Search

Background: Triple-negative breast cancer (TNBC) includes approximately 20% of all breast cancer and is characterized by its aggressive nature, high recurrence rates, and visceral metastasis. Pathological complete response (pCR) is an established surrogate endpoint for survival. The window of opportunity studies provide valuable information on the disease biology prior to definitive treatment. Objectives: To study the association of dynamic change in pathological, imagining, and genomic biomarkers that can prognosticate pCR. The study aims to develop a composite prognostic score. Design: Clinical, interventional, and prognostic biomarker study using the novel window of opportunity design. Methods: The study aims to enroll 80 treatment-naïve, pathologically confirmed TNBC patients, administering a single dose of paclitaxel and carboplatin during the window period before neoadjuvant chemotherapy (NACT). Tumor tissue will be obtained through a tru-cut biopsy, and positron emission tomography and computed tomography scans will be performed for each patient at two time points aiming to evaluate biomarker alterations. This will be followed by the administration of standard dose-dense NACT containing anthracyclines and taxanes, with the study culminating in surgery to assess pCR. Results: The study would develop a composite prognostic risk score derived from the dynamic change in the Ki-67, tumor-infiltrating lymphocytes, Standardized Uptake Value (SUV max), Standardized Uptake Value for lean body mass (SUL max), and gene expression level pre- and post-intervention during the window period prior to the start of definitive treatment. This outcome will aid in categorizing the disease biology into risk categories. Trial registration: The current study is approved by the Institutional Ethics Committee [Ethics: Protocol. no. JIP/IEC/2020/019]. This study was registered with ClinicalTrials.gov [CTRI Registration: CTRI/2022/06/043109]. Conclusion: The validated biomarker score will help to personalize NACT protocols in patients in TNBC planned for definitive treatment.

Abstract Bortezomib, lenalidomide, and dexamethasone induction chemotherapy (VRd), followed by autologous stem cell transplantation (ASCT), are the standard of care for patients with newly diagnosed multiple myeloma (NDMM). Pomalidomide is currently approved for relapsed-refractory multiple myeloma. This single-arm, open-label, phase 2 study was the prospective evaluation of the efficacy and safety of bortezomib, pomalidomide, and dexamethasone (VPd) induction for NDMM. We used Fleming’s two-stage design for sample size calculation. We included transplant-eligible and ineligible patients aged 18–75 years in the study. The patients received four cycles of VPd induction followed by response assessment. Thirty-four patients were included in the study, of which 31 completed all four cycles of induction. The median age was 52 years (32–72). Thirty (91%) patients had multiple myeloma, and three had multiple plasmacytomas with less than 10% bone marrow involvement. Nine (27%) had ISS-I, 9 (27%) had ISS-II, and 15 (46%) had ISS-III myeloma. Three patients had high-risk cytogenetic abnormalities. After four cycles of VPd induction, ten patients (32%) achieved stringent CR, nine had CR (29%), eight (26%) had VGPR, and 4 (13%) had PR. Fifteen (48%) had a complete metabolic response (CMR) on PET-CT. Two patients developed SAEs. Anemia was the most common hematological toxicity. Peripheral neuropathy and constipation were the most common non-hematological toxicities. Patients with ≥VGPR had significantly better 12-month PFS than those with PR. Patients with ≥VGPR and CMR on PET-CT had significantly better 12-month OS. Our study showed VPd induction is safe and efficacious in NDMM. Further Phase 3 studies are necessary to establish the superiority and survival benefits.

Abstract The benefit of three-drug induction chemotherapy over a two-drug induction has not been evaluated in pediatric acute myeloid leukemia (AML). We, therefore, conducted a randomized controlled trial to ascertain the benefit of a three-drug induction regimen. Patients aged 1–18 years with newly diagnosed AML were randomized to two cycles of induction chemotherapy with daunorubicin and ara-C (DA) or two cycles of ara-C, daunorubicin, and etoposide (ADE). After induction, patients in both arms received consolidation with two cycles of high-dose ara-C. The study’s primary objective was to compare the event-free survival (EFS) between the two arms. The secondary objectives included comparing the composite complete remission (cCR) rates, overall survival (OS), and toxicities. The study randomized 149 patients, 77 in the DA and 72 in the ADE arm. The median age was 8.7 years, and 92 (62%) patients were males. The median follow-up was 50.9 months. The cCR rate in the DA and ADE arm were 82% and 79% (p = 0.68) after the second induction. There were 13 (17%) induction deaths in the DA arm and 12 (17%) in the ADE arm (p = 0.97). The 5-year EFS in the DA and ADE arm was 34.4% and 34.5%, respectively (p = 0.66). The 5-year OS in the DA and ADE arms was 41.4% and 42.09%, respectively (p = 0.74). There were no significant differences in toxicities between the regimens. There was no statistically significant difference in EFS, OS, CR, or toxicity between ADE and DA regimens in pediatric AML. The trial was registered with the Clinical Trial Registry of India (Reference number: CTRI/2014/11/005202).

Glioma is the most devastating high-grade tumor of the central nervous system, with dismal prognosis. Existing treatment modality does not provide substantial benefit to patients and demands novel strategies. One of the first-line treatments for glioma, temozolomide, provides marginal benefit to glioma patients. Repurposing of existing non-cancer drugs to treat oncology patients is gaining momentum in recent years. In this study, we investigated the therapeutic benefits of combining three repurposed drugs, namely, metformin (anti-diabetic) and epigallocatechin gallate (green tea-derived antioxidant) together with temozolomide in a glioma-induced xenograft rat model. Our triple-drug combination therapy significantly inhibited tumor growth in vivo and increased the survival rate (50%) of rats when compared with individual or dual treatments. Molecular and cellular analyses revealed that our triple-drug cocktail treatment inhibited glioma tumor growth in rat model through ROS-mediated inactivation of PI3K/AKT/mTOR pathway, arrest of the cell cycle at G1 phase and induction of molecular mechanisms of caspases-dependent apoptosis.In addition, the docking analysis and quantum mechanics studies performed here hypothesize that the effect of triple-drug combination could have been attributed by their difference in molecular interactions, that maybe due to varying electrostatic potential. Thus, repurposing metformin and epigallocatechin gallate and concurrent administration with temozolomide would serve as a prospective therapy in glioma patients.

BACKGROUND: Plerixafor is used for patients at risk of Stem cell mobilization failure based on clinical factors or low peripheral blood CD34 count. It is also added upfront to any mobilization irrespective of risk factor, but the cost-effectiveness of the approach is an issue. Data on plerixafor in different settings of autologous hematopoietic stem cell (HSC) collection from India are scant. We are hereby reporting the experience of failure/success of mobilization rate and few important significant variables (CD34+ dosage, failed collection) between plerixafor and granulocyte colony-stimulating factor alone groups among autologous hematopoietic stem cell transplantation (aHSCT) at our institute. METHODS: This was a record-based single-center study on patients who underwent aHSCT from January 2013 to June 2019 at a tertiary care hospital. Descriptive statistics were used for baseline characteristics, transplant-related factors, and peritransplant outcomes. All statistical analyses were performed at the 5% significance level. RESULTS: During the study duration, a total of 96 patients had undergone autologous hematopoietic stem cell collection (aHSCC), all by peripheral blood stem cell harvest, requiring 131 apheretic collections. Of the total 131 collections in 96 patients, plerixafor was used in 63 apheresis collections (48% of total pheresis) in 40 patients. Among the 40 patients who were administered plerixafor to augment the collection, 34 patients had upfront use of plerixafor. We did not observe any significant adverse event related to plerixafor use. CONCLUSION: A rational utilization of plerixafor can facilitate the process and logistics of aHSCC outcome.

Lung cancer is one of the most common cancers and an important cause of cancer-related mortality. Recent advances in targeted therapy and immunotherapy have improved outcomes, but these have limited penetration in resource-constrained situations. We report the real-world experience in treating patients with lung cancer in India. A retrospective analysis of baseline characters, treatment and outcomes of patients with lung cancer seen between January 2015 to December 2018 (n = 302) at our center was carried out. Survival data were censored on July 31, 2019. A total of 302 patients (median age: 57 years [range, 23–84 years]; males [n = 203; 67.2%]) were registered. Adenocarcinoma was the most common histology (n = 225, 75%). The testing rate of epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutation analysis in stage IV adenocarcinoma (n = 191) was 67% and 63%, respectively. Systemic therapy (chemotherapy/gefitinib) was started after a median of 62 days (range, 1–748) from presentation and 38 days (range, 1–219 days) from diagnosis. The median progression-free survival (PFS) and overall survival (OS) were 4.3 months (95% CI, 3.2–5.4) and 9.0 months (95% CI, 7.6–10.5), respectively in the 141 patient without targetable mutations who started palliative chemotherapy. Of the 58 patients who tested positive for EGFR mutation, 41 (71%) started an EGFR tyrosine kinase inhibitor (TKI), and the median PFS and OS in these patients were 8.5 months (95% CI, 5.6–11.4) and 18.4 months (95% CI, 12.2–24.6), respectively. Only 1 out of 10 patients with stage IV ALK-positive adenocarcinoma was started on ALK inhibitor. On multivariate analysis of OS for patients who started on palliative chemotherapy, response to first-line treatment, long distance from the center, use of second line therapy, and a delay of > 40 days from diagnosis to treatment predicted improved survival. Despite providing free diagnostic and treatment services, there was considerable delay in therapy initiation, and a significant proportion of treatment noninitiation and abandonment. Measures should be taken to understand and address the causes of these issues to realize the benefits of newer therapies The apparent paradox of improved survival in those with long delay in initiation of treatment could be explained based on a less aggressive disease biology.

Context Clostridioides difficile infection (CDI) is one of the most common infectious causes of hospital-acquired diarrhea. The actual burden of the disease is underestimated in India due to inadequate diagnostic methods and limited studies conducted. Aims The aim of this study was to determine the burden and risk factors of CDI among patients with hospital-acquired diarrhea. Methods and Materials Stool specimen of patients (age > 1 year) with hospital-acquired diarrhea were screened for glutamate dehydrogenase antigen and toxin using an enzyme immunoassay. If both antigen and toxin were present, it was reported as positive for toxigenic CDI. Samples positive for antigen and negative for toxin were further tested with Cepheid GeneXpert assay for detecting the toxin producing gene. Results Of 75 patients (mean age 36.07 ± 20.79, 64% males), 14 (18.67%) patients were positive for toxigenic Clostridioides difficile (C. difficile) and 3 (4%) patients were nontoxigenic C. difficile. Addition of GeneXpert to the testing algorithm increased the yield of toxin detection in 5/14 patients who were negative by toxin assay. On analysis of risk factors, prolonged hospital stay was found to have significant association (p-value = 0.022). Patients with factors like intensive care unit stay, presence of diabetes mellitus as a comorbidity, and exposure to antibiotics like carbapenems and glycopeptides have been found to have a higher prevalence of CDI. Conclusions The prevalence of CDI in our population was 18.67% and the major risk factor associated was prolonged hospital stay. The addition of GeneXpert for the detection of toxin gene increased the yield from 12 to 18.68%.

Background Adherence to oral anticancer medication is important in cancer chemotherapy, with the advent of many oral anticancer regimens to ensure adequate cytologic response. Literature on adherence to oral anticancer therapy in India is very less. Materials and Methods This is a cross sectional analytical study consisting of all fit patients > 18 years of age taking oral anticancer therapy, with or without intravenous (IV) chemotherapy. Adherence was determined using Morisky–Green–Levine (MGL) scale, and factors affecting adherence details about cancer and treatment were obtained. All fit patients were recruited. Information was obtained using Tamil questionnaire and pro forma. Observation Of 152 patients, only 111 patients were found to be adherent to treatment. The mean age of the study population was 49.03 ± 13.48 years. Only 12.5% of patients were aware of the diagnosis, treatment, and outcome. The study population consisted mainly of patients with chronic myeloid leukemia, colorectal carcinoma, breast carcinoma, and stomach carcinoma, which amounted for 78.3% of the study population. Bivariate analysis concluded that duration of treatment, adverse drug reaction (ADR), duration of oral anticancer drug intake in a month, coadministration with IV anticancer drugs, and frequency of drug intake (anticancer drug) were significant factors affecting drug adherence. Multivariate analysis of the above variables was insignificant, but ADR tended toward significance. Conclusion Drug adherence plays a major role in treatment outcome in cancer patients. ADR was independently associated with decreased drug adherence. Key interventions which should include counseling and behavioral modifications will reduce nonadherence.

Introduction: Cancer is a global problem and it is a leading cause of death worldwide. Nausea, vomiting and retching are one of the common side effects that are seen among the majority of the patients undergoing chemotherapy. Foot massage is a complementary therapy that reduces Chemotherapy-Induced Nausea and Vomiting (CINV) and improves the quality of life among cancer patients undergoing chemotherapy. This study aim to measure the effectiveness of foot massage in reduction of nausea, vomiting & retching on patients undergoing chemotherapy treatment. Methods: A randomized clinical trial study was used to assess the effect of foot massage on patients with Chemotherapy-induced nausea and vomiting among patients undergoing highly emetogenic chemotherapy. Simple random sampling by the lottery method was used to select newly diagnosed cancer patients who underwent highly emetogenic chemotherapy (N= 82). Rhodes index of nausea, vomiting and retching questionnaire were used for data collection . SPSS 19, two-sample t-test, paired t-test and chi-square test were used for data analysis. Result: Nausea, vomiting, and retching were significantly reduced in the experimental group compared to the control group after the intervention. There was a significant difference between pre-intervention and post-intervention scores within the group. Conclusion: The findings of the study revealed that the foot massage therapy is effective in reducing chemotherapy-induced nausea and vomiting among patients undergone highly emetogenic chemotherapy. The study helped to conclude that foot massage can be considered effective intervention in chemotherapy patients.

CD34 and CD79a are markers of hematopoietic stem cell and B-lymphoid cells, respectively. The abnormal expression of these markers in megakaryocytes has been noticed in cases of myelodysplastic syndrome, inherited platelet disorders, and reactive erythrocytosis. As a routine practice, while studying post-induction chemotherapy marrows in acute leukemia, immunomarkers, positive in the initial diagnostic workup, were performed to look for the residual blasts. Interestingly, we noticed CD34 immunopositive megakaryocytes in four such cases. CD79a positive megakaryocytes were also seen in five other cases of post-induction acute lymphoblastic leukemia. All these megakaryocytes, which were regenerating and in clusters, showed both topographic and cytological features of dysmegakaryopoiesis. CD 34 and CD79a, which are often used to monitor residual disease in the post-chemotherapy bone marrow, show aberrant positivity in the megakaryocytes. This novel finding of regenerating megakaryocytes may be used as a feature of dysmegakaryopoiesis in megakaryocytes.

Letrozole, an aromatase inhibitor (AI), is the first-line adjuvant drug for treating hormone receptor-positive (HR+) breast cancer in postmenopausal women. However, harmful adverse events (AEs) and significant differences in drug response among individuals remain a significant problem in clinical application. Current evidence suggests that the observed individual variation in the treatment outcomes of AI is conferred by genetic variants. Hence, in this study, we examined the association of TCL1A gene polymorphisms with letrozole-induced AEs. The study subjects were postmenopausal HR+ breast cancer patients who were receiving adjuvant letrozole. Genomic DNA was isolated by a routine standard phenol-chloroform method. In total, 198 South Indian patients were genotyped for four single nucleotide polymorphisms (SNPs) in the TCL1A gene loci by the TaqMan allelic discrimination assay using the RT-PCR system. We used the odds ratio and 95% confidence interval to assess the genetic association. Musculoskeletal (MS) AEs and vasomotor symptoms (VMSs) are the most common side effects observed in the study cohort. Among 198 patients, 81 experienced musculoskeletal toxicity, reporting MS-AEs, 57 had VMSs, and 33 of them had both. The most frequently identified polymorphic variants in the patient series were rs11849538 (G), with an allele frequency of about 27.3%, followed by rs7158782-G (27.3%), rs7159713-G (25.8%), and rs2369049-G (22.5%). The genetic association analysis indicated no significant difference in the proportion of TCL1A gene variants between patients with and without AEs on either MS-AEs or VMSs. Though we observed high LD in all patient groups, the inferred haplotypes displayed a non-significant association with letrozole-induced specific AEs. However, the SNP functionality analysis by RegulomeDB provided a 2b rank score for rs7158782, suggesting a potential biological function. Our findings suggest that TCL1A gene polymorphisms may not play any role in the prediction of letrozole-induced AEs in South Indian HR+ breast cancer patients.

Background: Acute lymphoblastic leukemia (ALL) patients are susceptible to hepatitis B infection due to profound immunosuppression and repeated transfusions. However, the comparative effectiveness of hepatitis B vaccination in different phases of chemotherapy has not been studied. Aim: In this comparative interventional study (CTRI/2017/08/009402), vaccination in the induction phase (IP) was compared to that in the maintenance phase (MP). Materials and Methods: The participating ALL patients in both groups (29 per group) were vaccinated with double the dose of hepatitis B vaccine at 0, 1, and 2 months. The proportion of patients with seroprotective anti-hepatitis B surface titers (>10 IU/ml) was compared between the two groups after each dose. Results: The seroprotection rates between both the phases were similar following the first (relative risk [RR] = 4, confidence interval [CI]: 0.47–33.65) and third (RR = 1.4, CI: 0.73-2.84) doses of vaccination, whereas following the second dose of vaccination, the seroprotection rate in IP was significantly higher than that of MP (RR = 1.9, CI: 1.07–3.35). Conclusion: This study concluded that a 0, 1, and 2 schedule of hepatitis B vaccination has similar efficacy in both the IP and the MP of chemotherapy in ALL patients. As the IP has a higher trend of seroprotection rates compared to MP, vaccination in IP followed by revaccination postchemotherapy may be preferred in countries with a high prevalence of hepatitis B infection.

Background: With the introduction of newer anti-cancer agents, the adverse effects have become more rampant which call for concern in the treatment of patients with cancer. Hence, the assessment and management of dermatological adverse effects of anti-cancer therapy have become a significant part of the care of patients with cancer and require proper and close collaboration between the dermatologists and the oncologists. Aims: To assess the frequency and pattern of mucocutaneous adverse reactions to cancer chemotherapy and chemoradiation and grade them according to their severity and to identify hematological and biochemical changes related to cancer chemotherapy-induced mucocutaneous adverse reactions. Materials and Methods: This was a descriptive study done among 226 patients in an Indian tertiary care hospital, who presented with mucocutaneous adverse reactions to either chemotherapy alone or combination of chemotherapy and radiation to dermatology, medical oncology and radiotherapy outpatient departments. Detailed history and examination were undertaken. Visual analog score (VAS) was employed to quantify pain and pruritus. Correlation of various biochemical and hematological parameters with chemotherapy-induced adverse reactions was attempted and grading of adverse reactions was done based on the severity scale of Common Terminology Criteria for Adverse Events (CTCAE). Results: The common cutaneous adverse reactions observed in our study were nail changes (194 patients; 85.84%), followed by skin changes (191; 84.51%), hair changes (159, 70.35%), mucosal changes (34, 15.04%), and other miscellaneous manifestations. Grade 1 manifestations comprised of 49.91% of total manifestations followed by Grade 2 (45.45%) and Grade 3 (5.64%). In addition to bleomycin, other chemotherapeutic agents also had been shown to produce flagellate dermatitis in our study. Conclusion: Nail changes, skin changes, hair changes and mucosal changes occurred frequently as a significant side effect of chemotherapy, which a physician should be aware of, while selecting a chemotherapeutic drug.

With an increase in the use of high dose chemotherapeutic regimens, higher cure rates and longer survival periods of cancer patients, the incidence of secondary malignancies are increasing. Therapy related Myeloid Neoplasm (t-MN) is a second malignancy after chemotherapy/radiotherapy given for a prior malignancy. Of the various t-MN Acute Promyelocytic Leukaemia (APML) as a complication of chemo-radiotherapy is very rare. We report a rare case of therapy related APML in a breast cancer survivor.

Introduction: Nodal Peripheral T-Cell Lymphomas (NPTCL) are a rare and heterogeneous group of lymphomas seen to occur more often in Asian, including South Indian population. They have an overall poor prognosis. Aim: To document the varied spectrum of clinico-radiological, histopathological and follow-up parameters of NPTCL. Materials and Methods: This descriptive cohort study involved clinical, histopathological and haematological workup of NPTCL cases diagnosed from January 2008 to June 2013 in JIPMER, Puducherry, India. The cases were diagnosed as per World Health Organisation (WHO) 2008 classification. Results: NPTCL accounted for 25% of all Non-Hodgkin Lymphomas (80 cases). Peripheral T-cell Lymphoma-not otherwise specified (PTCL-NOS), Anaplastic Large Cell Lymphoma, ALK-positive (ALCL, ALK+), Anaplastic large cell lymphoma, ALK-negative (ALCL, ALK-) and Angioimmunoblastic Lymphoma (AITL) contributed to 51%, 29%, 10% and 10% of the cases respectively. A majority of patients (68%) had generalised lymphadenopathy, 26% had hepatosplenomegaly and 38% had marrow infiltration. Histomorphology showed wide variation within and in between the subgroups. Overall, necrosis, fibrosis and high mitosis were more common in ALCL while increased vascularity was seen prominently in AITL. At least 70% of the cases in each entity had advanced stage of disease. Conclusion: There is a three-fold increase in incidence of NPTCL lymphomas in JIPMER compared to WHO (2008). Most patients presented with advanced stage and in sixth decade, except ALCL. There was wide histomorphological variability among these cases. Awareness of the entity and its histopathological heterogeneity would be worthwhile in arriving at a conclusive diagnosis.

Introduction Follicular lymphoma (FL) is an indolent chronic lymphoproliferative disorder of B-cells with variable clinical behaviour. It is the second most common subtype of Non-Hodgkin lymphoma in western countries but reported to have a lower incidence in Asia. Materials and methods Cases of FL diagnosed in the Department of Pathology of our Institute from January 2009 to June 2015 were included in the study. The clinicopathological parameters including staging, histological details and immunohistochemical markers CD20, CD10, Bcl2 and Ki67 were recorded in all the cases. Results Of the 497 cases of Non-Hodgkin Lymphoma reported during the study period, 36 (7.2%) cases were follicular lymphoma. The mean age was 50 years with male to female ratio of 3.2:1. Grade 1/ 2 was seen in 70% cases. 22 % cases had low grade with high proliferation index (Ki67 > 40%). Granulomatous response was seen in two cases. Diffuse large cell lymphoma component was present in four cases. Bone marrow involvement and peripheral blood spill was seen in 12 (37.5%) and six cases (18.8%) respectively. 72% cases were in stage 3 or 4. Conclusion Incidence of FL was lower in our study than other Indian studies. FL presented in the elderly, with male predominance and disseminated stage. Features of low grade with high proliferation index, granulomatous response, leukemic involvement and transformation to high grade lymphoma are highlighted in the study.

Follicular Lymphoma (FL) is the second most common B-Non Hodgkin Lymphoma after diffuse large B cell lymphoma (DLBCL). Low grade FL is known for its indolent behavior; however, one subset of FL behave aggressively and may require intensive therapy. One of the diagnostic issues in FL is to identify this subgroup of cases. Proliferation index can have prognostic importance in this subset of cases. We discuss one case of low grade FL with a paradoxically high proliferative index. A 63 year male presented with generalized lymphadenopathy of one year duration, which was gradually increasing in size. On examination, patient had bilateral cervical, axillary and inguinal nodes. Biopsy of the left cervical lymph node was reported as FL - Grade 2, with high proliferative Index (60%). The patient was put on CHOP regimen targeted for high grade lymphomas, and had complete remission. High proliferative index in FL is a poor prognostic factor irrespective of the histologic grade. So, proliferative index should be assessed in all cases of FL as an adjunct to histologic grading.

Background: Palmar plantar erythrodysesthesia (PPE) is a dose limiting toxicity of anticancer agents. In some cases it may mandate for discontinuation of anticancer agents. Evaluation of data of PPE among reported adverse drug reactions (ADRs) from the Department of Medical Oncology could quantify the burden. Aim: To evaluate and analyse the PPE among reported ADRs from medical Oncology. Materials and Methods: The data of all cases of reported PPE were collected during January 2012 to September 2013 and were analysed with WHO causality assessment scale. The severity was clinically graded. The follow-up data regarding outcome of ADRs were also noted. Results: During the study period of 21 months a total of 1418 ADRs have been reported from 1076 patients. Among them PPE was reported from 31 cases (2.9%). Majority (32.2%) of these patients were on chemotherapy for breast cancer. Patient’s age ranged from 17 to 68 y and the median age was 50 y. There were 18 female (58%) and 13 male patients (42%). Capecitabine was the leading drug involved in PPE, reported with 20 cases (64.5%), and followed by docetaxel with 5 cases (16.1%). Majority (67.7%) of the reactions was categorized as certain and 64.5% was grade II severity clinically. Conclusion: Our findings show that PPE accounts for 2.9% of total reported ADRs from Medical Oncology during 21 months. Majority of the reactions were classified as certain. Capecitabine is commonly implicated drug.