 (2), pp. 202-207. Date of Electronic Publication: 2018 Aug 31.
DOI: 10.1016/j.ygyno.2018.08.006
Abstrakt: 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/m 2 weekly for six weeks. Four to six weeks after completion of chemoRT, patients were treated with four cycles of paclitaxel 135 mg/m 2 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/m 2 and carboplatin AUC 5 is feasible in women with LACC and positive PAN.
(Copyright © 2018 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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