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.

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.

A comparison of outcomes following total and selective peritonectomy performed at the time of interval cytoreductive surgery for advanced serous epithelial ovarian, fallopian tube and primary peritoneal cancer - A study by INDEPSO.

OBJECTIVES: To compare clinical outcomes following total and selective peritonectomy performed during interval cytoreductive surgery (CRS) for stage IIIC/IVA serous epithelial ovarian cancer. METHODS: In this retrospective study, extent of peritonectomy was classified as total parietal peritonectomy (TPP) which comprised of removal of the entire parietal peritoneum and the greater and lesser omenta or selective parietal peritonectomy (SPP) that included 1/>1 of parietal peritonectomies performed to resect sites of residual disease. A comparison of patient and disease characteristics, morbidity, mortality and survival outcomes between the two groups was made. RESULTS: From January 2013 to December 2017, 79 patients underwent CRS (TPP-30, SPP-49) with or without intraperitoneal chemotherapy (IPC). The median PCI was 14 for TPP and 8 for SPP. The 90-day grade 3-4 morbidity (23.3% for TPP, 14.2% for SPP, p = 0.58) the 90-day mortality was similar (p = 0.58). The median disease free survival (DFS) was 37 months for SPP and 33 months for TPP (p = 0.47) and median overall survival (OS) not reached for both. The 3-year OS was 95% for TPP and 70.8% for SPP (p = 0.06). The only independent predictor of OS was grade 3-4 morbidity (p = 0.01) and not TPP (p = 0.09). Microscopic residual disease was seen in 23.3% with normal looking peritoneum in TPP group. CONCLUSIONS: TPP was not associated with increased morbidity compared to SPP. There was a trend towards a longer OS in the TPP group and the finding of residual disease in 'normal looking' peritoneum' warrants prospective evaluation of the benefit of TPP in this setting.

Individualized Chemotherapy Benefit Prediction by EndoPredict in Patients With Early Breast Cancer in an Indian Cohort.

PURPOSE: There are new advancements in the modulation of the treatment of patients with early-stage breast cancer, including the use of several molecular profiling tests to identify or select those patients who require additional adjuvant chemotherapy together with hormonal therapy on the basis of a recurrence score. One such tool is EndoPredict (Myriad Genetics; Salt Lake City, UT), which provides support in clinical decision making. The objective of this analysis was to study the landscape of absolute chemotherapy benefit and the likelihood of recurrence within 5 to 15 years in Indian patients with breast cancer who are undergoing EndoPredict testing. PATIENTS AND METHODS: This study included 308 patients with hormone-positive, human epidermal growth factor receptor 2-negative early breast cancer. Their postsurgical blocks were analyzed using the EndoPredict test. The MEDCALC statistical tool (Panum Education; Seoul, Republic of Korea) was used to estimate the correlation coefficient and to conduct multiple regression analysis. RESULTS: On the basis of the EndoPredict EPclin Risk Score, 52.12% of patients were classified as being in the low-risk category and could safely forgo adjuvant chemotherapy. For every unit increase in the EPclin Risk Score, the percentage increase in absolute chemotherapy benefit was 6.82%. Similarly, the correlation between the likelihood of recurrence within 5 to 15 years and the EPclin Risk Score suggested that there is a 10.34% increase in recurrence for each unit of EPclin Risk Score. CONCLUSION: The EPclin Risk Score has good prognostic and predictive power; it also provides the range of chemotherapy benefit for Indian patients.

Can Low-cost Indo Cyanine Green Florescence Technique for Sentinel Lymph Node Biopsy Replace Dual Dye (Radio-colloid and Blue Dye) Technique in Early Breast Cancer: A Prospective Two-arm Comparative Study.

BACKGROUND: The objective of this study was to assess the detection and accuracy of sentinel lymph node (SLN) biopsy (SLNB) using the low-cost indocyanine green (ICG) fluorescence method and to compare this method with the gold standard dual-dye method (radio-colloid + methylene blue dye [MB]). MATERIALS AND METHODS: One hundred patients with node-negative early breast cancer assessed clinically and by ultrasound axilla underwent an SLNB procedure using technetium-99m radio-colloid, MB, and ICG. The detection rate of SLNs and positive SLNs and the number of SLNs were compared. The injection safety of ICG and MB was evaluated. RESULTS: One hundred female patients with a median age of 52.3 years participated in the study. Sixty-eight percent had a body mass index < 25, 85% presented with a palpable lump, of which 59% were in the outer quadrant. SLNs were identified in all 100 cases. A total of 290 SLNs were removed (mean, 2.9; range, 1-6). The identification rate with dual dye was 94%, whereas with ICG alone, it was 96%. The SLNB sensitivity rate and false negative rate were 97.6% versus 93.2% and 3.1% versus 6.2% in the ICG and dual-dye combination, respectively. None of the patients had any local or systemic reaction with ICG; 3 patients with blue dye had tattooing and staining of skin. CONCLUSION: ICG fluorescence imaging permits real time visualization of lymphatics and provides an additional dimension to SLN biopsy that is safe and effective. These results confirm high sensitivity for fluorescence localization with comparable performance to the gold standard. ICG can reliably replace dual dye and be employed as a sole tracer for SLNB in early breast cancer.

Toxicity profile of chemotherapy agents used in cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for peritoneal surface malignancies.

INTRODUCTION: Morbidity associated with cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is due to the synergistic effect of cytoreduction, effect hyperthermia and the cytotoxic agents used for HIPEC. This study was done to analyse the postoperative morbidity in relation to the chemotherapy agent used in patients undergoing CRS-HIPEC for peritoneal surface malignancy (PSM) in Indian set up. MATERIALS AND METHODS: Patient with PSM, underwent CRS-HIPEC as per the institutional protocol. Patients were stratified as per the chemotherapy drug used during HIPEC & perioperative outcome were documented. RESULTS: 163 patients underwent CRS-HIPEC for PSM: 67.4% were of ovarian primary. Others were colorectal, appendicular, gastric primary and rare tumors.Cisplatin was the most common drug used: as alone (57.05%) or in combination with Adriamycin (12.88%). Mitomycin-C (MMC) was used in 20% and oxaliplatin in 10%.Grade 3-5 morbidity in the whole cohort was 44.8% and grade 1-2 was 74%.Grade 1-2 electrolyte abnormality was the most common morbidity overall and grade 3-4 hematological toxicity was the most common severe morbidity. Frequency of grade 3-5 morbidity were 38.7%, 48.5%,50% and 61.9% for Cisplatin alone, MMC, oxaliplatin and Adriamycin + cisplatin respectively. None of the patients had grade 3-4 nephrotoxicity as sole complication. All major complications were highest in the group who received Adriamycin. Cisplatin was associated with higher rate of electrolyte imbalance, oxaliplatin with post-operative bleeding. Rates of other complications did not differ significantly. CONCLUSION: Cisplatin followed by MMC were the well tolerated drugs during HIPEC and tolerance to Adriamycin combination regimen in Indian patients was poor.

Impact of extent of parietal peritonectomy on oncological outcome after cytoreductive surgery and HIPEC.

BACKGROUND: In peritoneal surface malignancy (PSM), in spite of optimal cytoreductive surgery (CRS), majority of recurrences that occur are intraperitoneal. In patients with PSM, studies employing fluorescent imaging and microscopic examination have shown normal looking peritoneum may harbor active disease. This study was done to assess the recurrence pattern, oncological outcomes, and morbidity and mortality of the extent of peritonectomy in patients who underwent total parietal peritonectomy (TPP) or involved field peritonectomy (IFP) as a part of the procedure during CRS and hyperthermic intraperitoneal chemotherapy (HIPEC). METHODS: This was a retrospective analysis of prospectively collected data, from February 2013 to December 2017. A total of 163 patients with PSM underwent TPP or IFP with CRS plus HIPEC. Their oncological outcomes, recurrence pattern, postoperative morbidity and mortality were analyzed. RESULTS: Of the 163 cases, the primary organs of origin were ovary, colorectal, appendicular pseudomyxoma, stomach, mesothelioma and others (67.4%, 16.5%, 6.1%, 4.9%, 2% and 2%), respectively. TPP was performed in 70 patients and IFP in 93 patients. TPP group had higher mean PCI (16 vs. 14), longer duration of surgery (11 vs. 9 h), and more blood loss (1,243 vs. 675 mL). Overall G3-G4 morbidity was comparable in both groups (42.8% vs. 33.3%) as was mortality (5.7% vs. 4.4%). Kaplan-Meier analysis showed that with a median follow-up of 45 months, TPP group had a recurrence-free survival (RFS) of 26 months and overall survival (OS) was yet to be achieved, whereas the IFP group had a RFS and OS of 21 and 43 months, respectively. CONCLUSIONS: Performing TPP reduces the chance of missing the microscopic disease, therefore can minimize local recurrence, and better oncological outcomes. TPP can be performed with acceptable morbidity and mortality, at the cost of increased duration of surgery and higher blood loss.

Chasing Rainbows? the Possibility of "Cure" in Patients with Colorectal Peritoneal Metastases Undergoing Cytoreductive Surgery and HIPEC-a Retrospective Study by INDEPSO.

Cytoreductive surgery (CRS) and HIPEC results in a median disease-free survival (DFS) of 12-15 months, overall survival (OS) of 23-63 months, and cure in around 15% of patients with colorectal peritoneal metastases (CPM). The wide variation in OS may largely be attributed to different criteria for patient selection employed by different investigators. To evaluate outcomes of CRS and HIPEC for CPM in patients enrolled in the Indian HIPEC registry. A retrospective analysis of patients enrolled in the registry since its inception in March 2016 was performed. The impact of various prognostic factors on DFS and OS was evaluated. From Jan 2013 to Dec 2017, 68 patients underwent CRS with HIPEC at six Indian centers. The median PCI was nine [range 3-35]. Twenty-two (32.3%) had mucinous tumors. A CC-0 resection was performed in 53 (77.9%) and CC-1 in 14 (20.5%). The median DFS was 12 months [95% CI 11.037-12.963 months] and the median OS 25 months [95% CI 18.718-31.282]. The DFS was inferior in patients with right upper quadrant involvement (p = 0.02) and 90-day major morbidity (p = 0.002) and OS inferior in those with 90-day major morbidity (p < 0.001) and mucinous tumors with a PCI > 20. The DFS compares well with results obtained by pioneering teams but we have no "cured" patients. Better patient selection and utilization of systemic therapies could in the future improve the OS. There is a compelling need to identify subgroups of CPM that benefit from the addition of HIPEC to CRS.

Impact of Radicality Versus Timing of Surgery in Patients with Advanced Ovarian Cancer (Stage III C) Undergoing CRS and HIPEC-a Retrospective Study by INDEPSO.

HIPEC in addition to interval CRS has shown a survival benefit of 12 months compared to CRS alone. However, there are many controversial issues pertaining to CRS itself which should be addressed first. To compare NACT and primary CRS approaches when CRS is categorized according to the extent of resection. To evaluate the feasibility of performing HIPEC at these two time points. A retrospective analysis of patients with stage III C ovarian cancer undergoing primary and interval CRS + HIPEC was performed. The surgical approach for interval CRS was classified as (1) resection of sites of residual disease alone or (2) resection of sites involved before NACT. The morphological response was divided into different categories, and surgeons had to state what they consider residual disease and what they do not. From January 2013 to December 2017, 54 patients were included (18-primary; 36-interval). Median PCI 11 vs 6.5 (p = 0.07); CC-0 was obtained in 77.7%. Three surgeons resected previously involved sites; three sites of residual disease only. All surgeons resected areas of scarring. Twenty percent patients had residual disease in "normal-looking" peritoneum. Morbidity (p = 0.09), median OS (p = 0.71), and median DFS (p = 0.54) were similar in the two groups. Early recurrence occurred in 50% with resection of residual disease alone compared to 16.6% when previous disease sites were resected (p = 0.07). Interval CRS should be performed to resect sites involved prior to NACT and not just sites of residual disease. HIPEC can be performed in both primary/interval settings with acceptable morbidity.

Analysis of Clinical Outcomes of Pseudomyxoma Peritonei from Appendicular Origin Following Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy-A Retrospective Study from INDEPSO.

To evaluate the clinical outcomes of patients of pseudomyxoma peritonei of appendiceal origin undergoing cytoreductive surgery and HIPEC. Data collected from members, an independent collaborative group of Indian surgeons specializing in the management of peritoneal surface malignancy (INDEPSO), was analyzed retrospectively. Clinicopathological and perioperative outcomes of patients treated for pseudomyxoma peritonei (PMP) of appendicular origin were evaluated. Ninety-one patients were diagnosed with pseudomyxoma peritonei of appendicular origin between March 2013 and December 2017. The median age was 53 years and 60% were females. The median PCI was 27 [range 3-39] and a CC-0/1 resection was achieved in 83.5% patients. The most common histological grade was low-grade PMP, seen in 71.4% cases. The overall rate of grades 3-4 morbidity was 33% (30/91) and the 90-day mortality rate reported was 6.5%. Pulmonary complications and systemic sepsis emerged as the most significant factors affecting morbidity, mortality, and failure to rescue. At a median follow-up of 24 months, the median OS was not reached and the median PFS was 53 months. On univariate and multivariate analysis, high-grade histology, prior chemotherapy, debulking surgery alone without HIPEC, and high PCI > 10 were predictors of poor progression-free survival. The survival and morbidity results of pseudomyxoma peritonei from appendicular origin following cytoreductive surgery and hyperthermic intraperitoneal chemotherapy are encouraging. With further awareness and understanding of the disease, and improvement in surgical expertise and learning curve, there is scope for further reduction in morbidity and better improvement in survival.

Failure-to-Rescue Following Cytoreductive Surgery with or Without HIPEC is Determined by the Type of Complication-a Retrospective Study by INDEPSO.

To determine factors influencing failure-to-rescue in patients with complications following cytoreductive surgery and HIPEC. A retrospective analysis of patients enrolled in the Indian HIPEC registry was performed. Complications were graded according to the CTCAE classification version 4.3. The 30- and 90-day morbidity were both recorded. Three hundred seventy-eight patients undergoing CRS with/without HIPEC for peritoneal metastases from various primary sites, between January 2013 and December 2017 were included. The median PCI was 11 [range 0-39] and a CC-0/1 resection was achieved in 353 (93.5%). Grade 3-4 morbidity was seen 95 (25.1%) at 30 days and 122 (32.5%) at 90 days. The most common complications were pulmonary complications (6.8%), neutropenia (3.7%), systemic sepsis (3.4%), anastomotic leaks (1.5%), and spontaneous bowel perforations (1.3%). Twenty-five (6.6%) patients died within 90 days of surgery due to complications. The failure-to-rescue rate was 20.4%. Pulmonary complications (p = 0.03), systemic sepsis (p < 0.001), spontaneous bowel perforations (p < 0.001) and PCI > 20 (p = 0.002) increased the risk of failure-to-rescue. The independent predictors were spontaneous bowel perforation (p = 0.05) and systemic sepsis (p = 0.001) and PCI > 20 (p = 0.02). The primary tumor site did not have an impact on the FTR rate (p = 0.09) or on the grade 3-4 morbidity (p = 0.08). Nearly one-fifth of the patients who developed complications succumbed to them. Systemic sepsis, spontaneous bowel perforations, and pulmonary complications increased the risk of FTR and multidisciplinary teams should develop protocols to prevent, identify, and effectively treat such complications. All surgeons pursuing this specialty should perform a regular audit of their results, irrespective of their experience.

Patterns of pathological response to neoadjuvant chemotherapy and its clinical implications in patients undergoing interval cytoreductive surgery for advanced serous epithelial ovarian cancer- A study by the Indian Network for Development of Peritoneal Surface Oncology (INDEPSO).

OBJECTIVES: The goals were to study • The pattern of pathological response to neoadjuvant chemotherapy (NACT) and its clinical implications • The impact of chemotherapy response grade (CRG) on survival METHODS: A retrospective analysis of patients undergoing interval cytoreductive surgery (CRS) between January 2013 to December 2017 was performed. The surgical and pathological reports were analyzed and surgical and pathological PCI compared. The pathological response to chemotherapy was assessed using the score developed by Bohm. et al. RESULTS: In 79 patients, it was observed that sites involved by disease first like ovaries and pelvic peritoneum (lower region) were the last to respond preceded by the omentum, right upper quadrant (RUQ) peritoneum (upper region) and parietal peritoneum (middle region). Microscopic residual disease was seen in 20.2% in normal looking areas of peritoneum and in 20% with no gross residual disease in the RUQ. Visual inspection during surgery overestimated the disease extent in 40.5% and underestimated it in 15.1%. There was no difference in the progression free (p = 0.587) and overall survival (p = 0.157) between patients with CRG 1, 2 and 3 (poor, moderate, and complete/near complete response, respectively). Retroperitoneal nodes were positive in 0% with CRG 3, 27.5% with CRG 2 and 72.7% with CRG 1 (p < 0.0001). CONCLUSIONS: The pathological response to NACT follows a specific pattern. Visual inspection is of limited value in assessing disease extent following NACT. Surgery following NACT should target sites involved before NACT and not just residual disease. The response in regional nodes should be included in chemotherapy response scores.

Treading the beaten path with old and new obstacles: a report from the Indian HIPEC registry.

BACKGROUND: The Indian HIPEC registry is a self-funded registry instituted by a group of Indian surgeons for patients with peritoneal metastases (PM) undergoing surgical treatment. This work was performed to • Evaluate outcomes of cytoreductive surgery ± HIPEC in patients enrolled in the registry. • Identify operational problems. METHODS: A retrospective analysis of patients enrolled in the registry from March 2016 to September 2017 was performed. An online survey was performed to study the surgeons' attitudes and existing practices pertaining to the registry and identify operational problems. RESULTS: During the study period, 332 patients were enrolled in 8 participating centres. The common indication was ovarian cancer for three centres and pseudomyxoma peritonei for three others. The median PCI ranged from 3 to 23. A CC-0/1 resection was obtained in 94.7%. There was no significant difference in the morbidity (p = .25) and mortality (p = .19) rates between different centres. There was a high rate of failure-to-rescue (19.3%) patients with complications and the survival in patients with colorectal PM was inferior. A lack of dedicated personnel for data collection and entry was the main reason for only 10/43 surgeons contributing data. The other problem was the lack of complete electronic medical record systems at all centres. CONCLUSIONS: These results validate existing practices and identify country-specific problems that need to be addressed. Despite operational problems, the registry is an invaluable tool for audit and research. It shows the feasibility of fruitful collaboration between surgeons in the absence of any regulatory body or funding for the project.

Setting up of the Indian HIPEC Registry: A Registry for Indian Patients with Peritoneal Surface Malignancies.

There are various registries for patients with peritoneal metastases (PM) that aid pooling of data and generate evidence that dictates current clinical practice. This manuscript describes the setting up of the Indian HIPEC registry that was set up with a similar goal by a group of Indian surgeons. This is a registry for patients with PM treated with CRS and HIPEC in India. It also acts as a database for storing treatment-related information. Patients with PM from colorectal ovarian, gastric, appendiceal tumors, and other rare peritoneal tumors/metastases from rare tumors are enrolled in the registry. A coordinator updates the disease status of patients on a yearly basis. A private organization maintains the database. A non-disclosure agreement is signed between the company and each surgeon contributing to the registry to maintain confidentiality. For enrolling patients, securing institutional permission depends on the requirement of each institute; patient consent is mandatory. Data entry can be prospective or retrospective. To propose and conduct a study, the approval of a scientific committee linked to the registry is required. The Indian HIPEC registry is a practical database for Indian surgeons. There is no regulatory body that mandates collection and publication of scientific data in India. The onus is on each surgeon to capture valuable information pertaining to these common and rare diseases that could contribute to the existing scientific knowledge and guide the treatment of these patients in the future. The next challenge will be to enter data into the registry.

Assessment of Tumor Response and Resection Rates in Unresectable Colorectal Liver Metastases Following Neoadjuvant Chemotherapy with Cetuximab.

To investigate efficacy and safety of cetuximab combined with neo adjuvant chemotherapy regimen in patients with unresectable colorectal liver. This was a prospective trial with rate of Ro liver metastases resection as primary end point. Between January 2010 and December 2014, 46 patients with unresectable liver metastases from colon or rectum were enrolled. Patients received Cetuximab along with neoadjuvant chemotherapy where 34 (74 %) and 12 (2 6 %) patients received FOLFOX and FOLFIRI, respectively. They were assessed for response after 2-3 cycles by CT scan. Patients with resectable disease were offered liver surgery within 3-6 weeks of the last treatment cycle. The primary end point was resection rate of liver metastases, which was evaluated in all patients. Secondary end points were response rate according to Response evaluation criteria in solid tumors (RECIST) criteria, perioperative morbidity and mortality. An objective response was observed in 28 (60.9 %) patients. Seven (15.2 %) patients were reported radiologically to have a complete response (CR); 21 (45.7 %) patients had radiological partial response (PR). An additional 12 patients (26.1 %) demonstrated stable disease (SD) and only six patients (13.0 %) had disease progression (PD). Microscopically complete resections (R0 resection) was performed in all 28 patients (60.9 %). The most frequent toxicities were skin rash and diarrhoea. There was no operative mortality. Chemotherapy with cetuximab yields high response rates compared with historical controls, and leads to significantly increased resectability. Complete resection of previously unresectable colorectal liver metastases can be performed with minimal morbidity and mortality. This therapeutic strategy involves a multimodal approach.

The Initial Indian Experience with Cytoreductive Surgery and HIPEC in the Treatment of Peritoneal Metastases.

Worldwide, cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has been used for nearly 3 decades to treat peritoneal metastases (PM), improve quality of life, and prolong survival substantially in selected patients. In India, the use of the combined modality of treatment dates back a decade with majority of the efforts taking place within the last 5 years. The first PSOGI workshop (India) held in April 2015, at Bangalore, India offered an opportunity for Indian surgeons performing CRS and HIPEC to share their experience. To study the methodologies of CRS and HIPEC (hospital set up, equipment, training and surgical background) as well as the outcomes in terms of perioperative morbidity and mortality and short and long term survival of patients treated in India, Indian surgeons who had treated at least 10 patients with this combined modality were invited to present their experience. Data collection was retrospective. Analysis of the pooled data was carried out. Eight surgeons treated 384 patients with CRS and HIPEC over a period of 10 years. The commonest primary sites were ovary (as first line therapy n = 124), followed by appendix, including pseudomyxoma peritonei (n = 99), colorectum (n = 77), recurrent ovary (as second line therapy, n = 33), stomach (n = 15), primary peritoneal cancer (n = 10), peritoneal mesothelioma (n = 9) and rare tumors in 17 patients. The weighted mean PCI for all 384 patients was 18.25. 349/384 patients (90.88 %) had a complete cytoreduction (completeness of cytoreduction score of CC-0/1). Grade 3-5 complications developed in 108 patients (27.34 %) and 30 day mortality occurred in 28 (7.29 %) patients. This study showed that CRS and HIPEC can be performed with an acceptable morbidity and mortality in Indian patients. Most of the surgeons are on the learning curve and further improvement in these outcomes is expected over a period of time. Pooling of data related to both common and rare peritoneal cancers would be useful in knowing the disease behavior, response to treatment and outcomes in Indian patients. The 2015 PSOGI meeting provided a unique platform for data presentation with feedback from international experts in the field of peritoneal surface oncology. Future meetings are planned to expand the evaluation of Indian data and progress.

Prospective Randomized Study Comparing Robotic-Assisted Surgery with Traditional Laparotomy for Rectal Cancer-Indian Study.

Rectal cancer is one of the common cancers in India. Surgical management is the mainstay of initial treatment for majority of patients. Minimally invasive surgery has gained acceptance for the surgical treatment of rectal cancer because, compared with laparotomy, it is associated with fewer complications, shorter hospitalization, and faster recovery. The aim of this study is to evaluate the safety, feasibility, technique, and outcomes (postoperative, oncological, and functional) of robotic-assisted rectal surgery in comparison with open surgery in the Indian population. A prospective randomized study was undertaken from August 2011 to December 2012. Fifty patients who presented with rectal carcinoma were randomized to either robotic arm (RA) or open arm (OA) group. Both groups were matched for clinical stage and operation type. Technique and feasibility of robotic-assisted surgery in terms of operating time, estimated blood loss, margins status, total number of lymph nodes retrieved, hospital stay, conversion to open procedure, complications, and functional outcomes were analyzed. The mean operative time was significantly longer in the RA than in the OA group (310 vs 246 min, P < 0.001) but was significantly reduced in the latter part of the robotic-assisted patients compared with the initial patients. The mean estimated blood loss was significantly less in the RA compared with the OA group (165.14 vs 406.04 ml, P < 0.001). None of the patients had margin positivity. The mean distal resection margin was significantly longer in the RA than in the OA group (3.6 vs 2.4 cm, P < 0.001). A total of 100 % of patients in the RA group had complete mesorectal excision while two patients in the OA group had incomplete mesorectal excision. The average number of retrieved lymph nodes was adequate for accurate staging. The number of lymph nodes removed by robotic method is slightly higher than the open method (16.88 vs 15.20) but with no statistical significance. Conversion rate was nil. The mean hospital stay was significantly shorter in the RA group (7.52 vs 13.24 days, P < 0.001). Postoperative and functional outcomes were comparable between the two groups. Robotic-assisted surgery is an emerging technique in our country. Robotic-assisted rectal cancer surgery is safe with low conversion rates and acceptable morbidity and is oncologically feasible.

Anaesthetic management of extra-pleural pneumonectomy and hyperthermic intrathoracic chemotherapy procedure.

Malignant pleural mesothelioma is a rare tumour with survival of 9-17 months after diagnosis. Radical surgical resection by extra-pleural pneumonectomy combined with hyperthermic intrathoracic chemotherapy has shown to improve patient survival and better microscopic tumour control. Anaesthetic management of this procedure is challenging due to the complex pathophysiological changes associated with prolonged duration of surgery, one- lung ventilation, haemodynamic instability due to major blood loss, temperature variations including heat loss during pneumonectomy and rapid rise in temperature during hyperthermic chemotherapy, cardiac arrhythmias due to exposure to heated chemotherapeutics, cisplatin toxicity and acid-base changes. Intra-operative management involves protective ventilation, regulation of temperature and haemodynamics along with prevention of complications associated with 'heated chemotherapeutics'. Thorough pre-operative assessment and preparation, advanced intra-operative monitoring with prompt corrective interventions, will help in improved patient outcome in the immediate post-operative period. We present one such case done for the 1(st) time in India.

Intraoperative Frozen Section Evaluation of Sentinel Lymph Nodes in Breast Carcinoma: Single-Institution Indian Experience.

Sentinel lymph node biopsy is an established way of predicting axillary nodal metastasis in early breast cancer. Intraoperative frozen sections (FS) of sentinel lymph nodes (SLNs) can be used to detect metastatic disease, allowing immediate axillary lymph node dissection. The purpose of this study was to evaluate the accuracy of intraoperative frozen sections in evaluation of sentinel lymph nodes in cases of breast cancer. Between March 2006 and August 2010, a total of 164 patients with clinically node-negative operable breast cancer were subjected to sentinel lymph node biopsy of axillary lymph nodes using preoperative peritumoral injection of radioactive colloid and methylene blue. Intraoperative identification of sentinel nodes was done using a handheld gamma probe and identification of blue-stained nodes. The nodes were sent for frozen section examination. The results of frozen section were compared with the final histopathology. Out of the 164 cases, metastases were detected in SLN by frozen section in 38 cases. There were three false-negative cases (all showing micrometastasis on final histopathology). FS had sensitivity of 92.6 %, specificity of 100 %, and overall accuracy of 98.1 %. The positive predictive value was 100 %, and the negative predictive value was 97.6 %. FS for diagnosis of metastasis of SLNs is reliable. Patients with negative SLNs by the FS diagnosis can avoid reoperation for axillary lymph node dissection. However, FS may fail to detect micrometastases, especially in cases with small tumors.

Prospective randomized study comparing robotic-assisted hysterectomy and regional lymphadenectomy with traditional laparotomy for staging of endometrial carcinoma -initial Indian experience.

Robotic assisted hysterectomy with regional lymphadenectomy is increasingly used for the treatment of endometrial carcinoma. In the present study we evaluated the feasibility and technique of robotic assisted hysterectomy and lymphadenectomy in patients with endometrial carcinoma. A prospective randomized study was undertaken from July 2011 to June 2012, in 50 consecutive patients with carcinoma endometrium. Demographic (age, BMI) and perioperative data (operating time, estimated blood loss, total number of lymph nodes retrieved, hospital stay, conversion to open procedure, intraoperative and postoperative complications) of robotic assisted surgery were compared with open staging procedure. Mean age of the patient and BMI in both groups were comparable with no significant difference. Estimated blood loss (81.28 ml), hospital stay (1.94 days) and perioperative complications were significantly less in robotic assisted group in comparison to open method. Mean number of lymph nodes removed were 30.56 versus 27.6 which is suggestive of significant difference statistically. Operative time decreased as the experience of the surgeon increased but still significantly remained higher than the open procedure after 25 robotic assisted surgeries. All robotic surgeries were completed successfully without converting to open method. Robotic assisted staging procedure for endometrial carcinoma is feasible without converting to open method, with the advantages of decreased blood loss, short duration of hospital stay and less postoperative minor complications. Operative time will decrease further as the experience of surgeon increases. Para-aortic lymph node dissection is easily done and with a better ergonomics for surgeon.