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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 weekly for six weeks. Four to six weeks after completion of chemoRT, patients were treated with four cycles of paclitaxel 135 mg/m 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 and carboplatin AUC 5 is feasible in women with LACC and positive PAN.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6291247 | PMC |
| http://dx.doi.org/10.1016/j.ygyno.2018.08.006 | DOI Listing |
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