Tertiary Cancer Center In India Research Articles

MM-466 Early Impressions With Use of BCMA-Directed Therapy: Elranatamab in Multiply Relapsed/Refractory Multiple Myeloma: A Safety and Efficacy Analysis in a Tertiary Cancer Center in India

MM-466 Early Impressions With Use of BCMA-Directed Therapy: Elranatamab in Multiply Relapsed/Refractory Multiple Myeloma: A Safety and Efficacy Analysis in a Tertiary Cancer Center in India

Early Impressions With Use of BCMA-Directed Therapy: Elranatamab in Multiply Relapsed/Refractory Multiple Myeloma: A Safety and Efficacy Analysis in a Tertiary Cancer Center in India

Early Impressions With Use of BCMA-Directed Therapy: Elranatamab in Multiply Relapsed/Refractory Multiple Myeloma: A Safety and Efficacy Analysis in a Tertiary Cancer Center in India

Quality of Life Determinants in Patients with Metastatic Prostate Cancer: Insights from a Cross-Sectional Questionnaire-Based Study.

Prostate cancer is one of the most prevalent malignancies affecting men globally, with a significant impact on health-related quality of life (HRQOL). With the recent therapeutic advancements and improvements in survival, there is a need to understand the determinants of HRQOL in metastatic prostate cancer patients to optimize treatment strategies for quality of life as the number of survivors increases. The aim of this study was to identify clinical variables that affect HRQOL and its domains in patients with metastatic prostate cancer. We conducted a cross-sectional questionnaire-based study in patients diagnosed with metastatic prostate cancer at a tertiary cancer center in India. Baseline clinical features, treatment details, and completed Functional Assessment of Cancer Therapy-Prostate (FACT-P), composed of FACT-general (FACT-G) and prostate cancer-specific concerns subscale (PCS) and FACT-P Trial Outcome Index (FACT-P TOI) questionnaires, were collected. The mean total, as well as individual domain scores, were calculated. Additionally, these were stratified by the current treatment being received by patients. Linear regression was used to identify independent factors affecting HRQOL in these patients. Of the 106 enrolled patients, 84 completed the FACT-P questionnaire and were included in the analysis. The median age was 66 years, and at the time of assessment, 3 patients (3.6%) were receiving androgen deprivation therapy only, 53 patients (63.1%) were on ADT + androgen receptor-targeted agents (ARTAs), and 18 patients (21.4%) patients received ADT + chemotherapy. The mean (±standard deviation) of the FACT-P TOI score was 70.33 (±15.16); the PCS subscale was the most affected, followed by functional well-being. Patients on chemotherapy scored significantly higher on PCS, but the composite scores were not significantly different. Univariable regression identified obesity (body mass index > 25 kg/m2) and duration of first-line treatment as significant predictors of better HRQOL; however, obesity was the only independent predictor in multivariable analysis (β = 8.2; 95% confidence interval, 1.2 to 15.0; p = 0.022). Obesity also independently predicted a better FACT-P and its physical well-being domain score and PCS. Prostate cancer patients experience impaired QoL, especially in the prostate cancer-specific and functional well-being domains. Lower BMI is an independent predictor of poor QoL, and this requires efforts to assess the impact of strategies to manage the nutritional status of patients with metastatic disease on QoL outcomes.

Optimizing the Outcome of Pediatric Metastatic Neuroblastoma in a Nontransplant Setting in a Developing Country: Retrospective Study from a Tertiary Cancer Center in India

Abstract Objective This article estimates the survival of children over 1 year of age diagnosed with metastatic neuroblastoma (NB) and treated in a nontransplant facility and determines the factors affecting survival. Materials and Method Case records of children aged 1 to 14 years treated for metastatic NB in our center from January 2008 to December 2017 were studied. Patients received conventional chemotherapy followed by surgery, radiotherapy, and metronomic maintenance chemotherapy. Results Eighty-nine patients with metastatic NB received treatment. Mean age was 3.5 years and male:female ratio was 1.1:1. The most common primary site was suprarenal (55%) and the most common site of metastasis was bone marrow (76%). Forty percent patients had multiple metastatic sites. Mean baseline lactate dehydrogenase (LDH) was 3724 U/L (range 303–16609 U/L) and 65% patients had LDH > 750 U/L. Fifty-three patients (59.6%) had good response to chemotherapy as evidenced by clearance of metastatic disease, but out of them, 43 patients (81%) progressed subsequently. Twenty-six patients underwent surgery and 12 patients received maintenance therapy. Seventy-four patients (86%) developed recurrence and all but one died. Median time to recurrence and death were 9 months (range 0–120 months) and 10 months (range 1–123 months), respectively. At a median follow-up of 72 months (range 15–135 months), 16 patients are alive, with 5-year disease-free survival and overall survival of 17.6 and 18.4%, respectively. Age, baseline LDH, chemotherapy regimen, and response to treatment significantly affected survival. Conclusion Younger age, lower baseline LDH, and good response to chemotherapy appear to confer survival advantage in pediatric metastatic NB, and may be used for optimization of treatment in the nontransplant setting in developing countries.

End of Life Care Practices at a Tertiary Cancer Centre in India: An Observational Study.

To assess the End of life care (EOLC ) practices and the magnitude of futile care in a tertiary cancer center. To find out the barriers in provision of good EOLC in cancer patients. An observational study was done on 129 patients. Patients were enrolled using the palliative prognostic index (PPI) in the end of life stages. Socio-demographic and clinical details were recorded. Detailed counselling done by the palliative physician or the oncologist was recorded. The barriers in provision of care were recorded. In this study initial experience of 129 patients were analyzed. PPI score was >6 (survival shorter than 3 weeks) in 85 (65.89%) ; 34 (26.36%) had PPI score between >4 to 6 (survival between 3 to 6 weeks); and 10 (7.75%) patients had PPI score less than equal to 4( survival more than 6 weeks).77 (59.69%) patients preferred home as their place for EOLC while 41(31.78%) preferred hospital, 7 (5.43%) preferred hospice while 4 (3.10%) opted ICU for their EOLC . The most common barrier associated was caregiver related in 34 case, followed by physician related in 14 cases and patients related in 3 cases, because of hope of being cured in hospital, social stigma, fear of worsening of symptoms at home, denial. EOLC is the least studied part of patient care with various barriers. With proper communication and a good palliative care support, futile treatment can be avoided. With healthy communication we can empower family members and patients for a good EOLC.

Impact of Low BMI and Nutritional Status on Quality of Life and Disease Outcome in Breast Cancer Patients: Insights From a Tertiary Cancer Center in India

This study investigates the impact of Body Mass Index (BMI) on Quality of Life (QoL) and treatment outcomes in breast cancer (BC) patients, particularly focusing on underweight individuals with compromised nutritional status. A nonrandomized prospective study comprising 121 newly diagnosed patients across various BMI categories utilized FACT-B & FACIT-Sp-12 questionnaires. Follow-ups occurred at baseline, during (3rd and 6th), and after (12th month) anthracycline-taxane chemotherapy, either sequentially or concomitantly. Patients with low BMI (<18.5 kg/m2; 53.7%) exhibited significantly poorer QoL, marked by compromised nutritional indicators (low MUAC and SFT). Repeated measures ANOVA identified significant correlations between BMI groups in functional, social, and emotional QoL aspects (p < 0.05), with no notable differences in other domains. A Chi-square (ꭓ2) test underscored a significant link between BMI and treatment response (p < 0.0001), showing higher rates of non-responders among underweight patients (p = 4.259e−14). The study advocates pretreatment consultation with a dietitian as standard care for Indian BC patients, offering complimentary nutritional support for improved QoL outcomes and treatment responses.

A Clinical Trial Registry - India audit of listed head-and-neck cancer trials and studies from 2008-2022: A retrospective study

ABSTRACT Background: Clinical trials are vital for advancing cancer treatment, but gaps exist in establishing ethical practices and transparency, especially in the context of head-and-neck cancers (HNCs) in India. Objectives: The primary objective of the study was to conduct a critical audit of the Clinical Trials Registry – India (CTRI) from 2008 to 2022; to quantify the number of studies and trials related to HNCs. Our secondary objective was to evaluate the credibility, accountability, and ethical advancements attributed to these registrations within India’s clinical research landscape. Materials and Methods: This was a retrospective study conducted between October 2022 and August 2023 at Homi Bhabha Cancer Hospital and Research Center, a tertiary cancer center in India. A thorough examination of the CTRI and PubMed databases was performed, encompassing 356 HNC trials registered at CTRI. Parallelly, 926 peer-reviewed publications from the leading clinical trial centers were assessed for credibility and accountability. Results: Of the 356 trials, 211 (59.3%) were interventional; however, 225 (63.2%) lacked explicit primary endpoints. Tata Memorial Center, Mumbai, India registered the maximum share with 98 (27.5%) trials registered during the period. Among the leading trial centers, notable discrepancy between CTRI registration and subsequent publication was observed, ranging from 2.2-8% across Tata Memorial Center (Mumbai), All India Institute of Medical Sciences (New Delhi), and Kasturba Medical College (Manipal). Conclusion: This audit exposed substantial ethical and transparency gaps, with a marked concentration in a few institutions within the Indian HNC clinical trials’ landscape. The study calls for urgent reforms to improve multi-institutional collaboration and ethical standards for enhanced human trials.

Lymphoblastic lymphoma presenting as soft-tissue swelling – A single-center experience

Abstract: BACKGROUND: Lymphoblastic lymphomas (LBL) are a rare, aggressive type of non-Hodgkin lymphomas and constitute 2% of all lymphomas. It is classified as T-lymphoblastic lymphoma (T-LBL) and B lymphoblastic lymphoma (B-LBL) and resembles acute lymphoblastic leukemia (ALL), with no or limited bone-marrow involvement. LBL rarely present as soft-tissue swellings. Soft-tissue involvement is more common in B-LBL than in T-LBL. They occur predominantly in adolescents and young adults and have a prognosis similar to ALL. OBJECTIVE: p&gt;The aim was to study the clinical characteristics, treatment response, and survival of patients with lymphoblastic lymphoma presenting with soft-tissue swelling. SETTINGS AND DESIGN: This was a retrospective study of eight adolescent and adult patients with lymphoblastic lymphoma presenting with soft-tissue swelling conducted in the Department of Medical Oncology at a tertiary cancer center in India. STATISTICAL ANALYSIS: The baseline patient characteristics, treatment details, and response assessment were analyzed using descriptive statistics. Overall survival (OS) and progression-free survival were obtained by the Kaplan–Meier method, using the SPSS version. 11. MATERIALS AND METHODS: We present the clinical features, imaging, diagnosis, treatment, and outcome of eight cases of lymphoblastic lymphoma presenting with soft-tissue swellings. Patients above 14 years of age treated over 12 years were included in the study. RESULTS: There were five males and three females. The median age at diagnosis was 24 years. Common presenting complaints were swelling, pain, and paraparesis. The sites of involvement were the epidural mass, thigh, calf, breast, and anterior chest wall. The diagnosis was confirmed by immunohistochemistry. Seven patients were diagnosed with B-LBL and one with T-LBL. They were treated with intensive chemotherapy (six patients with Berlin–Frankfurt–Munster protocol and two with hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone). Three patients received consolidation radiotherapy and one received palliative radiotherapy. Seven patients attained remission after induction chemotherapy and four of them are currently alive at a median follow-up of 48 months. The 2-year OS was 71.4%. CONCLUSION: Even though rare, lymphoblastic lymphoma should be considered a differential diagnosis in patients presenting with soft-tissue swelling and should be managed with systemic chemotherapy similar to ALL.

Empty pelvis syndrome: a retrospective audit from a tertiary cancer center.

Empty pelvis syndrome (EPS) has been defined as a complications arising as a sequel of empty space created after extensive pelvic surgery involving perineal resection. However this definition has been heterogenous throughout the limited literature available. Hence, EPS is a significant yet under recognized complication vexing both patients and surgeons. Even till date, prevention and management of EPS remain a challenge. Various preventive strategies have been employed each with its own complications. Few small studies mentioned incidence of this dreaded complication in between 20 and 40%. But most of these studies quote vague evidence and especially only after TPE surgeries. To the best of our knowledge, incidence after APR and PE has never been mentioned in literature. To assess the clinical burden of empty pelvis syndrome in patients undergoing abdominoperineal resection (APR), posterior exenteration (PE), or total pelvic exenteration (TPE) for low rectal cancers. This is a retrospective audit from a high-volume tertiary cancer center in India. Patients who underwent APR, PE, or TPE between the years 2013 to 2021 were screened and analyzed for incidence, presentation, and management of empty pelvic syndrome (EPS). A total of 1224 patients' electronic medical records were screened for complications related to empty pelvis. The overall incidence of EPS was 95/1224 (7%) with 55/1024 (5%) in APR, 8/39 (20.5%) in PE, and 32/143 (21.9%) in TPE. The most common clinical presentation was small bowel obstruction 43/95 (45.2%) and most presented late, 56/95 (60%), i.e., after 30days of surgery. Most of the patients who had EPS were managed conservatively 55/95 (57%). EPS is a significant clinical problem that can lead to major morbidity, especially after exenterative surgeries warranting effective preventive strategies.

Telangiectatic Osteosarcoma—A Single-Center Experience

Telangiectatic osteosarcoma is an uncommon subtype of osteosarcoma accounting for less than 4% of all cases of osteosarcoma. It is characterized by distinctive radiographic, pathologic features, and prognostic implications. Radiologically and microscopically, it mimics aneurysmal bone cyst. The objective of this study was to study the clinical profile and treatment outcome of patients with telangiectatic osteosarcoma. Thirteen patients were diagnosed with telangiectatic osteosarcoma in the department of medical oncology at a tertiary cancer center in India during a 12-year period. All patients were above 15 years of age. The median age at presentation was 20 years, males were predominant, and the commonest sites of involvement were lower end of femur and upper end of humerus. Ten patients underwent treatment that consisted of neoadjuvant and/or adjuvant chemotherapy with ifosfamide, doxorubicin, cisplatin regimen and limb sparing surgery or amputation. Currently, eight out of ten patients are alive in remission at a median follow-up of 50 months with survival ranging from 18 to 138 months.

Does granulocyte transfusion help pediatric cancer patients with sepsis?

Sepsis-related mortality continues to be a major concern while treating pediatric cancer patients, more so with the rise in the incidence of multidrug-resistant organisms (MDRO). In this retrospective study conducted between January 2021 and December 2022 at a tertiary cancer center in India, granulocyte transfusion was offered in addition to standard antimicrobial therapy to 64 children with hematolymphoid malignancy who developed 75 episodes of severe sepsis following intensive chemotherapy. Forty-four (83%) of 53 blood culture proven sepsis was caused by MDROs. Thirty-seven (70%) patients with blood culture proven sepsis cleared the organism after granulocyte transfusion. Thirty-day mortality was 25% for the entire study cohort and 32% for patients with MDRO sepsis.

Assessing the feasibility of recording smartphone-based patient-reported outcomes in patients with cancer: A pilot study.

e13528 Background: We conducted this study to evaluate the feasibility of completing patient-reported outcomes (PROs) using a mobile-based secure system at home, as opposed to the traditional method of completing them in crowded outpatient oncology clinics during hospital visits, which may not be ideal in resource-limited settings. Methods: The study included patients aged over 18 years who were newly diagnosed with solid-organ cancer between July 2021 and July 2022 at a tertiary cancer center in India. Patients who were able to use a smartphone were invited to complete a mobile-based Edmonton Symptom Assessment Scale (ESAS) questionnaire, which was accessed via a secure link sent to their phone as a chat. The ESAS questionnaire included physical (six domains: pain, tiredness, drowsiness, shortness of breath, nausea, loss of appetite), psychological (anxiety and depression), and overall well-being (one domain) questions, each rated on a scale of 0-10, with a higher number indicating greater symptom burden. Symptoms were classified as mild (1-3), and moderate to severe (4-10). The primary objective was to determine the completion rate of the questionnaire, while the secondary objectives were to determine the incidence of moderate to severe symptoms, both physical and psychological, at cancer diagnosis. Multivariate logistic regression analysis was used to identify factors associated with moderate to severe symptoms. Results: We reached out to 707 consecutive patients who had recently been diagnosed with solid-organ cancer and used smart phone. The median age of participants was 53 years (with an interquartile range of 43-62 years), and 52.3% were female. Breast cancer (30.6%) was the most common diagnosis, followed by lung cancer (28.8%). Approximately, one-third of all patients had metastatic disease at diagnosis, while others were similarly distributed in stage I-III. Overall, 650 patients (91.9%) patients completed the mobile-based questionnaire; 38.9% of patients had moderate to severe physical symptoms and 30.9% had moderate to severe psychological symptoms. Pain (57.7%) and tiredness (58.7%) were the most commonly reported physical symptoms in moderate to severe category, while nausea (18.1%) and drowsiness (20.3%) were reported least frequently as moderate to severe. Anxiety (35.1%) was more prevalent than depression (26.1%). The total symptom score was mild in 76.5% of patients and moderate to severe in 18.8%. On multivariate logistic regression, patients with advancing age, female sex, and metastatic disease at diagnosis were more likely to report moderate to severe symptoms. Conclusions: Using smartphone-based PROs can be an efficient way to record symptoms in cancer patients, and their high completion rates make them suitable for routine use in oncology clinics, especially considering the increasing number of smartphone subscribers globally.

P-371 Docetaxel-based perioperative chemotherapy in gastric and gastroesophageal (GEJ) adenocarcinomas – a real world experience from a tertiary cancer centre in India

P-371 Docetaxel-based perioperative chemotherapy in gastric and gastroesophageal (GEJ) adenocarcinomas – a real world experience from a tertiary cancer centre in India

Outcome and prognostic variables in childhood rhabdomyosarcoma (RMS) with emphasis on impact of FOXO1 fusions in non-metastatic RMS: experience from a tertiary cancer centre in India.

While factors influencing outcomes of rhabdomyosarcoma (RMS) in developed countries have evolved from clinical characteristics to molecular profiles, similar data from developing countries are scarce. This is a single-centre analysis of outcomes in treated cases of RMS, with emphasis on prevalence, risk-migration and prognostic impact of Forkhead Box O1 (FOXO1) in non-metastatic RMS. All children with histopathologically proven RMS, treated between January 2013 and December 2018 were included. Intergroup Rhabdomyosarcoma Study-4 risk stratification was used, with treatment based on a multimodality-regimen with chemotherapy (Vincristine/Ifosfamide/Etoposide and Vincristine/Actinomycin-D/Cyclophosphamide) and appropriate local therapy. Formalin-fixed paraffin-embedded tissues were tested using Reverse Transcriptase-Polymerase Chain Reaction for FOXO1-fusions (PAX3(P3F); PAX7(P7F)). A total of 221 children (Cohort-1) were included, of which 182 patients had non-metastatic disease (Cohort-2). Thirty-six (16%), 146 (66%), 39 (18%) patients were low-risk (LR), intermediate-risk (IR) and high-risk, respectively. FOXO1-fusion status was available in 140 patients with localised RMS (Cohort 3). P3F and P7F were detected in 25/49 (51%) and 14/85 (16.5%) of alveolar and embryonal variants, respectively. The 5-year-event-free survival (EFS)/overall survival (OS) of Cohorts 1, 2 and 3 was 48.5%/55.5%, 54.6%/62.6% and 55.1%/63.7%, respectively. Amongst the localised RMS, presence of nodal metastases and primary tumour size > 10 cms were adverse prognostic factorvs (p < 0.05). On incorporating fusion-status in risk-stratification, 6/29 (21%) patients migrated from LR (A/B) to IR. All patients who re-categorised as LR (FOXO1 negative) had a 5-year EFS/OS of 80.81%/90.91%. FOXO1-negative tumours had a better 5-year relapse-free survival (58.92% versus 44.63%; p = 0.296) with a near-significant correlation in favourable-site tumours (75.10% versus 45.83%; p = 0.063). While FOXO1-fusions have superior prognostic utility compared to histology alone in localised, favourable-site RMS, traditional prognostic factors (tumour size and nodal metastases) impacted outcome the most in this subset. Strengthening of early referral systems in community and timely local intervention can help in improving outcome in resource-constrained countries.

Treatment Outcome of Burkitt's Lymphoma in Adolescents and Adults: A Retrospective Study

Abstract Introduction Burkitt's lymphoma (BL) is a highly aggressive B cell non-Hodgkin lymphoma (NHL) having three distinct subtypes: endemic, sporadic, and immunodeficiency-associated BL. Sporadic BL accounts for only 1 to 2% of adult NHL. Objectives The objective of this article was to study the clinical profile and treatment outcome of patients with BL. Materials and Methods This was a retrospective study of 60 patients with BL conducted in the department of medical oncology at a tertiary cancer center in India during a 10-year period. Patients with BL/leukemia above 14 years of age diagnosed during the study period were included and their clinical presentation, treatment details, and outcome were studied. Results Among 60 cases with BL, there were 41 males and 19 females. The median age at presentation was 42 years (range: 14–81 years). The main symptoms were lymphadenopathy, abdominal pain, and abdominal distension. Two patients each had paraparesis, breast lump, and jaw swelling and one patient had involvement of the cervix. Thirteen patients had features of tumor lysis at presentation. The Ann Arbor stage was I in 17, II in 16, III in 5, and IV in 22. Fifty-five patients received combination chemotherapy that included hyper-cyclophosphamide, vincristine, adriamycin, dexamethasone ± rituximab (hyper-CVAD ± R; 35), cyclophosphamide, adriamycin, vincristine, prednisolone/ cyclophosphamide, vincristine, prednisolone ± rituximab CHOP ± R (13), Berlin-Frankfurt-Munich protocol (4), and others (3). Thirty-four patients attained remission, 13 patients had progressive disease, and 8 patients died during chemotherapy. At a median follow-up of 113 months, 58% patients were alive. Conclusions BL accounts for 1.57% of NHL above the age of 14 years with male preponderance. Intensive, short-duration chemotherapy is the standard treatment. Treatment with hyper-CVAD ± R gives 8-year progression-free survival and overall survival (OS) of 60%. Treatment with CHOP ± R is an alternative option in elderly frail patients with an 8-year OS of 46%.

Ewing's sarcoma in adolescents and adults - 10-year experience from a tertiary cancer center in India.

Ewing's sarcoma (EWS) is an aggressive small round cell tumor, affecting bone and soft tissues and is mostly seen in childhood and second decade of life. EWS accounts for 10-12% of bone tumors in more than 15 years age group and is even rarer after 40 years of age. This retrospective analysis was conducted among patients aged more than 15 years with histologically proven EWS. Among 240 cases of EWS treated at our center during 2001-2010, 130 (54%) were more than 15 years of age. The median age was 20 years with a male: female ratio of 2.4:1. Ninety percent had skeletal EWS, 10% had extra skeletal EWS, and 37% patients were metastatic at presentation. Eighty-two received curative treatment with chemotherapy (vincristine, doxorubicin, cyclophosphamide, ifosfamide, etoposide (VAC/IE)) along with local treatment, radiotherapy (RT) in 61, surgery alone in seven, and RT plus surgery in 14. Two- and 5-year overall survival (OS) was 43.3% and 25.5%, respectively, for the entire series. The OS for the non-metastatic group was 63.2% at 2 years and 36.5% at 5 years, and the progression free survival was 53.7% at 2 years and 37.8% at 5 years. High lactate dehydrogenase was found to be a significant poor prognostic factor (P = 0.001). Median OS for localized central EWS was 49.2 months and that for peripheral EWS was 24 months. Patients more than 20 years of age with non-metastatic disease had better OS compared to those with 15-20 years of age. Treatment of EWS requires a multidisciplinary approach with radical surgery and/or radiation to control local disease and multiagent chemotherapy to control systemic disease. Long-term follow-up is essential because of disease relapse and treatment-related complications.

Impact of minimal residual disease on relapse in childhood acute lymphoblastic leukemia: Lessons learnt from a tertiary cancer center in India

Prognostic predictive value of end of induction minimal residual disease (EOI-MRD) is well established in acute lymphoblastic leukemia (ALL). We evaluated the factors likely to affect EOI-MRD positivity (>0.01%) by flow cytometry and relapse in different BFM-95 (Berlin–Frankfurt–Munich) risk groups among children and adolescents. In this retrospective study, data of 223 newly diagnosed patients with ALL was analyzed. Association between demographic and pretreatment characteristics with EOI-MRD was assessed. Risk factors for relapse were analyzed using univariate and multivariate Cox regression. Proportion of the SR (standard risk), MR (moderate risk), and HR (high risk) patients was 18.8%, 60.9%, 20.3%, respectively. Positive EOI-MRD among these risk groups was observed in 11.9%, 18.3%, and 55.5% patients respectively (p value <.01%). MRD positivity was more likely to be associated with older age (>10 years) and BFM-HR patients (p value .0008 and <.0001). Thirty-four (15.2%) patients relapsed in the whole cohort. On univariate analysis, statistically significant factors for RFS (relapse-free survival) included hyperleukocytosis, high-risk cytogenetics, NCI (National Cancer Institute) high risk, poor day-8 prednisolone response, BFM–HR and positive EOI-MRD status. Of all these only EOI-MRD retained its impact by multivariate analysis. Positive EOI-MRD significantly predicted relapse in BFM-MR with 5-year RFS of 88.0% and 68.4% (p value .02). Five-year RFS of EOI-MRD negative and positive groups were 86.4% and 65.5%, respectively (p value .004). EOI-MRD is a powerful tool to predict relapse in children and adolescent with ALL especially in BFM-MR. Application of MRD in HR patients needs to be redefined in conjunction with other variables.

Mini-plate versus Reconstruction Plate: A Comparative Analysis of Complications in Free Fibula Osteocutaneous Flaps for Oral Cancer

Background: Advanced Oral cancers require segmental mandibulectomy, which ideally requires fibula flap reconstruction. Mini-plates or reconstruction plates are used for fibula fixation as per the surgeon’s preference, but the complication rates of each have hardly been studied. The purpose of this study was to find the incidence of plate-related complications, the factors attributing to it, and the difference in complication rates between mini-plate and reconstruction plate for fibula flap fixation exclusively in oral cancer patients who underwent segmental mandibulectomy as part of ablative surgery. Materials and Methods: The study was a retrospective observational study of oral cancer patients who underwent free fibula osteocutaneous flap reconstruction for mandibulectomy defects from November 2010 to November 2020 at a tertiary cancer center in India. Statistical Methods: Chi-square test, Fisher’s exact test. Results: Thirty-nine patients were included in the study and the mean follow-up period was 31 months. Seventeen of them had mini-plate fixation, 16 had reconstruction plate fixation and in two patients, both were used. About 25.64% of patients had complications. In the mini-plate group, 11.7% of patients had complications whereas 44.4% had complications in the recon plate group. 9/32 patients who took adjuvant treatment had complications, and in this subset of patients, there was a significant difference in the incidence of complications between the mini and recon plate groups (P = 0.03). Conclusion: Mini-plates are associated with less complications while used for fixation in microvascular fibula osteocutaneous flaps in oral cavity malignancy who are potential candidates for adjuvant treatment.

Combination of image-guided IMRT and IGBT in locally advanced carcinoma cervix: Prospective evaluation of toxicities and clinical outcomes from a tertiary cancer center in India.

We aimed to assess the toxicity profile and clinical outcome in patients with locally advanced cervical cancer (LACC) treated with a combination of image-guided intensity-modulated radiation therapy (IG-IMRT) and image-guided brachytherapy (IGBT). 25 LACC patients were recruited in this single-arm prospective study. Whole pelvis IG-IMRT was delivered (45 Gy with simultaneously integrated nodal boost of 55 Gy in 25 fractions), with concurrent weekly cisplatin (40 mg/m2). Patients received IGBT of 7 Gy each in 4 fractions to high-risk clinical target volume (HR-CTV). First fraction was done under MRI, and subsequent fractions were performed under CT guidance. Primary endpoint was acute toxicity, and secondary endpoints were 2-year loco-regional control and late toxicity. The median age was 52 years, and FIGO 2018 stage distribution was IIA2, IIB, IIIB, and IIIC1 in 12%, 40%, 20%, and 28% patients, respectively. All patients received concurrent chemotherapy with median number of 5 cycles (range, 4-5 cycles). Grade 1 and 2 diarrhea, and grade 1 cystitis was reported in 4 (16%), 3 (12%), and 2 (8%) patients, respectively. Grade 1 and 2 anemia, and grade 1 and 2 dermatitis were observed in 3 (12%) and 2 (8%), and 3 (12%) and 3 (12%) patients, respectively. No patient reported grade 3-4 acute toxicity. At median follow-up of 29.5 months (range, 25-37 months), late grade 1 bladder toxicity was observed in 1 (4%) patient. Loco-regional control at 1 and 2 years were 96% and 92%, respectively. The combination of IG-IMRT and IGBT yielded excellent outcomes in terms of acute toxicity and loco-regional control.

Trans-rectal ultrasound-guided hybrid intra-cavitary and interstitial brachytherapy in carcinoma cervix: A feasibility study from a tertiary cancer center in India.

To report the feasibility of performing hybrid intra-cavitary and interstitial (IC/IS) brachytherapy in patients with carcinoma cervix under trans-rectal ultrasound (TRUS) guidance. All patients who received an external beam radiotherapy (EBRT) dose of 50 Gy in 25 fractions with weekly chemotherapy, followed by a brachytherapy boost (21 Gy in 3 fractions) were prospectively included for analysis. IC/IS brachytherapy was performed using Fletcher style tandem and ovoid applicator with interstitial component under TRUS guidance. Parameters of implant quality analyzed included ability to insert tandem, ratio of needles loaded to the number of needles inserted, and incidence of uterine or organ at risk (OARs) perforation. Dosimetric parameters evaluated were dose to point A*, TRAK, D90 high-risk clinical target volume (HR-CTV), and D2cc to OARs (bladder, rectum, and sigmoid). Width and thickness of the target was compared between TRUS (TRUSw and TRUSt) and MRI (MRIw and MRIt). Twenty carcinoma cervix patients treated with IC/IS brachytherapy were included for analysis. The mean HR-CTV volume was 36 cc. The median number of needles used were 6 (range, 2-10 needles). None of the patients had uterine perforation. Two patients had bowel and bladder perforation. The mean D90 HR-CTV and D98 HR-CTV were 87.3 Gy and 82 Gy EQD2, respectively. The mean D2cc to the bladder, rectum, and sigmoid were 80 Gy, 70 Gy, and 64 Gy EQD2, respectively. The mean dose to point A* was 70.4 Gy EQD2. The mean TRAK was 0.40. The mean TRUSw (±SD) and MRIw (±SD) were 4.58 cm (±0.44) and 4.49 cm (±0.50), respectively. The mean TRUSt (±SD) and MRIt (±SD) were 2.7 cm (±0.59) and 2.62 cm (±0.59), respectively. On statistical analysis, there was a significant correlation between TRUSw and MRIw (r = 0.93), and TRUSt and MRIt (r = 0.98). TRUS-guided IC/IS brachytherapy is feasible and provides adequate coverage of the target, with acceptable doses to OARs.