Villers A., Puech P.   Editorial Comment.  J. Urol..  2018 ;200 :1121
Vignion-Dewalle A. S., Baert G., Thecua E., Lecomte F., Vicentini C., Abi-Rached H., Mortier L., Mordon S.   Comparison of 10 efficient protocols for photodynamic therapy of actinic keratosis: How relevant are effective light dose and local damage in predicting the complete response rate at 3 months?.  Lasers Surg Med.  2018 ;50 :576-589

BACKGROUND: Topical photodynamic therapy is an established treatment modality for various dermatological conditions, including actinic keratosis. In Europe, the approved protocols for photodynamic therapy of actinic keratosis involve irradiation with either an Aktilite CL 128 lamp or daylight, whereas irradiation with the Blu-U illuminator is approved in the United States. Many other protocols using irradiation by a variety of light sources are also clinically efficient. OBJECTIVES: This paper aims to compare 10 different protocols with clinically proven efficacy for photodynamic therapy of actinic keratosis and the available spectral irradiance of the light source. Effective irradiance, effective light dose, and local damage are compared. We also investigate whether there is an association between the complete response rate at 3 months and the effective light dose or local damage. METHODS: The effective irradiance, also referred to as protoporphyrin IX-weighted irradiance, is obtained by integrating the spectral irradiance weighted by the normalized absorption spectrum of protoporphyrin IX over the wavelength. Integrating the effective irradiance over the irradiation time yields the effective light dose, which is also known as the protoporphyrin IX-weighted light dose. Local damage, defined as the total cumulative singlet oxygen molecules produced during treatment, is estimated using mathematical modeling of the photodynamic therapy process. This modeling is based on an iterative procedure taking into account the spatial and temporal variations in the protoporphyrin IX absorption spectrum during treatment. RESULTS: The protocol for daylight photodynamic therapy on a clear sunny day, the protocol for daylight photodynamic therapy on an overcast day, the photodynamic therapy protocol for a white LED lamp for operating rooms and the photodynamic therapy protocol for the Blu-U illuminator perform better than the six other protocols-all involving red light illumination-in terms of both effective light dose and local damage. However, no association between the complete response rate at 3 months and the effective light dose or local damage was found. CONCLUSIONS: Protocols that achieve high complete response rates at 3 months and low pain scores should be preferred regardless of the effective light dose and local damage. Lasers Surg. Med. 50:576-589, 2018. (c) 2018 Wiley Periodicals, Inc.

Vickers A., Vertosick E. A., Sjoberg D. D., Hamdy F., Neal D., Bjartell A., Hugosson J., Donovan J. L., Villers A., Zappala S., Lilja H.   Value of intact prostate specific antigen and human kallikrein 2 in the four kallikrein predictive model: an individual patient data meta-analysis.  J. Urol..  2018 ;199 :1470-1474

PURPOSE: The 4 kallikrein panel, commercially available as the 4Kscore(R), is a statistical model that has been shown to accurately predict Gleason Grade Group 2 or greater (high grade) cancer on biopsy and the long-term risk of distant prostate cancer metastases. The panel includes 2 novel markers, namely intact prostate specific antigen and hK2. It has been questioned whether these 2 additional markers add discrimination to the clinical predictors of patient age, digital rectal examination and prior biopsy, and the established molecular markers total and free prostate specific antigen. MATERIALS AND METHODS: We performed an individual patient data meta-analysis of published studies in which the 4 kallikrein panel was measured in men undergoing prostate biopsy. We assess the improvement in discrimination associated with including intact prostate specific antigen and hK2 along with total and free prostate specific antigen in the statistical model. RESULTS: Included in analysis were 14,510 men from a total of 10 studies. The fixed effects meta-analytical estimate of the discrimination of the model without intact prostate specific antigen and hK2 was 0.742 (95% CI 0.727-0.756) compared to 0.813 (95% CI 0.801-0.825) for the full kallikrein model. The 95% CIs did not overlap and the difference in discrimination was highly statistically significant (0.069, 95% CI 0.057-0.080, p <0.0001). Intact prostate specific antigen (increase in discrimination 0.059, 95% CI 0.050-0.069) and hK2 (increase in discrimination 0.024, 95% CI 0.020-0.029, each p <0.0001) added independently to the model. CONCLUSIONS: The clinical value of the panel could not be replicated using data readily available to urologists without measuring intact prostate specific antigen and hK2.

Vicentini C., Vignion-Dewalle A. S., Thecua E., Lecomte F., Maire C., Deleporte P., Béhal H., Kerob D., Duhamel A., Mordon S., Mortier L.   Photodynamic therapy for actinic keratosis of the forehead and scalp: a randomized, controlled, phase II clinical study evaluating the non-inferiority of a new protocol involving irradiation with a light-emitting, fabric-based device (the Flexitheralight .  Br. J. Dermatol..  2018

BACKGROUND: Photodynamic therapy (PDT) is an effective treatment for actinic keratosis (AK), particularly for patients with large areas of field cancerization. Among the approved protocols in Europe, the most widely used requires irradiation with the Aktilite CL 128 lamp. However, pain during irradiation and the suboptimal adaptability of the lamp relative to the treatment area are two limiting factors of this protocol. To overcome these limits, a new protocol (referred to as the Flexitheralight protocol) involving irradiation with a light-emitting, fabric-based device was developed. OBJECTIVES: This paper aims to assess the noninferiority, in terms of PDT efficacy for treating AK, of the Flexitheralight protocol compared with the conventional protocol, which requires irradiation with the Aktilite CL 128 lamp. METHODS: A monocentric, randomized, controlled, phase II clinical study was performed. Twenty-five patients with grade I-II AKs of the forehead and scalp were treated with methyl aminolaevulinate PDT in two symmetrical areas. One area was treated with the conventional protocol (n = 154 AKs), whereas the other area was treated with the Flexitheralight protocol (n = 156 AKs). The primary end-point was the lesion complete response (CR) rate at 3 months (an absolute noninferiority margin of -10% was used). The secondary end-points included patient-reported pain at the end of the irradiation. RESULTS: At 3 months, the lesion CR rate with the Flexitheralight protocol was noninferior to that obtained with the conventional protocol (66.0% vs. 59.1%, respectively; absolute difference, 6.9%; 95% confidence interval -0.6% to 14.5%). Patient-reported pain was significantly lower with the Flexitheralight protocol than with the conventional protocol (mean +/- SD: 0.4 +/- 0.6 vs. 5.0 +/- 2.6; P < 0.0001). CONCLUSIONS: The Flexitheralight protocol is noninferior in terms of efficacy and superior in terms of tolerability to the conventional protocol for treating AKs of the forehead and scalp.

Vicentini C., Abi-Rached H., Thecua E., Lecomte F., Deleporte P., Vignion A. S., Szeimies R. M., Mortier L., Mordon S. R.   PHOS-ISTOS CLINICAL TRIAL: A NEW SOLUTION FOR PHOTODYNAMIC TREATMENT OF ACTINIC KERATOSIS WITHOUT PAIN.  Lasers Surg. Med..  2018 ;50 :377-377
Vésale E., Azaïs H., Belghiti J., Nikpayam M., Uzan C., Canlorbe G.   [How I do… a colpocleisis with hysterectomy for vaginal prolapse (Pitié-Salpêtrière Hospital, Paris, France)].  Gynecol Obstet Fertil Senol.  2018 ;46 :440-443
Vermandel M., Quidet M., Vignion-Dewalle A. S., Leroy H. A., Leroux B., Mordon S., Reyns N.   Comparison of different treatment schemes in 5-ALA interstitial photodynamic therapy for high-grade glioma in a preclinical model: An MRI study.  Photodiagnosis Photodyn Ther.  2018

BACKGROUND: There is currently no therapy that prevents high-grade glioma recurrence. Thus, these primary brain tumors have unfavorable outcomes. Recently, 5-ALA photodynamic therapy (PDT) has been proposed to delay relapse and is highly expected to have potential synergistic effects with the current standard of care. However, PDT treatment delivery needs to be optimized by evaluating the impact of both the number of fractions and the light power used. OBJECTIVES: Previous studies have reported MRI examination-based outcomes for PDT in glioblastoma. Our study aimed to compare MRI markers across different treatment schemes that use interstitial PDT in high-grade glioma in a preclinical model. MATERIALS AND METHODS: Forty-eight "nude" rats were grafted with human U87 cells into the right putamen and subsequently submitted to interstitial PDT. The rats were randomized into six groups, including two different sham groups and four different treated groups (5 fractions at 5 mW or 30 mW and 2 fractions at 5 mW or 30 mW). After photosensitizer (PS) precursor (5-ALA) intake, an optical fiber was introduced into the tumor. Treatment effects were assessed with early high-field MRI to acquire T1 and T2 diffusion and perfusion images. RESULTS: There was no difference in the variation of the diffusion coefficient among the six groups (p = 0.0549, Kruskal-Wallis test). However, a significant difference was identified among the six groups in terms of variation in perfusion (p = 0.048, Kruskal-Wallis test), supporting a lesional effect in the treated groups. Additionally, the sham groups had significantly smaller edema volumes than were observed in the treated groups. Moreover, the 5-fraction group treated with 30 mW was associated with edema volumes that were significantly greater than those in the 5-fraction group treated with 5 mW (p = 0.019). CONCLUSION: Based on observations of MRI data and considering treatment effects, the 5-fraction group treated at 5 mW was not significantly different from the other treated groups in terms of cell deaths, characterized by diffusion imaging, or necrosis level. However, the significantly lower level of edema observed in this group indicated that this treatment scheme had limited toxicity.

Vermandel M., Dupont C., Lecomte F., Deleporte P., Mordon S. R., Reyns N.   INDYGO: FOLLOW-UP AND PRELIMINARY RESULTS OF THE FIRST EVER PILOT CLINICAL TRIAL ON INTRAOPERATIVE 5-ALA PDT FOR THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA.  Lasers Surg. Med..  2018 ;50 :S46-S46
Sophie D., Latxague C., Bensalah K., Bigot P., Paparel P., Beauval J. B., Salomon L., Bessede T., Lang H., Nouhaud F. X., Dariane C., Baumert H., Roupret M., Long J. A., Villers A., Patard J. J., Soulie M., Mejean A., Videau M. N., Bernhard J. C.   POSTOPERATIVE OUTCOMES OF ELDERLY PATIENTS UNDERGOING PARTIAL NEPHRECTOMY: A MULTICENTRIC-STUDY OF THE FRENCH RESEARCH NETWORK ON KIDNEY CANCER UROCCR.  J. Urol..  2018 ;199 :E538-E539