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Palliative electro‐chemotherapy in elderly patients with vulvar cancer: A phase II trial
Author(s) -
Perrone Anna M.,
Cima Simona,
Pozzati Federica,
Frakulli Rezarta,
Cammelli Silvia,
Tesei Marco,
Gasparre Giuseppe,
Galuppi Andrea,
Morganti Alessio G.,
De Iaco Pierandrea
Publication year - 2015
Publication title -
journal of surgical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.201
H-Index - 111
eISSN - 1096-9098
pISSN - 0022-4790
DOI - 10.1002/jso.24036
Subject(s) - medicine , quality of life (healthcare) , clinical endpoint , response evaluation criteria in solid tumors , chemotherapy , vulvar cancer , progressive disease , cancer , surgery , clinical trial , phases of clinical research , nursing
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. J. Surg. Oncol. 2015; 112:529–532 . © 2015 Wiley Periodicals, Inc.