Feasibility and early toxicity of intraoperative radiotherapy for breast cancer using the papillon + system: First results.

Background and Purpose: Breast intra operative radiation therapy has been evaluated with different systems delivering 20-21 Gy with treatment times around 30 min. Papillon + TM Contact X-ray machine was designed to produce a 50 kVp beam with a high dose rate ≥ 15 Gy/minute. A pilot study with the first prototype was conducted in Nice. Materials and methods: The inclusion criteria were age ≥ 60 years, unifocal ductal breast adenocarcinoma ≤ 2.5 cm, grade 1-2. Surgical local excision with sentinel node dissection was performed and the applicator was placed in the tumor bed after excision with a prescribed dose of 20 Gy. The main end point of the study was the doses measured with the Gafchromic films; two were located at the skin surface and two in the excision cavity. Secondary endpoints were early toxicity and relapse free survival. Results: Between 10/2018 and 09/2019, 26 patients were included. Mean Gafchromic doses were 18.8 Gy ± 2 Gy at the south pole, 15.6 Gy ± 2.81 Gy at the equator and 2.5 Gy ± 1.67 Gy at the skin. With a median follow-up time of 12 months, no skin or subcutaneous toxicity > grade 2, no local relapse and no metastasis were observed. Conclusion: This is the first phase II study testing the Papillon + tm system for breast IORT with in vivo dosimetry measurements and reassuring clinical data.

Prophylactic Radical Fimbriectomy with Delayed Oophorectomy in Women with a High Risk of Developing an Ovarian Carcinoma: Results of a Prospective National Pilot Study.

Risk-reducing salpingo-oophorectomy is the gold standard for the prophylaxis of ovarian cancer in high-risk women. Due to significant adverse effects, 20-30% of women delay or refuse early oophorectomy. This prospective pilot study (NCT01608074) aimed to assess the efficacy of radical fimbriectomy followed by a delayed oophorectomy in preventing ovarian and pelvic invasive cancer (the primary endpoint) and to evaluate the safety of both procedures. The key eligibility criteria were pre-menopausal women ≥35 years with a high risk of ovarian cancer who refused a risk-reducing salpingo-oophorectomy. All the surgical specimens were subjected to the SEE-FIM protocol. From January 2012 to October 2014, 121 patients underwent RF, with 51 in an ambulatory setting. Occult neoplasia was found in two cases, with one tubal high-grade serous ovarian carcinoma. Two patients experienced grade 1 intraoperative complications. No early or delayed grade ≥3 post-operative complications occurred. After 7.3 years of median follow-up, no cases of pelvic invasive cancer have been noted. Three of the fifty-two patients developed de novo breast cancer. One BRCA1-mutated woman delivered twins safely. Twenty-five patients underwent menopause, including fifteen who had received chemotherapy for breast cancer, and twenty-three underwent menopause before the delayed oophorectomy, while two did not undergo a delayed oophorectomy at all. Overall, 46 women underwent a delayed oophorectomy. No abnormalities were found in any delayed oophorectomy specimens. Radical fimbriectomy followed by delayed oophorectomy appears to be a safe and well-tolerated risk-reducing approach, which avoids early menopause for patients with a high risk of breast and ovarian cancer.

[Impact of COVID-19 pandemic on breast and gynecologic cancers management. Experience of the Surgery Department in the Nice Anticancer Center]. / Impact de la pandémie de COVID-19 sur les prises en charge pour cancer du sein et gynécologique.

INTRODUCTION: During the COVID-19 pandemic, the containment measures and the recommendations of several societies in oncology may have impacted the request for initial care for cancers. METHODS: In this monocentric retrospective study, the number and the characteristics of patients received for a first consultation for a breast or gynecologic tumor were compared between the containment period and a control period. The times from diagnosis to treatment and the type of initial care were compared too. RESULTS: During the outbreak, 91 patients were seen for a new request, versus 159 during the control period, a decrease of 43.5 %. Patients were older (62.9 versus 60.9 years old) but this difference was not significant. Tumor stage was not modified. Concerning senology, the time from the biopsy to the first consultation was 5.5 days longer during the outbreak (difference statistically insignificant). Among the 51 patients requiring a surgical treatment during the outbreak, 16 (31.48 %) were postponed after the end of the containment measures. After all, the average time from the consultation to the treatment was not modified. No modification of type of treatment was observed. DISCUSSION: At the height of the pandemic, benefits and risks of the cancer treatment had to be daily balanced against the risk of exposition to the COVID-19. The evaluation of practices for cancer care is essential to understand the real impact of COVID-19 outbreak on global cancer management, so as to get prepared to further crises.

Accelerated partial breast irradiation in the elderly: 5-Year results of the single fraction elderly breast irradiation (SiFEBI) phase I/II trial.

PURPOSE: To evaluate the clinical outcomes of a very-accelerated partial breast irradiation (vAPBI) in the elderly based on a single fraction of multicatheter interstitial high-dose rate brachytherapy (MIB). Mature results with a median follow-up of 5 years. METHODS AND MATERIALS: From November 2012 to September 2014, 26 patients (pts) (≥70) with early breast cancer were enrolled in a prospective phase II trial (NCT01727011). After lumpectomy, intraoperative catheter implant was performed for postoperative APBI (single fraction 16 Gy). Surveillance was performed twice a year after APBI. Oncologic outcome (local [LRFS], metastasis-free survival, cancer-specific survival, and overall survival [OS]) as well as late toxicity and cosmetic outcome were investigated. RESULTS: Median age was 77 years [69-89]. After a median follow-up of 63 months [60-68], 5-year LRFS, metastasis-free survival, cancer-specific survival, and overall survival rates were 100%, 95.5%, 100%, and 88.5%, respectively. Late toxicity was observed in 5 pts (19.2%) with a total of five events: 3 pts G1 (60%); and 2 pts G2 (40%). The observed late side effects were breast pain in 1 pt (G2 cytosteatonecrosis with occasional acetaminophen consumption), hypopigmentation (puncture site) in 2 pts (G1) and breast fibrosis in 2 pts (G1: 1 pt; G2: 1 pt). Cosmetic evaluation was excellent for 21 pts (81%) and good for 2 pts (19%). CONCLUSION: For elderly with early breast cancer, a vAPBI using a single fraction of postoperative MIB (16 Gy) provides excellent oncologic results, mainly in terms of local control and cancer death. Late toxicity and cosmetic profile are acceptable.

[Preoperative breast imaging review: Interests and limits of specialized validation in oncology]. / Relecture préopératoire en sénologie : intérêts et limites d'une validation spécialisée en oncologie.

OBJECTIVES: To evaluate the impact of systematic radiological review by breast specialist radiologist of malignant breast lesion imaging on the therapeutic management of patients. MATERIALS AND METHODS: Data collection was performed for patients with histopathologically proved breast cancer or suspicious breast lesion on imaging realized out of our institution. Patients underwent systematic mammary and axillary ultrasound, imaging review and if necessary complementary mammographic images. We analyzed the number of additional breast biopsies and axillary lymph node fine needle aspiration (FNA) with their histopathological results. We assessed their impact by comparing the final surgical treatment to the one planned before review. RESULTS: Two hundred and seventeen patients were included, with a total of 230 BIRADS 0, 4, 5 or 6 breast lesions. Seventy-six additional breast core biopsies were realized, leading to diagnose 43 additional BIRADS 6 lesions (24 infiltrative carcinomas, 9 DCIS and 10 atypical lesions) in 30 patients (13.82%). Thirty-five additional lymph node FNA were realized with 12 metastatic nodes and 3 false negative samples. Imaging review lead to change surgical treatment in 59 patients (27.19%, P<0.01) with modification in breast surgery in 37 patients, axillary surgery in 8 patients and both sites surgery in 12 patients. CONCLUSION: This study shows an impact of systematic radiological review by breast specialist radiologist in therapeutic management of patients treated for malignant breast lesion.

Patient satisfaction and acceptance of their totally implanted central venous catheter: a French prospective multicenter study.

INTRODUCTION: Most cancer patients require a totally implanted central venous catheter (TIVAD) for their treatment. In a previous study, we developed and validated a questionnaire dubbed QASICC (Questionnaire for Acceptance of, and Satisfaction with, Implanted Central Venous Catheter) assessing patient satisfaction with, and acceptance of, their TIVAD. In the present study, we conducted a large, prospective, multicenter study in cancer patients aimed to analyze factors that could influence patients' acceptance of, and satisfaction with, their device. METHODS: The QASICC is composed of 22 items assessing 5 dimensions. The construction and validation of the questionnaire was achieved using validated methodology to determine its psychometric characteristics. The questionnaire was submitted to 720 patients in 11 French institutions; 567 answers were analyzed. RESULTS: Younger patients had the most difficulties in coping with their TIVAD, especially regarding daily activities and their body image and private life compared to older patients. Sex was significantly related to patient satisfaction, with worse scores in women. Breast tumor location was also correlated with low TIVAD acceptance. TIVAD on the right side also positively influenced satisfaction and acceptance of the device. CONCLUSIONS: QASICC has proved to be efficient, and to detect known issues regarding daily activities and body image. As our population was mostly composed of women with breast cancer, our results reflect specific aspects of this population. The TIVAD remains generally well-accepted and our questionnaire should help health-care workers to better address the specific needs of their patients based on the answers provided.

[Multicenter validation study of a questionnaire assessing patient satisfaction with and acceptance of totally-implanted central venous access devices]. / Validation multicentrique d'un questionnaire évaluant l'acceptation et la satisfaction des patients porteurs de chambre à cathéter implantable : le questionnaire QASICC.

OBJECTIVE: Most cancer patients require a totally-implanted central venous access device (TIVAD) for their treatment. This was a prospective, multicenter, open study to: (i) develop and validate a French-language questionnaire dubbed QASICC (Questionnaire for Acceptance of and Satisfaction with Implanted Central Venous Catheter) assessing patient's satisfaction with and acceptance of their TIVAD; (ii) develop a mean score of patient's acceptance and satisfaction; (iii) look for correlation between QASICC score and TIVAD patient/tumor pathology/device characteristics. METHODS: From 2011 November to 2012 December, the first version of the QASICC questionnaire that included 27 questions assessing seven dimensions was re-tested among 998 cancer patients in eleven French cancer hospitals (eight cancer research institutes and three university/general hospitals). The goal was: (i) to reduce the questionnaire item and dimension number (pertinency, saturation effect, item correlation); (ii) to assess its psychometric properties, demonstrate its validity and independency compared to (EORTC) QLQC30; (iii) to correlate clinical and pathological patient's/tumor's/TIVAD's parameters with the QASICC questionnaire score (the higher the overall score, the greater the acceptance and satisfaction). The questionnaire was administered to the patient 30 days (±15 days) after TIVAD's implantation. RESULTS: Among 998 questionnaires given to cancer patients, 658 were analyzed and 464 were fully assessed as there was no missing data. Time to fill-in the questionnaire was five minutes in 90% patients. Final QASICC tool included twenty-two questions assessing four homogeneous dimensions (65%

Interstitial preoperative high-dose-rate brachytherapy for early stage cervical cancer: dose-volume histogram parameters, pathologic response and early clinical outcome.

PURPOSE: To analyze dose-volume histogram parameters and pathologic response after preoperative high-dose-rate brachytherapy (HDRB) for high-risk early stage cervical cancers (ESCCs). METHODS AND MATERIALS: From June 2007 to December 2011, 32 patients with a histologically proven invasive cervical cancer with high risk of local recurrence (size >2cm, adenocarcinoma type, perineural and/or lymphovascular invasion) underwent a preoperative HDRB, which delivered a total dose of 39Gy in nine fractions over 5 days. All the patients underwent hysterectomy after HDRB. RESULTS: With a median clinical target volume of 50cc (minimum-maximum, 42-74), the median V100 was 49cc (minimum-maximum, 42-50). Median D90 was 45Gy (equivalent dose at 2Gy per fraction, 56Gyαß10). Median D2cc was 34Gy, 31Gy, 28Gy, and 38Gyαß3 for bladder, rectum, sigmoid, and vagina, respectively. Twenty-eight patients (88.5%) achieved a complete histologic response after surgery, whereas for the 4 remaining patients, residual tumor cells (3 patients) and gross residual disease (1 patient) were observed in the pathologic specimen. With a median followup of 24 months (minimum-maximum, 5-48), no local recurrence was observed; 1 patient died of intercurrent cause. Early toxicity occurred within the 30 days after HDRB (Common Terminology Criteria for Adverse Events v3.0) was G1 diarrhea for 15 patients (47%) and G1 urinary frequency or urgency for 13 patients (40.6%). No G2-G3 toxicities were noticed. CONCLUSIONS: Preoperative HDRB for high-risk ESCCs represents a well-tolerated procedure, which leads to a high rate of postoperative pathologic response. Dose-volume histogram parameters were at least equivalent to those obtained with a low-dose-rate procedure. Long-term results will help to analyze the place of preoperative brachytherapy in the management of high-risk ESCCs.

Autologous fat grafting and breast cancer recurrences: retrospective analysis of a series of 100 procedures in 64 patients.

Autologous fat transfer (AFT) enhances the cosmetic results of breast reconstruction and corrects breast conserving operation sequelae. The question of its oncological safety remains, as in-vitro experiences have shown that adipocytes can stimulate cancer cell proliferation. This study analysed the records of patients who had AFT after breast cancer from 2004-2009. The primary end-point was cancer recurrence. The secondary end-points were AFT complications and post-AFT mammogram modifications. Sixty-four patients (100 AFT) were included. The mean follow-up for AFT was 46.44 months (SD = 21.4). Two breast cancer recurrences were recorded (3.1%). Among 55 mammograms analysed, only one patient presented radiological abnormalities. One complication of AFT (donor-site infection) was recorded. This series is in favour of the oncological safety of AFT after breast cancer. An accurate evaluation of the recurrence risk, before performing AFT, is an essential prerequisite and must lead one to postpone or avoid this procedure in high-risk patients.