Initiation Of Adjuvant Therapy Research Articles

Clinical Practice Guideline: Recommendations for the Perioperative Management of Pancreatic and Colorectal Cancer Patients.

Colorectal and pancreatic carcinoma are the most common cancers of the gastrointestinal tract. Their surgical treatment carries a high morbidity: Complications arise in 25% to 30% of cases, often prolonging recovery times and delaying the initiation of adjuvant therapy, leading, in turn, to worse oncological outcomes. The goal of multimodal perioperative management (mPOM) is to lower the postoperative complication rate through a combination of perioperative measures. This guideline on the perioperative management of gastrointestinal tumors (POMGAT) meets all requirements for an S3 guideline as specified by the Association of the Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF). These include a systematic literature search, quality assessment of the included publications, an evaluation of the reliability of the evidence according to the GRADE approach, and a structured consensus process. Meta-analyses have shown that mPOM lowers the complication rates of both pancreatic and colorectal resections (RD 0.96 with 95% confidence interval [0.92; 0.99] and RR 0.66 [0.54; 0.80], respectively). This shortens the hospital stay after pancreatic resections by a median of 2.33 days [-2.98; -1.69] and after colorectal resections by a median of 2.59 days [-3.22; -1.97]. Adherence to the POMGAT-S3 guideline for pancreatic and colorectal cancer surgery is associated with improved recovery, which can lead to a faster return to intended oncological treatment (RIOT) and thus to better long-term outcomes. These recommendations are not restricted to gastrointestinal cancer surgery; they can also be applied to visceral surgery for benign conditions, as well as to gynecological and urological operations.

One-stage scalp reconstruction using single-layer dermal regeneration template and split-thickness skin graft: a case series.

Scalp full-thickness defects reconstruction following the resection of skin carcinoma poses significant challenges due to scalp anatomy complexity and limited vascularity. Despite various techniques available, including tissue expansion and local flaps, no single method stands as the gold standard. Moreover, cases requiring adjuvant radiotherapy further complicate reconstruction, demanding durable solutions. This study explores the efficacy of Integra® Dermal Regeneration Template Single Layer (Integra DRTSL) followed by split-thickness skin grafting (STSG) in one-stage scalp reconstruction post oncologic resection. A retrospective analysis was conducted on patients undergoing this procedure from January 2020 to October 2023. Surgical outcomes, including graft take rates, complications, and adjuvant therapy tolerability, were assessed. Results demonstrated successful reconstruction in the majority of cases, with a complete graft take rate of 77% and minimal complications. Notably, the single-stage approach facilitated timely initiation of adjuvant therapy, crucial for oncologic management. Healing times were notably reduced (< 60 days), enabling early radiotherapy commencement. No local recurrences were observed during the 16-month follow-up. The use of Integra DRTSL with STSG in one-stage reconstruction presents a promising alternative, offering optimal cosmetic and functional outcomes with low complication rates. This approach streamlines the reconstruction process, ensuring timely adjuvant therapy initiation and maximizing patient outcomes, especially in the context of scalp cutaneous tumors requiring radiotherapy. This research was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of University of Campania "Luigi Vanvitelli" (protocol code N. 0013333, 29 April 2021).

Third ventricle teratoma with malignant transformation

Intracranial germ cell tumors(GCTs) are rare and heterogeneous group of primary brain tumors, mainly affecting pediatric population and young adults. The current understanding of the etiology of intracranial GCTs and their optimal management strategies remain controversial. Treatment plans differ depending on the subtype GCT and may vary among physicians and institutions. Central nervous system non-germinomatous germ cell tumor (NGGCT) usually requires surgical resection with histological verification, chemotherapy, and radiation. The extent of surgical resection is an important prognostic factor alongside the etiology and genetics of NGGCT. This article presents a rare clinical case of a rapidly growing teratoma located in the posterior part of third ventricle of a 17-year-old male presenting with symptoms of intracranial hypertension. Surgical total resection was preceded by endoscopic third ventriculostomy. Immunohistochemistry revealed the presence of embryonal carcinoma and immature teratoma cells turning the tumor into mixed type NGGCT with unfavorable prognosis. Despite the complete resection of the tumor and the timely initiation of adjuvant therapy, a rapid progression of the disease with subsequent unfavorable outcome was observed 3.6 months after the surgical treatment.

Comparing oncologic and surgical outcomes of robotic and laparoscopic distal pancreatectomy: a propensity-matched analysis

BackgroundThe frequency of minimally invasive distal pancreatectomy is gradually exceeding that of the open approach. Our study aims to compare short-term outcomes of robotic (RDP) and laparoscopic (LDP) distal pancreatectomies for pancreatic ductal adenocarcinoma (PDAC) using a national database.MethodsThe National Cancer Database was utilized to identify patients with PDAC who underwent distal pancreatectomy from 2010–2020. Short-term technical and oncologic outcomes such as margin status and nodal harvest were included. Propensity-score matching (PSM) was performed comparing LDP and RDP cohorts. Multivariate logistic-regression models were then used to assess the impact of institutional volume on the MIDP surgical and technical oncologic outcomes.Results1537 patients underwent MIDP with curative intent. Most cases were laparoscopic (74.4%, n = 1144), with a gradual increase in robotic utilization, from 8.7% in 2010 to 32.0% of MIDP cases ten years later. For PSM, 698 LDP patients were matched with 349 RDP. The odds of conversion to an open case were 58% less in RDP (12.6%) compared to LDP (25.5%) with no statistically significant difference in technical oncologic results. There was no difference in length of stay (OR = 1.0[0.7–1.4]), 30-day mortality (OR = 0.5[0.2–2.0]) or 90-day mortality (OR = 1.1[0.5–2.4]) between RDP and LDP, although there was a higher 30-day readmission rate with RDP (OR = 1.71[1.1–2.7]). There were statistically significant differences in technical oncologic outcomes (nodal harvest, margin status, initiation of adjuvant therapy) based on MIDP volume quartiles.ConclusionLaparoscopic and robotic distal pancreatectomy have similar peri- and post-operative surgical and oncologic outcomes, with a higher rate of conversion to open in the laparoscopic cohort.

Real-world use and outcomes of targeted therapy and immunotherapy for adjuvant treatment of BRAF -mutated melanoma patients in the United States.

Using a customized, harmonized US electronic health record database, real-world prescription patterns of first-line adjuvant immunotherapy and targeted therapy were retrospectively assessed for BRAF V600-mutated melanoma. Adults with BRAF V600 mutation-positive stage IIIA-D cutaneous melanoma who received first-line adjuvant immunotherapy (nivolumab or pembrolizumab) or targeted therapy (dabrafenib plus trametinib) between 1 January 2014 and 30 August 2020 in the NOBLE database were included. Patients were followed from first-line adjuvant therapy initiation for at least 6 months, until death, progression, follow-up loss, or data cutoff. Primary endpoints were proportion of patients receiving either therapy in first-line and second-line, treatment switching, treatment timing, and status at the end of first-line therapy. Secondary endpoints included discontinuation rates, recurrence-free survival (RFS), and overall survival (OS). Of 318 patients evaluated, 67.6% received nivolumab, 14.2% pembrolizumab, and 18.2% targeted therapy as first-line adjuvant therapy. Median treatment duration was longest for nivolumab (292 days) and shortest for targeted therapy (115 days). Reason for discontinuation was recorded for 195 of 274 patients who discontinued first-line therapy; most common reasons were treatment completion and treatment-related toxicity [87/158 (55.0%) and 29/158 (18.4%), respectively, in immunotherapy-treated patients; 9/37 (24.3%) and 21/37 (56.8%) in targeted therapy-treated patients]. Median RFS and OS for targeted therapy and nivolumab were not reached and were 34.6 and 38.1 months, respectively, for pembrolizumab. These results inform on prescription preferences and clinical outcomes for BRAF V600-mutated melanoma patients in the first-line adjuvant setting.

A systematic review on the effect of immediate autologous microsurgical breast reconstruction on the timely initiation of adjuvant therapy

A systematic review on the effect of immediate autologous microsurgical breast reconstruction on the timely initiation of adjuvant therapy

LGG-15. DEEP LEARNING ENABLES LONGITUDINAL RISK PREDICTION FOR PEDIATRIC LOW-GRADE GLIOMAS AFTER SURGERY

Abstract BACKGROUND Disease progression is challenging to predict following surgery for pediatric low-grade glioma (pLGG), and early progression indicators on MRI surveillance imaging would help guide management. Longitudinal surveillance imaging data may capture subtle temporal tumor changes and patterns that could inform recurrence risk but are difficult to synthesize clinically. We applied deep, self-supervised learning to longitudinal surveillance MRI to predict short-interval event-free-survival (EFS) risk from time-of-scan. METHODS We retrospectively collected data from 278 patients (2,174 scans) who underwent surgical resection for pLGG at Dana-Farber Cancer Institute/Boston Children’s Hospital (DFCI/BCH) from 1990-2022. A deep-learning model was pretrained with T2-FLAIR sequences to determine the chronological scan order for each patient (temporal pretraining). The model was fine-tuned to predict 1-year EFS from point-of-scan using a subset of scans from DFCI/BCH and then validated on a hold-out dataset (511 scans, 67 patients). Separately, the model was fine-tuned on an external dataset from the Children’s Brain Tumor Network (CBTN) and validated on a hold-out set (204 scans, 61 patients). Results were compared to a model trained without temporal pretraining. RESULTS Median follow-up and interval between scans were 73 and 6.3 months for DFCI/BCH and 20 and 5.8 months for CBTN. Temporal pretraining improved performance for 1-year EFS, for DFCI/BCH (AUC: 0.83 [0.71-0.90] vs. 0.78 [0.62-0.91]; F1-score: 0.80 vs. 0.67), and CBTN hold-out sets (AUC: 0.75 [0.58-0.90] vs. 0.53 [0.35-0.70], p=0.01; F1-score: 0.65 vs. 0.55). Increasing the number of longitudinal scans available to the model incrementally improved performance up to 7 scans/patient for DFCI/BCH and 10 scans/patient for CBTN. CONCLUSIONS Deep-learning with temporal pretraining improves the predictive analysis of tumor growth patterns in postoperative pLGG surveillance MRI, enabling accurate short-interval EFS prediction. This model could help inform patients and clinicians regarding surveillance regimen and initiation of adjuvant therapy.

Assessing quality of care in early stage resected stage non-small cell lung cancer (NSCLC): An evaluation of epidermal growth factor receptor (EGFR) testing and adjuvant (adj) therapy (tx).

8072 Background: In December 2020, the FDA approved the use of osimertinib in the treatment of stage IB-IIIA (ES) NSCLC patients (pts) with EGFR exon 19 deletions and exon 21 L858R mutations (EGRFm) following tumor resection. Using real-world data, we sought to understand EGFR testing rates among ES pts and whether pts received osimertinib in the adjuvant setting based on EGFRm. Methods: We used the Integra Connect PrecisionQ real-world de-identified database of over 3 million cancer pts across 500 sites of care. From this database, we identified Stage IB – IIIA pts evaluated via medical chart curation who underwent lung cancer resection (R) between 12/1/2021 to 7/31/2023 (N = 803). We assessed adj treatment by stage, EGFR testing rates overall and by stage, EGFR testing rates by adjuvant treatment and non-adj treatment pts, timing of EGFR testing, and treatment rates with an EGFR TKI among EGFRm pts. Descriptive analyses were used and proportions were compared using a chi-squared test. Results: The mean age of the 803 ES R pts in the sample was 69 (SD = 8.3), 53.3% of the pts were female, , and 12% never smoked. We found adj treatment rates among ES R pts to be 56%; these were highest among stage IIIA (N = 245) pts at 70.2%, compared to stage IIB (N = 241) at 68.8%, stage IIA (N = 69) at 53.6% and stage IB (N = 240) at 31.7% (p &lt; 0.001). Among ES R pts, 70% (N = 563) were tested for EGFR; this rate was 78% (N = 455) among ES pts who were R and received adj treatment, compared to 59% (N = 348) among ES R pts who did not receive adj treatment (p &lt; 0.001). EGFR testing rates were highest among stage IIB pts at 76%, compared to stage IIIA pts at 73%, stage IIA pts at 72%, and stage IB pts at 60% (p &lt; .001). Among ES pts who were R and tested for EGFR (N = 563), 14% were tested before surgery, 38% were tested after surgery but before adj treatment, and 48% were tested after initiating adjuvant therapy. EGFRm was found in 10.4% of EGFR tested pts. Among EGFRm ES R pts (N = 59), 54% were treated with an EGFR TKI. EGFRm ES R pts treated with an adj EGFR TKI were highest among stage IIB pts (N = 14) at 93%, compared to stage IIA pts (N = 5) at 60%, stage IB pts (N = 20) at 45%, and stage IIIA pts (N = 20) at 35% (p &lt; 0.01). However, only 69% (N = 41) of EGFRm ES R pts received adj treatment (either chemotherapy or EGFR TKI) and among those pts, 78% (N = 32) received an EGFR TKI. Conclusions: Based on our findings using real-world data for EGFR testing and adjuvant osimertinib use, and in light of the published results from the ADAURA trial which showed disease free survival benefit (HR 0.2) and overall survival benefit (HR 0.49) of adjuvant osimertinib in ES NSCLC, we have identified an opportunity to improve patient outcomes following resection of ES NSCLC by increasing EGFR testing and encouraging treatment with EGFR TKI in exon 19 deletion or exon 21 L858R mutated pts.

Evaluation of long-term outcome following therapeutic mammaplasty: the effect of wound complication on initiation of adjuvant therapy and subsequent oncological outcome.

Therapeutic mammaplasty (TM) facilitates large tumour resection while maintaining optimal aesthetic outcome. It carries higher wound complication risks, which may delay adjuvant therapy initiation. Whether this delay affects oncological outcome requires evaluation. Data were collected for consecutive patients receiving TM at the Leeds breast unit (2009-2017). A prospectively maintained database was used to determine tumour characteristics, wound complication rates, receipt of adjuvant therapy and breast cancer recurrence or death. In total 112 patients (median age of 54 years) underwent 114 TM procedures. The most common histological subtypes were invasive ductal carcinoma (61.4%), invasive lobular carcinoma (13.2%) and ductal carcinoma in situ (13.2%). Of the patients, 88.2% had oestrogen receptor-positive cancer and 14% had human epidermal growth factor receptor-positive cancer; 26.3% had multifocal cancer. The median tumour size was 30mm. The median Nottingham Prognostic Index was 4.2. The local recurrence rate was 3.5% (median follow-up of 8.6 years). The 5- and 10-year disease-free survival (DFS) was 88.5% and 83.5%, and the equivalent overall survival (OS) rates were 94% and 83.5%. Wound complication rate was 23.6% (n=27), the commonest being wound infection (11.4%; n=13) and T-junction wound breakdown (10.5%; n=12). The median time to adjuvant therapy was 72 days (interquartile range [IQR] 56-90) for patients with wound complications, and 51 days (IQR 42-58) for those without. However, this delay did not affect DFS or OS (log-rank test; p=0.58 and p=0.94, respectively). This was confirmed on Cox regression analysis. Our study finding demonstrates that although wound complications after TM leads to a modest delay to adjuvant therapy, the long-term oncological outcomes were comparable with those in patients without wound complications.

Sex-Specific Survival and Treatment Delay in Oropharyngeal Squamous Cell Carcinoma.

As the majority of oropharyngeal squamous cell carcinoma (OPSCC) is diagnosed in males, outcomes among females are not well-characterized. We identify sex-specific factors in OPSCC to refine female prognostication. Retrospective cohort. National Cancer Database (NCDB). OPSCC cases from the 2004 to 2019 NCDB were identified. Sociodemographic, clinical, and treatment characteristics (including timing between diagnosis and treatment administration) were compared between sexes. Multivariable Cox proportional hazard regression models were constructed to characterize survival in overall and female-only cohorts. Similar multivariable binomial logistic regression and survival models were constructed to assess odds of treatment delays and their effects on survival, respectively. A total of 192,973 OPSCC patients were identified; 36,695 (19%) were female. Females had more human papillomavirus (HPV) negative, lower clinical T and N stage, and higher comorbidity disease. Females experienced lower survival in HPV negative (hazard ratio, HR = 1.11, P < .001) but not HPV-positive disease. Females were more likely to have any treatment initiated over the median of 28 days (odds ratio, OR = 1.04, P = .014) or delays in adjuvant radiotherapy initiation over 6 weeks (OR = 1.11, P = .032). Treatment delay over 60 days (HR = 1.17, P = .016) and delay in adjuvant therapy initiation (HR = 1.24, P = .02) were associated with worse survival among females. In one of the largest analyses of OPSCC, females had poorer survival than males, specifically in HPV-negative disease, despite presentation with less advanced disease. Notably, delays in any treatment initiation and adjuvant radiotherapy initiation were more likely in HPV-negative women and associated with worse survival, highlighting potential systemic weaknesses contributing to poor prognosis among females.

BREAST CANCER ASSISTANCE JOURNEY FROM THE PERSPECTIVE OF THE PUBLIC HEALTHCARE SERVICE OF RIO GRANDE DO SUL

Objective: This study aims to characterize the breast cancer (BC) patient journey in Rio Grande do Sul (RS), Brazil, through the perspectives of the High Complexity Oncology Assistance Centers (CACONs) and High Complexity Oncology Assistance Units (UNACONs). Methods: Conducted between March and May 2023 across 17 RS Oncology public healthcare services, the cross-sectional study utilized a 54-question questionnaire administered to healthcare professionals. The survey covered various aspects, including diagnosis, treatment, funding, and multidisciplinary teamwork. Results: Descriptive analysis revealed that BC patients undergo screening tests upon treatment entry (88.2%), with immunohistochemistry commonly performed externally (64.7%) and PCR often requested (82.4%) for adjuvant therapy initiation, taking an average of 90 to 250 days for all procedures. Patients encounter challenges such as lengthy hospital stays, extensive travel to treatment centers, treatment side effects, and high transportation expenses, often leading to treatment discontinuation. The most time-consuming stage is treatment, with subcutaneous infusion proving more time-efficient than intravenous administration. Physical limitations, mobility issues, late diagnosis (90-day average), and limited access to care significantly impact patients' quality of life. Healthcare teams face difficulties with outdated guidelines, lack of intravenous treatment facilities, and extended administration durations. Institutions confront barriers like drug shortages, guideline disparities, and logistical challenges. Conclusion: The study concludes by emphasizing the identified hurdles in BC patients' public healthcare journey, underscoring the need to address delays in screening, resource constraints, and disparities in access to care based on geographical, socioeconomic, and racial/ethnic factors to enhance overall quality of care and equity within the system.

Comparing oncologic and surgical outcomes of robotic and laparoscopic pancreatoduodenectomy in patients with pancreatic cancer: a propensity-matched analysis.

Minimally invasive Pancreatoduodenectomy (MIPD), or the Whipple procedure, is increasingly utilized. No study has compared laparoscopic (LPD) and robotic (RPD) approaches, and the impact of the learning curve on oncologic, technical, and post-operative outcomes remains relatively understudied. The National Cancer Database was queried for patients undergoing LPD or RPD from 2010 to 2020 with a diagnosis of pancreatic cancer. Outcomes were compared between approaches using propensity-score matching (PSM); the impact of annual center-level volume of MIPD was also assessed by dividing volume into quartiles. A total of 3,342 patients were included. Most (n = 2,716, 81.3%) underwent LPD versus RPD (n = 626, 18.7%). There was a high rate (20.2%, n = 719) of positive margins. Mean length-of-stay (LOS) was 10.4 ± 8.9days. Thirty-day mortality was 2.8% (n = 92) and ninety-day mortality was 5.7% (n = 189). PSM matched 625 pairs of patients receiving LPD or RPD. After PSM, there was no differences between groups based on age, sex, race, CCI, T-stage, neoadjuvant chemo/radiotherapy, or type of PD. After PSM, there was a higher rate of conversion to open (HR = 0.68, 95%CI = 0.50-0.92)., but there was no difference in LOS (HR = 1.00, 95%CI = 0.92-1.11), 30-day readmission (HR = 1.08, 95% CI = 0.68-1.71), 30-day (HR = 0.78, 95% CI = 0.39-1.56) or 90-day mortality (HR = 0.70, 95% CI = 0.42-1.16), ability to receive adjuvant therapy (HR = 1.15, 95% CI = 0.92-1.44), nodal harvest (HR = 1.01, 95%CI = 0.94-1.09) or positive margins (HR = 1.19, 95% CI = 0.89-1.59). Centers in lower quartiles of annual volume of MIPD demonstrated reduced nodal harvest (p = 0.005) and a higher rate of conversion to open (p = 0.038). Higher-volume centers had a shorter LOS (p = 0.012), higher rate of initiation of adjuvant therapy (p = 0.042), and, most strikingly, a reduction in 90-day mortality (p = 0.033). LPD and RPD have similar surgical and oncologic outcomes, with a lower rate of conversion to open in the robotic cohort. The robotic technique does not appear to eliminate the "learning curve", with higher volume centers demonstrating improved outcomes, especially seen at minimum annual volume of 5 cases.

Abstract B017: Disease free survival as a predictor of overall survival in patients with high-risk endometrial cancer receiving adjuvant chemotherapy

Abstract Introduction: Disease-free survival (DFS) is often evaluated as a primary endpoint in early settings for several cancers, including endometrial cancer (EC). However, the role of DFS as a potential predictor of overall survival (OS) in EC is unknown. Elucidating the association between DFS and OS in EC is critical for contextualizing findings from trials where DFS is a primary endpoint, such as KEYNOTE-B21, which assesses the effect of treatment with pembrolizumab + adjuvant chemotherapy (CTX) vs. adjuvant CTX, with or without radiotherapy in patients with EC at high risk of recurrence. This real-world study assessed the association between DFS and OS and the impact of recurrence on OS in elderly patients with EC at high risk of recurrence receiving adjuvant CTX. Methods: SEER-Medicare data (2007–2019) were used to identify patients with EC at high risk of recurrence who received adjuvant CTX with or without radiotherapy. Patients were defined as high risk of recurrence if they had either Stage I or II EC with non-endometroid histology or Stage III or IVA EC with any histology. An EC recurrence was defined as having a diagnosis with a distinct secondary cancer &amp;gt;90 days after end of adjuvant CTX or receipt of additional cancer treatment &amp;gt;90 days after end of adjuvant CTX. Kaplan-Meier (KM) analyses were used to estimate OS (time from initiation of adjuvant therapy [index date] to death) and DFS (time from index date to earliest of recurrence or death). The correlation between DFS and OS was assessed using Kendall’s τ rank correlation. Landmark analyses were used to compare OS between patients with vs. without a recurrence at 1-, 3-, and 5-years post the index date; hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using adjusted Cox models. KM analyses were used to estimate OS from a recurrence (index date) for recurrent patients and from an imputed index date (using frequency matching) for non-recurrent patients. Results: Of 794 eligible patients, 253 (31.9%) experienced a recurrence over a median follow up of 3.6 years. Median age at diagnosis was 71.9 years, 69.8% had stage I/II disease, and 86.6% had non-endometrioid carcinoma. Median OS was not reached (5-year OS: 72.5%) and median DFS was 7.9 years (5-year DFS: 58.7%). A significant positive correlation between DFS and OS was observed (Kendall’s τ =0.83; 95% CI: 0.79–0.86; p&amp;lt;0.001). Patients with a recurrence had significantly higher risk of death than those without, at landmark points 1- (HR: 4.4; 95% CI: 2.8–7.0; p&amp;lt;.001), 3- (HR: 5.2; 95% CI: 3.1–8.7; p&amp;lt;.001), and 5-years (HR: 5.1; 95% CI: 2.2–11.7; p&amp;lt;.001). Patients with a recurrence had significantly shorter median OS than those without (median OS: 1.4 years vs. not reached; p&amp;lt;.001). Conclusions: In elderly patients with EC at high risk of recurrence who received adjuvant CTX, DFS was strongly correlated with OS and having a recurrence was associated with significantly higher risk of death. Our findings suggest that DFS is a strong predictor of OS in this population and may be a useful surrogate endpoint. Citation Format: Kalé Kponee-Shovein, Vimalanand S. Prabhu, Yan Song, Lei Chen, Mu Cheng, Yeran Li, Yezhou Sun, Annalise Hilts, Qi Hua, Jasmine Lichfield, Linda Duska. Disease free survival as a predictor of overall survival in patients with high-risk endometrial cancer receiving adjuvant chemotherapy [abstract]. In: Proceedings of the AACR Special Conference on Endometrial Cancer: Transforming Care through Science; 2023 Nov 16-18; Boston, Massachusetts. Philadelphia (PA): AACR; Clin Cancer Res 2024;30(5_Suppl):Abstract nr B017.

Airway protection and outcomes after staged versus concurrent bilateral neck dissections with transoral base of tongue cancer resection.

To assess airway, safety, and resource utilization outcomes between transoral base of tongue (BOT) surgery with staged versus concurrent bilateral neck dissections (BND). A retrospective cohort study of patients with human papilloma virus (HPV)-related BOT cancer who underwent transoral surgery and BND from January 2015 through June 2022 was conducted. Free flap patients were excluded. Of 126 patients (46 [37%] staged and 80 [63%] concurrent BND), there were no significant differences in rates of postoperative intubation, tracheostomy, intensive care admission, operative takebacks, gastrostomy, and 30-day readmission. Total operative time (median difference 1.4 [95% CI 0.9-1.8] hours), length of stay (1.0 [1.0-1.0] day), and time between primary surgery and adjuvant therapy initiation (4.0 [0.0-8.0] days) were lower in the concurrent BND cohort. Concurrent BND alongside transoral BOT resection is safe with similar airway outcomes and lower total operative time, length of stay, and time to adjuvant therapy initiation compared to staged BND.

From molecular signatures to radiomics: tailoring neurooncological strategies through forecasting of glioma growth.

Contemporary oncological paradigms for adjuvant treatment of low- and intermediate-grade gliomas are often guided by a limited array of parameters, overlooking the dynamic nature of the disease. The authors' aim was to develop a comprehensive multivariate glioma growth model based on multicentric data, to facilitate more individualized therapeutic strategies. Random slope models with subject-specific random intercepts were fitted to a retrospective cohort of grade II and III gliomas from the database at Kepler University Hospital (n = 191) to predict future mean tumor diameters. Deep learning-based radiomics was used together with a comprehensive clinical dataset and evaluated on an external prospectively collected validation cohort from University Hospital Zurich (n = 9). Prediction quality was assessed via mean squared prediction error. A mean squared prediction error of 0.58 cm for the external validation cohort was achieved, indicating very good prognostic value. The mean ± SD time to adjuvant therapy was 28.7 ± 43.3 months and 16.1 ± 14.6 months for the training and validation cohort, respectively, with a mean of 6.2 ± 5 and 3.6 ± 0.7, respectively, for number of observations. The observed mean tumor diameter per year was 0.38 cm (95% CI 0.25-0.51) for the training cohort, and 1.02 cm (95% CI 0.78-2.82) for the validation cohort. Glioma of the superior frontal gyrus showed a higher rate of tumor growth than insular glioma. Oligodendroglioma showed less pronounced growth, anaplastic astrocytoma-unlike anaplastic oligodendroglioma-was associated with faster tumor growth. Unlike the impact of extent of resection, isocitrate dehydrogenase (IDH) had negligible influence on tumor growth. Inclusion of radiomics variables significantly enhanced the prediction performance of the random slope model used. The authors developed an advanced statistical model to predict tumor volumes both pre- and postoperatively, using comprehensive data prior to the initiation of adjuvant therapy. Using radiomics enhanced the precision of the prediction models. Whereas tumor extent of resection and topology emerged as influential factors in tumor growth, the IDH status did not. This study emphasizes the imperative of advanced computational methods in refining personalized low-grade glioma treatment, advocating a move beyond traditional paradigms.

Postoperative complications following neoadjuvant therapy and surgery in a phase 2 borderline resectable pancreatic cancer clinical trial (Alliance A021501).

664 Background: Postoperative complications in patients with borderline resectable pancreatic cancer treated with neoadjuvant therapy and pancreatectomy in the national cooperative group setting have not been previously characterized. Further, the impact of preoperative hypofractionated radiotherapy on postoperative outcomes is largely unknown. We sought to quantify perioperative morbidity among patients with pancreatic cancer who received neoadjuvant modified FOLFIRINOX chemotherapy with or without hypofractionated radiotherapy on a multicenter clinical trial. Methods: The A021501 phase 2 trial randomized patients with borderline resectable pancreatic ductal adenocarcinoma to 8 doses of mFOLFIRINOX (Arm 1) or 7 doses of mFOLFIRINOX then hypofractionated radiotherapy (Arm 2), followed by pancreatectomy (Dec 31, 2016-Jan 1, 2019). Patients underwent resection according to defined operative standards at enrolling centers without specific requirements for either surgeon or hospital volume. Surgical complications and adverse events were assessed and captured at a single time point of 90 days after surgery and compared between treatment arms. Results: Of 126 enrolled patients, 51 (40%) underwent pancreatectomy (n=32, Arm 1; n=19, Arm 2) at 28 institutions. Vascular resection was performed in 19 patients (37%). One patient in Arm 2 died within 90 days after surgery. Rates of any surgical complication were 19% (n=6) in Arm 1 and 42% (n=8) in Arm 2 (p=0.07). Median length of stay was 7 days (range 5-38 days). Five (10%) patients required reoperation within 90 days. Readmission rates were higher in Arm 2 than Arm 1 (16% vs. 42%, p=0.04) but there were no differences in rates of reoperation, pancreatic fistula or abscess requiring drainage, or wound infection between study arms. 54% of patients (n=26/48) experienced a grade 3 or higher adverse event, with no difference between treatment arms (47% versus 67%, p=0.7). Rates of initiation of adjuvant therapy did not differ between treatment arms (66% vs. 68%, p=0.4). Pancreatic fistula and abscess were associated with adjuvant therapy (p&lt;0.01). No difference in overall survival was observed based on occurrence of surgical complications (HR 1.1; 95% CI 0.5-2.6). Conclusions: In this national cooperative group study of patients with borderline resectable pancreatic cancer,postoperative complications following neoadjuvant chemotherapy, radiation, and surgical resection were consistent with rates previously reported by high-volume institutions and using large datasets. Multimodality trials of preoperative therapy for locoregionally advanced pancreatic cancer may be safely performed in the cooperative group setting. Clinical trial information: NCT02839343 .

Effect of time interval between surgery and the initiation of adjuvant therapy on the oncologic outcomes of early-stage endometrial cancer.

To identify the impact of time interval between surgery and initial adjuvant radiotherapy on oncologic outcomes in early-stage endometrial cancer. This retrospective cohort study included patients with stage I/II endometrial cancer who underwent surgical staging and adjuvant therapy at Songklanagarind Hospital from January 1, 2007, to December 31, 2017. Patients were categorized into two groups: TI <6 weeks and TI ≥6 weeks. The effects of TI and clinicopathological factors on recurrence-free survival (RFS) and overall survival (OS) were analyzed using Cox proportional-hazards regression. In total, 177 patients were enrolled, with 52% receiving adjuvant radiotherapy at <6 weeks (overall median TI 5.7 weeks). The recurrence and death rates were 13% and 10.2%, respectively. The median follow-up time was 46.6 months. The overall 3-year RFS and OS rates were 88.2% and 85.2%, respectively. The TI significantly affected the 3-year RFS (94.4% vs 81.2%; P = 0.008) and 3-year OS (95.5% vs 83.2%; P = 0.012) in patients with TI <6 and ≥6 weeks, respectively. In multivariate analysis, the depth of myometrial invasion (MI), presence of lymphovascular space invasion, and TI were independent prognostic factors for both RFS and OS. Delaying the TI (≥6 weeks) was significantly associated with a worse RFS (hazard ratio [HR] 3.70; 95% confidence interval [CI]: 1.34-10.22; P = 0.012) and an inferior OS (HR 3.80; 95% CI: 1.23-11.69; P = 0.02). A delay in the TI between surgery and the initiation of adjuvant radiotherapy of ≥6 weeks negatively affected the oncologic outcomes in early-stage endometrial cancer.

Contralateral prophylactic mastectomy: Weighing the risks of delayed chemotherapy, radiotherapy, and hormonal therapy

Many patients with unilateral breast cancer opt for contralateral prophylactic mastectomy (CPM) at the time of therapeutic mastectomy (immediate CPM) or following completion of adjuvant therapy. Studies show that immediate CPM increases the risk of surgical complications related to unilateral mastectomy (UM) alone, which may lead to delays in adjuvant therapy initiation. However, it is unclear if these complications cause clinically significant delays in initiating adjuvant chemotherapy, radiotherapy, or hormonal therapy. A retrospective chart review was conducted on patients with breast cancer who underwent immediate CPM versus UM alone at Columbia University Medical Center from January 2000 to December 2020. Patient demographic and oncologic characteristics; complications; and timing of adjuvant chemotherapy, radiotherapy, and/or hormonal therapy relative to therapeutic mastectomy were collected. In this study, 239 UM alone patients were propensity score matched to 239 immediate CPM patients. No significant difference in complication rates was found between the index and contralateral breasts in CPM patients. A similar percentage of CPM and UM patients experienced postoperative complications (19% vs. 17%, p = 0.64). No significant difference in time to adjuvant chemotherapy, radiotherapy, or hormonal therapy was found between CPM patients with complications and all CPM patients or all UM patients. There is a lack of clear guidance for clinical decision-making regarding timing of CPM relative to adjuvant therapy. Our study suggests that immediate CPM does not significantly increase the risks of postoperative complications or complication-related delays in the initiation of adjuvant chemotherapy, radiotherapy, or hormonal therapy. This information may help patients and providers to plan, select, and schedule breast cancer treatment options.

The Buccal Fat Pad as a Primary Flap for the Reconstruction of Intraoral Defect After Resection of Oral Cavity Malignant Tumors: A Retrospective Study.

Among the various local and regional flaps used for the reconstruction of intraoral defects after oral cavity cancer surgery, the pedicled buccal fat pad (BFP) flap is considered a reliable alternative. Reconstruction with a BFP flap is particularly feasible in oral cavity areas, such as the posterior maxilla, buccal mucosa, retromolar trigone, and gingivobuccal sulcus. The purpose of this study was to analyze the outcomes of pedicled BFP as a primary reconstruction flap for small to medium intraoral posterior oral cavity postresection defects operated in our institute. This study was designed as a retrospective study. Thirty-seven patients with oral cavity cancer underwent wide local excision with adequate margins, followed by reconstruction of the defect with a pedicled BFP flap. Defect size, postoperative healing of the surgical site, mouth opening at 6 months, and any associated complications were assessed. The mean age of the patients was 47.38±9.95 years with a male-to-female ratio of 3.6:1. Mean defect size at the greatest dimension was 5.01±1.39 cm. The mean preoperative mouth opening of patients was 35±6.4 mm, whereas the mean postoperative mouth opening after 6 months of follow-up was 27.8±9.2 cm. The BFP flap is a convenient, reliable, and feasible reconstruction modality after oncological resection of posterior oral cavity cancers. Harvesting a BFP flap is minimally invasive with fewer complications, shorter recovery time, no donor site morbidity, and allows early initiation of adjuvant therapy postoperatively.

Efficacy and Safety of Perampanel in Children with Drug-Resistant Focal-Onset Seizures: A Retrospective Review

Background: Epilepsy is one of the most common neurological disorders. Existing antiseizure medications (ASMs) are still unable to control seizures in one-third of these patients, making the discovery of antiseizure therapies with novel mechanisms of action a necessity. Aim of the Study: This study aimed to determine the safety and efficacy of perampanel (PER) as an adjuvant treatment for children with drug-resistant focal-onset seizures with or without focal to bilateral tonic-clonic seizures. Patients and methods: This is a single-center retrospective study of 38 epileptic pediatric patients, aged 2 to 14, at King Faisal Specialist Hospital and Research Center whose seizures were pharmaco-resistant to more than two antiseizure medications and followed for at least three months after PER adjuvant therapy initiation. Efficacy was assessed by the PER response rate at 3-, 6-, and 12-month follow-up evaluations, and side effects were also reported. Results: Multiple seizure types were reported. Myoclonic seizures were the predominant type of epilepsy in 17 children (44.7%). At 3 months, 6 months, and 12 months of follow-up, approximately 23.4%, 23.4%, and 18.4% of the patients were seizure-free at these time points, respectively. Adverse events were documented in 14 patients (35.7%) and led to the discontinuation of PER in 26.3%, 31.6%, and 36.8% of the studied group at the 3-, 6-, and 12-month follow-ups, respectively. The most common adverse events included dizziness or drowsiness, irritability, gait disturbance, and confusion; however, all were transient, and no serious adverse effects occurred. Conclusion: Our findings confirm the therapeutic efficacy of adjunctive PER in the treatment of drug-resistant epilepsy in children. As an adjunctive treatment for epilepsy, perampanel demonstrated sufficient effectiveness and tolerability.