No. 370-Management of Squamous Cell Cancer of the Vulva

Francis, Julie A.; Eiriksson, Lua; Dean, Erin; Sebastianelli, Alexandra; Bahoric, Boris; Salvador, Shannon

doi:10.1016/j.jogc.2018.07.004

Cited by 28 publications

(25 citation statements)

References 65 publications

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“…As shown in Table 3, the policy of abandoning adjuvant radiotherapy in patients with a single positive lymph node is recommended in most published national guidelines [4,[7][8][9][10][11]. Most of the national guidelines take the number of nodes, presence of extra-capsular spread and the size of the metastasis into consideration when recommending adjuvant radiotherapy.…”

Section: Discussionmentioning

confidence: 99%

“…The current ESGO guidelines [4] and most, but not all [7] other guidelines, recommend adjuvant radiotherapy, except for patients with one clinically occult and pathologically intracapsular lymph node metastasis [8][9][10][11]. However, some recent publications have questioned these recommendations and have recommended adjuvant radiotherapy for all patients with lymph node metastases, irrespective of the number and/or pathological characteristics of these metastases [12][13][14][15].…”

Section: Introductionmentioning

confidence: 99%

“…Any (CRT if ≥2) CRT if any node > 2 mm n.m. JSGO 2018 [10] >1 n.m. If yes: RT GOC/SOGC 2019 [11] >1 RT if any node ≥5 mm If yes: RT…”

mentioning

confidence: 99%

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Radiotherapy is not indicated in patients with vulvar squamous cell carcinoma and only one occult intracapsular groin node metastasis

Velden

Pleunis

Barlow

et al. 2021

Gynecologic Oncology

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Radiotherapy is not indicated in patients with vulvar squamous cell carcinoma and only one occult intracapsular groin node metastasis

Velden

Pleunis

Barlow

et al. 2021

Gynecologic Oncology

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“…Patients with locally advanced or metastatic disease at presentation have a 5-year survival of 53% and 19% respectively [3]. Patients with recurrent metastatic disease have survival rates between 14 and 15% [2]. Furthermore, no standard-of-care exists for patients who recur or relapse after primary therapy.…”

Section: Introductionmentioning

confidence: 99%

A phase 2 study of combined chemo-immunotherapy with cisplatin-pembrolizumab and radiation for unresectable vulvar squamous cell carcinoma

et al. 2020

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Background Unresectable or metastatic vulvar cancer has relatively poor outcomes despite chemotherapy-sensitized radiation therapy and combination cytotoxic therapy. Despite the virus-associated and immunogenic nature of this disease, novel immunotherapy options that exploit this advantage are currently lacking. Platinum agents such as cisplatin have been shown to prime dendritic cells for T-cell costimulation, promote downregulation of inhibitory checkpoint molecules, and sensitize tumor cells to cytotoxic T-cell killing. Radiation therapy has also been shown to promote immunogenetic cell death as monotherapy and in combination with cisplatin. In combination with pembrolizumab, cisplatin-sensitized radiation is hypothesized to increase overall response rates and recurrence-free survival in patients with vulvar cancer, via induction of an anti-tumor inflammatory response. Methods We propose a single-arm phase II clinical trial of pembrolizumab combined with cisplatin-sensitized radiation therapy for women with unresectable, locally advanced, or metastatic vulvar cancer. The first three patients with locally advanced or unresectable disease will receive cycle 1 of pembrolizumab followed by a break and resumption of pembrolizumab at cycle 4 and as part of a safety cohort. All other patients, including the fourth patient with locally advanced/unresectable disease, will receive weekly cisplatin and pembrolizumab every 3 weeks, concurrently with daily radiation therapy. Following the completion of Cis-RT, patients will continue pembrolizumab maintenance for a total of 12 cycles. Archived tissue will be used for HPV status, MSI status, PD-L1, and TIL stratification post hoc. Imaging will be performed at baseline and every 3 cycles (21-day cycles) as per standard-of-care. Laboratory analysis will occur on the first day of each cycle. Discussion The combination of cisplatin-sensitized radiation and immune checkpoint blockade has not been evaluated in the upfront setting for vulvar cancer. In this rare malignancy, there are limited interventional clinical trials. This trial is designed to be as accessible as possible by allowing patients to receive cisplatin and radiation locally according to accepted standard-of-care while receiving pembrolizumab and adverse event monitoring at a centralized site. A robust suite of translational correlative studies has also been built into the trial to evaluate tumor-directed immune activation. Trial registration NCT04430699

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“…Patients with locally advanced or metastatic disease at presentation have a 5-year survival of 53% and 19% respectively 3 . Patients with recurrent metastatic disease have survival rates between 14-15% 2 . Furthermore, no standard-of-care exists for patients who recur or relapse after primary therapy.…”

Section: Introductionmentioning

confidence: 99%

A phase 2 study of combined chemo-immunotherapy with cisplatin-pembrolizumab and radiation for unresectable vulvar squamous cell carcinoma

Yeku

Russo

Lee

et al. 2020

Preprint

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Background: Unresectable or metastatic vulvar cancer has relatively poor outcomes despite chemotherapy-sensitized radiation therapy and combination cytotoxic therapy. Despite the virus-associated and immunogenic nature of this disease, novel immunotherapy options that exploit this advantage are currently lacking. Platinum agents such as cisplatin have been shown to prime dendritic cells for T-cell costimulation, promote downregulation of inhibitory checkpoint molecules, and sensitize tumor cells to cytotoxic T-cell killing. Radiation therapy has also been shown to promote immunogenetic cell death as monotherapy and in combination with cisplatin. In combination with pembrolizumab, cisplatin-sensitized radiation is hypothesized to increase overall response rates and recurrence-free survival in patients with vulvar cancer, via induction of an anti-tumor inflammatory response. Methods: We propose a single-arm phase II clinical trial of pembrolizumab combined with cisplatin-sensitized radiation therapy for women with unresectable, locally advanced, or metastatic vulvar cancer. The first three patients with locally advanced or unresectable disease will receive cycle 1 of pembrolizumab followed by a break and resumption of pembrolizumab at cycle 4 and as part of a safety cohort. All other patients, including the fourth patient with locally advanced/unresectable disease, will receive weekly cisplatin and pembrolizumab every 3 weeks, concurrently with daily radiation therapy. Following the completion of Cis-RT, patients will continue pembrolizumab maintenance for a total of 12 cycles. Archived tissue will be used for HPV status, MSI status, PD-L1, and TIL stratification post-hoc. Imaging will be performed at baseline and every 3 cycles (21-day cycles) as per standard-of-care. Laboratory analysis will occur on the first day of each cycle. Discussion: The combination of cisplatin-sensitized radiation and immune checkpoint blockade has not been evaluated in the upfront setting for vulvar cancer. In this rare malignancy, there are limited interventional clinical trials. This trial is designed to be as accessible as possible by allowing patients to receive cisplatin and radiation locally according to accepted standard-of-care while receiving pembrolizumab and adverse event monitoring at a centralized site. A robust suite of translational correlative studies has also been built into the trial to evaluate tumor-directed immune activation. Trial registration: NCT04430699

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No. 370-Management of Squamous Cell Cancer of the Vulva

Cited by 28 publications

References 65 publications

Radiotherapy is not indicated in patients with vulvar squamous cell carcinoma and only one occult intracapsular groin node metastasis

Radiotherapy is not indicated in patients with vulvar squamous cell carcinoma and only one occult intracapsular groin node metastasis

A phase 2 study of combined chemo-immunotherapy with cisplatin-pembrolizumab and radiation for unresectable vulvar squamous cell carcinoma

A phase 2 study of combined chemo-immunotherapy with cisplatin-pembrolizumab and radiation for unresectable vulvar squamous cell carcinoma

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