Clinical study: Treatment improves outcomes for women with locally advanced vulvar cancer (71+% cure rate with gemcitabine, cisplatin, & radiation)

Medical Xpress / NRG Oncology / Soc of Gynecologic Oncology (SGO) 2023 Annual Meeting ^ | March 27, 2023 | N.S. Horowitz et al

[ConservativeMind]

Results from the Phase II NRG-GOG-0279 clinical study indicate that women with locally advanced squamous cell carcinoma of the vulva who received gemcitabine concurrently with cisplatin and intensity-modulated radiation therapy (IMRT) exhibited increased rate of pathologic complete responses (pCR). This is also the first clinical trial to standardize IMRT.

"Women with locally advanced vulvar cancer are currently treated with standard chemoradiation, which results in a high number of patients experiencing locoregional recurrence in their lifetime. NRG-GOG-0279 was designed to determine whether the addition of gemcitabine to cisplatin and higher doses of radiation administered with IMRT, could improve the efficacy of the treatment," stated Neil S. Horowitz, MD.

NRG-GOG-0279 analyzed 52 eligible and treated women with locally advanced vulvar cancer (LAVC) that was not amendable to surgery. Patients received 64 Gy to the vulva and 50 or 64 Gy to the groins and low pelvis for positive nodes and unresectable nodes respectively. Cisplatin (40mg/m2) and gemcitabine (50mg/m2) were administered weekly throughout IMRT. Response was then assessed at six to eight weeks following treatment.

NRG-GOG-0279 assessed pCR as the primary endpoint, with a main goal of improving pCR outcomes by 20% or more when compared to the pCR rate of 50% reported for the GOG-0205 trial. If successful, this would warrant further investigation into this study approach. The trial also evaluated complete clinical response (cCR), PFS, overall survival (OS), and adverse events as secondary endpoints.

Patients on the trial received a median of six cycles of gemcitabine and cisplatin. Of the 44 patients who had radiation therapy compliance reviewed 33 (75%) had high quality IMRT and 11 patients (25%) had minor deviations. Of the 44 evaluable patients, 38 patients achieved pCR (73.1%, 90% CI 61.2–83.0%) and 37 had cCR (71.2%, 90%CI 59.1–81.3%).

[ConservativeMind]

This was for cancer that was not operable, and over 71% were cured.

[ConservativeMind]

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