Abstract
PURPOSETo assess efficacy and toxicity of cisplatin (C) and gemcitabine (G) with intensity-modulated radiation therapy (IMRT) in patients with locally advanced vulvar cancer not amenable to surgery.METHODSPatients enrolled in a single-arm phase II study. Pretreatment inguinal-femoral nodal assessment was performed. Sixty-four Gy IMRT was prescribed to the vulva, with 50-64 Gy delivered to the groins/low pelvis. Radiation therapy (RT) plans were quality-reviewed pretreatment. C 40 mg/m2 and G 50 mg/m2 were administered once per week throughout IMRT. Complete pathologic response (CPR) was the primary end point. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method, and adverse events were assessed with Common Terminology Criteria for Adverse Events v 4.0.RESULTSFifty-seven patients enrolled, of which 52 were evaluable. The median age was 58 years (range, 25-58), and 94% were White. Forty (77%) had stage II or III disease, and all had squamous histology. A median of six chemotherapy cycles (range, 1-8) were received. Eighty-five percent of RT plans were quality-reviewed with 100% compliance to protocol. Seven patients came off trial because of toxicity or patient withdrawal. Of 52 patients available for pathologic assessment, 38 (73% [90% CI, 61 to 83]) achieved CPR. No pelvic exenterations were performed. With a median follow-up of 51 months, the 12-month PFS was 74% (90% CI, 62.2 to 82.7) and the 24-month OS was 70% (90% CI, 57 to 79). The most common grade 3 or 4 adverse events were hematologic toxicity and radiation dermatitis. There was one grade 5 event unlikely related to treatment.CONCLUSIONWeekly C and G concurrent with IMRT sufficiently improved CPR in women with locally advanced vulvar squamous cell carcinoma not amenable to surgical resection.
Original language | English |
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Pages (from-to) | 1914-1921 |
Number of pages | 8 |
Journal | Journal of Clinical Oncology |
Volume | 42 |
Issue number | 16 |
DOIs | |
State | Published - Jun 1 2024 |
Bibliographical note
Publisher Copyright:© American Society of Clinical Oncology.
Funding
Supported by National Cancer Institute grants to NRG Oncology U10CA180822 (NRG Oncology Statistics and Data Management Center) and U10CA180868 (NRG Oncology Operations).
Funders | Funder number |
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National Childhood Cancer Registry – National Cancer Institute | U10CA180868, U10CA180822 |
National Childhood Cancer Registry – National Cancer Institute |
ASJC Scopus subject areas
- Oncology
- Cancer Research