Search

PURPOSE Anorexia occurs in 30%-80% of patients with advanced malignancies, which may be worsened with chemotherapy. This trial assessed the efficacy of olanzapine in stimulating appetite and improving weight gain in patients receiving chemotherapy. METHODS Adults (≥18 years) with untreated, locally advanced, or metastatic gastric, hepatopancreaticobiliary (HPB), and lung cancers were randomly assigned (double-blind) to receive olanzapine (2.5 mg once a day for 12 weeks) or placebo along with chemotherapy. Both groups received standard nutritional assessment and dietary advice. The primary outcomes were the proportion of patients with weight gain > 5% and the improvement in appetite (assessed by the visual analog scale [VAS] and the Functional Assessment of Chronic Illness Therapy system of Quality-of-Life questionnaires Anorexia Cachexia subscale [FAACT ACS]). Secondary end points were change in nutritional status, quality of life (QOL), and chemotherapy toxicity. RESULTS We enrolled 124 patients (olanzapine, 63 and placebo, 61) with a median age of 55 years (18-78 years), of whom 112 (olanzapine, 58 and placebo, 54) were analyzable. The majority (n = 99, 80%) had metastatic cancer (gastric [n = 68, 55%] > lung [n = 43, 35%] > HPB [n = 13, 10%]). The olanzapine arm had a greater proportion of patients with a weight gain of > 5% (35 of 58 [60%] v 5 of 54 [9%], P < .001) and improvement in appetite by VAS (25 of 58 [43%] v 7 of 54 [13%], P < .001) and by FAACT ACS (scores ≥37:13 of 58 [22%] v 2 of 54 [4%], P = .004). Patients on olanzapine had better QOL, nutritional status, and lesser chemotoxicity. Side effects attributable to olanzapine were minimal. CONCLUSION Low-dose, daily olanzapine is a simple, inexpensive, well-tolerated intervention that significantly improves appetite and weight gain in newly diagnosed patients on chemotherapy.

Objectives: Multiparameter flow cytometry is increasingly being used in determining DNA content in several hematological malignancies where abnormal DNA ploidy is a useful prognostic marker. This study was done to analyze the DNA ploidy of plasma cells in multiple myeloma (MM) by flow cytometry and explore its role as a prognostic factor. Material and Methods: Propidium-iodide staining technique and gating based on light scatter properties were used. DNA index (DI) of the tumor sample was calculated as the ratio of the DNA content of the G0-G1 population of the myeloma cells with the normal control cells (lymphocytes) present in the same sample. Based on DI, ploidy was categorized as diploidy, hypodiploidy, and hyperdiploidy and the results were correlated with the clinical outcome. Results: Among 32 patients, none had hypodiploid DNA content, 8 (25%) patients had hyperdiploid DNA, and 24 (75%) patients had diploid DNA. There was no significant association between DI and international staging system staging (P = 0.68), Eastern Cooperative Oncology Group Performance Status (P = 0.59), and post-induction remission status (P = 0.10). The median overall survival (OS) in the study patients was 20 (CI 11.4–28.8) months and the median progression-free survival was not reached. There was no difference in the OS among patients with diploid MM and hyperdiploid MM (P = 0.84). Conclusion: Although hyperdiploid MM has been reported to have a better prognosis than diploid MM, we did not find any significant difference possibly due to the small sample size. Nevertheless, flow cytometry is a useful tool in DNA ploidy analysis and its role as a prognostic factor in various hematologic malignancies including MM can be further explored.

miRNAs are known to be aberrantly expressed in the serum, tissue, and Peripheral Blood Mononuclear Cells (PBMC) of cancer patients and could serve as potential noninvasive diagnostic markers for breast cancer. The aim of this study was to identify the differentially expressed miRNA using next-generation sequencing (NGS) from the paired PBMC samples from breast cancer patients and age-matched healthy individuals and explore their functional significance.In this study, PBMCs were employed for the detection of miRNAs by NGS in locally advanced breast cancer (LABC) women of South Indian origin who were divided into three age groups, (a) 40yrs-50yrs (b) 50yrs-60yrs and (c) 60yrs-70yrs, compared with age-matched control groups.Four miRNAs (hsa-miR-192-5p, hsa-miR-24-2-2p, hsa-miR-3609, and hsa-miR-664b-3p) were found to be differentially expressed among LABC patients compared with age matched healthy women of the South Indian population. While miR-24-2-5p, miR3609, and miR-664b-3p were down-regulated, miR-192-5p was up-regulated. Gene Ontology (GO) annotations implicated miRNA with signaling pathways in peripheral nerve synapses, glutamatergic synapse, and cell morphogenesis, all of which play a pivotal role in the manifestation of cancer.Four miRNAs- 3 (While miR-24-2-5p, miR3609, and miR-664b-3p) downregulated and one upregulated (miR-192-5p) were identified as potential biomarkers for patients with locally advanced breast cancer. These markers could be validated in studies with a larger sample size.

Survival of children with acute lymphoblastic leukemia (ALL) has improved from 10% to 90% over the last six decades. Survival gains in adult ALL have been more modest and confined to the adolescent and young adult population. Age is an important factor in determining outcomes in ALL. Additional factors like adverse biology, less intense treatment regimens, and poorer tolerance to therapy contribute to inferior survival among adults. Indian physicians face unique challenges while managing these patients. These are high infection rates, limited access to high-end investigations, and newer drugs. In this context, the management decisions in an individual patient are highly nuanced. Through a case-based review, we discuss representative scenarios in adult ALL where we detail our current approach to treatment in the context of available evidence.

Introduction Caudal-type homeobox 2 (CDX2), a nuclear protein, is essential for the proliferation and development of intestinal epithelial cells and is frequently downregulated during tumorigenesis. CDX2 inhibits cell growth as well as stimulates differentiation by activating intestinal specific genes, thus lack of CDX2 favors tumor growth and aggressiveness. Objectives We aimed to evaluate the pattern of CDX2 expression in all stages of colorectal cancer (CRC) and study its association with baseline characteristics and prognosis. Materials and Methods Study was conducted as an ambispective observational study, enrolling cases of CRC retrospectively from January 2014 to July 2016 (30 months), and prospectively during next 18-month period till January 2018. We performed CDX2 staining by immunohistochemistry on the available biopsy blocks of CRC patients during the study period. Total 286 patients were registered during the study period, of which only 110 biopsy blocks were available for staining. CDX2 scoring was done by a semiquantitative method on whole tissue section for the intensity and percentage of the cells showing positivity. Correlation of CDX2 expression was done with baseline clinical and histopathologic characteristics, and survival. Results Of 110 patients, 77 (70%) constituted colon cancer and 33 (30%) were rectal cancer. The median age was 54.2 years, 62 (56.4%) being male and 48 (43.6%) female with male-to-female ratio 1.3:1. In the study cohort, 33 (30%) patients had stage II disease, 30 (27.3%) stage III, and 47 (42.7%) were stage IV. Seventy-three (66.4%) were positive for CDX2 and 37 (33.4%) were negative. Loss of CDX2 expression was significantly associated with advanced stage, rectal site, poor grade of differentiation, and presence of lymphovascular invasion (LVSI). With median follow-up of 16 months, progression-free survival (PFS) at 2 years was 30% for CDX2 negative patients compared with 67% for CDX2 positive (p = 0.009), while overall survival (OS) at 2 years was 46% for CDX2 negative versus 77% for positive patients (p = 0.01). Conclusion Loss of CDX2 expression is associated with advanced stage, higher tumor grade, presence of LVSI, and worse PFS and OS and thereby functions as a poor prognostic factor in CRC.

The blast phase (BP) is challenging to treat and leads to inferior survival in chronic myeloid leukemia (CML). Allogeneic hematopoietic stem cell transplant (AlloSCT) is the only curative option for CML-BP. We are sharing our experience of AlloSCT in seven patients with CML-BP who underwent transplants during the period from January 2017 to December 2019. Three patients each had myeloid-BP, lymphoid-BP, and one patient had mixed phenotypic BP. Donors were matched siblings in four, mismatched siblings in one, and haploidentical in two. All patients received peripheral blood stem cell grafts. The median CD34+ dose was 7.6 (range: 6.6–8.9) × 106 cells/kg. Neutrophil engraftment was observed at a median of 15 (10–20) days and platelet engraftment at 19 days (10–22). At a median follow-up of 24 months, the 2-year leukemia-free survival (LFS) and overall survival (OS) were 43% and 57%, respectively. Transplant-related, non-relapse mortality was observed in three patients. AlloSCT results in promising survival for carefully selected patients of CML-BP, especially with a matched sibling donor.

Double pneumonia with Pneumocystis jirovecii (PCP) and Mycobacterium tuberculosis (MTB) has been reported in patients with acquired immune deficiency syndrome. A similar immune-suppressed state exists in allogeneic transplant survivors treated for graft-versus-host disease (GVHD). The clinical features and imaging findings could be quite similar in both the etiologies. Reaching a timely diagnosis and initiation of appropriate therapy is essential to prevent complications. We report a patient who had concurrent PCP and MTB pneumonia while on treatment for chronic GVHD. We describe the diagnostic challenge, the treatment, and outcome of this patient. We intend to sensitize physicians to consider more than one etiology in this subset of patients.

Background and objective Delays in the management of osteosarcoma (OGS) lead to tumor progression and the development of metastasis, resulting in a decrease in overall survival (OS). The primary objective of this study was to determine whether delays occur in implementing the individual steps in the management of OGS in South India. Methods In this study, core biopsy reports between October 2019 and October 2021 were retrospectively examined for a diagnosis of OGS. The primary outcome variables in this study were time to MRI, time to biopsy, time to biopsy report, time to neoadjuvant chemotherapy (NACT), time to surgery, and time to adjuvant chemotherapy (ACT). Statistical analysis was performed by comparing the outcome variables with the hypothesized mean. Results There were 38 patients with primary non-metastatic OGS. Of these, 92% received NACT, and 74% completed full treatment. The mean time to MRI was 11.3 ± 6.7 days, mean time to NACT was 15.3 ± 12.7 days, mean time to surgery was 31.1 ± 15.3 days, and mean time to ACT was 29.7 ± 10.1 days. Time to MRI was more than seven days in 68% of the cases, while time to NACT was more than seven days in 74%. Time to surgery was more than 21 days in 83% of the cases, and time to ACT was more than 21 days in 82% of the cases. Conclusion Based on our findings, there is a significant delay (p0.05) in time to MRI, time to NACT, time to surgery, and time to ACT. The delay in time to surgery is more than the delay in time to MRI, time to NACT, and time to ACT. The delay is due to a variety of reasons, the most common being the long waiting period at the hospital.

We explored the prognostic impact of simple indices that reflect the immunological milieu (neutrophils to lymphocyte ratio [NLR] and systemic immune-inflammation [SII]) in 49 platinum-resistant relapsed ovarian cancer patients. The median progression-free survival (PFS) and overall survival (OS) were 4 and 8 months, respectively. Patients with a lower NLR (≤2.89) had a better PFS (5 vs. 2 months [p = 0.02]) and OS (9 vs. 5 months [p = 0.20]). Factors associated with a worse PFS were NLR > 2.8 (hazard ratio [HR] =2.32, p = 0.02) and SII > 639 (HR =3.70, p = 0.002). SII > 639 independently predicted PFS (HR =4.13, p = 0.03). Future studies should study the validity of inflammatory markers and could consider incorporating it as a biomarker in clinical trials.

Background: Patients with platinum-resistant ovarian cancer (PROC) have limited therapeutic options and poor survival. There is a need for the development of newer therapies. Sodium valproic acid (VPA) is a short-chain fatty acid histone deacetylase (HDAC) inhibitor with antitumor activity in preclinical models of PROC. Synergism with conventional cytotoxic agents like etoposide has been demonstrated. Methodology: In this prospective, single-arm, open-label, phase 2 study, we included patients ≥18 years with histologically or cytologically confirmed PROC and Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-3. Patients received oral VPA 60 mg/kg/day in three divided doses for three days (D1-D3), followed by oral etoposide 50 mg once daily for two consecutive weeks (D4-D17). Serum samples were collected to assess peak VPA drug levels. The primary endpoint was the overall response rate (ORR). The secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity. We sought to show an improvement in response rate from 25% (historically with oral etoposide) to 40% with the addition of VPA. Results: 27 patients were enrolled in the study, and 18 [median age: 52 (45-59) years; serous histology:17(94%); ECOG-PS 2 or 3: 14 (78%)] were evaluable for the response after four months. Nine patients were lost from follow-up before achieving the primary endpoint (mainly due to Covid-related lockdown issues). The median number of prior lines of treatment was 2 (1-3). ORR was 0% according to GCIG criteria. The disease was stable in two patients [clinical benefit rate (CBR) of 11%]. The median OS and PFS were seven months and two months, respectively. Grade ≥3 adverse events were reported in 6 (33%) patients. Conclusion: The addition of valproic acid to oral etoposide in patients with PROC and poor general condition was not helpful and failed to improve responses compared to those historically achieved with single-agent etoposide.

BACKGROUND: Cytarabine based therapy has been the standard consolidation regimen for AML (acute myeloid leukemia) for decades. However, the optimal dose, regimen and schedule is not known. HIDAC (high dose cytarabine at 18 g/m(2)) has been the conventional standard, however, recent studies have shown that intermediate doses of cytarabine (IDAC) have equal efficacy and lesser toxicities. METHODS: We retrospectively analysed 75 AML patients who entered consolidation out of 167 patients who underwent induction therapy between 2014 and 2018. HIDAC (at 18 g/m(2)) was given to 39 patients and 36 patients received IDAC at 9 g/m(2). RESULTS: Median age was 28 years (range 2–60). Male: female ratio was 1.02. More courses were administered in out-patient setting in IDAC group 61% (n = 58/95 courses) than in HIDAC 29% (n = 29/101 courses); p

Background Treatment protocols for acute lymphoblastic leukemia (ALL) have evolved over time to give excellent cure rates in children and moderate outcomes in adults; however, little is known how delays in chemotherapy affect long-term survival. Objectives To find the association of delays during different treatment phases on the survival outcomes. Materials and Methods Data from 149 ALL cases treated between 2009 and 2015 were retrospectively analyzed. Treatment course in commonly used protocols was divided into three phases—induction, consolidation (postremission), maintenance, and also a combined intensive phase (induction plus consolidation) for the purpose of analysis, and delay in each phase was defined based on clinically acceptable breaks. Analysis was done to find the impact of treatment delay in each phase on the survival outcomes. Results The median age was 12 years (range, 1–57). Multi-center Protocol-841 (MCP-841) was used for 72%, German Multicenter Study Group for Adult ALL (GMALL) for 19%, and Berlin, Frankfurt, Muenster, 95 protocol (BFM-95) for 9% of patients. Delay in induction was seen in 52%, consolidation in 66%, and during maintenance in 42% of patients. The median follow-up was 41 months, and 3-year survival outcomes for the entire cohort were event-free survival (EFS)—60%, relapse-free survival (RFS)—72%, and overall survival (OS)—68%. On univariate analysis, delay in induction adversely affected EFS (hazard ratio [HR] = 1.78, p = 0.04), while delay in intensive phase had significantly worse EFS and RFS (HR = 2.41 [p = 0.03] and HR = 2.57 [p = 0.03], respectively). On separate analysis of MCP-841 cohort, delay in intensive phase affected both EFS (HR = 3.85, p = 0.02) and RFS (HR = 3.42, p = 0.04), whereas delay in consolidation significantly affected OS with (HR = 4.74, p = 0.04) independently. Conclusion Treatment delays mostly in intensive phase are associated with worse survival in ALL; attempts should be made to maintain protocol-defined treatment intensity while adequately managing toxicities.

Yolk sac tumor is a malignant germ cell tumor, which typically occurs in the gonads with elevated serum alpha-fetoprotein (AFP). Among extragonadal sites, the liver is an uncommon location for primary pediatric yolk sac tumors. Other common hepatic tumors in this age group presenting with elevated serum AFP like hepatoblastoma and hepatocellular carcinoma must be differentiated from yolk sac tumors for initiating appropriate treatment and accurate prognostication. Lung metastasis with refractoriness to chemotherapy is an extraordinary presentation that has never been documented in the literature. We report our experience with a 2-year-old female child initially misdiagnosed as hepatoblastoma. It was found that LIN28 positivity by immunohistochemistry aided in confirmation of the histopathological diagnosis of primary yolk sac tumor of the liver.

Cytomegalovirus (CMV) retinitis is one of the common complications in profoundly immunosuppressed patients such as those with acquired immune deficiency syndrome. It has been rarely reported in patients with lymphoma on aggressive chemotherapy. We encountered a patient with bilateral CMV retinitis who developed this vision-threatening complication while on low-dose palliative metronomic chemotherapy with oral drugs (cyclophosphamide, procarbazine, etoposide, and prednisolone). Though the infection resolved with treatment, there was residual vision loss. This case is presented to sensitize clinicians to the possibility of unusual infections in patients on long-term oral chemotherapies.

The study aimed at identifying the profile of gut colonization of patients with acute leukemia who underwent induction chemotherapy and its association with induction events and outcome. Baseline bacterial stool culture with resistance pattern of isolates were recorded. Multi-drug resistance was defined as resistance to at least two antibiotic classes including beta lactam and fluoroquinolones. During induction chemotherapy, blood and clinically indicated cultures were taken during febrile neutropenic episodes. Association studies were done between gut colonization and induction events/outcome. Among 109 patients enrolled, 71 (65.13%) patients undergoing induction chemotherapy were colonized with bacteria, with nearly 50% of colonizers harboring multi-drug resistant bacteria. Organisms isolated from stool pre-induction were mostly gram negative (98%), with Escherichia coli and Klebsiella pneumoniae being the commonest. 65.13% patients developed febrile neutropenia. Overall multi-drug resistant positivity during febrile neutropenia was 70.14%. Concordance of 8.45% was observed between isolates from stool and organisms isolated from cultures during febrile neutropenia. There were significant proportion of gut colonized gram-negative multi-drug resistance bacteria among patients with acute leukemia. There was a low concordance rate between baseline stool isolates and subsequent cultures during the induction. There was no significant association between gut colonization and induction events/outcomes studied.

Genetic factors could be attributed to the variability in docetaxel plasma levels and its subsequent therapeutic response. The objectives of this study were to assess the effect of ABCB1 gene polymorphisms [SNPs rs1045642 (C3435T) and rs1128503 (C1236T)] on docetaxel plasma levels and also to analyze the influence of docetaxel plasma levels on tumour response in the ethnically distinct South Indian population. 104 locally advanced breast cancer (LABC) patients on docetaxel-based neo‐adjuvant chemotherapy (NACT) were included. The plasma docetaxel levels were estimated using the validated reverse phase liquid chromatography with mass spectrometry (LC–MS/MS). DNA was extracted (phenol‐chloroform extraction method) and the real‐time PCR system using validated TaqMan® SNP genotyping assay method was used for genotyping. Tumour response was assessed by RECIST criteria based on the MRI images. Patients with “CT/TT” genotype of the SNP C1236T had a C0/Ct ratio of 1.6 times higher than those with “CC” genotype (13.5 ± 6.5 vs 8.3 ± 3.1, p = 0.002). Though not significant, patients with “CT/TT” genotype had greater initial plasma concentration (C0) and area under the plasma concentration–time curve (AUC0−t). Conversely, the SNP C3435T was not associated with the plasma docetaxel levels. Furthermore, the C0 and normalized C0 were found to be higher in tumour responders compared to non-responders (p

Diffuse large B cell lymphoma (DLBCLs) constitute 40% of all non-Hodgkin lymphoma and it represent a heterogeneous group of neoplasms rather than a single clinicopathological entity. We analysed the outcomes and clinical features based on the cell of origin in a series of patients with DLBCL from our institute. Medical case records of all newly diagnosed DLBCL treated in our institute from January 2015 to July 2017 were analysed for this study. Cell of origin classification was based on immunohistochemistry using Hans algorithm. Kaplan–Meier curves were used to determine survival. Ninety-five patients were diagnosed to have DLBCL subtype. Immunophenotypic subtyping was available for 71 patients. The median age at diagnosis was 56 years with no difference between Germinal centre B cell (GCB) and non-Germinal centre B cell (non-GCB) subtypes. Approximately 44% of patients had extra-nodal disease, stomach being the commonest site. Forty percent of patients had stage III/IV disease. Bulky disease and extra-nodal presentation was predominantly seen with non-GCB subtype (46% vs 20% and 36% vs 29% respectively). Rituximab was used in 75% of the patients with DLBCL. The 2-year disease-free survival was 70% versus 53% (p = 0.38) in GCB versus non-GCB subtype. This is one of the few data on DLBCL patients reported from India which has described outcomes based on the cell of origin. The disease-free survival in our country appears to be superior in GCB subtype which needs to be confirmed in a larger subset of patients.

Objective The aim of this study was to find the level of anxiety and depression and its clinical and sociodemographic determinants among the parents of children with cancer on chemotherapy. Materials and Methods Hamilton-A (HAM-A) and Hamilton-D (HAM-D) scales were used to assess anxiety and depression, respectively, in this cross-sectional study. The assessed parents were administered the questionnaire along with collection of sociodemographic and clinical data through a structured data collection proforma between August 2018 and November 2018. Statistical Analysis The sociodemographic factors and the clinical characteristics were analyzed and have been expressed descriptively and associations between the sociodemographic characteristics, clinical characteristics of the children, and the calculated scores obtained from HAM-A and HAM-D scales were analyzed using chi-squared test. A p-value of Results Out of 101 parents, 86 (85.14%) were found to have a mild, moderate, or severe depression score. Parents of children with solid tumors undergoing chemotherapy had higher frequency of severe and very severe depression. Majority of the parents (56.4%) assessed with HAM-A scale had mild level of anxiety that was significantly affected by the level of education. Conclusion This study confirmed a very high frequency of depression and anxiety in the parents of children affected with cancer undergoing chemotherapy. Type of cancer (solid or hematological) was found to be a predictor of depression, while education level was found to be a predictor of anxiety in the parents.

Aim Triple negative subtype (TNBC) is an aggressive breast cancer with inferior survival. Pathological CR (pCR) is a good surrogate endpoint for survival among patients receiving neoadjuvant chemotherapy (NACT). We attempted to validate the composite score(CPS) (Jaccqueline et al, J Clin Oncol 26:246-252) combining clinical and pathological variables among TNBC patients receiving NACT at our center. Methodology Data of patients with TNBC who underwent NACT between January 2014 to July 2017 was retrospectively analysed. The composite CPS score included cTN stage and y pTN stage, and ranged from 0 to 4. This was calculated using an online software (http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=bcnt). The scores obtained from the calculator was used to develop a risk grouping into low risk (0,1) and High risk (2,3,4). Overall survival (OS)and disease free survival (DFS) were calculated using the Kaplan-Meier method and differences was examined using the log rank test. Results Seventy-eight patients with TNBC [median age: 45 (24-75)] had received NACT (anthracyclines and taxanes). Early and locally advanced breast cancer constituted 17 (21.8 %) and 61 (78.2%) respectively and 22 (28.2 %) achieved pCR. After a median follow up of 28 months (5-62), 3-yr DFS and OS were 59% and 82% respectively for the entire population. The 3-yr DFS in low (n=18) and high risk (n=60) patients was 85.7% and 51.4% respectively (p=0.032). The 3-yr OS in the low and high risk was 93% and 79% respectively(p=0.28, NS). Conclusion Our study supports the use of the composite clinical pathological score (CPS) as a prognostic marker in patients with non-metastatic triple negative breast cancer. The risk stratification developed may help identify patients who may require additional adjuvant therapy. Citation Format: Biswajit Dubashi, Smita Kayal, Kirankumar Matta, Divya bala Thumaty, Nisha Yadav, D Kadambari, Pampa ch Toi, K Gunaseelan, Prasanth Ganesan. Neoadjuvant composite score as a prognostic marker in early and locally advanced triple negative breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P3-07-13.

Background In autologous stem cell transplant (ASCT) for lymphomas, no standard conditioning regimen has been defined so far. Thus, the choice is guided by the center's familiarity and experience with a particular regimen. Objective To determine the response, toxicity, and survival outcomes in lymphoma patients who underwent ASCT with CBV (cyclophosphamide, carmustine, and etoposide) conditioning regimen. Materials and Methods Between January 2013 and May 2019, 45 consecutive lymphoma patients who had ASCT with CBV conditioning regimen were included in this retrospective study. CBV consisted of cyclophosphamide (1.5 g/m2/day × 4 days), carmustine (300 mg/m2 × 1 day), and etoposide (125 mg/m2 twice daily × 3 days). Baseline characteristics, pre transplant response, apheresis, post-transplant toxicities, post-transplant response, and survival outcomes were collected. Endpoints were toxicity, response, event-free survival (EFS), and overall survival (OS). Results The median age was 30 (range: 6–64) years. Diagnosis was Hodgkin lymphoma (HL) in 26 (58%) and non-Hodgkin lymphoma (NHL) in 19 (42%). Forty-three patients (95%) had chemosensitive disease; 22(49%) in CR, and 21 (46%) in PR. The median CD34 was 2.95 × 106/kg (range: 0.9–9.56). The median time to neutrophil engraftment was 11 days (9–23) and 13 (8–36) days for platelets. All patients had febrile neutropenia, clinically and/or microbiologically documented infection was seen in 75% of patients. The most common grade 3/4 toxicities were mucositis (n = 4, 9%), diarrhea (n = 4, 9%), and nausea/vomiting (n = 2, 4%). The average days of hospitalization was 18 (range: 10–37). Day 100 mortality was 6.6% (n = 3). The median follow-up was 44.8 months. The median EFS for the entire cohort was 23.8 months; for HL, the median EFS was not reached, and for NHL, it was 7.97 months (95% confidence interval [CI]: 1.57–14.37). The median OS for the entire cohort and for HL was not reached; for NHL, it was 24.3 months (95% CI: 0.56–48.11). Conclusion CBV conditioning regimen was well tolerated with low grade 3/4 toxicities and efficacy comparable to literature data.

Introduction: The role of aspirin in cancer prevention has been well defined; the last decade revealed its therapeutic role with Giampieri et al. (2016) showed improved efficacy with aspirin added to capecitabine in heavily pre-treated metastatic colorectal cancer. Aspirin affects tumour growth through the PI3K pathway, which regulates apoptosis and autophagy. The objective of our study was to compare the efficacy of Aspirin plus EOX chemotherapy versus EOX alone in locally advanced and metastatic gastric cancer. Methods: All patients with advanced gastric cancer reporting to the Department of Medical oncology between March 2017 to May 2019 were screened for study eligibility. They were randomly assigned to standard EOX with or without aspirin at a daily dose of 150 mg. Tumor measurements were assessed at baseline and 3-4 cycles by an independent blinded radiologist according to RECIST criteria 1.1. Toxicity profiles were recorded as per CTCAE v 4.03. Per protocol group was identified as 70 patients. The primary endpoint was overall response rates in the per-protocol group defined as patients who received a minimum of 3 cycles and had an evaluable response after randomization. The secondary endpoints included toxicity analysis, Progression-free survival, and Overall survival.Results: Ninety-five patients who fulfilled the study inclusion and exclusion criteria were randomized to group1 EOX (50) or group 2 EOX plus Aspirin(45). Seventy patients were included for the per-protocol analysis. The overall response rate in group1 was 27% compared to group2, which was 42%, P=0.176. The median duration of follow was 29 (18.56-39.45) months. The median overall survival (n=95) of group 1 versus group 2 was 11 (8.58-13.42) months and 10 (6.86-13.14) months, respectively, P=0.90. There was no statistical significance in the overall survival per-protocol analysis (n=70) between group one 12(8.75-15.25) months versus group two 12(6.21-17.79)months, P= 0.50. Conclusions: There was no improvement in the response rates, progression-free survival, and overall survival on adding Aspirin to EOX chemotherapy in locally advanced and metastatic gastric cancer in an unselected population. A further role of PI3K mutation as a biomarker needs to be evaluated in this setting.