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)

Witteveen, Petronella O.; Velden, J. van der; Vergote, Ignace; Guerra, Carlos; Scarabeli, C; Coens, Corneel; Demonty, Gaston; Reed, Nicholas

doi:10.1093/annonc/mdp043

Cited by 81 publications

(53 citation statements)

References 24 publications

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“…Interstitial brachytherapy is one of the possible treatment modalities in selected patients. Vulvar cancer represents approximately 4-5% of all gynecological tumors [1,2,3]. It is usually classified into two groups: the first is associated with human papillomavirus (HPV) infection and usually occurs in younger patients; the second is not HPV associated and is observed mostly in elderly patients with 'lichen sclerosus' as a predisposing risk factor [2,4].…”

Section: Purposementioning

confidence: 99%

Interstitial high-dose-rate brachytherapy in locally advanced and recurrent vulvar cancer

Kellas-Ślęczka¹,

Białas²,

Fijałkowski³

et al. 2016

jcb

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Purpose: The aim of the study was to report our experience with high-dose-rate interstitial brachytherapy (HDR-ISBT) in locally advanced and recurrent vulvar cancer.Material and methods: Between 2004 and 2014, fourteen women with locally advanced or recurrent vulvar cancer were treated using HDR-ISBT in our Centre. High-dose-rate interstitial brachytherapy was performed as a separate treatment or in combination with external beam radiotherapy (EBRT) (given prior to brachytherapy).Results: Patients were divided into: group I (n = 6) with locally advanced tumors, stages III-IVA after an incisional biopsy only, and group II (n = 8) with recurrent vulvar cancer after previous radical surgery. In group I, median follow up was 12 months (range 7-18 months); 1-year overall survival (OS) was 83%. Transient arrest of cancer growth or tumor regression was noticed in all patients but 4/6 developed relapse. Median time to failure was 6.3 months (range 3-11 months). The 1-year progression-free survival (PFS) was 33%. In group II, median follow up was 28 months (range 13-90 months). The 1-year and 3-year OS was 100% and 80%, respectively. The arrest of cancer growth or tumor regression was achieved in all patients. In 4/8 patients neither clinical nor histological symptoms of relapse were observed but 4/8 women experienced relapse. Median time to failure was 31 months (range 13-76 months). The 1-year and 3-year PFS was 100% and 62.5%, respectively. Two patients (14.3%) in group II had severe late toxicity (G3).Conclusions: High-dose-rate interstitial brachytherapy is a well-tolerated treatment option in selected patients with advanced or recurrent vulvar cancer. It is a safe and effective treatment modality for advanced and recurrent vulvar cancer, yielding good local control with acceptable late treatment related side effects. In our study, patients with recurrent vulvar cancer had better results in HDR-ISBT treatment, probably because of the smaller tumor volume. This hypothesis should be verified in a larger group of patients.

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Section: Purposementioning

confidence: 99%

Interstitial high-dose-rate brachytherapy in locally advanced and recurrent vulvar cancer

Kellas-Ślęczka¹,

Białas²,

Fijałkowski³

et al. 2016

jcb

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“…In a further study enrolling patients with locally advanced vulvar cancer the efficacy of a combination therapy with bleomycin, methotrexate and lomustine was analyzed (median overall survival 7.8 months) although significant side effects were noted [Wagenaar et al 2001]. Single-agent therapy with weekly paclitaxel appears to be less effective, with a mean progression-free survival of only 2.6 months [Witteveen et al 2009]. Efficacy analysis across these trials is difficult due to heterogeneous in-and exclusion criteria, so that to date none of the regimens can be generally recommended for routine application.…”

Section: Systemic Treatment For Advanced or Metastatic Vulvar Cancermentioning

confidence: 99%

Management of patients with vulvar cancer: a perspective review according to tumour stage

et al. 2013

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Treatment of patients with vulvar cancer is challenging for gynaecologic oncologists. Owing to the localization in a sensitive area, surgical radicality and the indication for adjuvant treatment have to be balanced with psychosocial aspects to treat patients adequately. Clinical management is therefore highly dependent on the tumour stage. For patients with early-stage disease (FIGO I-II) therapy mainly concentrates on surgery with resection of the primary tumour and staging of the groin lymph nodes. In intermediate-stage vulvar cancer (FIGO III), advanced disease is expressed by affected inguinofemoral lymph nodes bringing radical lymphadenectomy and adjuvant therapy as well as radiation or chemoradiation into the focus of treatment. For locally advanced or metastatic vulvar cancer (FIGO IV) neoadjuvant or definitive chemoradiation has to be considered besides surgery. Owing to the low incidence of the disease, the level of evidence for different treatment modalities is poor. This review therefore puts different recommendations of clinical management in context and highlights the need for future trials.

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“…Data are limited due to the rarity of the disease. Table 1 highlights the chemotherapy regimen to treat recurrent/metastatic vulvar carcinoma [9][10][11][12][13][14][15][16].…”

Section: Discussionmentioning

confidence: 99%

Pembrolizumab in Recurrent Squamous Cell Carcinoma of the Vulva: Case Report and Review of the Literature

Shields

Gordinier

2018

Gynecol Obstet Invest

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Advanced vulvar cancer is associated with a very poor prognosis. Surgical resection is the mainstay of treatment, with radiation indicated for areas at high risk for recurrence. When surgical and radiation options have been exhausted, the effectiveness of systemic chemotherapy is poor. No biologic or targeted agents have been approved for the management of advanced or recurrent vulvar cancer. Pembrolizumab, a humanized monoclonal antibody against programmed death 1 (PD-1), has been successfully used as a target of tumor immune therapy in small cell lung cancer and melanoma. We present the first case in the literature of a patient with recurrent vulvar cancer who was treated successfully with pembrolizumab. Caris next-generation testing revealed a PD-L1 and PD-1 mutation (PD-L1 positive, 2+, 100%). She attained a complete clinical remission after 2 cycles, and a CT scan after 6 cycles revealed a significant response by RECIST criteria. After completing 10 cycles, treatment was stopped due to complications of severe malnutrition related to narcotic abuse. A CT scan 10 weeks after the final treatment revealed no adenopathy. Pembrolizumab is a safe and effective chemotherapeutic agent to treat recurrent vulvar carcinoma.

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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)

Abstract: Paclitaxel shows moderate activity for local control in advanced vulvar cancer.

Cited by 81 publications

References 24 publications

Interstitial high-dose-rate brachytherapy in locally advanced and recurrent vulvar cancer

Interstitial high-dose-rate brachytherapy in locally advanced and recurrent vulvar cancer

Management of patients with vulvar cancer: a perspective review according to tumour stage

Pembrolizumab in Recurrent Squamous Cell Carcinoma of the Vulva: Case Report and Review of the Literature

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