Phase II study on paclitaxel in patients with recurrent, metastatic or locally advanced vulvar cancer not amenable to surgery or radiotherapy: a study of the EORTC-GCG (European Organisation for Research and Treatment of Cancer--Gynaecological Cancer Group).
BACKGROUND
No standard treatment options are available for patients with advanced, recurrent or metastatic vulvar carcinoma not amenable for locoregional treatment.


METHODS
In this phase II study, patients with advanced vulvar cancer received paclitaxel (Taxol) every 3 weeks for up to 10 cycles. Primary objective was response rate. Secondary objectives were response duration and toxicity. Response evaluation was assessed by World Health Organisation criteria, toxicity according to Common Toxicity Criteria.


RESULTS
Thirty-one women from 10 institutions were included, with a median age of 64 (range 47-84), of which 29 were assessable for response. On study patients received a median of four cycles (range 1-10).


RESULTS
Grade 3 and 4 neutropenia was seen in eight patients (8/29 = 27.6%), which in one patient resulted in neutropenic fever and treatment-related death. Further treatment-related grade 3/4 toxicity includes fatigue in three patients (10.3%) and neuropathy in one patient (3.4%).


RESULTS
Overall response was 13.8% (n = 4; two complete responses + two partial responses). With a median follow-up of 24 months, median PFS was 2.6 months (95%confidence interval 2.04-4.21).


CONCLUSIONS
Paclitaxel shows moderate activity for local control in advanced vulvar cancer.
Witteveen
P O
PO
Department of Medical Oncology, University Medical Center Utrecht. Electronic address: P.O.Witteveen@umcutrecht.nl.
van der Velden
J
J
Department of Gynaecological Oncology, Academic Medical Center, Amsterdam, The Netherlands.
Vergote
I
I
Department of Gynaecological Oncology, University Hospital Leuven, Belgium.
Guerra
C
C
Department of Gynaecological Oncology, Hospitais da Universidade de Coimbra, Coimbra, Portugal.
Scarabeli
C
C
Department of Gynecological Oncology, Azienda Ospedaliera di Pavia, Italy.
Coens
C
C
EORTC Headquarters, Brussels, Belgium.
Demonty
G
G
EORTC Headquarters, Brussels, Belgium.
Reed
N
N
Department of Clinical Oncology, Gartnavel General Hospital, Glasgow, UK.
D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D017239:Paclitaxel / Q000627:therapeutic use*; D014846:Vulvar Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*
D000970:Antineoplastic Agents; D017239:Paclitaxel