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

被引:8
作者
Horowitz, Neil S. [1 ]
Deng, Wei [2 ]
Peterson, Ivy [3 ]
Mannel, Robert S. [4 ]
Thompson, Spencer [4 ]
Lokich, Elizabeth [5 ]
Myers, Tashanna [6 ]
Hanjani, Parvis [7 ]
O'Malley, David M. [8 ,9 ]
Chung, Ki Young [10 ]
Miller, David S. [11 ]
Ueland, Frederick R. [12 ]
Dizon, Don S. [13 ]
Miller, Austin [2 ]
Mayadev, Jyoti S. [14 ]
Leath, Charles A. [15 ]
Monk, Bradley J. [16 ]
机构
[1] Brigham & Womens Hosp, Dana Farber Canc Inst, Boston, MA 02115 USA
[2] Gynecol Oncol Grp Stat & Data Ctr, NRG Oncol, Buffalo, NY USA
[3] Mayo Clin, Rochester, MN USA
[4] Univ Oklahoma, Hlth Sci Ctr, Oklahoma City, OK USA
[5] Womens & Infants Hosp, Providence, RI USA
[6] Bay State Hlth, Springfield, MA USA
[7] Abington Hlth, Abington, PA USA
[8] James CCC, Columbus, OH USA
[9] Ohio State Univ, Wexner Med Ctr, Columbus, OH USA
[10] Prisma Hlth Canc Inst, Greenville, SC USA
[11] Univ Texas Southwestern Med Ctr, Dallas, TX USA
[12] Univ Kentucky, Coll Med, Lexington, KY USA
[13] Lifespan, Providence, RI USA
[14] Univ Calif San Diego, Sch Med, La Jolla, CA USA
[15] Univ Alabama Birmingham, ONeal Comprehens Canc Ctr, Birmingham, AL USA
[16] GOG Fdn Inc, GOG Partners, Phoenix, AZ USA
关键词
ADVANCED CERVICAL-CANCER; INTRAEPITHELIAL NEOPLASIA; CHEMOTHERAPY; CONCURRENT; RADIOTHERAPY; CHEMORADIATION; EXENTERATION; POSITIVITY; HPV;
D O I
10.1200/JCO.23.02235
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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. Gemcitabine, cisplatin, and IMRT improves complete pathologic response in locally advanced vulvar carcinoma.
引用
收藏
页码:1914 / 1921
页数:11
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