Phase II study of definitive chemoradiation for locally advanced squamous cell cancer of the vulva: An efficacy study

Triest, Baukelien van; Rasing, M.; Velden, J. van der; Hullu, Joanne A. de; Witteveen, Petronella O.; Beukema, Jannet C.; Steen-Banasik, E Van der; Westerveld, Henrike; Snyers, A.; Peters, Max; Creutzberg, Carien L.; Nout, Remi A.; Lutgens, Ludy; Jürgenliemk-Schulz, Ina M.

doi:10.1016/j.ygyno.2021.07.020

Cited by 17 publications

(15 citation statements)

References 34 publications

(51 reference statements)

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“…As regards the management of locally advanced stages, surgical treatment still remains the pivotal option [ 14 ], despite often requiring large tissue resections, plastic reconstruction, and careful management of severe morbidity [ 15 , 16 , 17 ]. However, some new developments have been introduced as effective possible alternative strategies currently available, including radiation or chemo-radiation, but these suffer from the main limitation of non-repeatability over time, in case of recurrence [ 18 , 19 , 20 , 21 ].…”

Section: Introductionmentioning

confidence: 99%

The Vulvar Immunohistochemical Panel (VIP) Project: Molecular Profiles of Vulvar Squamous Cell Carcinoma

Garganese

Inzani

Fragomeni

et al. 2021

Cancers

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Introduction: The study’s aim was to investigate the immunohistochemical (IHC) expression of biological markers as potential prognostic/therapeutic factors in vulvar squamous cell carcinoma (VSCC). Methodology: A series of 101 patients surgically treated at our center from 2016 to 2020 were retrospectively enrolled: 53 node-negative (Group A) and 48 node-positive (Group B). A total of 146 samples, 101 from primary tumor (T) and 45 from nodal metastases (N), were investigated. The IHC panel included: p16, p53, MLH1, MSH2, MSH6, PMS2, PD-L1, CD3, HER2/neu, ER, PR, EGFR, VEGF, and CD31. The reactions were evaluated on qualitative and semi-quantitative scales. Generalized Linear Model (GLM) and cluster analysis were performed in R statistical environment. A distance plot compared the IHC panel of T with the correspondent N. Results: In Group A: p16-positive expression (surrogate of HPV-dependent pathway) was significantly higher (20.8% vs. 6.2%, p = 0.04). In Group B: PD-L1 positivity and high EGFR expression were found, respectively, in 77.1% and 97.9% patients (T and/or N). Overall, p16-negative tumors showed a higher PD-L1 expression (60.9% vs. 50.0%). In both groups: tumoral immune infiltration (CD3 expression) was mainly moderate/intense (80% vs. 95%); VEGF showed strong/moderate-diffuse expression in 13.9% of T samples; CD31, related to tumoral microvessel density (MVD), showed no difference between groups; a mutated p53 and over-expressed PD-L1 showed significant association with nodal metastasis, with Odds Ratios (OR) of 4.26 (CI 95% = 1.14–15.87, p = 0.03) and 2.68 (CI 95% = 1.0–7.19, p < 0.05), respectively; since all mismatch repair proteins (MMR) showed a retained expression and ER, PR, and HER2/neu were negative, they were excluded from further analysis. The cluster analysis identified three and four sub-groups of molecular profiles, respectively, in Group A and B, with no difference in prognosis. The molecular signature of each N and corresponding T diverged significantly in 18/41 (43.9%) cases. Conclusions: Our results support a potential role of immune checkpoint inhibitors and anti-VEGF and anti-EGFR drugs especially in patients with worse prognosis (metastatic, HPV-independent). A panel including EGFR, VEGF, PDL1, p16, and p53 might be performed routinely in primary tumor and repeated in case of lymph node metastases to identify changes in marker expression.

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Section: Introductionmentioning

confidence: 99%

The Vulvar Immunohistochemical Panel (VIP) Project: Molecular Profiles of Vulvar Squamous Cell Carcinoma

Garganese

Inzani

Fragomeni

et al. 2021

Cancers

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“…A subgroup survival analysis revealed that patients who received radiotherapy were substantially more likely to survive than those who received postoperative radiotherapy alone. This may be related to the fact that some chemotherapeutic drugs such as uorouracil and cisplatin [25], in addition to their anti-tumor effects, also act as radiosensitizers, resulting in a 15%-20% reduction in the dose of radiotherapy, thus reducing the incidence of acute local radiotherapy reactions in patients and improving their tolerability [26][27][28].…”

Section: Discussionmentioning

confidence: 99%

The role of postoperative radiotherapy in patients with vulvar squamous carcinoma: findings based on the SEER database

Wang

Sun

2022

Preprint

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Introduction: The role of postoperative radiotherapy in treating squamous cell carcinoma of the vulva remains controversial. This study evaluated the effect of radiotherapy on the survival of patients with postoperative squamous cell carcinoma of the vulva.Methods： Clinical and prognostic information on patients diagnosed with vulvar squamous cell carcinoma from 2010 to 2015 was collected from the Surveillance, Epidemiology, and Prognosis (SEER) database. A propensity score matching (PSM) approach was used to balance the differences in clinicopathological characteristics between groups. The impact of postoperative radiotherapy on overall survival (OS) and disease-specific survival (DSS) was assessed.Results： The study included 3629 patients with squamous cell carcinoma of the vulva, of whom 767 (21.1%) underwent postoperative radiotherapy. After propensity score matching, multivariate analysis showed that Age, M stage, tumor size, and lymph node surgery were independent prognostic factors affecting patient survival. Postoperative radiotherapy improved patients' overall survival and disease-specific survival. Further subgroup survival analysis showed that overall survival was significantly improved among patients who received radiotherapy in patients with Grade III, IV, AJCC stage III, N1, lymph node metastasis, large tumor diameter, and those who received chemotherapy.Conclusion: Postoperative radiotherapy may provide a survival benefit for patients with squamous cell carcinoma of the vulva, especially for AJCC stage III, lymph node metastases, large tumor diameter, and those receiving postoperative chemotherapy.

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“…Rishi et al observed a severe late toxicity rate of 19 % in 26 patients treated with definitive radiation, although this study included patients with prior pelvic radiation. ( Rishi et al, 2020 ) Finally, a phase II study of definitive IMRT or 3D-CRT with concurrent capecitabine reported an acute grade ≥ 3 skin toxicity rate of 54 %; however, only 10 % of patients developed late skin toxicity ( van Triest et al, 2021 ). The explanation for the higher incidence of acute and late toxicity observed in our study with prior reports ultimately unclear.…”

Section: Discussionmentioning

confidence: 99%

Incidence and predictors of toxicity in the management of vulvar squamous cell carcinoma treated with radiation therapy

McCall

Eng

Shelton

et al. 2022

Gynecologic Oncology Reports

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Phase II study of definitive chemoradiation for locally advanced squamous cell cancer of the vulva: An efficacy study

Cited by 17 publications

References 34 publications

The Vulvar Immunohistochemical Panel (VIP) Project: Molecular Profiles of Vulvar Squamous Cell Carcinoma

The Vulvar Immunohistochemical Panel (VIP) Project: Molecular Profiles of Vulvar Squamous Cell Carcinoma

The role of postoperative radiotherapy in patients with vulvar squamous carcinoma: findings based on the SEER database

Incidence and predictors of toxicity in the management of vulvar squamous cell carcinoma treated with radiation therapy

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