A comparative study of indocyanine green instillation in inguinal node versus foot web space using da Vinci indocyanine green FireFly™ technology in identifying thoracic duct during robotic-assisted transthoracic oesophagectomy.

INTRODUCTION: Chyle leak is a serious complication following oesophagectomy with incidence varies from 1% to 9%. Near infra-red fluorescence imaging of thoracic duct (TD) can provide real-time dynamic imaging during the surgery. In this study, we intend to compare indocyanine green (ICG) dye instillation through inguinal node with subcutaneous first web space instillation for visualisation of TD during robotic-assisted minimally invasive oesophagectomy (RAMIE) procedure. PATIENTS AND METHODS: A prospective study of 50 patients underwent RAMIE with da Vinci X System. After general anaesthesia, patients were divided into inguinal node and foot first web space ICG instillation group. The former group had 1 ml of ICG dye instilled on bilateral inguinal nodes under ultrasound guidance and while the other group received 1 mL of ICG dye injected at bilateral foot first web space and then underwent surgery. TD was visualised using ICG FireFly™ fluorescence technology, first at the time of docking and subsequently for every 5 min until 60 min of instillation time and analysed. RESULTS: Twenty-five patients were enrolled in each group. The mean docking time for thoracic phase was 13.76 ± 3.43 min. TD was visualised in 72% (18/25) of cases of first web space instillation group, whereas 100% in ultrasound guidance inguinal node instillation group. None of the patients had a chyle leak. CONCLUSION: ICG FireFly™ fluorescence technology for the identification of TD during oesophageal mobilisation is safe and effective and provides real-time dynamic visualisation with high accuracy in ultrasound-guided bilateral inguinal node instillation group. It is an effective method for the surgeons planning to negotiate their initial learning curve in RAMIE procedures.

Consensus guidelines for the management of HR-positive HER2/neu negative early breast cancer in India, SAARC region and other LMIC by DELPHI survey method.

BACKGROUND: Precise prognostication is the key to optimum and effective treatment planning for early-stage hormone receptor (HR) positive, HER2/neu negative breast cancer patients. Differences in the breast cancer incidence and tumor anatomical features at diagnosis, pharmacogenomics data between Western and Indian women along with the vast diversity in the economic status and differences in insurance policies of these regions; suggest recommendations put forward for Western women might not be applicable to Indian/Asian women. Opinions from oncologists through a voting survey on various prognostic factors/tools to be considered for planning adjuvant therapy are consolidated in this report for the benefit of oncologists of the sub-continent, SAARC and Asia's LMIC (low and middle-income countries). METHODS: A three-phase DELPHI survey was conducted to collect opinions on prognostic factors considered for planning adjuvant therapy in early-stage HR+/HER2/neu negative breast cancer patients. A panel of 25 oncologists with expertise in breast cancer participated in the survey conducted in 2021. The experts provided opinions as 'agree' or disagree' or 'not sure' in phases-1 and 2 which were conducted virtually; in the final phase-3, all the panel experts met in person and concluded the survey. RESULTS: Opinions on 41 statements related to prognostic factors/tools and their implications in planning adjuvant endocrine/chemotherapy were collected. All the statements were supported by the latest data from the clinical trials (prospective/retrospective). The statements with opinions of consensus less than 66% were disseminated in phase-2, and later in phase-3 with supporting literature. In phase-3, all the opinions from panelists were consolidated and guidelines were framed. CONCLUSIONS: This consensus guideline will assist oncologists of India, SAARC and LMIC countries in informed clinical decision-making on adjuvant treatment in early HR+/HER2/neu negative breast cancer patients.

Prospective analysis of impact of learning curve in robotic-assisted rectal surgery in the high-volume Indian tertiary care centre.

Background: Minimally invasive surgery in rectal cancer has gained prominence owing to its various advantages in surgical outcomes. Due to rapid adoption of robotics in rectal surgery, we intended to assess the pace in which surgeons gain proficiency using cumulative summation (CUSUM) technique in learning curve. Materials and Methods: This was a prospective study of 262 rectal cancer cases who underwent robotic-assisted low anterior resection and abdominoperineal resection (RA-LAR and RA-APR). Parameters considered for the study were console time, docking time, lymph nodal yield, total operative time and post-operative outcomes. We used Manipal technique of port placements and modified centroside docking for the procedure. Results: The mean age of our study was 46.62 ± 5.7 years, the mean body mass index (BMI) was 31.51 ± 3.2 kg/m2. 215 (82.06%) underwent RA-LAR and 47 (17.93%) underwent RA-APR. 2.67% of cases required to open during our initial period. We had three phases of learning curve, initial phase (11th case), plateau phase (29th case) and then phases of mastery (30th case onwards). Our mean total operative time reduced from 5.5 to 3.5 h (210 ± 8.2 min), console time from 4.5 to 2.9 h (174 ± 4.5 min) and docking time from 15 to 9 ± 1 min from 30th case onwards. Conclusion: RA surgeries for rectal cancer have got good oncological and functional outcomes in high BMI, male pelvis and low rectal cancers. Learning curve can be shortened with constant self-auditing of the surgeon and team with each surgeries performed, reviewing the steps and by improving techniques.

Prospective analysis of 164 fires of da Vinci SureForm SmartFire stapler in oncological cases: Indian cohort of 76 consecutive cases.

Background: The application of robotic staplers in surgeries has increased in recent years. Robotic platform enhances ability of the surgeon to directly control and manoeuvre staplers to achieve required angulation and sealing within the confines of the thorax and pelvis. Hence, in this study, we intended to learn the effectiveness of the SureForm™ SmartFire™ technology stapling system in various oncological procedures. Patients and Methods: Prospective study of 76 patients who underwent robotic-assisted total oesophagectomy, gastrectomies, hemicolectomies, low anterior resection/abdominoperineal resection and lobectomies/metastasectomy for respective malignancies for 16 months. Internal data log of the da Vinci surgical system for reload colour, reloads used, clamp attempts and staple fires used during each procedure along with patient's post-operative outcomes were recorded. Results: One hundred and sixty-four firings have been made in 76 cases, with the majority being green reloads (76.8%) and average reloads for radical cystectomy 3.5, lobectomies/metastasectomy 3.44 and oesophagectomy 2.55. None of the cases had incomplete firings and required force-fire activation. In forty per cent of cases, the robotic stapler had to pause for sequential compression and seal. Seventy per cent of anterior resection procedures had at least one firing >45° beyond the laparoscopy limit. Collectively 52% SureForm stapler fires in anterior resection with >45° angle of fire. None of the cases had bleed or leak. Conclusion: SureForm™ SmartFire™ robotic staplers can be used for various oncological surgeries with minimal peri-operative leak and bleeding and has better articulation in closed spaces. Further case-matched comparative studies with laparoscopic or handheld powered staplers would be required for useful operative decision-making and analyse the clinical outcomes.

Bowel Anastomosis After or Before HIPEC: A Comparative Study in Patients Undergoing CRS+HIPEC for Peritoneal Surface Malignancy.

BACKGROUND: Anastomotic leak after cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) remains a dreaded complication. There is no consensus statement regarding the optimal timing for bowel anastomoses to perform after or before HIPEC. METHODS: Patients who underwent CRS+HIPEC and had at least one bowel anastomosis were retrospectively analyzed to evaluate if timing of anastomosis done after or before HIPEC had an impact on bowel complication rates (anastomotic leak and perforation). RESULTS: From 2013 to 2019, 214 of 370 patients underwent CRS+HIPEC and had at least one bowel anastomosis. Of these 214 patients, 104 and 110 patients had anastomosis after and before HIPEC, respectively. A total of 324 anastomoses were performed, with a mean of 0.87 anastomoses per patient (range 1-4). The incidence of anastomotic leaks was comparable between the pre- and post-HIPEC groups (3.6% vs. 4.8%; p > 0.05), as was the bowel complication rate (7.6% vs. 7.2%). After multivariate analysis, prior surgical score >1 (odds ratio [OR] 4.3), recurrent cancers (OR 7.4), and more than two anastomosis (OR 3.8) were considered independent risk factors for bowel complications. CONCLUSION: Anastomosis of the bowel performed after or before HIPEC does not affect bowel complication rates (leak/perforation). Higher prior surgical score, surgery for recurrent cancers, and more than two bowel anastomosis are independent risk factors for predicting bowel complications. Prehabilitation, standardization of steps, immediate attention and repair of serosal tears, and thorough inspection of the bowel before closure helps to decrease bowel complications. The timing of anastomosis can be at the discretion of the surgeon.

Impact of Covid-19 on gastrointestinal cancer surgery: A National Survey.

PURPOSE: To understand the actual impact of the Covid-19 pandemic and frame the future strategies, we conducted a pan India survey to study the impact on the surgical management of gastrointestinal cancers. METHODS: A national multicentre survey in the form of a questionnaire from 16 tertiary care gastrointestinal oncology centres across India was conducted from January 2019 to June 2021 that was divided into a 15-month pre-Covid era and a similar period of active Covid pandemic era. RESULTS: There was significant disruption of services; 13 (81%) centres worked as dedicated Covid care centres and 43% reported suspension of essential care for more than 6 months. In active Covid phase, there was a 14.5% decrease in registrations and proportion of decrease was highest in the centres from South zone (22%). There was decrease in resections across all organ systems; maximum reduction was noted in hepatic resections (33%) followed by oesophageal and gastric resections (31 and 25% respectively). There was minimal decrease in colorectal resections (5%). A total of 584 (7.1%) patients had either active Covid-19 infection or developed infection in the post-operative period or had recovered from Covid-19 infection. Only 3 (18%) centres reported higher morbidity, while the rest of the centres reported similar or lower morbidity rates when compared to pre-Covid phase; however, 6 (37%) centres reported slightly higher mortality in the active Covid phase. CONCLUSION: Covid-19 pandemic resulted in significant reduction in new cancer registrations and elective gastrointestinal cancer surgeries. Perioperative morbidity remained similar despite 7.1% perioperative Covid 19 exposure.

Primary Gastric Synovial Sarcoma in a Child: A Case Report and Review of the Literature.

Synovial sarcoma is a mesenchymal neoplasm that shows a specific t(X;18) translocation that leads to the formation of SS18-SSX gene fusions and is most commonly seen in soft tissues of the extremity. The gastrointestinal tract is a very rare site of involvement. We report a case of primary gastric synovial sarcoma in a 13-year-old male child. Synovial sarcoma should be included in the differential diagnosis when spindle cell neoplasms are encountered in the stomach. A high degree of suspicion, followed by the necessary immunohistochemistry and molecular studies, is required to make an accurate diagnosis.

Adaptations and Safety Modifications to Perform Safe Minimal Access Surgery (Minimally Invasive Surgery: Laparoscopy and Robotic) during the COVID-19 Pandemic.

It is inevitable that some patients with suspected or confirmed COVID-19 may require urgent surgical procedures. The objective of this review was to discuss the modifications required in the operating room during COVID-19 times for minimal access, laparoscopy, and robotic surgery, especially with regard to minimally invasive surgical instruments, buffalo filter, trocars with smoke evacuator, and special personal protection equipment. We have discussed the safety measures to be followed for the suspected or confirmed COVID-19 patient. In addition to surgical patients, health care workers should also protect themselves by following the guidelines and recommendations while treating these patients. Although there is little evidence of viral transmission through laparoscopic or open approaches, we recommend modifications to surgical practice such as the use of safe smoke evacuation and minimizing energy device use to reduce the risk of exposure to aerosolized particles to the health care team. Therefore, hospitals must follow specific protocols and arrange suitable training of the health care workers. Following well-established plans to accomplish un-deferrable surgeries in COVID-19-positive patients is strongly recommended.

Sentinel node mapping using indocyanine green and near-infrared fluorescence imaging technology for endometrial cancer: A prospective study using a surgical algorithm in Indian patients.

BACKGROUND: Indocyanine green (ICG) fluorescence with high-definition, three-dimensional imaging systems is emerging as the latest strategy to reduce trauma and improve surgical outcomes during oncosurgery. MATERIALS AND METHODS: This is a prospective study involving 100 patients with carcinoma endometrium who underwent robotic-assisted Type 1 pan-hysterectomy, with ICG-directed sentinel lymph node (SLN) biopsy from November 2017 to December 2019. The aim was to assess the feasibility and diagnostic accuracy of SLN algorithm and to evaluate the location and distribution of SLN in pelvic, para-aortic and unusual areas and the role of frozen section. RESULTS: The overall SLN detection rate was 98%. Bilateral detection was possible in 92% of the cases. Right side was detected in 98% of the cases and left side was visualised in 92% of the cases. Complete node dissection was done where SLN mapping failed. The most common location for SLN in our series was obturator on the right hemipelvis and internal iliac on the left hemipelvis. SLN in the para-aortic area was detected in 14% of cases. In six cases, SLN was found in atypical locations, that is pre-sacral area. Eight patients had SLN positivity for metastasis and underwent complete retroperitoneal lymphadenectomy. Comparison of final histopathological report with frozen section reports showed no false negatives. CONCLUSIONS: SLN mapping holds a great promise as a modern staging strategy for endometrial cancer. In our experience, cervical injection was an optimal method of mapping the pelvis. ICG showed a high overall detection rate, and bilateral mapping appears to be a feasible alternative to the more traditional methods of SLN mapping in patients with endometrial cancer. The ICG fluorescence imaging system is simple and safe and may become a standard in oncosurgery in view of its staging and anatomical imaging capabilities. This approach can reduce the morbidity, operative times and costs associated with complete lymphadenectomy while maintaining prognostic and predictive information.

A prospective randomized controlled trial comparing conventional Intuitive® procedure card recommended port placement with the modified Indian (Manipal) technique.

INTRODUCTION: The da Vinci® X hybrid systems (Intuitive Surgical®, Sunnyvale CA) provides standard sites recommendations for port placement during robotic surgery; including that for colorectal procedures. The author's encountered challenges while adhering to the provided instructions, such as clash of instruments and arms and need for additional ports, and hence to overcome these challenges attempted a few innovative technical modifications. The surgical results as well as merits of the revised Indian (Manipal) port placement with single docking technique are presented here. METHODS: Twenty patients underwent robotic rectal resection at the Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, India, between December 2017 and June 2018. A randomised controlled study was conducted to compare the two techniques. Ten patients were operated using hybrid da Vinci® 'X' system using the manufacturer's recommendations and 10 by the modified Indian (Manipal) port placement with a single docking technique. RESULT AND CONCLUSIONS: The Indian (Manipal) modifications of port placements are optimal for colorectal procedures such as low anterior resection as well as for ultralow anterior resections. The intraoperative parameters compared between the recommendations of the Intuitive® (da Vinci® systems) and attempted modifications demonstrated statistically significant advantages with the use of the revised techniques. The improvements offered by this modification include no additional requirements of ports or staplers, lesser clash amongst instruments as well as arms, better mobilisation of splenic flexure amongst others.

cAMP regulated EPAC1 supports microvascular density, angiogenic and metastatic properties in a model of triple negative breast cancer.

Breast cancer is a leading cause of cancer-related mortality in women. Triple-negative breast cancer (TNBC; HER2-, ER-/PR-) is an aggressive subtype prone to drug resistance and metastasis, which is characterized by high intratumor microvascular density (iMVD) resulting from angiogenesis. However, the mechanisms contributing to the aggressive phenotypes of TNBC remain elusive. We recently reported that down-regulation of exchange factor directly activated by cyclic AMP (cAMP), also known as EPAC1, leads to a reduction in metastatic properties including proliferation and cell migration in TNBC cell lines. Here, we report that EPAC1 supports TNBC-induced angiogenesis, tumor cell migration and invasiveness as well as pro-metastatic phenotypes in endothelial cells induced through the tumor secretome. Using an approach that integrates proteomics with bioinformatics and gene ontologies, we elucidate that EPAC1 supports a tumor-secreted network of angiogenic, cell adhesion and cell migratory pathways. Using confocal microscopy, we show that signaling molecules involved in focal adhesion, including Paxillin and MENA, are down-regulated in the absence of EPAC1, and electric cell substrate impedance sensing technique confirmed a role for EPAC1 on TNBC-induced endothelial cell permeability. Finally, to provide a translational bridge, we studied iMVD and therapy response using a primary human tumor explant assay, CANscriptTM, which suggests a link between therapy-modulated neovascularization and drug sensitivity. These data provide mechanistic insight into the role of EPAC1 in regulating the tumor microenvironment, iMVD and cancer cell-induced angiogenesis, a dynamic mechanism under drug pressure that may associate to treatment failure.

Watson for Oncology and breast cancer treatment recommendations: agreement with an expert multidisciplinary tumor board.

Background: Breast cancer oncologists are challenged to personalize care with rapidly changing scientific evidence, drug approvals, and treatment guidelines. Artificial intelligence (AI) clinical decision-support systems (CDSSs) have the potential to help address this challenge. We report here the results of examining the level of agreement (concordance) between treatment recommendations made by the AI CDSS Watson for Oncology (WFO) and a multidisciplinary tumor board for breast cancer. Patients and methods: Treatment recommendations were provided for 638 breast cancers between 2014 and 2016 at the Manipal Comprehensive Cancer Center, Bengaluru, India. WFO provided treatment recommendations for the identical cases in 2016. A blinded second review was carried out by the center's tumor board in 2016 for all cases in which there was not agreement, to account for treatments and guidelines not available before 2016. Treatment recommendations were considered concordant if the tumor board recommendations were designated 'recommended' or 'for consideration' by WFO. Results: Treatment concordance between WFO and the multidisciplinary tumor board occurred in 93% of breast cancer cases. Subgroup analysis found that patients with stage I or IV disease were less likely to be concordant than patients with stage II or III disease. Increasing age was found to have a major impact on concordance. Concordance declined significantly (P ≤ 0.02; P < 0.001) in all age groups compared with patients <45 years of age, except for the age group 55-64 years. Receptor status was not found to affect concordance. Conclusion: Treatment recommendations made by WFO and the tumor board were highly concordant for breast cancer cases examined. Breast cancer stage and patient age had significant influence on concordance, while receptor status alone did not. This study demonstrates that the AI clinical decision-support system WFO may be a helpful tool for breast cancer treatment decision making, especially at centers where expert breast cancer resources are limited.

Robot-assisted thyroidectomy using a gasless, transaxillary approach for the management of thyroid lesions: Indian experience.

AIM: Since last decades, more and more thyroidectomies have been performed by the minimally invasive method. Compared to conventional thyroidectomy, minimally invasive thyroidectomy has a superior cosmetic result. However, the outcome depends, in a large extent, on the skill of the operator and the learning curve is relatively long. Robotic thyroidectomy (RT) is a relatively new approach in treating thyroid lesions with improved ergonomics and surgical outcomes. PURPOSE: We performed a prospective study of robotic-assisted transaxillary approach for thyroidectomy in Indian patients to examine the feasibility of the procedure. MATERIALS AND METHODS: A total of 35 patients underwent RT. Demographics, surgical indications, operative findings, postoperative functional outcome, local complications and pathological outcomes were recorded and analyzed. RESULTS: The median age of the cohort was 28.6 years and 31 of the patients were women. The median size of the largest nodule was 3.2 cm (range, 1.0-4.5 cm). The median size of the largest nodule was 3.2 cm (range, 1.0-4.5 cm). Eighteen patients underwent less than total thyroidectomy and 17 patients underwent total thyroidectomy, with no conversion. The mean console time standard deviation was 115 min initially, and with experience, it reduced to 106 min for subsequent cases. The mean blood loss was 13 ml. Post-operative outcome was good with no serious complication noted in our series. CONCLUSION: Robotic-assisted thyroidectomy using a gasless transaxillary approach is a feasible, safe and noninferior surgical alternative for selected patients. We believe with time RT will be widened and it will be performed more often.

Hyperthermic intraperitoneal chemotherapy for peritoneal surface malignancies: A single institution Indian experience.

BACKGROUND: Cytoreductive surgery followed by hyper- thermic intraperitoneal chemotherapy (HIPEC) has shown better oncological outcomes in peritoneal surface malignancies (PSM). We assessed the feasibility and perioperative outcomes of this procedure in Indian patients. METHODS: In this prospective observational study from February 2013 to April 2015, we included 56 patients (41 females, 73.2%) with PSM. They had a good performance status, were either treatment-naïve or previously treated by surgery and systemic chemotherapy. They underwent cytoreductive surgery followed by HIPEC using a hyperthermia pump, with the temperature at 42 °C for 30-90 minutes. The chemotherapy regimen was based on the primary malignancy. Perioperative outcome data were collected and analysed. We also analysed the short-term oncological outcomes. RESULTS: Our patients included those with peritoneum confined ovarian carcinoma (32, 57.1%), colorectal carcinoma (9, 16.1%), pseudomyxoma peritonei (7, 12.5%), meso- thelioma (2, 3.6%), gastric carcinoma (2, 3.6%) and others (4, 7.1%). The median duration of surgery including HIPEC was 9 hours and the median hospital stay was 12 days. The median time for gastrointestinal recovery was 5 days. One-fifth of patients (11, 19.7%) required an extended stay in the inten- sive care unit. The most common grades 3 and 4 complications were hypocalcaemia 32.1%, hypokalaemia 32.1%, anaemia 21.4% and thrombocytopenia 7.1%. Major morbidity requiring surgical intervention occurred in 8.9% of patients. The 60-day operative mortality was 1.8%. At a median follow-up of 16 months, 7.1% developed peritoneal recurrence, 8.9% had systemic recurrence and 7.1% succumbed to the disease. Patients with platinum-resistant ovarian carcinomas had more peritoneal recurrence (3.6%). CONCLUSION: In patients with PSM, surgical cytoreduction and HIPEC is feasible and potentially beneficial. It can be done with low mortality and acceptable morbidity. It requires a dedicated team of surgeons, anaesthetists and intensivists and proper infrastructure.

Navigating patient journey in early diagnosis of lung cancer in India.

Lung cancer (LC) is one of the leading causes of cancer deaths worldwide. In India, the incidence of LC is increasing rapidly, and a majority of the patients are diagnosed at advanced stages of the disease when treatment is less likely to be effective. Recent therapeutic developments have significantly improved survival outcomes in patients with LC. Prompt specialist referral remains critical for early diagnosis for improved patient survival. In the Indian scenario, distinguishing LC from benign and endemic medical conditions such as tuberculosis can pose a challenge. Hence, awareness regarding the red flags-signs and symptoms that warrant further investigations and referral-is vital. This review is an effort toward encouraging general physicians to maintain a high index of clinical suspicion for those at risk of developing LC and assisting them in refering patients with concerning symptoms to specialists or multidisciplinary teams as early as possible.

Cytoreductive Surgery with HIPEC as Primary Treatment for Advanced Epithelial Ovarian Carcinoma: Upfront or Interval-ISPSM Collaborative Study.

Cytoreductive surgery with HIPEC has shown promising results in the interval setting of advanced epithelial ovarian cancer. Its role in upfront setting has not yet been established. All eligible patients underwent CRS-HIPEC as per institution protocol. Relevant data was collected prospectively in institutional HIPEC registry and analyzed retrospectively for the study period from February 2014 to February 2020. Out of 190 patients, 80 underwent CRS-HIPEC in upfront setting and 110 in interval setting. The median age was 54 ± 7.45 years, upfront group had higher PCI (14.1 ± 8.75 vs. 9.6 ± 5.2. 2), and required longer duration of surgery (10.6 ± 1.73 vs. 8.4 ± 1.71 h) had more blood loss (1025 ± 668.76 vs. 680 ± 302.23 ml). The upfront group required more diaphragmatic resections, bowel resections, and multivisceral resections. The overall G3-G4 morbidity was comparable (25.4% vs. 27.3%), upfront group had more surgical morbidity (20% vs. 9.1%) whereas interval group had more medical morbidity, i.e., electrolyte imbalance and hematological. After a median follow-up of 43 months, median DFS was 33 months in the upfront vs. 30 months in the interval group, p = 0.75, median OS was 46 months interval group and was not yet achieved in upfront group.(p = 0.13). Four-year OS was 85% vs. 60%. In patients of advanced EOC upfront CRS HIPEC showed promising outcomes and trend towards better survival with similar morbidity and mortality. The upfront group had more surgical morbidity whereas interval group had more medical morbidity. Multiinstitutional randomized studies are needed to define patient selection and study morbidity patterns and compare the outcomes between CRS-HIPEC in the upfront and interval setting for advanced epithelial ovarian cancer.

Real-World Experience with Nivolumab in Metastatic Renal Cell Carcinoma Patients Who Have Progressed on Prior Therapies: A Single-Center Study from India.

Amit RauthanIntroduction Nivolumab monotherapy is approved for the treatment of metastatic renal cell carcinoma (mRCC) patients who have progressed on prior therapies based on the pivotal Checkmate-025 trial. There is limited literature on the efficacy and safety profile of usage of nivolumab in the treatment of mRCC in India in a real-world setting. Methods A retrospective analysis was performed of patients who received nivolumab monotherapy for mRCC after having progressed on prior therapies. Tumor response was graded according to RECIST v1.1 and Kaplan-Meier survival analysis was used to estimate progression-free survival (PFS) and overall survival (OS). Immune-related adverse events (irAEs) were documented and graded according to CTCAE v5.0. Results Between 2016 and 2019, 35 patients received nivolumab for mRCC at our center after progression on prior therapies. A majority of the patients ( n = 30, 85.7%) received it in a second-line setting, and the remaining in the third line and beyond setting. Clear cell was the most common histology ( n = 26, 74.3%). There were 18 patients (51.42%) who belonged to IMDC intermediate risk, while 17 (48.58%) patients were at poor risk. The overall response rate was 60%, with complete response (CR) in 11.4%. Median duration of response was not reached among responders. Median PFS was 5 months (95% confidence interval [CI]: 3.06-6.93) and median OS was 26 months (95% CI: 1.90-50.09). Ongoing survival of 47, 42, 34, and 22 months was noted in four patients with CR, respectively. In our study, 23 patients (65.71%) experienced any grade of irAE. Grade 3 irAEs was seen in four patients (11.42%). Most common irAE was thyroid dysfunction seen in 12 patients (34.2%). Treatment discontinuation due to irAEs occurred in three patients (8.57%). Conclusion Nivolumab showed good efficacy with high response rates and an OS comparable to the pivotal Checkmate-025 trial. It was well tolerated with safety profile in terms of irAE consistent with those reported in literature.

Treatment Response After Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastases of Colorectal Originf.

The objective of this study is to analyze oncological outcomes of patients with peritoneal metastases (PM) of colorectal origin treated with Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC). Background: PIPAC has been demonstrated to be a feasible and safe novel treatment for patients with PM of various origins. Only small series reports on survival after PIPAC by disease entity. Methods: International retrospective cohort study of consecutive patients with PM of colorectal origin. Outcome measures were overall survival (OS), radiological response according to Response Evaluation Criteria in Solid Tumors (RECIST), histological response (peritoneal regression grading score [PRGS]: complete response: 1-4: no response), change of peritoneal cancer index (PCI), and symptom control. Results: Seventeen eligible centers compiled 256 non-selected patients (mean age 61 [50.6-69.2], 43% female) and 606 procedures. Sixty-three percent were treated after 2 lines of chemotherapy, median PCI at PIPAC1 was 18 (interquartile range [IQR] = 10-27). Median OS was 19.00 months (IQR = 12.9-29.8) from diagnosis and 9.4 months (IQR = 4.5-16.8) from PIPAC1. One hundred and four of 256 patients (40.6%) had ≥3 procedures (per protocol [pp]) with the following outcomes at PIPAC3: RECIST: 59.3% partial response/stable, 40.7% progression; mean PRGS: 2.1 ± 0.9. Median PCI was 21 (IQR = 15-29) at baseline and 20 (IQR = 12-27) at PIPAC3 (P = 0.02). Fifty-six (54%) and 48 (46%) patients were symptomatic at baseline and PIPAC3, respectively (P = 0.267). Median OS for the pp cohort was 11.9 months (IQR = 10.7-15.0) from PIPAC1. Independent predictors for survival were radiological response (HR = 3.0; 95% CI = 1.6-5.7) and no symptoms (HR = 4.5, 95% CI = 2.2-9.1) at PIPAC3. Conclusions: Objective treatment response and encouraging survival were demonstrated after PIPAC for colorectal PM. Prospective registry data and comparative studies are now needed in to confirm these data.

Assessment of Treatment Response after Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) for Appendiceal Peritoneal Metastases.

Background The aim of this study was to analyse survival and surrogates for oncological response after PIPAC for appendiceal tumours. Methods This retrospective cohort study included consecutive patients with appendiceal peritoneal metastases (PM) treated in experienced PIPAC centers. Primary outcome measure was overall survival (OS) from the date of diagnosis of PM and from the start of PIPAC. Predefined secondary outcome included radiological response (RECIST criteria), repeat laparoscopy and peritoneal cancer index (PCI), histological response assessed by the Peritoneal regression grading system (PRGS) and clinical response. Results Final analysis included 77 consecutive patients (208 PIPAC procedures) from 15 centres. Median OS was 30 months (23.00-46.00) from time of diagnosis and 19 months (13.00-28.00) from start of PIPAC. 35/77 patients (45%) had ≥3 procedures (pp: per protocol). Objective response at PIPAC3 was as follows: RECIST: complete response 4 (11.4%), 11 (31.4%) partial/stable; mean PRGS at PIPAC3: 1.8 ± 0.9. Median PCI: 21 (IQR 18-27) vs. 22 (IQR 17-28) at baseline (p = 0.59); 21 (60%) and 18 (51%) patients were symptomatic at baseline and PIPAC3, respectively (p = 0.873). Median OS in the pp cohort was 22.00 months (19.00-NA) from 1st PIPAC. Conclusion Patients with PM of appendiceal origin had objective treatment response after PIPAC and encouraging survival curves call for further prospective evaluation.

Mucormycosis of the Breast in a Patient With Breast Carcinoma After COVID-19 Pneumonia.

Mucormycosis is a rare, but potentially fatal, fungal infection which is caused by mucormyctes. These forms of fungi are typically known to infect immuno-compromised individuals but are rare in immunocompetent individuals. Herein, we report the case of a 52 year-old female who was diagnosed with right breast carcinoma in Manipal Hospital, a tertiary cancer care center. The patient was a known diabetic and hypertensive and who had recently recovered from coronavirus disease-2019 (COVID-19) pneumonia. In the due course of management, she developed mucormycosis infection at the operative site in her right breast where she had a radiation therapy-induced wound. This patient was successfully treated with an aggressive regimen of early surgical debridement along with administration of systemic amphotericin B.