Randomized Controlled Trial of Neoadjuvant Short-Course Radiotherapy Followed by Consolidation Chemotherapy Versus Long-Course Chemoradiotherapy in Locally Advanced Rectal Cancer: Comparison of Overall Response Rates.

BACKGROUND: Management of locally advanced rectal cancer (LARC) is evolving with current emphasis on the addition of chemotherapy to short course radiotherapy (SCRT). We primarily aimed to analyse the difference in overall response rates between SCRT with sequential chemotherapy and standard long-course chemoradiotherapy (LCCRT)in LARC. METHODS: After randomization, patients in arm A received 45 Gy in 25 fractions over 5 weeks with concurrent capecitabine while patients in arm B received 25 Gy in 5 fractions over 1 week followed by 3 cycles of CAPOX (capecitabine and oxaliplatin) chemotherapy. Clinical and radiological response assessment was made after the completion of neoadjuvant treatment, a week prior to surgery. Adjuvant chemotherapy was added to complete 6 months of peri-operative chemotherapy. Surgery was performed between 8 and 10 weeks of completion of radiation treatment in both arms. RESULTS: Of the 33 patients recruited in this study between February 2020 to July 2021, 17 patients were randomized to arm A and 16 to arm B. The rates of complete tumour regression were 23.1% in arm A versus 35.7% in arm B (p-value = 0.683). Pathological complete response (pCR) rate was 20% arm A versus 30% in arm B (0.446). A higher number of patients in arm B experienced grade 3 diarrhoea, whereas acute skin toxicity was seen only in arm A. SCRT had fewer treatment interruptions compared to LCCRT. CONCLUSIONS: SCRT followed by three cycles of CAPOX chemotherapy in the neoadjuvant setting is comparable to LCCRT in terms of tumour response. This may be a better alternative regimen with fewer treatment interruptions in a resource-limited setting.

Improving the performance status in advanced non-small cell lung cancer patients with chemotherapy (ImPACt trial): a phase 2 study.

PURPOSE: This phase II trial is designed to test whether the performance status (PS) of metastatic non-small cell lung cancer (mNSCLC) patients (pts) can improve with chemotherapy if their poor PS (Eastern Cooperative Oncology Group (ECOG) PS of ≥ 2) is due to disease burden rather than comorbidities. METHODS: Age18-65 years, Charlson's comorbidity index < 9, serum albumin ≥ 3.5 g/dl, adequate bone marrow and organ function, & ECOG PS ≥ 2 as judged by the worst score of three independent physicians were administered 3 doses of weekly paclitaxel at 60 mg/m2/dose. The primary endpoint was an improvement in ECOG PS by 1 point at 4 weeks; others: toxicity (CTCAE v 5.0), quality of life (QoL) assessment at baseline and 4 weeks by EORTC QLQ-C30 and EORTC QLQ-LC13. Optimal Simon's 2-stage design was used. RESULTS:  Forty-six patients were included with a median age of 56 years (interquartile range, IQR 54-59), 12 (26%) had comorbid conditions, and 87% with ECOG PS 3/4. PS improved in 11 pts at 4 weeks and in 7 beyond this time point. Grade 3/4 toxicities are seen in 20% (most common: anemia and diarrhea). At a median follow-up of 4.8 m (95% CI 3.27-14.9), the median progression-free survival and overall survival were 3.3 months (95% CI 2.36-5.6) and 6.8 months (95% CI 2.47-8.8), respectively. QoL improved for global QoL, role functioning, pain, dyspnea, insomnia, pain in the chest, pain in other parts, and worsened for alopecia and sore mouth. CONCLUSIONS:  Abbreviated chemotherapy is a useful, well-tolerated strategy in carefully selected poor PS mNSCLC patients that can improve PS and QoL. CLINICAL TRIAL: Clinical trial information: CTRI/2020/01/022617.

Efficacy and Safety of Percutaneous Radiological Gastrostomy (PRG) as a Rescue Measure for Enteral Feeding in Patients with Advanced Head, Neck, and Upper Digestive Malignancies.

Background Percutaneous radiologic gastrostomy is an established mode of enteral feeding for nutritional support for patients with dysphagia from upper digestive tract malignancy. Its role as a rescue measure in patients with advanced malignancy, presenting with absolute dysphagia and failure of nasogastric tube insertion has not been well established. Purpose This study was performed to assess technical success and long-term outcomes of percutaneous radiologic gastrostomy (push type) for nutritional support for patients with absolute dysphagia as a last ditch nonsurgical rescue effort for enteral access. Materials and Methods This was a prospective observational study of 31 patients who underwent push-type percutaneous radiologic gastrostomy over a period of 2 years (March 2017-March 2019). The study was a part of a larger trial approved by the institutional ethics committee. Patients were followed till the removal of tube, death, or 1 year, whichever was earlier. Gastrostomy tube-related problems and complications were documented. Descriptive summary statistics were employed to analyze the success rate and complications. Results Thirty-one patients with mean age 56 years (26-78 years) including 18 males and 13 females with head and neck squamous cell cancer and esophageal cancer presenting with absolute dysphagia or significant dysphagia with failed nasogastric or endoscopic enteral access were included. Overall technical success was 93.5% (29/31), achieved in 26/31 patients with just fluoroscopy guidance and 3/5 patients with computed tomography guidance. One major (3.3%) and two minor (6.5%) complications were encountered. Five out of 29 gastrostomy tubes had to be exchanged, after a mean of 44 days (1-128 days) after insertion. Conclusion Percutaneous radiologic gastrostomy is a safe and effective intervention even as a rescue measure in patients with absolute dysphagia from advanced upper digestive tract malignancies.

Patterns of Multimodality Management of Gastric Cancer-Single Institutional Experience of 372 Cases From a Tertiary Care Center in North India.

Introduction: Worldwide gastric cancer is the 5th most commonly diagnosed cancer and the leading cause of gastrointestinal cancer-related deaths. Alone surgery provides long-term survival improvements in 20% of the patients with local advanced gastric cancer. The results can be improved considering multimodal management including chemotherapy and radiotherapy. However, in low middle-income countries like India, multimodal management is challenging. Herein, we evaluated the experience of multimodal management of gastric cancer and the long-term outcome. Methods: Retrospective analysis of the data of 372 patients was done from a prospectively maintained computerized database from 1994 to 2021. Records were analyzed for demographic details, treatment patterns, recurrences, and long-term outcomes (DFS and OS). Statistical analysis was done with the package SPSS version 26 (IBM Corp, Chicago, Illinois, USA). Results: This study included 372 patients. The mean age of the patients was 54.07. A total of 307 patients (82.5%) were operated upfront, 45 (12%) received NACT, and 20 (5.5%) underwent the palliative procedure. A total of 53.2% underwent curative resection. R0 resection rate was achieved in 95% of patients. A total of 72.58% of patients required adjuvant treatment, and the majority of the patients underwent chemoradiotherapy. The most common site of metastasis was the liver. Median follow-up was 50.16 months. The 3-year disease-free survival and overall survival were 36.28% and 67.8%, and the 5-year disease-free survival and overall survival were 30.15% and 37.7%, respectively. Conclusion: Our study suggested that multimodal management is required in locally advanced gastric cancer to achieve good long-term outcomes. The treatment sequence can be tailored based on the available resources.

Treatment outcomes and prognostic factors in locally advanced non-small cell lung cancer - An experience from normal India.

Context: Chemoradiation is the standard of care in locally advanced non-small cell lung cancer (LA-NSCLC). Clinical presentation, disease course, and available treatment options are challenges to overcome. Little is known about the ideal timing and interaction of the two modalities, its relevance in day-to-day decision-making and the treatment outcome. Aims: The study evaluates the demographic profile, treatment pattern, outcome, and radiotherapy (RT) practice and patient care of LA-NSCLC at a tertiary cancer center. Setting and Design: This is a retrospective study from a tertiary cancer centre. Archives of patients of LA-NSCLC treated between June 2016 and June 2018 were included in our study. Materials and Methods: Clinical, demographic characteristics, treatment patterns, and outcomes were recorded. RT practice and patient care process including the integration of RT with other specialties, waiting time, and compliance to treatment were documented and analyzed. Statistical Analysis: Overall survival (OS) and progression-free survival (PFS) were the primary endpoints of the study. Log-rank test was used for univariate analysis for the factors on OS, and Cox's proportional hazards model was used for multivariate analysis for cofactors on OS. Results: Two hundred and thirty-two patients of lung cancer were treated during the study period. Fifty-four patients were squamous cell carcinoma, 108 were adenocarcinoma, and 12 were others. Out of 59 patients of LA-NSCLC, 34 underwent definitive chemoradiation. The median follow-up was 11 months (0.7-29), median overall treatment time was 44 days, median PFS was 8.9 months (range: 1.6-28.6), and median OS was 9.4 months (1.7-44.8). Time to start any oncological intervention was 1 month (0.1-4.3) and time to start RT was 2.1 months (0.1-5.4). Adherence to treatment was 91.2%. Age ≥65 and performance status ≥2 were significant for OS on univariate analysis and none on multivariate analysis. Conclusions: One-third of the cases of NSCLC present in LA stage and a third are suitable for definitive chemoradiation and only 20% undergo the planned treatment.

Long-Term Survivors of Metastatic Colorectal Cancer: A Tertiary Care Centre Experience.

Background Prognosis of metastatic colorectal cancer (mCRC) is poor and goal of treatment is mainly palliative unless there is limited metastatic disease which is surgically resectable. Here, we report a case series of long-term survivors treated predominantly with chemotherapy. Methods This is a single-center retrospective analysis of patients of mCRC. Records of metastatic colorectal cancer patients registered at Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, between the year 2005 and 2015 were retrieved and reviewed. Inclusion criteria were patients who survived 5 years or more, treated mainly by chemotherapy, with either initial presentation as metastatic disease or those who progressed after initial surgery with or without adjuvant therapy. The details about the patient characteristics, treatment, and outcome were collected. The data were censored on September 30, 2020. Results Records of 370 mCRC patients were reviewed. Thirty-one patients with all the available details fulfilled the criteria for inclusion in the study. Median age was 53 years (range, 22-74 years). Sixteen were women (51.6%). Twenty-four (77%) were newly diagnosed cases with initial presentation as metastatic disease. Commonest site of primary was on the left (21, 67.6%) followed by right side and transverse colon in 5 patients each. Liver was the most common site of metastasis ( n = 18, 58.06%). In metastatic setting, the most common chemotherapy regimen used in the first line was CAPOX ( n = 11, 35.48%). Only three patients could undergo metastatectomy. Monoclonal antibodies could be used only in 14 patients. Median overall survival (OS) of this cohort is 81.6 months (95% confidence interval [CI], 69.73-117.9). Conclusion A small but significant proportion of mCRC patients may achieve and maintain durable responses and long term survival with use of combination of chemotherapy with or without biologics.

Colorectal Cancers in Low- and Middle-Income Countries-Demographic Pattern and Clinical Profile of 970 Patients Treated at a Tertiary Care Cancer Center in India.

PURPOSE: Globally, colorectal cancer (CRC) ranks third in terms of incidence and second in terms of mortality. A relatively low burden of CRC has been reported from low- and middle-income countries (LMIC), and there is a paucity of publications related to CRC from LMIC. PATIENTS AND METHODS: A computerized comprehensive structured CRC clinical database was developed. All the patients with histopathologically proven CRC undergoing either curative and palliative multimodality management or surgical interventions between 2000 and 2019 were included in the study. A descriptive analysis of the demographic profile and clinical spectrum was performed. RESULTS: A total of 970 patients of CRC were treated between 2000 and 2019. Of these, 401 patients (41.3%) had colon cancer and 569 (58.7%) had rectal cancer. The male-to-female ratio was 1.79:1. The mean age at presentation was 47.7 years. A total of 337 (34.7%) patients qualified as young CRC (≤ 40 years of age at diagnosis). The commonest symptom among patients with colon cancer was abdominal pain; 55.6% of patients had a right-sided primary tumor as compared with 42.2% with left-sided tumors. The commonest symptom among patients with rectal cancer was bleeding per rectum. The predominant location of the tumor was in the lower rectum (58%). Majority of patients with CRC presented with locally advanced stage II and III disease. The most common histologic subtype encountered for both colon and rectal cancers was adenocarcinoma (84.8% and 81.2%, respectively). CONCLUSION: This study has revealed certain important findings related to CRC in LMIC including a higher burden of young colorectal cancer, a relatively higher proportion of rectal cancers in comparison with colon cancer, a high percentage of patients with low-rectal cancer, and advanced stage at presentation.

Safety and Efficacy of Modified FOLFIRINOX in Unresectable or Metastatic Gallbladder Cancer: A Phase II Pilot Study.

PURPOSE: For unresectable gallbladder cancer (GBC), gemcitabine and platinum is standard combination; however, outcome is poor. We conducted this study to find feasibility of modified flourouracil, oxaliplatin, and irinotecan in this group. MATERIALS AND METHODS: We conducted a prospective, phase II single-arm pilot study. Inclusion criteria were histologically proven GBC and Eastern Cooperative Oncology Group 0-1. Primary end points were overall response rates and overall survival. The following treatment was given: oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, and irinotecan 150 mg/m2, all once on day 1, fluorouracil 2,400 mg/m2 continuous intra-venous infusion over 46 hours repeated every 2 weeks, and maximum 12 doses, with primary granulocyte colony-stimulating factor prophylaxis. RESULTS: Between February 2019 and July 2020, 29 patients with unresectable GBC were enrolled. The median age was 52 years, and 18 were females. The Eastern Cooperative Oncology Group was 0 in 4. Five had bilirubin > normal, and 15 each had high serum alkaline phosphatase and carbohydrate antigen 19-9. Twenty-five patients had stage IV disease, and remaining unresectable locally advanced disease. A median of 8.5 cycles was given, and 11 completed treatment. Nine stopped chemotherapy because of progression, and one because of toxicity, and treatment is ongoing in three. Twenty-two required dose reduction. A treatment delay of 1-2 weeks was seen in 25 patients. Best response was complete response 1, partial response 13 (overall response rate 48.2%), and stable disease 9. Four patients with metastatic disease underwent R0 resection. As on cutoff date, nine are surviving (three without disease). Eighteen died of PD, and in two, cause was unknown. There was no toxic death. The median overall survival and progression-free survival were 309 and 252 days, respectively. Twenty-three patients experienced grade III or IV toxicity, and common were diarrhea (13), vomiting (12), and anemia (7). CONCLUSION: First-line modified flourouracil, oxaliplatin, and irinotecan is feasible in unresectable GBC with encouraging responses. Toxicities are higher but manageable. Higher response rates make this an option to explore in borderline resectable cases.

Radiation cystitis: A late effect of radiotherapy in a patient with cervical rhabdomyosarcoma.

We report the case of a 22-year old female presenting with an embryonal rhabdomyosarcoma of the cervix that was successfully treated by surgery followed by adjuvant radiation therapy and chemotherapy. She subsequently developed radiation cystitis after 10 years of follow-up. She was successfully treated with cystoscopic fulguration. In this report, we discuss a review of management strategies for cervical rhabdomyosarcoma and also throw some light on incidence and management of radiation cystitis after pelvic radiotherapy. We discuss the dose independence of radiation cystitis, which can be seen after as low as 4500 cGy of pelvic radiation.

Metastatic colo-rectal cancer: real life experience from an Indian tertiary care center.

BACKGROUND: No data exist for the long-term outcome of metastatic colorectal cancer (mCRC) from the Southern part of Asia. The primary objective of the study is to evaluate the survival outcome of mCRC from an Indian tertiary care center. The study also aims to highlight the treatment pattern practiced and the unique clinico-pathologic characteristics. METHODS: This is a single-center retrospective observational study done at a large referral tertiary care center in North India. All patients with synchronous or metachronous mCRC who received at least one dose of chemotherapy for metastatic disease, registered between 2003 to 2017 were included. Primary outcome measures were overall survival and progression-free survival and prognostic factors of overall survival. Descriptive analysis was done for the clinicopathological characteristics and treatment patterns. Kaplan Meier method for overall survival and progression-free survival. Cox regression analysis was performed for the determination of the prognostic factors for overall survival. RESULT: Out of 377 eligible patients, 256 patients (68%) had de novo metastatic disease and the remaining 121 (32%) progressed to metastatic disease after initial treatment. The cohort was young (median age, 46 years) with the most common primary site being the rectum. A higher proportion of signet (9%) and mucinous histology (24%). The three common sites of metastasis were the liver, peritoneum, and lung. In the first line, most patients received oxaliplatin-based chemotherapy (70%). Only 12.5% of patients received biologicals in the first-line setting. The median follow-up and median overall survival of study cohort were 17 months and 18.5 months. The factors associated with poor outcome for overall survival on multivariate analysis were ECOG performance status of > 1, high CEA, low albumin, and the number of lines of chemotherapy received (< 2). CONCLUSION: The outcome of mCRC is inferior to the published literature. We found a relatively higher proportion of patients with the following characteristics; younger, rectum as primary tumor location, the signet, and mucinous histology, higher incidence of peritoneum involvement. The routine use of targeted therapies is limited. Government schemes (inclusion of targeted therapies in the Ayushman scheme), NGO assistance, and availability of generic low-cost targeted drugs may increase the availability.

Assessment of Brain Metastasis at Diagnosis in Non-Small-Cell Lung Cancer: A Prospective Observational Study From North India.

PURPOSE: The incidence of symptomatic brain metastasis at diagnosis in non-small-cell lung cancer (NSCLC) is 5%-10%, and up to 40% develop during the disease course. There is a paucity of data supporting the role of brain imaging at diagnosis in asymptomatic cases particularly from resource-constraint settings. Here, we present our experience of mandatory baseline brain imaging with contrast-enhanced computed tomography (CECT) scans of all patients with NSCLC. MATERIALS AND METHODS: This was a prospective observation study of patients with NSCLC with mandatory baseline brain CECT and a CNS examination. All histology proven patients with NSCLC diagnosed between January 2018 and October 2019 were included irrespective of stage. RESULTS: A total of 496 patients were enrolled. The median age was 57 years (range, 23-84) with majority being males (75%) and smokers (66%). The prevalence of epidermal growth factor receptor mutations and anaplastic lymphoma kinase fusions was 33.4% and 12%, respectively. Brain imaging leads to upstaging in 7% cases. The prevalence of brain metastases was 21% (n = 104), with half being asymptomatic (51%). Factors associated with higher proportion of brain metastasis were young age (≤ 40 years), adenocarcinoma histology, poor Eastern Cooperative Oncology Group performance status (3 and 4), and high neutrophil-lymphocyte ratio (NLR) (> 2.5). After a median follow-up of 10.8 months (95% CI, 7.33 to 12.73), the median overall survival was 7.46 versus 12.76 months (hazard ratio 0.67; 95% CI, 0.46 to 0.96; P = .03) in patients with and without brain metastases, respectively. On multivariate analyses, high NLR and molecular graded prognostic assessment affected the overall survival significantly. CONCLUSION: In our study, 21% of patients had brain metastasis at diagnosis detected with a mandatory baseline brain imaging with CECT. NLR and molecular graded prognostic assessment are significant predictors of survival in patients with brain metastasis.

An Open-Label Randomized Controlled Trial Comparing the Efficacy and Safety of Pemetrexed-Carboplatin versus (Weekly) Paclitaxel-Carboplatin as First-Line Chemotherapy in Advanced Non-Squamous Non-Small Cell Lung Cancer.

BACKGROUND: Before the approval of first-line immune checkpoint inhibitors, platinum doublets were the standard of care in patients with treatment-naïve advanced non-small cell lung cancer (NSCLC) without targetable driver mutations. Pemetrexed-platinum combinations are preferred in non-squamous NSCLC. However, there has been no direct comparison to paclitaxel-carboplatin. METHODS: This open-label randomized trial was designed to compare pemetrexed-carboplatin with (weekly) paclitaxel-carboplatin in treatment-naïve advanced/metastatic non-squamous NSCLC without driver mutations. Patients received either pemetrexed 500 mg/m2 and carboplatin AUC 5 every 3 weeks, or paclitaxel 80 mg/m2 on day 1, day 8, and day 15 with carboplatin AUC 5 every 4 weeks for 4 cycles. Patients in both arms were allowed to receive pemetrexed maintenance. RESULTS: A total of 180 patients were enrolled. The study was terminated early; however, at the time of analysis 75.8% of the required events had occurred. Finally, 164 patients were evaluable, 83 in the pemetrexed arm and 81 in the paclitaxel arm. After a median follow-up of 17 months, progression-free survival (PFS) rates at 6 months were not different in the two treatment arms (47.45 vs. 48.64%, p = 0.88). The median PFS values were 5.67 months (95% CI 3.73-7.3) and 5.03 months (95% CI 2.63-7.43) in each arm, respectively (HR 1.13, 95% CI 0.81-1.59, p = 0.44). The median overall survival was also not different: 14.83 months (95% CI 9.5-18.73) and 11.3 (95% CI 8.3-19.7; HR 1.19, 95% CI 0.8-1.78, p = 0.37). All grade toxicities were similar except for alopecia and peripheral neuropathy, which were higher in the paclitaxel arm. CONCLUSION: Pemetrexed-carboplatin is not superior to (weekly) paclitaxel-carboplatin as the first-line regimen in advanced non-squamous NSCLC in terms of PFS.

Cytotoxic chemotherapy in advanced non-small cell lung cancer with poor performance status: A retrospective analysis from routine clinical practice.

BACKGROUND: Platinum-based combination chemotherapy is recommended as the standard treatment for patients with advanced non-small-cell lung cancer (NSCLC), but its benefit is limited to patients with performance status (PS) of 0 or 1. However, it is not clear whether these benefits apply to patients with poor performance status (PS 2 and above) and there are no predictors of outcome to suggest whom to treat. The patients with poor performance status (PS 2 and above) accounts for a significant portion (up to 30%) of patients of our practice. In this retrospective analysis, we have analyzed our experience of chemotherapy in patients with poor performance status. METHOD: A retrospective analysis of patients of advanced NSCLC with poor PS (ECOG PS 2 or more), treated with chemotherapy from October, 2016 to June, 2018 was done. Patients with driver mutations who were treated with first line tyrosine kinase inhibitors were excluded. Hospital case records were reviewed for baseline characteristics, treatment details, and outcome data. Kaplan-Meier curves were drawn to estimate progression free survival. Log-rank test was used to assess factors affecting survival. Data was analyzed using STATA ver 11 (StataCorp. 2009. College Station, TX: StataCorp LP). P value <0.05 was taken as significant. RESULT: A total of 96 patients were included in the analysis. The median age of the patients was 62 years (range 30-84 years). Majority (67.7%) was males and 65% patients were smokers (current or former). Patients with ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 2 constituted 64.5% of this cohort and 34 patients (33.5%) had an ECOG PS of 3 or 4. The most common chemotherapy regimen used was combination of weekly paclitaxel (60 mg/m2) and carboplatin (AUC2) in 57.8%. Most patients (64%) could complete 4 or more cycles of chemotherapy, however, 15 patients (15.7%) could receive only 1 cycle. Grade 3/4 toxicities were observed in 22 (23%) % patients, which were hematological in most cases (anemia and thrombocytopenia). At least one point improvement in ECOG PS from baseline during chemotherapy was observed in 43 patients (45%) after 4 cycles of chemotherapy. Objective response and disease control rates were 20% and 48.42%, respectively. After a median follows-up of 11.2 months, median progression free survival was 6.3 months (95% confidence interval 5-10.63). On univariate analysis, we found that male sex and use of weekly paclitaxel-carboplatin were associated with better progression-free survival PFS. CONCLUSION: Systemic chemotherapy in modified doses and schedules in advanced NSCLC patients with PS 2 and above is feasible and may be associated with better symptom palliation with clinical benefit and improved survival.

Adjuvant radiation therapy for malignant tumours of the eyelid: Experience from a tertiary cancer centre in India.

Background: . Tumours of the eyelid are a rare subgroup of neoplasms with varied histology and inherent differences in clinical behaviour. Surgery is the standard of care, and adjuvant radiation therapy (RT) is given in the presence of features suggesting a high risk of local recurrence. The treatment of lymph nodes in the neck is debatable. We reviewed the utility of RT for lymph nodes in the neck in patients with malignant tumours of the eyelid. Methods: . We reviewed medical records of all patients with tumours of the eyelid treated at our centre from July 2006 to December 2014 for their demographic, clinical profile, treatment details and outcome. Results: . The records of 37 patients were included for analysis, of these 34 underwent surgery and 21 received adjuvant RT. Their median age was 60 (range 30-85) years. Sebaceous cell carcinoma was the most common (50.4%). The median disease-free survival (DFS) was 35 months (95% CI 17.9-52.0). The 1- and 3-year DFS were 82.7% and 45%, respectively. Univariate analysis showed a superior outcome with early stage (T1) tumours (p=0.01), RT dose of ≥60 Gy and those underwent lymph node dissection (p=0.03). The presence of high-risk factors including close or positive margin had an inferior outcome with a trend towards statistical significance (p=0.06). Conclusion: . We found a favourable outcome with early T stage, RT dose of ≥60 Gy and lymph node dissection. High-risk histopathological features including close margins and positive lymph nodes merit adjuvant RT including regional lymph nodes.

Modified gemcitabine and oxaliplatin or gemcitabine + cisplatin in unresectable gallbladder cancer: Results of a phase III randomised controlled trial.

AIM: To determine equivalence of modified gemcitabine and oxaliplatin compared with gemcitabine and cisplatin in unresectable gallbladder cancer (GBC). Primary end-point was overall survival (OS). METHODS: Open label, prospective, randomised phase III equivalence study. Inclusion criteria included histologically proven unresectable GBC, 18 years or older, adequate organ functions and Eastern Cooperative Oncology Group ≤2. SAMPLE SIZE: 108 patients were required in each arm to have an equivalence margin of ±2 months with power of 80%. TREATMENT: Modified gemcitabine and oxaliplatin (mGemOx)-gemcitabine 900 mg/m2, oxaliplatin 80 mg/m2, maximum 6 cycles; gemcitabine + cisplatin (CisGem)-gemcitabine 1000 mg/m2, cisplatin 25 mg/m2, maximum 8 cycles, all day 1 and 8 every 3 weeks. RESULTS: Two hundred sixty subjects were recruited between February 2011 and July 2015. Two hundred forty-three patients (119, mGemOx and 124, CisGem) received at least 1 dose and analysed for safety and efficacy (modified intention to treat). Median OS was 8·5 months for whole group (95% confidence interval [CI]: 7·9-9·1). Median OS in mGemOx was 9 months and 8·3 months in CisGem; p = 0·057 (hazard ratio = 0·78; 95% CI = 0·60-1·02). Restricted mean OS for follow-up limited to 30 months was 11·2 months (95% CI: 9·8-12·6) in mGemOx and 10·4 months (95% CI: 9·1-11·7) in CisGem. Difference of the mean was 0·8 months with 95% CI, exceeding 2 months (-1·1 to 2·7), hence rejecting equivalence. Peripheral neuropathy, thrombocytopaenia in mGemOx and nephrotoxicity was higher with CisGem. CONCLUSION: This trial failed to show equivalence of eight cycles of CisGem to six cycles of mGemOx. Numerically OS was better with mGemOx. Toxicities were different. The trial was not powered to answer superiority. CLINICAL TRIAL REGISTRATION: CTRI/2010/091/001406.

Multimodality management of incidentally detected gall bladder cancer: long term results from a tertiary care cancer centre.

BACKGROUND: Gall bladder cancer (GBC) is the most common biliary tract malignancy in India. GBC present either with incidental diagnosis after simple cholecystectomy (SC) or with a primary gall bladder mass. Incidentally detected gall bladder cancer (ICGB) has traditionally been thought to be a relatively early stage disease but there are controversies associated with various aspects of its management. In this article we describe our experience with multimodality management of ICGB. METHODS: A retrospective analysis of incidentally detected GBC patients was performed to analyze the profile of presentation and treatment outcome. After initial radiological evaluation for operability, all the patients underwent surgical exploration. If found resectable, revision surgery including 2 cm wedge resection of liver and lymphadenectomy was done followed by concurrent chemo-radiation for tumors T2 and above stages. RESULTS: A total of 54 patients with incidentally detected GBC with a male to female ratio of 1:3 and mean age of 47.5 years were included in the study. Thirty-four (63%) patients underwent curative resection followed by adjuvant chemoradiotherapy. The remaining 20 patients had metastatic/unresectable disease. The 5 years disease free and overall survival (OS) for patients receiving curative treatment was 64% and 72% respectively. On univariate analysis, presence of residual disease in the gallbladder fossa and liver were significant risk factors for disease recurrence. Depth of invasion, adjuvant treatment received and stage were significant prognostic factors for OS. CONCLUSIONS: Incidentally detected GBC is increasing in incidence. A multi-modality approach with revision surgery and adjuvant chemo-radiation treatment may yield better outcome. Presence of residual disease is a poor prognostic factor. Optimal evaluation before SC and early referral to specialty center is therefore important in patients with suspicion of gallbladder malignancy because first chance is probably the best chance.

Locally advanced cervical cancer - neoadjuvant chemotherapy followed by concurrent chemoradiation and targeted therapy as maintenance: A phase II study.

AIM: The survival in locally advanced cervical cancer remains low. We evaluated the role of neoadjuvant chemotherapy (NACT), chemoradiotherapy (CRT), followed by gefitinib maintenance in locally advanced cervical cancer. MATERIALS AND METHODS: Twenty-five patients with locally advanced carcinoma cervix were enrolled between July 2012 and May 2013. Patients received 6 weekly doses of NACT Paclitaxel (60 mg/m2) and carboplatin (AUC 2), followed by CRT and brachytherapy. The analysis of epidermal growth factor receptor (EGFR) expression was carried out by immunohistochemistry. Gefitinib (250 mg daily) was given as maintenance therapy for 1 year after completion of chemoradiation. Comparison of EGFR expression and survival outcomes was done. RESULTS: Twenty-four of 25 patients completed the neoadjuvant chemotherapy and concurrent chemoradiotherapy. Post-CRT, all patients were started on gefitinib maintenance, and twenty patients completed the intended 1 year of gefitinib maintenance. Nineteen (76%) patients had a radiological complete response to NACT. EGFR was moderately or strongly expressed in 86.3% of the patients. The 3-year overall survival was 69.8%, and 3-year progression-free survival was 51.4%. Expression of EGFR was not found to be a significant factor affecting overall survival or progression-free survival. CONCLUSIONS: Weekly neoadjuvant chemotherapy is associated with a good response rate in locally advanced cervical cancer. Neoadjuvant chemotherapy, chemoradiation, followed by gefitinib maintenance gives good survival outcome in patients with locally advanced cervical cancer.

Cutaneous metastases from neuroendocrine carcinoma of the cervix-An unusual metastatic lesion from an uncommon malignancy.

Neuroendocrine carcinoma (NEC) is an uncommon and aggressive type of small cell cervical cancer. NECs mostly arise from gastro-entero-pancreatic tract and the lung, but rarely from other organs like cervix. NEC of the cervix is a rare malignancy and constitutes 0.9%-1.5% of cervical tumors. NECs of cervix are common in perimenopausal females and present with abnormal vaginal bleeding and mimic squamous cell cancers, usually with no distinguishing features. On Immunohistochemistry, presence of chromogranin, synaptophysin, and CD-56 is necessary to make a diagnosis of small cell carcinoma. These tumors are notorious for local as well as distant relapses in comparison to their squamous and adenocarcinoma counterpart. NECs are characterized by highly aggressive clinical behavior and carry a poor prognosis. They commonly metastases to lung, liver, brain, and bones even in early stages of the disease. Metastasis to skin is a rare occurrence. We herein report a case of a NEC of the uterine cervix with multiple cutaneous metastases. After the initial diagnosis of NEC of cervix, the patient received concurrent chemoradiation followed by intracavitary brachytherapy. On subsequent follow-up, the patient developed multiple cutaneous metastasis along with liver metastases. This case is reported in view of rarity of the case with skin metastases. To the best of our knowledge, only 3 cases of cutaneous metastases from NEC of the cervix are reported till date. Being a rare malignancy, evidence in the literature is in form of case reports and small case series. Thus, the optimal treatment strategy varies for these patients. Multimodality management with teamwork is necessary to manage individual patients.

Alveolar soft part sarcoma of orbit: A rare diagnosis.

OBJECTIVE: Alveolar soft part sarcoma (ASPS) is an aggressive, rare tumour with unique morphological and histopathological features. METHODS: We report a rare case of orbital ASPS and its management in a young male who presented with painless proptosis and progressive loss of vision. RESULT: Twenty-two year male presented with a history of gradually increasing proptosis with loss of vision since 12months. He underwent radical re-excision of mass with right orbital exenteration and reconstruction using temporalis muscle flap. Adjuvant radiotherapy to a dose of 64Gy in 32 fractions over 6.5weeks was planned in view of positive surgical margins. Patient is free of disease and currently under follow up in multidisciplinary clinic. CONCLUSION: Function preserving surgery remains the standard treatment approach in localised disease however the complex anatomy and locally aggressive nature makes it difficult to achieve clear surgical margin. Adjuvant radiotherapy has shown to improve local control in patients with positive surgical margins.

Anaplastic hemangiopericytoma of eyelid: An unusual location.

Hemangiopericytomas (HPCs) are rare soft tissue tumors. The eyelid is a very uncommon site for these tumors, and an anaplastic variant of HPC in the eyelid has not been reported before. A 44-year-old male presented with complaints of slowly progressive, painless swelling on the inner aspect of the left upper eyelid for 9 months. He underwent local excision of the swelling and histopathology revealed a WHO Grade III anaplastic HPC. Whole body 18 F-fluorodeoxyglucose positron emission tomography-computed tomography done postoperatively did not show any evidence of local or distant disease. The patient was planned for adjuvant radiotherapy of 60 Gy in 30 fractions over 6 weeks in view of high grade of histopathology and doubtful margins. He is disease free at the time of the last follow-up. To the best of our knowledge, this is the first case of anaplastic HPC of eyelid being reported in English literature.