Phase II Trial of Cisplatin, Gemcitabine, and Intensity-Modulated Radiation Therapy for Locally Advanced Vulvar Squamous Cell Carcinoma: NRG Oncology/GOG Study 279

Neil S. Horowitz, Wei Deng, Ivy Peterson, Robert S. Mannel, Spencer Thompson, Elizabeth Lokich, Tashanna Myers, Parvis Hanjani, David M. O'Malley, Ki Young Chung, David S. Miller, Frederick R. Ueland, Don S. Dizon, Austin Miller, Jyoti S. Mayadev, Charles A. Leath, Bradley J. Monk

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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 languageEnglish
Pages (from-to)1914-1921
Number of pages8
JournalJournal of Clinical Oncology
Volume42
Issue number16
DOIs
StatePublished - 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).

FundersFunder number
National Childhood Cancer Registry – National Cancer InstituteU10CA180868, U10CA180822
National Childhood Cancer Registry – National Cancer Institute

    ASJC Scopus subject areas

    • Oncology
    • Cancer Research

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