Palliative electro-chemotherapy in elderly patients with vulvar cancer: A phase II trial.
OBJECTIVE
The primary endpoint of this trial was to assess clinical response (cCR) of squamocellular vulvar cancer (V-SCC) in elderly patients treated with electro-chemotherapy (ECT). Secondary endpoints were symptoms relief and local tumor control.


METHODS
A phase II study was designed and elderly patients with V-SCC unfit for other treatments were treated. Response Evaluation Criteria in Solid Tumors (RECIST criteria) were applied to evaluate tumor response. Quality of life (QoL) was evaluated by visual analogue score (VAS) for pain and four items of vulvar cancer subscale (VCS), of functional assessment of vulvar cancer therapy (FACT-V) [16], before, one month after the procedure and during follow-up.


RESULTS
Median age was 85 years (range 66-96 years). One month after treatment complete response was observed in 13 patients (52%), partial response in 7 (28%), stable disease in 3 (12%), and progressive disease in 2 (8%). Local tumor control at 1 and 6 months was 91% and 53%, respectively. Symptom free survival at 1 and 6 months was 78% and 40%, respectively, with significant reduction of pain (P < 0.01). One-year overall survival was 34%.


CONCLUSIONS
Our study showed that ECT produces high response rate with significant reduction of pain and improvement of local symptoms.
Oncologic Gynecology Unit, Sant'Orsola-Malpighi Hospital, Bologna, Italy.
Anna M
AM
Perrone
Department of Experimental, Radiation Oncology Center, Diagnostic and Specialty Medicine-DIMES, Sant'Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.
Simona
S
Cima
Oncologic Gynecology Unit, Sant'Orsola-Malpighi Hospital, Bologna, Italy.
Federica
F
Pozzati
Department of Experimental, Radiation Oncology Center, Diagnostic and Specialty Medicine-DIMES, Sant'Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.
Rezarta
R
Frakulli
Department of Experimental, Radiation Oncology Center, Diagnostic and Specialty Medicine-DIMES, Sant'Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.
Silvia
S
Cammelli
Oncologic Gynecology Unit, Sant'Orsola-Malpighi Hospital, Bologna, Italy.
Marco
M
Tesei
Medical Genetics Unit, S.Orsola-Malpighi Hospital, Bologna, Italy.
Giuseppe
G
Gasparre
Department of Experimental, Radiation Oncology Center, Diagnostic and Specialty Medicine-DIMES, Sant'Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.
Andrea
A
Galuppi
Department of Experimental, Radiation Oncology Center, Diagnostic and Specialty Medicine-DIMES, Sant'Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.
Alessio G
AG
Morganti
Oncologic Gynecology Unit, Sant'Orsola-Malpighi Hospital, Bologna, Italy.
Pierandrea
P
De Iaco
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D053672:Electrochemotherapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D009367:Neoplasm Staging; D010166:Palliative Care; D011379:Prognosis; D015996:Survival Rate; D014846:Vulvar Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology
electro-chemotherapy; palliative therapies; phase II trial; vulvar cancer