A computer synoptic operative report versus a report dictated by a surgeon in advanced ovarian cancer.

OBJECTIVE: To evaluate the role of a computer synoptic operative report in enhancing the quality and completeness of surgical reporting for advanced ovarian cancer surgeries. METHODS: The study was conducted at a tertiary cancer center between January 2016 and September 2021, and the computer synoptic operative report was implemented in May 2019. The study compared two cohorts: the first consisted of the 'before computer synoptic operative report (P1)' period, during which the operative reports were dictated freely by the surgeons, and the second consisted of the 'after computer synoptic operative report (P2)' period, during which all surgeons used the computer synoptic operative report. RESULTS: The study analyzed 227 operative reports, with 104 during period 1 (P1) and 123 during period 2 (P2). In the P1 group, more than half of the patients (54 out of 104, 52%) underwent interval surgery after completing six cycles of chemotherapy; In contrast, in the P2 group, all interval debulking surgeries were performed after fewer than six chemotherapy cycles (p<0.001). Although interval debulking surgery after fewer than six chemotherapy cycles was more frequent in P2, the rate of primary debulking surgery was similar between the groups. The median intra-operative peritoneal carcinomatosis index was higher in P2 (2 in P1 vs 4 in P2, p<0.001), and mean blood loss was higher in P1 (308 mL vs 151 mL, p<0.001). The rate of complete cytoreduction was similar between P1 and P2 (97% vs 87%, respectively, p=0.6). The median length of hospital stay was 12 days in the P1 group and 16 days in the P2 group (p=0.5). Compliance with all eight significant items was higher in the P2 group, with all items present in 66% of the operative reports in the P2 group compared with none of the reports in the P1 group. Compliance for the following items was: International Federation of Obstetrics and Gynecology stage (24% vs 100%), histology (76% vs 97%), CA125 (63% vs 89%), type of surgery (38% vs 100%), peritoneal carcinomatosis index (21% vs 100%), complete cytoreduction score 36% vs 99%), Aletti score (0% vs 89%), and blood loss (32% vs 98%) for P1 and P2; respectively. CONCLUSION: The use of the computer synoptic operative report improved the completeness and quality of the surgical information documented in advanced ovarian cancer surgeries.

The impact of modern preoperative high-dose-rate brachytherapy in early-stage cervical cancer.

PURPOSE: To analyze the clinical outcomes and the safety of preoperative high-dose-rate (HDR) image-guided adaptive brachytherapy (IGABT) followed by minimally invasive surgery (MIS) in the multidisciplinary management of early-stage cervical cancer. METHODS AND MATERIALS: Medical records of all consecutive patients with early-stage cervical cancer treated at our institution between 2012 and 2018 with preoperative IGABT in a multidisciplinary approach were reviewed. Treatment schedule was pelvic node dissection, preoperative IGABT followed 6-8 week later by MIS hysterectomy. RESULTS: Seventy patients with cervical cancer FIGO stages (IB1 18.6%, IB2 75.7% and IIA1 5.7%) were treated by preoperative HDR brachytherapy. With a median follow-up of 37.4 months [95% confidence interval, 32.1-39.7 months] isolated vaginal vault recurrence was not observed, 3 pelvic relapses were reported (4.3%). None of patients received postoperative radiotherapy (EBRT) or radiochemotherapy. The estimated 3-year local and pelvis relapse free survival for the entire population were respectively 98% [95% confidence interval, 89%-100%] and 90% [80%-96%]. The estimated 3-year disease-free survival (DFS) for the entire population was 88% [77-94%]. The 3-year overall survival (OS) rate was 97% [88%-99%]. Microscopic vaginal resection margin (R1) was observed in one patient ([1].4%). Lymph-vascular space invasion (LVSI) was found found in 6 (8.6%) patients. Forty-eight late complications in 36 patients (51.4%) were observed. Five (7.1%) grade 3 vaginal wound dehiscence toxicities were observed. Urinary and gastrointestinal toxicities were grade 1-2. No grade 4-5 complications were observed. CONCLUSIONS: Preoperative image-guided adaptive brachytherapy followed by minimally invasive surgery allows high local control, reduces positive surgical margins and rates of lymph-vascular space invasion avoiding adjuvants treatments. Surgical approaches must be discussed with patients including preoperative brachytherapy as a down-staging treatment.

Adjuvant chemotherapy for small, lymph node-negative, triple-negative breast cancer: A single-center study and a meta-analysis of the published literature.

BACKGROUND: Current guidelines recommend adjuvant chemotherapy for patients with small, lymph node-negative, triple-negative breast cancer (TNBC) measuring >5 mm (T1b disease), but clinical evidence to support this recommendation is lacking. Thus, the current study aimed to evaluate the survival benefit of adjuvant chemotherapy in patients with T1N0M0 (measuring ≤2 cm) TNBC with different tumor sizes. METHODS: The authors retrospectively evaluated consecutive patients with pT1N0M0 TNBC who were diagnosed between 2000 and 2016 at Sun Yat-Sen University Cancer Center. For the meta-analysis, electronic medical databases were searched for all relevant studies regarding the effect of adjuvant chemotherapy on the target population. RESULTS: Of the 351 enrolled patients, 309 (88%) received adjuvant chemotherapy and 42 patients (12%) did not. The distribution by T classification was T1a in 19 patients (5.4%), T1b in 67 patients (19.1%), and T1c in 265 patients (75.5%). Adjuvant chemotherapy significantly improved recurrence-free survival (RFS) in the patients with T1c disease, but not those with T1b and T1a disease. Meanwhile, there was no difference in RFS noted according to the chemotherapy regimen among patients with T1c disease. Seven eligible studies comprising 1525 patients with T1N0M0 (941 with T1a/bN0M0) were included in the meta-analysis. The meta-analysis demonstrated that adjuvant chemotherapy significantly reduced the rate of disease recurrence for patients with T1a/b disease as a group, but the population driving that was only patients with T1b disease, not those with T1a disease. CONCLUSIONS: Although the retrospective analysis demonstrated a survival benefit of adjuvant chemotherapy only for patients with T1cN0 TNBC, the meta-analysis showed it also is beneficial for individuals with T1bN0 TNBC. For patients with T1cN0M0 TNBC, less intensive chemotherapy regimens achieve an excellent survival outcome similar to that of intensive anthracycline and taxane combination chemotherapy.

Consensus Statement on Robotic Mastectomy-Expert Panel From International Endoscopic and Robotic Breast Surgery Symposium (IERBS) 2019.

OBJECTIVES: To achieve a consensus statement on robotic mastectomy. BACKGROUND: Robotic-assisted surgery has gained much attention especially the results of few case series reporting on the technical feasibility, safety and early oncologic outcomes of robotic-assisted mastectomy in a few centers worldwide. The aim of this consensus statement was to develop and provide standardized guidelines on robotic mastectomy based on consensus statement by a panel of experts from indications to outcome measures and indicators, thereby providing a valuable guide for breast surgeons worldwide. METHODOLOGY: An internationally representative expert panel of 10 surgeons was invited to participate in the generation of a consensus statement. 52 statements were created in 6 domains: indications, contraindications, technical considerations, patient counseling, outcome measures and indicators, training and learning curve assessment. Experts were asked to vote if they agree, disagree or of the opinion that the statement should be rephrased. Two electronic rounds via online survey of iterative rating and feedback were anonymously completed, followed by a final round of in-person meeting during the inaugural International Endoscopic and Robotic Breast Surgery Symposium 2019 from May 24 to 25, 2019. Consensus was reached when there was at least 80% agreement on each statement. RESULTS: A total of 53 statements with at least 80% agreement were generated after 3 rounds of voting; 21 statements from first round of voting, 20 statements from second round of voting and 12 statements from the final round of in-person meeting. All experts agreed that the consensus statement served as expert recommendations but not mandatory for a successful and safe practice of robotic mastectomy. CONCLUSION: Robotic mastectomy is a promising technique and could well be the future of minimally invasive breast surgery whereas proving to be safe and feasible. The first consensus statement on robotic mastectomy from an international panel of experts serves as an extremely important milestone and provides recommendations for breast surgeons keen to embark on this technique.

Lessons from radiochemotherapy and modern image-guided adaptive brachytherapy followed by hysterectomy.

PURPOSE: To analyze the clinical outcomes and the safety of radiochemotherapy (RCT) and image-guided adaptive brachytherapy (IGABT) and to evaluate the impact of hysterectomy (HT) as completion of treatment for cervical cancer. METHODS AND MATERIALS: 145 patients with locally advanced cervical cancer were treated at our institution. Patients underwent RCT and IGABT, then hysterectomy (HT) as completion of treatment was performed, with the exception of patients with surgical contraindications, para aortic metastatic disease or patients who refused surgery. Clinical outcomes and morbidity were retrospectively reviewed in both groups. Local relapse free survival (LRFS), pelvic relapse free survival (PRFS) and overall survival (OS) were analyzed. RESULTS: Completion HT was performed in 90 (62.1%) patients. Complete histological response and microscopic disease were found in 77 patients (85.6%). Local relapse was observed in 14 patients (9.6%) without differences between completion HT group and the definitive RCT and IGABT group (Odds Ratio OR = 1.73 [0.57-5.23], p = 0.33). The estimated 3-year LRFS and PRFS for the entire population were respectively 90% [84%-94%] and 93% [87%-96%], with no significant differences between them (respectively Hazard Ratio HR = 0.57 [0.20-1.64], p = 0.30 and HR = 0.37 [0.10-1.31], p = 0.12). The estimated 3-year OS rate for the whole population was 84% [75%-91%] with no significant differences between groups (HR = 0.81 [0.32-2.06], p = 0.65). Regarding morbidity, grade ≥ 2 vaginal toxicity was more frequent in the definitive RCT and IGABT group (43.6% vs 26.7%, p = 0.04). All grade 4 toxicity events were reported in the completion HT group. CONCLUSIONS: Due to high severe toxicity, RCT and IGABT with dose escalation followed by completion hysterectomy don't seem compatible. No benefit and increased severe late morbidity were observed. Combined intracavitary/interstitial technique is mandatory in large target volume at brachytherapy.

EVAN-G score in patients undergoing minimally invasive gynecology oncologic surgery in an Enhanced Recovery After Surgery (ERAS) program.

INTRODUCTION: Enhanced Recovery After Surgery (ERAS) has been proven to decrease the length of hospital stay without increasing re-admission rates or complications. There are limited data on the satisfaction of patients undergoing minimally invasive surgery for gynecologic malignancy within ERAS programs. The aim of this study was to evaluate patient satisfaction after minimally invasive surgery for gynecologic malignancy within the ERAS program using the 'Evaluation du Vécu de l'Anésthésie Génerale (EVAN-G)' questionnaire. METHODS: This observational retrospective study was conducted at the Paoli-Calmettes Institute between June 2016 and December 2018. All the included patients underwent minimally invasive surgery for a gynecologic malignancy. EVAN-G, a validated questionnaire, was used to measure peri-operative patient satisfaction. This questionnaire consists of 26 items assessing six elements: attention, privacy, information, pain, discomfort, and waiting time. Each element is assessed via a 5-step numerical scale and then transformed to a 0-100 scale according to the degree of satisfaction. The EVAN-G questionnaire was given to patients before surgery and collected during the post-operative consultation (2-3 weeks after surgery). RESULTS: A total of 175 patients underwent minimally invasive surgery for gynecologic malignancy within the ERAS program. Of these, 92 patients were included in the study and 83 patients were excluded. The overall patient compliance rate with our ERAS program was 90%. The analysis of the EVAN-G score of all participants showed an overall high level of satisfaction with a mean score of 81.9 (range 41.6-100). Patients with peri-operative complications or having prolonged hospitalization also showed high levels of satisfaction with a mean score of 80.5 (41.6-100) and 83.2(55-100), respectively. CONCLUSION: In this study we showed a high patient satisfaction with the ERAS program. When comparing length of stay and complications, neither extended length of stay nor development of complications after minimally invasive surgery impacted patient satisfaction.

Prediction of early discharge after gynaecological oncology surgery within ERAS.

OBJECTIVES: Enhanced recovery after surgery programs (ERAS) have been proven to decrease the length of hospital stay without increasing readmission rates or complications. However, the patient and operative characteristics that improve the chance of a successful early hospital discharge are not well established. The aim of this study was to design a nomogram which could be used before surgery, using the characteristics of patients, to establish who could benefit from early discharge (POD ≤ 2 days). METHODS: This observational study has been prospectively conducted. All the included patients were referred for surgical treatment of gynecologic cancer. We defined two sub-groups of patients on surgical procedure characteristics: isolated procedures (hysterectomy or lymphadenectomy) and combined procedures (at least the association of two procedures). RESULTS: 230 patients were enrolled during the study protocol. 83.9% of patients were treated with a minimally invasive surgery (MIS). 159 patients (69.1%) were discharged on or before POD 2. On multivariate analysis, the surgical approach (open surgery vs. laparoscopy, OR 0.02 (95% CI [0-0.07]), p < 0.001) and the type of surgery (combined procedure versus isolated procedure, OR 0.41 (95% CI [0.18-0.91]), p = 0.028) were found to be significant predictors of increased hospital stay. A nomogram has been built for the purpose of predicting eligible patients for early post-operative discharge based on the multivariate analysis results (AUC = 0.86, 95% CI [0.81-0.92]). CONCLUSION: The use of MIS for isolated procedures in oncologic indications constitutes an independent factor of early discharge in a setting of ERAS. These promising preliminary results still require to be validated on a prospective cohort.

The actual benefit of intraoperative radiation therapy using 50 kV x-rays in early breast cancer: A retrospective study of 676 patients.

This French study reports the 5-year results of partial-breast irradiation using intraoperative radiation therapy (IORT) with 50 kV x-rays, in select early breast cancer patients. We report a retrospective analysis of 676 consecutive early breast cancer patients treated between November 2011 and December 2015 by partial-breast irradiation using the INTRABEAM® system. Patients were highly selected based on the ASTRO and GEC-ESTRO criteria and underwent breast-conservative surgery and IORT, completed with additional whole-breast irradiation (WBI) when unexpected unfavorable prognostic factors were found at the final pathology report. Patients' outcomes relative to local and distant control, overall and breast cancer-specific survival, and toxicity are presented, as well as rates of additional WBI. Additional WBI was mandatory in one third of patients (31%), mainly due to lymph node involvement and extensive intraductal component. With a median follow-up time of 54 months, the 5-year local recurrence rate was 1.7% [95%CI: 0.9-3.3]; the median time to local recurrence was 23 months; ipsilateral breast recurrences mainly occurred in the same quadrant (7/11); in the restricted population, meeting all predefined criteria and treated with IORT alone (406 patients), the local recurrence rate was 1.5% [95%CI: 0.6-3.6]. Five-year distant tumor control was 98.6% [95%CI: 97.2-99.3], and the median time to distant recurrence was 22 months. Five-year overall survival was 96.5% [95%CI: 94.2-97.8], and 5-year breast cancer-specific survival was 98.9% [95%CI: 97.6-99.7]. In patients treated with IORT alone, there was no grade 3 toxicity, only four grade 3 (mainly fibrosis) affected patients treated with IORT and WBI. Grade 1-2 toxicity rates were 14% and 34.4% in patients treated with IORT alone and IORT plus WBI, respectively. Partial-breast irradiation using IORT by a 50 kV photon device is safe and well-tolerated in select patients with early breast cancer and is a valuable option in patients reluctant for adjuvant WBI.

Robotic Nipple-Sparing Mastectomy and Immediate Breast Reconstruction With Robotic Latissimus Dorsi Flap Harvest: Technique and Results.

Introduction. Only few cases of robotic latissimus dorsi flap reconstruction (RLDFR) have been reported in indication of reconstruction for breast cancer (BC). We report our experience of combined robotic nipple-sparing mastectomy (R-NSM) and RLDFR, and analyze technique, indications, and reproducibility. Methods. All patients with R-NSM and RLDFR from November 2016 to August 2, 2018, were analyzed, and technics have been described. Complication rate with Clavien-Dindo grading and postoperative hospitalization length (days) are reported. Results. Thirty-five R-NSM with RLDFR were performed in 22 cases for primitive BC and 13 for local recurrence. In 12 patients, another surgical procedure was performed during the same time (axillary lymph node dissection or contralateral breast surgery). R-NSM was realized through a short axillar incision, with inside-only installation for 12 patients (34.3%): 18 nonautologous and 17 autologous RLDFR associated with implant in 9 patients. In logistic regression, mastectomy weight >330 g was significantly associated with the use of implant (odds ratio [OR] = 17, P = .015), and significant factor of the time of anesthesia ≥380 minutes was 2 installations (OR = 10.4, P = .049). The median duration of hospitalization stay was 4 days. Complications rates were 51.4% (18/35; 9 grade-1, 2 grade-2, and 7 grade-3). In logistic regression, associated other surgical procedure was predictive of grade-3 complications (OR = 6.87, P = .053). Conclusion. We confirmed the reproducibility and safety of R-NSM and RLDFR with a decreased complication rate. NSM was performed in 42.8% of our patients after previous radiotherapy. We observed an increase of grade-3 complications when R-NSM and RLDFR was combined to another surgical procedure.

Isolated ipsilateral local recurrence of breast cancer: predictive factors and prognostic impact.

BACKGROUND: Tumour features associated with isolated invasive breast cancer (BC) ipsilateral local recurrence (ILR) after breast conservative treatment (BCT) and consequences on overall survival (OS) are still debated. Our objective was to investigate these points. METHODS: Patients were retrospectively identified from a cohort of patients who underwent BCT for invasive BC in 16 cancer centres. End-points were ILR rate and OS. The impact of ILR on OS was assessed by multivariate analysis (MVA) for all patients and according to endocrine receptors (ERs) and grade or tumour subtypes. RESULTS: Of 15,570 patients, ILR rate was 3.1%. Cumulative ILR rates differed according to ERs/grade (ERs+/Grade2: HR 1.42, p = 0.010; ERs+/Grade3: HR 1.41, p = 0.067; ERs-: HR 2.14, p < 0.0001), endocrine therapy (HR 2.05, p < 0.0001) and age < 40-years old (HR 2.28, p = 0.005) in MVA. When MVA was adjusted on tumour subtype, the latter was the only independent factor. OS-after-ILR was significantly different according to ILR-free intervals (HR 4.96 for ILR-free interval between 2 and 5-years and HR 9.00 when < 2-years, in comparison with ≥ 5-years). CONCLUSION: ERs/Grade status, lack of endocrine therapy and tumour subtypes predict isolated ILR risk in patients treated with BCT. Short ILR-free-intervals represent a strong pejorative factor for OS. These results may help selecting initial treatment as well as tailoring ILR systemic chemotherapy.

Adjuvant chemotherapy in lobular carcinoma of the breast: a clinicopathological score identifies high-risk patient with survival benefit.

BACKGROUND: Invasive lobular carcinomas (ILCs) represent approximately 10% of all breast cancers. Despite this high frequency, benefit of adjuvant chemotherapy (CT) is still unclear. METHODS: Our objective was to investigate the impact of CT on survival in ILC. Patients were retrospectively identified from a cohort of 23,319 patients who underwent primary surgery in 15 French centers between 1990 and 2014. Only ILC, hormone-positive, human epidermal growth factor 2 (HER2)-negative patients who received adjuvant endocrine therapy (ET) were included. End-points were disease-free survival (DFS) and overall survival (OS). A propensity score for receiving CT, aiming to compensate for baseline characteristics, was used. RESULTS: Of a total of 2318 patients with ILC, 1485 patients (64%) received ET alone and 823 (36%) received ET + CT. We observed a beneficial effect of addition of CT to ET on DFS and OS in multivariate Cox model (HR = 0.61, 95% confidence interval, CI [0.41-0.90]; p = 0.01 and 0.52, 95% CI [0.31-0.87]; p = 0.01, respectively). This effect was even more pronounced when propensity score matching was used. Regarding subgroup analysis, low-risk patients without CT did not have significant differences in DFS or OS compared to low-risk patients with CT. CONCLUSION: ILC patients could derive significant DFS and OS benefits from CT, especially for high-risk patients.

Lymph node positivity in different early breast carcinoma phenotypes: a predictive model.

BACKGROUND: A strong correlation between breast cancer (BC) molecular subtypes and axillary status has been shown. It would be useful to predict the probability of lymph node (LN) positivity. OBJECTIVE: To develop the performance of multivariable models to predict LN metastases, including nomograms derived from logistic regression with clinical, pathologic variables provided by tumor surgical results or only by biopsy. METHODS: A retrospective cohort was randomly divided into two separate patient sets: a training set and a validation set. In the training set, we used multivariable logistic regression techniques to build different predictive nomograms for the risk of developing LN metastases. The discrimination ability and calibration accuracy of the resulting nomograms were evaluated on the training and validation set. RESULTS: Consecutive sample of 12,572 early BC patients with sentinel node biopsies and no neoadjuvant therapy. In our predictive macro metastases LN model, the areas under curve (AUC) values were 0.780 and 0.717 respectively for pathologic and pre-operative model, with a good calibration, and results with validation data set were similar: AUC respectively of 0.796 and 0.725. Among the list of candidate's regression variables, on the training set we identified age, tumor size, LVI, and molecular subtype as statistically significant factors for predicting the risk of LN metastases. CONCLUSIONS: Several nomograms were reported to predict risk of SLN involvement and NSN involvement. We propose a new calculation model to assess this risk of positive LN with similar performance which could be useful to choose management strategies, to avoid axillary LN staging or to propose ALND for patients with high level probability of major axillary LN involvement but also to propose immediate breast reconstruction when post mastectomy radiotherapy is not required for patients without LN macro metastasis.

Skin sparing mastectomy and robotic latissimus dorsi-flap reconstruction through a single incision.

BACKGROUND: Robotic latissimus dorsi-flap reconstruction (RLDFR) after skin-sparing mastectomy (SSM) for breast cancer (BC) has been performed through a single nipple incision. We report results of SSM with RLDFR, mainly with analysis of feasibility, morbidity, indications, and technique standardization. METHODS: We determined characteristics of patients, previous treatment of BC, and type of reconstruction. Surgical technique, duration of surgery, and complication rate were reported according to three successive periods: P1-3. RESULTS: Forty RLDFR, with breast implant for 16 patients, with previous breast radiotherapy in 30% had been performed. In logistic regression, factors significantly associated with duration of surgery ≥ 300 min were P2 (OR 0.024, p = 0.004) and P3 (OR 0.012, p = 0.004) versus P1. The median mastectomy weight was 330 g and 460 g for BMI < and ≥ 23.5 (p = 0.025). Length of hospitalization was 4 days. Total complication rate was 20% (8/40): seven breast complications (four re-operations) and one RLDF complication with re-operation. Periods were significantly predictive of complications (p = 0.045). CONCLUSION: SSM with RLDFR is feasible, safe, and reproducible. We reported a decrease of duration of surgery, length of post-operative hospitalization, and complication rate.

Overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the SERC trial: axillary dissection versus no axillary dissection in patients with involved sentinel node.

BACKGROUND: Three randomized trials have concluded at non inferiority of omission of complementary axillary lymph node dissection (cALND) for patients with involved sentinel node (SN). However, we can outline strong limitations of these trials to validate this attitude with a high scientific level. We designed the SERC randomized trial ( ClinicalTrials.gov , number NCT01717131) to compare outcomes in patients with SN involvement treated with ALND or no further axillary treatment. The aim of this study was to analyze results of the first 1000 patients included. METHODS: SERC trial is a multicenter non-inferiority phase 3 trial. Multivariate logistic regression analysis was used to identify independent factors associated with adjuvant chemotherapy administration and non-sentinel node (NSN) involvement. RESULTS: Of the 963 patients included in the analysis set, 478 were randomized to receive cALND and 485 SLNB alone. All patient demographics and tumor characteristics were balanced between the two arms. SN ITC was present in 6.3% patients (57/903), micro metastases in 33.0% (298), macro metastases in 60.7% (548) and 289 (34.2%) were non eligible to Z0011 trial criteria. Whole breast or chest wall irradiation was delivered in 95.9% (896/934) of patients, adjuvant chemotherapy in 69.5% (644/926), endocrine therapy in 89.6% (673/751) and the proportions were similar in the two arms. The overall rate of positive NSN was 19% (84/442) for patients with cALND. Crude rates of positive NSN according to SN status were 4.5% for ITC (1/22), 9.5% for micro metastases (13/137), 23.9% for macro metastases (61/255) and were respectively 29.36% (64/218), 9.33% (7/75) and 7.94% (10/126) when chemotherapy was administered after cALND, before cALND and for patients without chemotherapy. CONCLUSION: The main objective of SERC trial is to demonstrate non inferiority of cALND omission. A strong interaction between timing of cALND and chemotherapy with positive NSN rate was observed. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov , number NCT01717131 October 19, 2012.

Enhanced recovery after surgery program in older patients undergoing gynaecologic oncological surgery is feasible and safe.

BACKGROUND: Enhanced Recovery After Surgery Programs (ERP) include multimodal approaches of perioperative patient's clinical pathways designed to achieve early recovery after surgery and a decreased length of hospital stay (LOS). By allowing patients to return rapidly to their everyday surroundings, older patients are those who could take the greatest benefit from ERP. This is the first study to date to assess feasibility and safety of ERP on older patients undergoing gynaecologic oncological surgery. METHODS: Data were prospectively collected between December 2015 and September 2017 at the Institut Paoli-Calmettes, a French comprehensive cancer centre. All the patients included in the study were referred for hysterectomy and/or pelvic or para-aortic lymphadenectomy for gynaecological cancer. The primary objective was to achieve similar LOS in patients ≥70 years old compared to younger patients without increasing the proportion of complications and readmission rates. A binary (LOS < or ≥ 2 days) logistic regression was built, including age, Charlson score, BMI, ASA score, oncological indication, surgical procedures and surgical approaches. G8 score was estimated for all the ≥70 years old patients. RESULTS: Of a total of 329 patients, 75 were ≥70 years old and 254 were <70. Except a disparity in oncological indications with a higher proportion of endometrial cancer in the ≥70 years old group (56% vs. 27%; p < 0.01), there were no differences in patient's characteristics and surgical procedures. Age ≥ 70 years was associated with a longer LOS (means, 3.88 vs. 3.11 days; p = 0.024) only in univariate analysis. Considering the logistic regression, age was no longer associated with LOS. Total hysterectomy with pelvic lymphadenectomy and ASA score ≥ 3 were independently associated with longer LOS while mini-invasive techniques were associated with a shorter LOS. Morbidities and readmissions occurred respectively in 23% and 8% of the total population without any difference between the two groups. In the ≥70 years old population, G8 score was not predictive of LOS, morbidities or readmissions. CONCLUSION: Although it is already widely accepted that ERP improves early recovery, our study shows that ERP for patients over 70 years of age undergoing gynaecologic oncological surgery is as safe and feasible as on younger patients.

Contribution of intraoperative radiotherapy (IORT) for therapeutic de-escalation in early breast cancer: Report of a single institution's experience.

The spread of systematic screening and the emergence of oncoplastic techniques allow more breast conservative treatment associating lumpectomy and external beam radiation therapy. In order to furthermore facilitate the patient's treatment, intraoperative radiation therapy (IORT) has been developed. The oncological safety of this technique has been studied, and is considered acceptable. Many questions remain unsolved in regard of the toxicity of this procedure as well as the patient's selection criteria. In this study, we present the first results and complications rate of patients treated by IORT in a single French institution. Between 2012 and 2015, all patients with breast cancer treated in a one-step procedure associating lumpectomy and IORT were retrospectively included in a monocentric cohort. Acute and long-term toxicities were evaluated using CTCAE v4.0 classification. 280 breast cancers were treated using IORT procedure. Additional external beam radiation therapy was requested for 45.7% patients. The acute complications rate was 14.6%, with 5 surgical revisions needed (1.78%). With a median follow up of 911 days, the long-term grade-3 toxicity rate was 1.1%. The only risk factor for local fibrosis was external beam radiation therapy (EBRT) (OR = 1.99; IC95 [1.05-3.81], P = 0.036). Three patients (1.07%) were diagnosed with local recurrence. The results from this cohort confirm the low complication and recurrence rate of IORT procedure. A good selection of patients is necessary in order to lower the EBRT rate and allow therapeutic de-escalation. The classification of tumors into IHC subsets seems a good selection gate. Intraoperative radiation therapy appears to have a low toxicity rate with an acceptable local recurrence risk, and should therefore be considered as an option in the treatment of early breast cancer.

Benefit of adjuvant chemotherapy with or without trastuzumab in pT1ab node-negative human epidermal growth factor receptor 2-positive breast carcinomas: results of a national multi-institutional study.

PURPOSE: Benefit of adjuvant trastuzumab-based chemotherapy for node-positive and/or >1 cm human epidermal growth factor receptor 2-positive (HER2+) breast carcinomas has been clearly demonstrated in randomized clinical trials. Yet, evidence that adjuvant chemotherapy with or without trastuzumab is effective in pT1abN0 HER2+ tumors is still limited. The primary objective of this study was to investigate the impact of adjuvant chemotherapy ± trastuzumab on outcome in this subpopulation. PATIENTS AND METHODS: A total of 356 cases of pT1abN0M0 HER2 + breast cancers were retrospectively identified from a large cohort of 22,334 patients, including 1248 HER2+ patients who underwent primary surgery at 17 French centers, between December 1994 and January 2014. The primary end point was disease-free survival (DFS). A multivariate Cox model was built, including adjuvant chemotherapy, tumor size, hormone receptor status, and Scarff Bloom Richardson (SBR) grade. RESULTS: A total of 138 cases (39%) were treated with trastuzumab-based chemotherapy, 29 (8%) with chemotherapy alone, and 189 (53%) received neither trastuzumab nor chemotherapy. Adjuvant chemotherapy ± trastuzumab was associated with a significant DFS benefit (3-year 99 vs. 90%, and 5-year 96 vs. 84%, Hazard ratio, HR 0.26 [0.10-0.67]; p = 0.003, logrank test) which was maintained in multivariate analysis (HR 0.19 [0.07-0.52]; p = 0.001). Metastasis-free survival was also increased (HR 0.25 [0.07-0.86]; p = 0.018, logrank test) at 3-year (99 vs. 95%) and 5-year (98 vs. 89%) censoring. Exploratory subgroup analysis found DFS benefit to be significant in hormone receptor-negative, hormone receptor-positive, and pT1b tumors, but not in pT1a tumors. CONCLUSIONS: Adjuvant chemotherapy ± trastuzumab is associated with a significantly reduced risk of recurrence in subcentimeter node-negative HER2+ breast cancers. Most of the benefit may be driven by pT1b tumors.

Value of Dynamic Contrast-enhanced and Diffusion-weighted MR Imaging in the Detection of Pathologic Complete Response in Cervical Cancer after Neoadjuvant Therapy: A Retrospective Observational Study.

Purpose To evaluate the association between dynamic contrast material-enhanced (DCE) and diffusion-weighted (DW) magnetic resonance (MR) imaging with pathologic complete response after preoperative combined chemotherapy and radiation therapy for cervical carcinoma and evaluate the risk of local recurrence. Materials and Methods The institutional ethics committee approved the study and waived the requirement to obtain informed consent. The study comprised 52 patients with locally advanced carcinoma, treated first with combined chemotherapy and radiation therapy, who underwent MR imaging before final surgery between June 2011 and July 2015. Three radiologists evaluated conventional, DW, and DCE MR images to identify a complete response. The standard of reference was surgical-pathologic findings. Results An initial increase in signal intensity on DCE MR images that was greater in the cervical lesion than in the myometrium was defined as time-signal intensity curve type B and showed a significant association with incomplete response (P = .0004). DCE MR imaging parameters (ie, maximum slope enhancement, area under the gadolinium concentration-time curve during the first 90 seconds after gadolinium injection [AUGC90], and volume transfer constant [Ktrans]) and a low signal intensity on apparent diffusion coefficient (ADC) maps were significantly associated with an incomplete response (P = .027, P = .041, P = .037, and P = .032, respectively). A mean ADC of 0.0014 m2/sec or less (hazard ratio [HR] = 8.3), low ADC signal intensity (HR = 7.3), high signal intensity at DW imaging (HR = 7.1), and time-signal intensity curve type B (HR = 4.3) were associated with earlier recurrence (P < .05). Excellent agreement between readers was found for time-signal intensity curve analysis (κ > 0.9) and the following parameters: AUGC90, Ktrans, and maximum slope enhancement (intraclass correlation coefficient, >0.9). Conclusion DCE MR imaging parameters, especially the time-signal intensity curve, and DW imaging are associated with complete response and incomplete response and could potentially help oncologists with management decisions. Moreover, DCE and DW MR imaging could help oncologists accentuate the follow-up for patients with a high risk of local recurrence to assess for recurrence. © RSNA, 2017 Online supplemental material is available for this article.

Enhanced recovery after surgery program in Gynaecologic Oncological surgery in a minimally invasive techniques expert center.

BACKGROUND: Enhanced Recovery After Surgery Programs (ERP) includes multimodal approaches of perioperative patient's clinical pathways designed to achieve early recovery after surgery and a decreased length of hospital stay (LOS). METHODS: This observational study evaluated the implementation of ERP in gynaecologic oncological surgery in a minimally invasive techniques (MIT) expert center with more than 85% of procedures done with MIT. We compared a prospective cohort of 100 patients involved in ERP between December 2015 and June 2016 to a 100 patients control group, without ERP, previously managed in the same center between April 2015 and November 2015. All the included patients were referred for hysterectomy and/or pelvic or para-aortic lymphadenectomy for gynaecological cancer. The primary objective was to achieve a significant decrease of median LOS in the ERP group. Secondary objectives were decreases in proportion of patients achieving target LOS (2 days), morbidity and readmissions. RESULTS: Except a disparity in oncological indications with a higher proportion of endometrial cancer in the group with ERP vs. the group without ERP (42% vs. 22%; p = 0.003), there were no differences in patient's characteristics and surgical procedures. ERP were associated with decreases of median LOS (2.5 [0 to 11] days vs. 3 [1 to 14] days; p = 0.002) and proportion of discharged patient at target LOS (45% vs. 24%; p = 0.002). Morbidities occurred in 25% and 26% in the groups with and without ERP and readmission rates were respectively of 6% and 8%, without any significant difference. CONCLUSION: ERP in gynaecologic oncological surgery is associated with a decrease of LOS without increases of morbidity or readmission rates, even in a center with a high proportion of MIT. Although it is already widely accepted that MIT improves early recovery, our study shows that the addition of ERP's clinical pathways improve surgical outcomes and patient care management.