Organ-preserving Approach Research Articles

Colonoscopic-Assisted Laparoscopic Wedge Resection for Colonic Lesions: A Prospective Multicenter Cohort Study (LIMERIC-Study).

The aim of this study was to evaluate the safety and efficacy of a modified CAL-WR. The use of segmental colectomy in patients with endoscopically unresectable colonic lesions results in significant morbidity and mortality. CAL-WR is an alternative procedure that may reduce morbidity. This prospective multicenter study was performed in 13 Dutch hospitals between January 2017 and December 2019. Inclusion criteria were (1) colonic lesions inaccessible using current endoscopic resection techniques (judged by an expert panel), (2) non-lifting residual/recurrent adenomatous tissue after previous polypectomy or (3) an undetermined resection margin after endoscopic removal of a low-risk pathological T1 (pT1) colon carcinoma. Thirty-day morbidity, technical success rate and radicality were evaluated. Of the 118 patients included (56% male, mean age 66 years, standard deviation ± 8 years), 66 (56%) had complex lesions unsuitable for endoscopic removal, 34 (29%) had non-lifting residual/recurrent adenoma after previous polypectomy and 18 (15%) had uncertain resection margins after polypectomy of a pT1 colon carcinoma. CAL-WR was technically successful in 93% and R0 resection was achieved in 91% of patients. Minor complications (Clavien-Dindo i-ii) were noted in 7 patients (6%) and an additional oncologic segmental resection was performed in 12 cases (11%). Residual tissue at the scar was observed in 5% of patients during endoscopic follow-up. CAL-WR is an effective, organ-preserving approach that results in minor complications and circumvents the need for major surgery. CAL-WR, therefore, deserves consideration when endoscopic excision of circumscribed lesions is impossible or incomplete.

Phase II trial of organ preservation program using short-course radiation and folfoxiri for rectal cancer (SHORT-FOX).

TPS218 Background: Locally advanced rectal cancer is treated with preoperative chemoradiotherapy followed by total mesorectal excision (TME). While this trimodal approach achieves low rates of local recurrences, distant metastasis rates can exceed 25%. Total neoadjuvant therapy (TNT) has been shown in OPRA, RAPIDO, and PRODIGE23 to reduce risk of distant metastasis and improve rates of pathological complete response compared to standard preoperative chemoradiotherapy. Thus, TNT not only addresses distant disease, but gives opportunity to reduce locoregional morbidity through organ preservation. We propose a treatment approach that incorporates TNT with FOLFOXIRI and up-front short-course radiation with the goal of increasing clinical complete response (cCR) rates and thereby eligibility for organ preservation. Currently, clinical response following neoadjuvant therapy is best assessed by a multidisciplinary team and includes flexible endoscopy and MRI. Circulating tumor DNA (ctDNA) analysis can be used as a noninvasive method for tumor monitoring. Biomarker development is essential to better select patients for treatment de-escalation and monitor for recurrence in order not to jeopardize the excellent cure rates following standard of care therapy. Methods: This is a single-arm, open-label, non-randomized study of an organ preservation approach using short-course radiation followed by FOLFOXIRI for patients with > T2N0 or low T2N0, M0 rectal adenocarcinoma (NCT04380337). Patients undergo radiation (25 Gy/5 fractions + 5 Gy/1 fraction boost) followed by 8 cycles of FOLFOXIRI. Patients are assessed for response at 8 weeks following chemotherapy completion using pelvic MRI (MRI Tumor Regression Grading), flexible sigmoidoscopy, and digital rectal exam. Those who achieve a cCR can defer TME and be surveilled. The primary objective is to assess cCR, with the hypothesis that this approach will achieve higher cCR rates than historical controls (40 versus 20%). Secondary objectives include assessing toxicity, local regrowth rate, disease-free survival, colostomy-free survival, overall survival, and longitudinal health-related quality of life. ctDNA will be collected throughout treatment and surveillance, and correlative studies will assess the association between ctDNA levels and cCR, local regrowth, and disease-free survival. A Simon 2-stage design addressed our primary objective. Assuming a one-sided type 1 error of 0.1, power of 0.9, a null cCR of 0.2 versus an alternate cCR of 0.4, we plan to enroll 37 patients. The null hypothesis will be rejected if > = 11 patients have cCR. Seventeen patients have been enrolled and the trial is currently on hold for planned interim analysis for futility and safety. If < = 3 patients have cCR or if > = 7 patients have non-hematologic grade 4+ toxicity, the study will be stopped. Otherwise, we will continue to enroll 20 more patients. Clinical trial information: NCT04380337.

Impact of Surgical Margins on Overall Survival after Gastrectomy for Gastric Cancer: A Validation of Japanese Gastric Cancer Association Guidelines on a Western Series

PurposeNo consensus exists on the resection extent needed to ensure oncological safety in gastrectomy for gastric adenocarcinoma (GAC). This study aims to assess the impact of margin adequacy according to Japanese Gastric Cancer Association (JGCA) guidelines on overall survival (OS).Patients and MethodsPatients who underwent surgery for stage I–III GAC at our institution between 2010 and 2017 were included. Margin adequacy according to JGCA, National Comprehensive Cancer Network (NCCN), and European Society for Medical Oncology (ESMO) guidelines was assessed, and their predictive value on OS was evaluated with Harrell’s C-index. Patients were analyzed according to their margins’ adherence to JGCA guidelines, and a propensity score matching (PSM) was run. Indication to either total gastrectomy (TG) or distal gastrectomy (DG) according to each guideline was also assessed.ResultsA total of 279 patients were included, of whom 220 (79%) underwent DG. Adequate margins according to JGCA were obtained in 209 patients (75%). On multivariate analysis, JGCA margin adequacy was independently associated with OS, together with American Society of Anesthesiologist class, neoadjuvant chemotherapy, lymphadenectomy extent, R0 resection, and postoperative N stage. After PSM, patients with JGCA adequate margins showed better OS, recurrence-free survival (RFS), and local RFS than patients with JGCA inadequate margins. For 220 DG, JGCA guidelines would have recommended TG in 25 patients (11%), NCCN in 30 (14%), and ESMO in 90 (41%) (p < 0.001).ConclusionAdequacy of surgical resection margins to JGCA guidelines leads to improved survival outcomes and allows for a more organ-preserving approach than Western guidelines.

Органосохраняющие методы лечения пациенток с миомой матки и аномалией развития мочевой системы (клиническое наблюдение)

Congenital anomalies of the urogenital system constitute approximately 20 to 30% of all birth defects. Renal dystopia means a congenital abnormal location of one or both kidneys. The authors present a clinical case report, demonstrating the efficacy of uterine artery embolization as an alternative method of treatment for patients with uterine fibroids and renal dystopia. Uterine artery embolization is not only an organ- preserving treatment option for women who wish to retain the reproductive organ but also offers a clear visualization of the individual anatomical variations. Taking into consideration a strong patient’s wish to preserve the uterus and her individual vascular anomalies (absence of the left uterine and renal arteries), uterine artery embolization was an alternative treatment option which enabled to preserve both the uterus and the left kidney. The scheduled examination findings demonstrated a 1.87-fold reduction of the uterine volume and a 12.8-fold reduction of the fibroid size from baseline, and color doppler ultrasonography revealed that the uterine fibroid was avascular. For patients with diagnosed congenital anomalies of the urogenital system, the authors recommend using computer tomography and referrals to interdisciplinary specialists for choosing the appropriate uterine fibroid treatment options KEYWORDS: uterine fibroids, pelvic kidney dystopia, uterine artery embolization, organ-preserving treatment methods, congenital anomalies of the urogenital system, computer tomography. FOR CITATION: Antropova E.Yu., Sharafutdinov B.M., Mazitova M.I. et al. Organ-preserving approach to the treatment of patients with uterine fibroids and congenital anomaly of the urinary system (a clinical case). Russian Journal of Woman and Child Health. 2022;5(4):320–325 (in Russ.). DOI: 10.32364/2618-8430-2022-5-4-320-325.

Role sharing between minimally invasive oesophagectomy and organ preservation approach for surgically resectable advanced oesophageal cancer.

Oesophageal cancer is a dismal disease since it metastasizes widely even from an early stage. In order to improve treatment outcomes, multidisciplinary treatments including surgery, chemotherapy and radiotherapy have been developed. While oesophagectomy is the mainstay in the treatment strategy, it is highly invasive since it requires two to three field approaches. To reduce surgical stress and morbidity, minimally invasive oesophagectomy including thoracoscopy, robotic assisted surgery and mediastinoscopy were introduced. Various clinical trials proved that these techniques decrease the post-operative morbidity rate. Furthermore, with the advancement of multidisciplinary treatment with a higher response rate, the possibility arose for omission of surgical resection in remarkable responders to neoadjuvant therapy. However, in order to safely provide organ preservation without increasing the risk of post-treatment recurrence, an accurate tumour monitoring system is required. Although endoscopy and computed tomography imaging have been a standard, the detection rate of residual tumours after treatment is still unsatisfactory. Utilizing liquid biopsy which could evaluate tumour derivative and host response, an appropriate monitoring system of tumour burden during multidisciplinary treatment can be developed. With the advancement of minimally invasive surgery and multidisciplinary treatment, the treatment strategy needs to be highly individualized based on the tumour biology, patients' condition and their preferences. Along with the improvement of the tumour monitoring system, appropriate role sharing can be achieved between a minimally invasive surgery and the organ preservation approach.

Post-cricoid and Upper Oesophagus Cancers Treated with Organ Preservation Using Intensity-modulated Image-guided Radiotherapy: a Phase II Prospective Study of Outcomes, Toxicity and Quality of Life

AimsTo prospectively examine the outcomes, toxicity and quality of life (QoL) of patients with post-cricoid and upper oesophagus (PCUE) cancers treated with an organ-preservation approach of (chemo)-radiotherapy using intensity-modulated image-guided radiotherapy (IM-IGRT). Materials and methodsThis phase II prospective study was conducted at a tertiary cancer centre from February 2017 to January 2020. Forty patients with squamous cell carcinoma of PCUE of stage T1-3, N0-2, M0 were accrued. Gross exolaryngeal extension/dysfunctional larynx were major exclusion criteria. Patients received 63–66 Gy in once-daily fractions using volumetric modulated arc therapy with daily IGRT. Outcome measures included disease-related outcomes, patterns of failure, Radiation Therapy Oncology Group toxicities, feeding tube dependency and QoL. ResultsThe median follow-up was 22 months. Twenty-six (87.5%) patients had locoregionally advanced disease and 34 (85%) patients received (chemo)-radiotherapy. A complete response was observed in 26 (65%) patients. The 2-year locoregional control, event-free survival and cause-specific survival were 59.6%, 40.2% and 44.8%, respectively. The volume of primary tumour (GTVPvol) exceeding 28 cm3 had inferior overall survival (P = 0.005) on univariate analysis. Multivariable analysis showed GTVPvol and positron emission tomography-computed tomography maximum standardised uptake value to be independently predictive for event-free and overall survival. A feeding tube requirement at presentation was seen in 11 (27.5%) patients, whereas long-term feeding tube dependency at 6 months was seen in 10 (37%) patients. For QoL, a statistical improvement in pain, appetite loss and swallowing was observed over time. ConclusionAlthough the outcomes of PCUE cancers remain dismal, the use of state of the art diagnostic modalities, careful case selection and modern radiotherapy techniques improved outcomes as compared with before in this exclusive analysis of PCUE cancers.

Clinical Significance of Endoscopic Response Evaluation to Predict the Distribution of Residual Tumor after Neoadjuvant Chemotherapy for Esophageal Squamous Cell Carcinoma.

To appropriately adopt the organ preservation approach, including subsequent chemoradiotherapy (CRT) in patients who respond to neoadjuvant chemotherapy (NAC), the distribution of residual disease, including pathological lymph nodes (LNs) and recurrence site, needs to be recognized preoperatively. This study was designed to evaluate whether endoscopic response evaluation can predict residual tumor distribution. Patients with esophageal squamous cell carcinoma who underwent transthoracic esophagectomy (TTE) were retrospectively reviewed. Endoscopic responder (ER) to NAC was defined according to primary tumor endoscopic findings. Recurrence-free survival (RFS), overall survival (OS), and residual tumor patterns were compared between groups. Of 193 patients, 40 (20%) were classified as ER. ERs showed significantly better RFS and OS. The pN location was found within the primary tumor and cN field in 88% of ERs, which was significantly higher than non-ERs at 63% (p = 0.004). Furthermore, the postoperative recurrence incidence in the distant organ was significantly lower in the ERs than the non-ERs (8%, 32%, respectively, p = 0.002). Residual disease, including postoperative initial recurrence, existed within the same field as the primary tumor and cN in 88% of ERs, significantly higher than 42% in the non-ERs (p < 0.001). Endoscopic response evaluation can preoperatively predict distribution of residual tumors after NAC, which could help radiation field selection in subsequent definitive CRT when patients prefer to omit TTE. Along with improvements in NAC response rate, this could facilitate organ preservation in patients who respond to NAC.

&#8220;Watch and wait&#8220; strategy in the treatment of patients with rectal carcinoma.

Innovative treatment strategies which do not involve oncosurgical radical rectal resection have been explored within the last decades in the management of patients with rectal carcinoma. Resection of the rectum with total mesorectal excision is burdened not only with significant postoperative morbidity, but also with symptoms of bowel, urinary and sexual dysfunctions, which can significantly affect patients quality of life. The aim of these alternative strategies is to preserve the anatomy and function of the rectum (so called organ preservation approach). This approach includes three innovative strategies: &#8220;watch and wait&#8221; strategy, neoadjuvant radiochemotherapy completed with transanal rectal carcinoma excision (or excision of the scar remaining after neoadjuvant therapy) and neoadjuvant radiochemotherapy of an early rectal carcinoma. So far, evidence supporting the organ preservation approach is highly insufficient in the available literature. There are no clear indication criteria for these strategies, no unequivocal criteria for complete clinical response detection and vague recommendations regarding an optimal neoadjuvant regimen or patients follow-up. Organ preservation approach is therefore considered to be an experimental treatment strategy, which should be offered only to patients within clinical trials with a high-quality design and very careful long-term follow-up. Patients considered for &#8220;watch and wait&#8221; must be informed properly about the benefits and drawbacks of the strategy including the risk of rectal carcinoma recurrence in 30% of the patients.

Organ preservation in the multimodality approach to locally advanced oesophageal cancer: festina lente.

Morbidity and impacts on quality of life remain significant issues following oesophagectomy for oesophageal cancer. This paper reviews and weighs the current evidence both in favour of and against the adoption of an organ-preserving approach in patients with a complete clinical response to neoadjuvant therapy.

878P Clinical profile and treatment outcomes of locally advanced carcinoma larynx treated with organ preservation approach: A retrospective analysis

Chemoradiation (CRT) is the standard of treatment of patients with locally advanced carcinoma (Ca) larynx with intact cartilage and functional larynx. Patients who not eligible for chemoradiation are treated by Radical radiotherapy (RT).

International consensus recommendations on key outcome measures for organ preservation after (chemo)radiotherapy in patients with rectal cancer.

Multimodal treatment strategies for patients with rectal cancer are increasingly including the possibility of organ preservation, through nonoperative management or local excision. Organ preservation strategies can enable patients with a complete response or near-complete clinical responses after radiotherapy with or without concomitant chemotherapy to safely avoid the morbidities associated with radical surgery, and thus to maintain anorectal function and quality of life. However, standardization of the key outcome measures of organ preservation strategies is currently lacking; this includes a lack of consensus of the optimal definitions and selection of primary end points according to the trial phase and design; the optimal time points for response assessment; response-based decision-making; follow-up schedules; use of specific anorectal function tests; and quality of life and patient-reported outcomes. Thus, a consensus statement on outcome measures is necessary to ensure consistency and facilitate more accurate comparisons of data from ongoing and future trials. Here, we have convened an international group of experts with extensive experience in the management of patients with rectal cancer, including organ preservation approaches, and used a Delphi process to establish the first international consensus recommendations for key outcome measures of organ preservation, in an attempt to standardize the reporting of data from both trials and routine practice in this emerging area.

Association of tumor volume and outcomes in T3 larynx cancer with organ preservation approach.

e18044 Background: Organ preservation approaches to treatment of locally advanced larynx cancers are widely used and consist of radiotherapy (RT) with or without concurrent systemic therapy (CRT). Analyses of the National Cancer Database point to decreasing survival as CRT became widely adopted in place of total laryngectomy (TL). Tumor volume in T3 laryngeal tumors has been postulated as one variable to explain this finding, with higher volume associated with lower local control based on small sample size studies largely in pre-intensity modulated radiotherapy (IMRT) era, and low volume T3 tumors being associated with improved local control with CRT. We sought to validate these findings in a contemporary cohort of T3 larynx patients treated with IMRT. Methods: This was a national, multicentre retrospective cohort study of patients diagnosed with American Joint Committee on Cancer (AJCC) T3 N0-3 M0 glottic and supraglottic cancers who underwent curative intent IMRT with or without systemic treatment from 2002-2018. Tumor volumes were calculated using a validated standardized approach by a Neuroradiologist. Primary predictor was tumor volume, primary outcome was local control (LC), and secondary outcomes included overall survival (OS), as well as late grade 3+ toxicities. Kaplan Meier estimates and log-rank tests were used for survival analyses, with Cox proportional hazards used for univariable analyses. Results: 246 patients met inclusion criteria, 147 glottic and 99 supraglottic cancers. At baseline, glottic patients were more likely to be male (p &lt; 0.01), have a fixed vocal cord (p &lt; 0.01), not have pre-epiglottic space invasion ( &lt; 0.01), be cN0 (p &lt; 0.01), and have lower grade tumors (p &lt; 0.01). Mean tumor volumes for glottic and supraglottic tumors were 5.0 (4.2-5.8) cc and 13.0 (10.3–15.6) cc respectively. Univariable analysis showed systemic therapy was associated with improved local failure (HR 0.49, 95%CI 0.24 – 0.99, p = 0.05). Within the glottic cohort, tumor volume was not associated with local failure (HR 1.09, 95%CI 0.71 – 1.67, p = 0.38), however having a local failure event was associated with increased feeding tube dependence (HR 2.52, 95%CI 1.05 – 6.02, p = 0.04). Median local failure free survival in the overall cohort was 28.5 months, with median OS 23.2 months. There was a trend towards improved local control in the supraglottic cohort compared to glottic patients (log-rank p = 0.08), but the supraglottic cohort had significantly worse overall survival (log-rank p = 0.02). Conclusions: In this retrospective cohort study, there were baseline and outcome differences between patients with T3 glottic and supraglottic larynx cancer, with worse overall survival in supraglottic patients. Tumor volume was not associated with local control in the glottic cohort. These findings are pending further validation in a larger cohort and will be analyzed separately for supraglottic tumors.

Genome-wide circulating tumor DNA monitoring for bladder cancer treatment management and organ preservation.

e16527 Background: Bladder cancer (BC) is the 9th most commonly diagnosed cancer worldwide and each year responsible for 165,000 deaths. Neoadjuvant combination chemotherapy, followed by radical cystectomy, is used for the management of localized muscle-invasive bladder cancer. One of the critical challenges in this therapeutic regimen is monitoring the tumor load to assess therapeutic efficacy – this is typically performed by assessing pathological downstaging in the cystectomy specimen. A high frequency of patients presents with T0N0 at cystectomy (no indication of residual disease), and consequently, it is vital to investigate organ preservation approaches to identify those patients who may qualify for bladder preservation. For precision oncology, we need to develop quantitative and non-invasive diagnostic methodologies to help the oncologist tailor the treatments to individual patients and monitor them for further clinical decision-making. Methods: Cell-free DNA (cfDNA) mutation detection has shown significant promise in its ability to monitor minimal residual disease and disease relapse by detection of cancer mutations in the peripheral blood. However, the combination of low tumor fraction and limited input material obtained from a typical plasma sample restricts the probability of detecting low metastatic burden in cfDNA through current deep targeted sequencing methods. Results: Here we present results from applying whole-genome sequencing (WGS) of cfDNA. We integrate a genome-wide mutation and copy number monitoring approach coupled with advanced signal processing and Artificial Intelligence (AI) for measuring the tumor load from low-input blood samples (̃1mL of plasma) with ultra-sensitive detection. The increased sensitivity allowed clinical detection of tumor fraction down to 8*10-5 and recurrence detection sensitivity achieving &gt; 65% at the first two months post-surgery. The WGS cfDNA approach is being evaluated on a patient cohort of more than 50 bladder cancer patients with longitudinal plasma sampling during neoadjuvant chemotherapy (response measure), pre-cystectomy (complete response measure), and post-surgery (relapse monitoring). Conclusions: The results indicate the clinical potential of genome-wide mutation integration as an ultra-sensitive, non-invasive diagnostic method for bladder cancer clinical management and bladder organ preservation.

More on the Modern Approach to Diagnostics and Treatment of Spleen Trauma in Children

Today, the problem of spleen injury in children still appears relevant. The choice of diagnostics and treatment tactics at the present stage is far from being unified. The priority direction is the organ-preserving approach, which is possible and justified in children, which significantly reduces surgical aggression and prevents the likelihood of negative consequences of splenectomy. The choice of the optimal diagnostic method and determination of safe treatment tactics was the purpose of our study. Thirty-nine injured children were treated in 2007–2019. The predominant cause of spleen injury was fall from height (64.1%). Echography was the main diagnostic method, which was performed around the clock. Splenectomy was performed in 7 patients (17.9%), in 32 children (82.1%) the organ was preserved. One case (2.6%) was fatal. The analysis of our own results showed that the widespread use of echography, particularly by surgeons, is necessary in the emergency service and greatly simplifies the work. The developed local protocol for diagnosis and treatment is simple and accessible, since it is based on the interpretation of the main criteria, such as systemic hemodynamics and hemoperitoneum. Continued bleeding reasons diagnostic laparoscopy. With unstable hemodynamics, large hemoperitoneum, laparotomy is indicated.

Matched-Pair Analysis of Survival in the Patients with Advanced Laryngeal and Hypopharyngeal Squamous Cell Carcinoma Treated with Induction Chemotherapy Plus Chemo-Radiation or Total Laryngectomy.

Simple SummaryThere are no randomized studies comparing organ-preservation protocols with chemo-selection to the classical total laryngectomy plus (chemo)radiotherapy. Thus, we performed a matched-pair analysis to compare these two treatments with respect to locoregional control, disease-specific survival (DSS), and overall survival (OS) in patients with locally advanced squamous cell carcinoma of the larynx and hypopharynx. The results did not show differences between the two treatments for patients with T3/T4a larynx and T2–T4a hypopharynx cancer with respect to OS and DSS, locoregional control, and metastasis-free survival.Background: We performed a comparative analysis between an organ-preservation protocol and surgery followed by radiotherapy in patients with locally advanced squamous cell carcinoma of the larynx and hypopharynx; Methods: 60 previously untreated patients who were treated with induction chemotherapy followed by chemoradiotherapy in responders were compared with a control group of 60 patients treated with up-front surgery. Both groups were statistically comparable, according to the subsite, TNM (tumor-node-metastasis) stage, age, and sex; Results: Mean age was 58 years and 92% were male. No significant statistical difference was observed for overall survival (OS) (HR 0.75; 95% CI 0.48–1.18; P = 0.22) and disease-specific survival (DSS) (HR 0.98; 95% CI 0.52–1.83, P = 0.96). Also, there was no significant difference for recurrence-free survival (HR 0.931; 95% CI 0.57–1.71; P = 0.81), metastases-free survival (HR 2.23; 95% CI 0.67–7.41; P = 0.19), and the appearance of second primary tumors (HR 1.22; 95% CI 0.51–2.88; P = 0.64); Conclusions: The results of the organ-preservation approach did not appear inferior to those of surgery plus (chemo)radiotherapy for patients with T3/T4a larynx and T2–T4a hypopharynx cancer with respect to OS and DSS, locoregional control and metastases-free survival.

AB172. SOH21AS181. Ileo-ileal intussusception in the adult patient: an organ-preserving approach to management

Background: Intussusception in adults is rare and frequently goes undiagnosed, which can have clinical consequences. We present a rare case of small bowel intussusception in an adult female due to a small bowel benign fibrous lesion. To our knowledge, this is the first reported case managed by intraluminal excision of the causative lesion by enterotomy as opposed to formal bowel resection and anastomosis.

MR-Guided Radiotherapy for Rectal Cancer: Current Perspective on Organ Preservation.

Online MRI-guided radiotherapy (MRgRT) is one of the most recent technological advances in radiotherapy. MRgRT permits the visualization of tumorous and healthy tissue while the patient is on the treatment table and online daily plan adaptations following the observed anatomical changes. In the context of rectal cancer, online MRgRT is a very promising modality due to the pronounced geographical variability of tumor tissues and the surrounding healthy tissues. This current paper will discuss the possible applications of online MRgRT, in particular, in terms of radiotherapy dose escalation and response prediction in organ preservation approaches for rectal cancer.

Subtotal versus total gastrectomy for remnant gastric cancer: a systematic review and meta-analysis of observational studies.

Subtotal gastrectomy (SG) has become a general option for distal gastric cancer. However, the availability of an organ-preserving approach for the treatment of remnant gastric cancer (RGC) is still controversial. Thus, the objective of the present study was to assess the safety and efficacy of SG for RGC by integrating data from published articles. We searched the PubMed, Cochrane Library, and Web of Science databases for studies that compared SG versus total gastrectomy (TG) for RGC published from the inception of the databases until May 2020. A meta-analysis was performed using the Review Manager Version 5.0 software program from the Cochrane Collaboration. Three retrospective cohort studies with 144 patients were included. The meta-analysis revealed that the operative time of the SG group was significantly shorter than that in the TG group (MD: -34.84. 95% CI: -59.97- -9.71, P = 0.007). There was no significant difference in intraoperative blood loss (MD: -109.19. 95% CI: -240.37-21.99, P =0.10), length of postoperative hospital stay (MD: 0.40. 95% CI: -3.03-3.83, P = 0.82), postoperative complications (RR: 1.41. 95% CI: 0.76-2.63, P = 0.28), or recurrence (RR: 2.33, 95% CI: 0.48-11.44, P = 0.30). SG for RGC tended to be correlated with favorable 5-year overall survival; however, the association was not statistically significant (HR: 0.89, 95% CI: 0.63-1.26, P = 0.51). Organ-preserving approaches such as SG may be a safe and feasible treatment option for early-stage RGC.

INNOVA: Interval or neoadjuvant chemotherapy in rectal cancer—A phase II randomized study comparing interval versus neoadjuvant chemotherapy in magnetic resonance imaging-defined high-risk rectal cancer.

91 Background: Total neoadjuvant treatment is a promising option in rectal cancer. We aim to compare neoadjuvant versus interval chemotherapy in high risk rectal cancer to identify the optimal sequencing of treatment. Methods: Using a Simon two-stage design, newly diagnosed MRI defined high risk rectal cancer patients were randomly assigned in a 1:1 ratio to receive three 21 day cycles of chemotherapy with Capecitabine 1000 mg/m2 and Oxaliplatin 130 mg/m2 either before (Arm A-neoadjuvant) or after (Arm B-interval) chemoradiation followed by surgery. Primary end point was the pathological complete response (pCR) following surgery. A heirarchial model was used to assess the primary and secondary end points (toxicity and compliance) and compare the two regimens. (Clinical Trial Registry of India No. CTRI/2015/01/005385). Results: In this single centre study conducted between November 2015 and February 2020, 42 patients were randomised in the first stage. A pCR was seen in 4 patients in Arm A and 6 in Arm B. Hence another 52 patients were randomised in the second stage of which an additional 3 and 2 patients had a pCR leading to an overall pCR of 7 and 8 patients (15.5% vs 17% and 18.4% vs 19.5% in the intent-to-treat and per-protocol populations in Arm A and B respectively. This exceeded the minimum predetermined number of 5 pCR needed to qualify for further evaluation for each arm. Grade ≥3 toxicity was observed in 2.2% of 132 cycles and 4.6% of 129 cycles of chemotherapy delivered in 45 and 43 patients in Arm A and B respectively while 11/43 (25.5%) and 10/47 (21.2%) patients experienced grade ≥3 toxicity during chemoradiation. Treatment break of &gt; 7 days was seen in 23.2% and 29.7% of patients in Arm A and B respectively while 93.3% in Arm A and 100% of patients in Arm B completed all 3 planned cycles of pre-operative chemotherapy. A non-significant trend towards greater pathological downstaging was seen in Arm B than in Arm A (ypT1-2 39% vs 26.3%; p = 0.1 and ypN0 68.3% vs 57.9%; p = 0.5 respectively). Conclusions: In this phase two study, both neoadjuvant and interval chemotherapy emerged eligible for further evaluation against the standard of care in a future phase III study. Although we could not pick one winner based on pCR, toxicity or compliance, the greater downstaging observed with interval chemotherapy suggests it could play a greater role in an organ preservation approach. Clinical trial information:CTRI/2015/01/005385, UTN no: U111111650578.

The effect of gender on outcomes in esophageal cancer.

170 Background: Few epidemiological studies address differences in outcomes by gender in locoregional esophageal cancer (LEC) for which the current standard of care is chemoradiation followed by surgical resection. Although male gender is associated with the majority of LEC cases, we sought to determine if gender could impact clinical presentation as well as surgical and oncologic outcomes in our single institution 20 year experience. Methods: A retrospective query of our institution’s IRB-approved database of patients that had surgical therapy between 2008 and 2019 for esophageal cancer (EC) was performed. Patients were stratified by gender and analyzed based on characteristics such as tumor histology, tumor location, clinical stage at presentation, age at diagnosis, receipt of neoadjuvant therapy, surgical intent, surgical complications, length of post-operative hospital stay, response to neoadjuvant therapy, final pathology, and recurrence. Chi-square, ANOVA and Kaplan Meier survival analysis were performed on the previously defined groups. Results: The cohort studied included 1180 patients with resection for EC. Of those, 1005 (85.2%) had adenocarcinoma, 145 (12.3%) had squamous cell cancer (SCC), 10 (0.8%) had adenosquamous carcinoma, and 20 (1.7%) had other histological variants. There were 985 (83.5%) male patients and 195 (16.5%) female patients. SCC was more common in females (29.2% in females vs. 8.9% in males, p = 0.000) and females tended to have tumor location in the upper thoracic esophagus more often (4.7% in females vs. 0.9% of males, p = 0.000). Additionally, females developed surgical complications more often than males (72.2% vs. 64.7%, p = 0.045). Staging at diagnosis (p = 0.508), receipt of neoadjuvant treatment (p = 0.676), and age at diagnosis (65.3 years in males vs. 66.3 years in females, p = 0.934) had no association with gender. Response to neoadjuvant therapy (p = 0.157) and cancer recurrence (p = 0.434) did not have significant associations with gender. The median overall survival was not statistically significantly different but trended to be longer for females (73.4 months in females [95% CI: 51.5-95.4] vs. 47.0 months in males [95% CI: 39.6-54.5], p = 0.160). Conclusions: Based on our high-volume cancer center study, female patients were more likely to have SCC, upper thoracic esophageal lesions, and surgical complications following resection. While univariate analysis did not demonstrate significant differences in overall survival between genders, there are plans to report additional data after controlling for other variables. Further studies are warranted to validate these findings, given the potential for higher prioritization of an organ preservation approach for this patient population.