Palliative electro-chemotherapy in elderly patients with vulvar cancer: A phase II trial.

Abstract

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.

• Authors: Anna M Perrone, Simona Cima, Federica Pozzati, Rezarta Frakulli, Silvia Cammelli, Marco Tesei, Giuseppe Gasparre, Andrea Galuppi, Alessio G Morganti, Pierandrea De Iaco
• Journal: Journal of surgical oncology (J Surg Oncol) Vol. 112 Issue 5 Pg. 529-32 (Oct 2015) ISSN: 1096-9098 [Electronic] United States
• PMID: 26345705 (Publication Type: Clinical Trial, Phase II, Journal Article)
• Copyright: © 2015 Wiley Periodicals, Inc.

Topics

• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Electrochemotherapy
• Female
• Follow-Up Studies
• Humans
• Neoplasm Staging
• Palliative Care
• Prognosis
• Survival Rate
• Vulvar Neoplasms (drug therapy, mortality, pathology)