Does weekly cisplatin improve resectability of locally advanced vulvar cancer treated initially with EBRT?
NA as this was a phase II trial
EBRT 32 fractions of 1.8 Gy/fx with weekly Cisplatin 40mg/m2 x 5-7 weeks
Primary End Point:
Complete pathologic response
Locally-advanced, previously untreated SCC of the vulva w/T3/T4 primary tumors not amenable to surgical resection by standard radical vulvectomy
- PS 0-3
- Adequate bone marrow, renal, hepatic fxn
- Judged "capable of tolerating a radical course of chemoradiation"
- Vulvar melanomas or sarcomas
- Septicemia or severe infection
- GI bleeding or severe GI sx
- Prior radiation or cytotoxic chemotherapy
- Concurrent invasive malignancy (exception non-melanoma skin cancer)
- Any evidence of cancer in the last 5 years
40/58 (70%) completed study treatment (>97% of radiation + at least 5 cycles of chemotherapy)
- 37/58 (64%) with complete clinical response
- 29/58 (50%) with complete pathological response
Patients with an inoperable tumor or lymph nodes benefit from chemoradiatoin if an operation of lesser scope can ultimately be performed.
Laurel K Berry
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