Prognostic Factors and Outcomes of Early-Stage Hodgkin's Lymphoma: Multi-Institutional Data From South India.

Early-stage Hodgkin's lymphoma (ESHL) is highly curable, usually with a combination of chemotherapy and radiation. Real-world data may show differences in survival and prognostic factors when compared to clinical trials. There is limited published literature on ESHL from India. The data on the baseline characters, treatment, and outcomes of patients with ESHL (stage IA, IB, and IIA) were obtained from five institutions' medical records and entered in a common database. Event-free survival (EFS) and overall survival (OS) were estimated using the Kaplan Meier method, and cox-regression analysis was used to identify prognostic factors. There were 258 patients [median age was 37 (18-75) years; [males:160 (62%); stage I: 41%; B symptoms: 17 (6%); bulky disease:19 (15%)] treated between 2000 and 2020 who were evaluable. The common chemotherapies used were ABVD [N = 180 (70%)], COPP-ABVD hybrid [N = 52 (21%)], and COPP [N = 14 (5%)]. Median number of cycles were 4 (2-8) and 93 (47%) received radiation at end of treatment. After a median follow-up of 60 months, the 5 years EFS was 87% and OS was 92%. On multivariate analysis, the following factors adversely affected the EFS: Male gender [hazard ratio (HR) = 2.23, P = 0.02] and Hemoglobin < 10.5g/dL [hazard ration (HR) = 2.20, P = 0.02], and the following adversely affected the OS: Hemoglobin < 10.5g/dL [hazard ratio (HR) = 4.05, P = 0.001], Male gender [hazard ratio (HR) = 3.59, P = 0.004], Stage 2 [hazard ratio (HR) = 2.65, P = 0.002] and ECOG PS (2-3) [hazard ratio (HR) = 3.35, P = 0.01]. Using the hemoglobin, stage and gender a 3-item prognostic score could identify patients with very good outcomes (score 0; 5 years OS:100%) and poor outcomes (score 3; 5 years OS; 49%). This is one of the first multi-center real-world data exclusively focusing on ESHL from India. Though the survival of the entire population was good, there are subsets of patients who have poor outcomes, which may be identified using simple parameters. These parameters need validation in a larger dataset. Supplementary Information: The online version contains supplementary material available at 10.1007/s12288-023-01692-9.

Optimization and Validation of a Harmonized Protocol for Generating Therapeutic-Grade Dendritic Cells in a Randomized Phase II Clinical Trial, Using Two Varied Antigenic Sources.

Autologous dendritic cell (DC)-based immunotherapy is a cell-based advanced therapy medicinal product (ATMP) that was first introduced more than three decades ago. In the current study, our objective was to establish a harmonized protocol using two varied antigenic sources and a good manufacturing practice (GMP)-compliant, manual method for generating clinical-grade DCs at a limited-resource academic setting. After obtaining ethical committee-approved informed consent, the recruited patients underwent leukapheresis, and single-batch DC production was carried out. Using responder-independent flow cytometric assays as quality control (QC) criteria, we propose a differentiation and maturation index (DI and MI, respectively), calculated with the QC cut-off and actual scores of each batch for comparison. Changes during cryopreservation and personnel variation were assessed periodically for up to two to three years. Using our harmonized batch production protocol, the average DI was 1.39 and MI was 1.25. Allogenic responder proliferation was observed in all patients, while IFN-gamma secretion, evaluated using flow cytometry, was detected in 10/36 patients and significantly correlated with CD8+ T cell proliferation (p value-0.0002). Tracking the viability and phenotype of cryopreserved MDCs showed a >90% viability for up to three years, while a mature DC phenotype was retained for up to one year. Our results confirm that the manual/semi-automated protocol was simple, consistent, and cost-effective, without the requirement for expensive equipment and without compromising on the quality of the final product.

Outcomes with chemotherapy in carcinoma penis: Experience from a tertiary cancer center.

Background: Carcinoma penis is more common in India compared to the West. The role of chemotherapy in carcinoma penis is ambiguous. We analyzed the profile and outcomes of patients with carcinoma penis treated with chemotherapy. Methods: We analyzed the details of all patients with carcinoma penis treated at our institute between 2012 and 2015. We collected particulars regarding demography, clinical presentation, treatment details, toxicities, and outcomes of these patients. Event-free and overall (OS) survival were calculated from the time of diagnosis until documentation of disease relapse/progression or death for the patients with advanced carcinoma penis who were eligible for chemotherapy. Results: There were 171 patients with carcinoma penis treated at our institute during the study period including 54 (31.6%) patients with stage I, 49 (28.7%) patients with stage II, 24 (14.0%) patients with stage III, 25 (14.6%) patients with stage IV, and 19 (11.1%) patients with recurrent disease at presentation. The present study included 68 patients with advanced carcinoma penis (stages III and IV) who were eligible for chemotherapy, with a median age of 55 years (range: 27-79 years). Sixteen patients received paclitaxel and carboplatin (PC) and 26 patients cisplatin and 5-FluoroUracil (CF). Neoadjuvant chemotherapy (NACT) was given to four patients with stage III and nine patients with stage IV disease. Of the 13 patients given NACT, we observed a partial response in five (38.5%), stable disease in two (15.4%), and progressive disease in five (38.5%) evaluable patients. Six (46%) patients underwent surgery after NACT. Only 28/54 (52%) patients received adjuvant chemotherapy. After a median follow-up of 17.2 months, the 2-year OS rates were 95.8, 89, 62.7, 51.9, and 28.6% for stages I, II, III, IV, and recurrent disease, respectively. The 2-year OS of patients who were given chemotherapy versus those who were not given chemotherapy were 52.7 and 63.2%, respectively (P = 0.762). Conclusions: We report the real-world outcomes of two chemotherapeutic regimens used in consecutive patients with advanced carcinoma penis. Both PC and CF seemed effective and safe. However, approximately half of patients with advanced carcinoma penis do not receive the planned/indicated chemotherapy. We need further prospective trials regarding the sequencing, protocols and indications of chemotherapy in this malignancy.

Real-World Experience of Treating Young Adult Patients with Breast Cancer from a Single Center in Southern India.

Priya IyerBackground Breast cancer in young adults is rare and accounts for 5 to 6% of all cancers in this age group. We conducted the present study to look at the demographic features, clinical presentation, and outcomes in this group of patients treated at our center. Patients and Methods The study included breast cancer patients between the age of 15 and 30 years treated at our institute from January 2009 to December 2016. Data were analyzed retrospectively from case records. Event-free survival (EFS) and overall survival (OS) were calculated using the Kaplan-Meier method. Results Young adult breast cancers were reported in 145 out of 6,000 patients (2.41%) diagnosed with breast cancer in the study period. The median age of the patients was 29 years (range: 21-30 years). Stage I, II, III, and IV was observed in 3.4, 33.7, 46.2, and 16.5% of patients, respectively. The median follow-up was 45 months (range: 1.7-128.1 months). The 5-year EFS and OS for stage I, II, III, and IV was 100, 74.5, 47.9, and 0% and 100, 90.8, 55.1, and 0%, respectively. On univariate analysis, stage of the disease and pregnancy-associated breast cancers were found to have a significant association with decreased EFS and OS ( p < 0.001, p = 0.008 and p < 0.001, p = 0.001, respectively). On multivariate analysis, stage of disease and pregnancy-associated breast cancers remained significant predictors of EFS and OS. Conclusion Breast cancers in young adults are rare but need to be diagnosed at an early stage to improve survival. Pregnancy-associated breast cancers need to be managed optimally without delay owing to their aggressive tumor biology.

Metaplastic carcinoma of the breast: real-world outcome from a tertiary cancer centre in India.

Metaplastic carcinoma (MPC) is a rare subgroup of breast tumours accounting for <5% of all invasive breast cancers. Histologically confirmed 40 MPC from January 2001 to December 2018 were identified from our electronic database: stage I 2.5% (n = 1), stage II 40% (n = 16), stage III 45% (n = 18) and stage IV 12.5% (n = 5). The mean tumour size was 6 cm, node-negative in 60%, and hormone receptor-negative in 75%. Among the 35 non-metastatic patients, 17 (48.6%) received initial neoadjuvant treatment (NAT), followed by surgery, and only 1 had a complete pathological response. At a median follow-up of 60 months, 17% (n = 6) had a recurrence. All six of them had lung metastasis. The 5-year overall survival (OS) and disease-free survival were 64.4% and 66.3%, respectively. Age more than 46 years (p = 0.027), tumour size more than 5 cm (p = 0.037), and nodal positivity (p = 0.001) were predictors of OS. In node-positive patients, the 5-year OS in those who underwent initial surgery was 80% and after NAT was 21.4% (p = 0.069). In node-negative patients, the 5-year OS after initial surgery was 83.3% and after NAT was 90% (p = 0.380). A statistical significance could not be demonstrated due to the small number of patients. Due to chemoresistance, the concept of initial NAT in MPC of the breast is a subject to be studied in the future. Upfront surgery should be considered for operable diseases (including stage III), followed by a decision on adjuvant therapy. Optimal treatment and effective systemic therapy regimens are yet to be defined.

Therapeutic Outcomes in High-Grade B-Cell Lymphoma, NOS: Retrospective Analysis.

The nomenclature high-grade non-Hodgkin's lymphoma was repurposed in the World Health Organization (WHO) 2016 update as high-grade B cell lymphoma (HGBL). However, among the HGBL entities HGBL, not otherwise specified (NOS) remains a poorly described entity with a lack of literature regarding its treatment and prognosis. The baseline characteristics, treatment, and outcome of HGBL, NOS cases were analyzed. Thirty HGBL, NOS patients were diagnosed between January 2017 and December 2019. Their median age was 49.3 years, and 30% had advanced IPI. The majority received R-CHOP chemotherapy, while five patients received dose-adjusted R-EPOCH. At a median follow-up of 15 months, nine patients had disease progression or relapse. EFS and OS were 22 months (12.1-31.9 months) and 37 months (29.4-44.0 months) respectively. Only NCCN-IPI ≤ 2 showed significant influence on the outcome. The results were similar to the outcomes previously reported. This study highlights the importance of NCCN-IPI in ascertaining the prognosis of HGBL, NOS. The literature review suggests that more intensive chemotherapy is ideal for HGBL, NOS. However, prospective trials are needed to prove whether the treatment of HGBL, NOS can be tailored based on NCCN-IPI.

The continuing conundrum in oligometastatic breast carcinoma: A real-world data.

The optimal management in Oligometastatic (OM) breast carcinoma is not defined. OBJECTIVES: To identify the prognostic factors influencing OM and the effect of Locoregional treatment (LRT) on survival in OM. METHODOLOGY: Patients with ≤5 metastases and each with ≤ 5 cm size were defined as OM. Data of OM were extracted from the Institute Registry between 2012 and 2018. The impact of prognostic factors on survival was analysed by univariate and multivariate Cox regression. The Kaplan Meier survival curves were used to plot PFS and OS. RESULTS: There were 170 patients with OM. The median follow-up was 61 months. Median OS was 43.3 months. The median OS was 74 months in OMD vs 22.7 months in Oligorecurrent disease (ORD) with 5year OS rate of 55.3% vs 16.5% respectively. In the multivariate analyses of OMD both Ki67 ≤ 50% and hormone therapy (HT) showed significant favourable survival outcome. While premenopausal status and HT showed significant survival benefits in ORD. The worse survival outcome in ORD could be because of their aggressive biology and deficit in LRT compared to literature review. The prognostic factors were swayed by the uneven distribution of HR status, grade and Ki67. CONCLUSION: The survival of OM was influenced by OMD, Ki67 ≤ 50%, premenopausal status and HT. The lesser survival rates of OM in the long term suggest the need for curative LRT to metastatic sites and primary tumor. The potential role of HT and targeted therapy with or without LRT need to be assessed in future randomised trials.

Psychosocial issues and concerns of cancer patients due to COVID-19 pandemic lockdown.

BACKGROUND: The COVID-19 pandemic lockdown has posed numerous unique challenges for cancer patients, families and healthcare workers. However, the reports on psychosocial issues associated with such situations are scarce. This study aims to determine the psychosocial issues faced by cancer patients during COVID-19 pandemic lockdown. METHODS: Cancer patients irrespective of diagnosis and treatment status were assessed for fear of progression (FOP), distress and quality of life (QOL) using Fear of Progression- Short Form, Distress Thermometer and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) 30, respectively. The demographics, disease and treatment related details were obtained from case record form. Psychological issues and concerns were collected using a structured interview. Descriptive statistics, Mann Whitney U-test and Linear Regression were performed using SPSS ver 20.0. RESULTS: Among the 219 patients, 118 (52.5%) had either interruption in their on-going cancer treatment or the initiation of cancer treatment was delayed as a result of COVID-19 lockdown. Overall, 74% of the patients experienced distress, 55.3% experienced FOP and 58% had low global health status. Pain followed by fatigue remained as major issues among patients during lockdown. Interruption in treatment and logistical issues were strongly associated with increased distress (p = 0.026) and FOP (p = 0.004). Global health status (p = 0.037), emotional functioning (p = 0.000), social functioning (p = 0.000) and financial concerns (p = 0.046) differed significantly between patients with and without treatment interruption. Age (ß = -0.159), mode of transport (ß = -0.135), challenges in meeting daily needs (ß = -0.245) and being out-casted by the society (ß = -0.227) predicted distress. CONCLUSION: More than half of the patients had interruptions in their treatment as a result of COVID-19 lockdown. Cancer patients have had increased physical and psychological concerns as a result of the pandemic situation and its associated changes. Specific guidelines ought to be framed for providing continued and holistic cancer care for patients during such lockdown.

Phase 2 non-randomised trial of secondary cytoreduction and hyperthermic intraperitoneal chemotherapy in recurrent platinum-sensitive ovarian cancer.

BACKGROUND: The role of secondary cytoreduction with hyperthermic intraperitoneal chemotherapy (HIPEC) is not clearly defined in recurrent platinum-sensitive ovarian cancer (PSOC). There is a paucity of studies on secondary cytoreduction with HIPEC in PSOC from developing countries like India. This study was done to assess the feasibility and safety of secondary cytoreduction and HIPEC in recurrent PSOC. METHODS: This was a prospective, non-randomised, open-label, phase 2 trial of secondary cytoreduction and HIPEC (Cisplatin 75 mg/m2 43°C over 60 minutes) in patients with recurrent platinum-sensitive epithelial carcinoma of ovary/fallopian tube/peritoneum done in a tertiary cancer centre from February 2016 to August 2019. The primary outcome was to assess the overall survival (OS) and the secondary outcomes were to assess the progression-free survival (PFS) and toxicity. RESULTS: Twenty-seven patients were screened and among them, 15 patients were included in this analysis with a median follow-up of 25 months. The mean cancer antigen (CA) 125 at the time of recurrence was 149 U/mL (range: 10-2,030 U/mL) and the median platinum-free interval was 21 months. The perioperative chemotherapy used was paclitaxel + carboplatin 53.3% (8/15), liposomal doxorubicin + carboplatin 40% (6/15) and none 6.5% (1/15). The median Peritoneal Carcinomatosis Index score was 8 (range: 3-25). The Clavien Dindo score was I, II and III in 6.7%, 26.7% and 13.3% patients, respectively. Recurrence was radiological and biochemical in 60% (9/15) and 7% (1/15), respectively. The most common site of recurrence was intra-abdominal (peritoneal). The median PFS and OS were 15 months (range: 0-34) and 26 months (range: 23-29), respectively. The grade 3 or 4 toxicity was 40%. CONCLUSION: Secondary cytoreduction with HIPEC is feasible and safe in recurrent PSOC. Conclusive evidence that secondary cytoreduction with HIPEC is essential awaits the results from ongoing randomised controlled trials.

Haploidentical Hematopoietic Stem Cell Transplantation in Leukemia's: Experience from a Cancer Center in India.

There has been a surge in haploidentical hematopoietic stem cell transplantation (HSCT) in India recently. However, there is a paucity of data on haploidentical HSCT from India. The report is an analysis of data of haploidentical HSCT performed at our center. Analysis of patients with acute leukemia or chronic myeloid leukemia who underwent haploidentical HSCT during 2014-2019 was performed. The graft versus host disease (GVHD) prophylaxis was post-transplant Cyclophosphamide with Mycophenolate-mofetil and Cyclosporine. All patients were transfused peripheral blood stem cells from donors. Overall survival (OS) was calculated using the Kaplan-Meier method. Twenty-one patients underwent haploidentical HSCT. Fourteen-patients were males. The median age of patients was 15 years. Fludarabine with total body irradiation was the most common conditioning regimen (n = 15, 71.4%). The median duration for neutrophil and platelet engraftment was 14 days. Cumulative incidence of acute and chronic GVHD was 19%, and 38% respectively. The median follow-up was 26 months and the two-year OS was 38%. Twelve (57%) patients died during the study period, 8 patients (38%) died from transplant-related mortality (TRM), and 4 from disease relapse. Sepsis was the cause of death in six of the eight TRM. Nine out of 21 patients (42.8%) are leukemia-free on follow-up. Haploidentical HSCT is a promising modality of treatment in patients who have no suitable matched donors. Though the TRM remains high, good disease control was achieved in 42.8% of patients. Multi-drug resistant bacterial infection remains a challenge in performing haploidentical HSCT in developing countries.

Locally Advanced Breast Cancer (LABC): Real-World Outcome of Patients From Cancer Institute, Chennai.

PURPOSE: There are sparse data on the outcome of patients with locally advanced breast cancer (LABC). This report is on the prognostic factors and long-term outcome from Cancer Institute, Chennai. METHODS: This is an analysis of untreated patients with LABC (stages IIIA-C) who were treated from January 2006 to December 2013. RESULTS: Of the 4,577 patients with breast cancer who were treated, 2,137 patients (47%) with LABC were included for analysis. The median follow-up was 75 months (range, 1-170 months), and 2.3% (n = 49) were lost to follow-up at 5 years. The initial treatment was neoadjuvant concurrent chemoradiation (NACR) (77%), neoadjuvant chemotherapy (15%), or others (8%). Patients with triple-negative breast cancer had a pathologic complete response (PCR) of 41%. The 10-year overall survival was for stage IIIA (65.1%), stage IIIB (41.2%), and stage IIIC (26.7%). Recurrence of cancer was observed in 27% of patients (local 13% and distant 87%). Multivariate analysis showed that patients with a tumor size > 10 cm (hazard ratio [HR], 2.19; 95% CI, 1.62 to 2.98; P = .001), hormone receptor negativity (HR, 1.45; 95% CI, 1.22 to 1.72; P = .001), treatment modality (neoadjuvant chemotherapy, HR, 0.56; 95% CI, 0.43 to 0.73; P = .001), lack of PCR (HR, 2.36; 95% CI, 1.85 to 3.02; P = .001), and the presence of lymphovascular invasion (HR, 1.97; 95% CI, 1.60 to 2.44; P = .001) had decreased overall survival. CONCLUSION: NACR was feasible in inoperable LABC and gave satisfactory long-term survival. PCR was significantly higher in patients with triple-negative breast cancer. The tumor size > 10 cm was significantly associated with inferior survival. However, this report acknowledges the limitations inherent in experience of management of LABC from a single center.

COVID19 in children with cancer in low- and middle-income countries: Experience from a cancer center in Chennai, India.

Crowded outpatient clinics and common wards in many hospitals in low and middle-income countries predispose children, caregivers, and health care workers to infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We report on the clinical features and outcomes of 15 children with cancer at our center who tested positive for SARS-CoV-2. Five out of 15 patients were symptomatic, and one patient required intensive care and respiratory support. All the patients in the study have recovered from the SARS-CoV-2 infection without any sequelae and have resumed their cancer treatment.

Recurrent cervical cancer treated with palliative chemotherapy: real-world outcome.

INTRODUCTION: Cervical cancer is the third most common cancer in India. There is limited data on the treatment of relapsed cervical cancer from India; therefore, we report the outcomes of patients with recurrent cervical cancer who were treated with palliative chemotherapy (CT). MATERIALS AND METHODS: This was a retrospective study of patients with recurrent cervical cancer who received palliative CT from January 2012 to December 2016. The demographic details, clinical profile and survival outcomes were collected. Patients were treated with carboplatin or paclitaxel and carboplatin. Local radiation was given for symptomatic patients. Patients were assessed for responses clinically and/or radiologically after three and six cycles of CT. Progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan-Meier method. RESULTS: Forty-six patients with recurrent cervical cancer were included in this analysis, with a median follow-up of 9.4 months. The median age was 49.5 (25-65) years and the median disease-free interval was 31.3 (2-196) months. Biopsy confirmation of relapse was established in 63%. The median number of CT cycles was six. Twenty-four (52.2%) patients completed six cycles of CT. The overall response rate was 56.5%. Patients with a complete or a partial response were more likely to have PFS > 6 months (p < 0.0001). Median PFS and OS were, respectively, 8.4 (95% CI 6.1-10.7) months and 10.3 (95% CI 6.8-13.8) months. The completion of all cycles of CT and the site of metastasis (nodal vs. visceral or combined) were found to be associated with OS. CONCLUSION: Palliative CT with paclitaxel carboplatin is a safe and effective option in Indian patients with recurrent cervical cancer, with more than half of the patients completing the prescribed CT. Further prospective trials may be required to place this treatment in the right context, in this era of immunotherapy and targeted therapy. However, knowing the outcomes in our population and prognostic factors will help in better prognostication of patients, thereby channelling our limited resources where necessary.

Gastrointestinal Stromal Tumours (GIST): Indian Experience of Rare Malignancy.

GISTs are rare tumours of the GI tract arising from the intestinal cells of Cajal. Though various risk stratification systems have been proposed, none has been universally accepted. We audited the survival and recurrence patterns in our patients and evaluated clinicopathological features to identify prognostic factors affecting survival. We conducted a retrospective analysis of patients treated at our hospital from 1999 to 2012. Patient variables, clinicopathological factors and treatment variables were collected. Sixty-three patients were evaluated and treated at our institute of which 38 were non-metastatic. The most common site of origin was the stomach. On univariate analysis, presence of metastasis, male gender, high mitotic rate, non-gastric primary and epithelioid histology were significantly associated with poor overall survival. Tumour size > 10 cm, mitotic rate > 10/50 hpf and presence of necrosis significantly affected disease-free survival for non-metastatic patients. Multivariate analysis showed higher mitotic rate and non-gastric primary to correlate with worse outcome. In our experience, a high mitotic rate and non-gastric primary independently predicted a poor prognosis in GIST.

Perioperative versus postoperative chemotherapy for gastric cancer: A propensity score matched analysis.

AIM: In advanced gastric cancer, chemotherapy, given either perioperatively or as an adjuvant treatment, has been shown to improve survival when compared to surgery alone. However, no trial has compared these two approaches head-to-head. Hence, we aimed to compare the short- and long-term outcomes of patients with gastric cancer who received either perioperative chemotherapy or adjuvant chemotherapy. METHODS: Retrospective analysis of patients with gastric cancers treated from 2010 to 2016. Using propensity score matching, resected patients who received perioperative chemotherapy were matched for histology, nodal dissection, and extent of surgery with another cohort of patients who received only adjuvant chemotherapy to create two matched groups of 101 patients each-group A (perioperative) and group B (adjuvant)-and the outcomes were compared between them. RESULTS: The patient demographics were evenly distributed in the two groups. There was no difference in the median number of chemotherapy cycles delivered (6 vs 6, P = .8) or the grade 3-4 toxicity (17.2% vs 12.1%, P = .26) in group A and group B, respectively. We could not demonstrate a significant difference in the postoperative mortality (2.6% vs 0%) or overall postoperative complications (23% vs 19%) between groups A and B. The overall recurrence rate (37% vs 42%), 3-year disease-free survival rate (51% vs 48%), and 3-year overall survival rate (53% vs 55%) were not significantly different in group A and group B, respectively. CONCLUSIONS: We were unable to detect a significant difference in the short-term or long-term outcomes of patients with gastric cancer undergoing either perioperative or adjuvant chemotherapy.

Study of pathological complete response rate with neoadjuvant concurrent chemoradiation with paclitaxel in locally advanced breast cancer.

BACKGROUND: Neoadjuvant concurrent chemoradiation (CTRT) is not widely practiced in breast cancers. The current study presents our experience with the use of neoadjuvant CTRT in patients with locally advanced breast cancers (LABC) treated at our center. METHODS: The study included all consecutive female patients with inoperable stage III LABC treated at Cancer Institute (W.I.A), Chennai, India, from December 2015 to September 2016. Data were collected retrospectively from the patients' case records. The impact of neoadjuvant CTRT on the pathological complete response (pCR) and survival was analyzed. Neoadjuvant chemotherapy consisted of 4 cycles of adriamycin and cyclophosphamide given either before or after 4 cycles of paclitaxel. All chemotherapy cycles were given once in 3 weeks. Concurrent radiotherapy was incorporated with 2 cycles of paclitaxel. RESULTS: The study included 100 patients with a median age of 49 years, among whom 9 (9%) had IIIA disease, 73 (73%) IIIB, and 18 (18%) had IIIC disease. The hormone receptor-positive disease was observed in 36 (36%) patients, triple-negative in 24 (24%), and Her2/neu positive disease in 40 (40%) patients. All patients were operable after completing the planned neoadjuvant treatments. Ninety-one out of 100 (91%) patients underwent modified radical mastectomy whereas 9 (9%) did not consent for surgery. Among the patients who underwent MRM, 34/91 (37.7%) patients had a pCR. Moreover, pCR was observed in 12/22 (54.5%) patients with triple-negative disease, 10/34 (29.4%) patients with hormone receptor-positive disease, and 12/35 (34.2%) patients with Her2/neu positive disease (P = 0.19). Most common morbidity observed was grade 3 skin reactions. The 2-year event-free survival and overall survival for the entire cohort was 73.1% and 88%, respectively. CONCLUSION: Neoadjuvant CTRT is associated with a higher pCR rate than what has been reported with neoadjuvant chemotherapy alone. Further prospective studies are required to confirm our findings.

Plasmablastic lymphoma - single centre experience with infusional EPOCH chemotherapy.

BACKGROUND: Plasmablastic lymphoma (PBL) is a rare type of aggressive large B - cell non-Hodgkin Lymphoma (NHL) which was initially described in HIV positive individuals and later was also described in immune-competent individuals. It was included as a distinct entity in the WHO lymphoma classification in 2008. METHODS: The clinical features, HIV status, treatment details, and outcomes of patients diagnosed with plasmablastic lymphoma from January 2012 to December 2018 were retrospectively collected from the patient records and analyzed. The survival analysis was done by Kaplan Meier analysis and the comparison was done by the Log Rank test. RESULTS: The median age of 25 patients, included in the study was 41 years (Range 13-71 years). Males constituted 76 %. HIV positivity was 72 %. Stage IV disease was present in 76 %. Extranodal involvement was seen in 96 %. Out of 25 patients, seven did not receive any treatment and three received metronomic oral chemotherapy due to poor performance status at presentation. Fifteen patients received chemotherapy on a curative intent. Infusional EPOCH chemotherapy was given in 13 patients. CHOP and CHOEP chemotherapy was given in one patient each. The median number of cycles was 6 (Range: 3-8). The overall response rate of patients treated on a curative intent was 80 % (Complete response and partial response in 8 and 4 respectively). Three patients underwent high dose chemotherapy with autologous stem cell rescue at first remission. The median event-free survival (EFS) and median overall survival (OS) of the whole study population was 5.9 and 12.4 months respectively, with a median follow of 26.9 months. The median EFS was 13.8 months and the median OS was not reached in the curative-intent group. The factors adversely influencing the EFS and OS were Age > 40 years, high IPI, and non-curative intent of treatment. CONCLUSION: Plasmablastic lymphoma commonly presents as stage 4 disease with extranodal involvement and is more common in immune-deficient individuals. Infusional EPOCH chemotherapy is a promising option that induces long term remission.

Olanzapine versus metoclopramide for the treatment of breakthrough chemotherapy-induced vomiting in children: An open-label, randomized phase 3 trial.

BACKGROUND: Breakthrough chemotherapy-induced vomiting (CIV) is defined as CIV occurring after adequate antiemetic prophylaxis. Olanzapine and metoclopramide are two drugs recommended for the treatment of breakthrough CIV in children, without adequate evidence. We conducted an open-label, single-center, phase 3 randomized controlled trial comparing the safety and efficacy of olanzapine and metoclopramide for treating breakthrough CIV. PROCEDURE: Children aged 5-18 years who developed breakthrough CIV after receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy were randomly assigned to the metoclopramide or olanzapine arm. The primary objective of the study was to compare the complete response (CR) rates between patients receiving olanzapine or metoclopramide for treating breakthrough CIV during 72 hours after the administration of the study drug. Secondary objectives were to compare CR rates for nausea and toxicities between the two arms. RESULTS: Eighty patients were analyzed (39 in the olanzapine arm and 41 in the metoclopramide arm). CR rates were significantly higher in the olanzapine arm compared with the metoclopramide arm for vomiting (72% vs 39%, P = 0.003) and nausea (59% vs 34%, P = 0.026). Seven patients in the metoclopramide arm crossed over to the olanzapine arm and none crossed over in the olanzapine arm (P < 0.001). The mean nausea score in the olanzapine arm was significantly lower than the metoclopramide arm after the initiation of the rescue antiemetic (P = 0.01). Hyperglycemia and drowsiness were more commonly seen in the olanzapine arm. CONCLUSION: Olanzapine is superior to metoclopramide for the treatment of breakthrough CIV in children. Drowsiness and hyperglycemia need to be monitored closely in children receiving olanzapine for breakthrough CIV.

"Hairy Cell Leukemia (HCL): 'Real World' Outcome".

HCL is an uncommon B cell lympho-proliferative disorder with high remission rates. There is paucity of data on the long-term outcome of HCL from India. We retrospectively collected data from individual case records of patients with HCL who were treated in Cancer Institute, Chennai from January 2001 until January 2018. Sixteen patients were diagnosed with HCL and were treated with cladribine (81%), interferon (13%) and one patient received only best supportive care (6%). All the treated patients achieved complete response. More than half of the patients developed febrile neutropenia but there were no treatment related mortality. The 5-year DFS was 77% and 5-year OS was 80%. Relapse of disease was seen in 27%. HCL is a curable malignancy with high remission rates and survival comparable to patient treated in west.

A modified olanzapine-based anti-emetic regimen for the control of nausea and vomiting in patients receiving weekly cisplatin.

Background There is limited data on specific antiemetic protocols for control of chemotherapy-induced nausea/vomiting (CINV) caused by weekly cisplatin regimens. Olanzapine is an active agent against CINV and may offer better control of nausea compared to aprepitant/fosaprepitant-based regimens. The usual antiemetic dose of olanzapine (10 mg for four days) causes problems with drowsiness. A lower dose may be as effective with lesser side effects in patients receiving weekly cisplatin. Objective To assess the control of nausea, vomiting, and occurrence of side effects with a modified olanzapine-based antiemetic regimen among patients with carcinoma of the cervix receiving concurrent cisplatin with pelvic radiotherapy. Setting Tertiary cancer hospital in Southern India. Methods We used a modified regimen "mini-OPD", oral olanzapine (5 mg) days 1 and 2, intravenous palonosetron (0.25 mg) and dexamethasone (12 mg) on day 1 of cisplatin administration in patients with carcinoma of the cervix receiving concurrent chemoradiotherapy with weekly cisplatin (40 mg/m2/week). At our centre, these patients remained inpatients throughout chemoradiotherapy. CINV-related outcomes were captured in the patients' records by the treating physician in the subsequent week (up to 6 times per patient depending on the number of cycles). We audited these records to calculate the complete response (CR defined as no emetic episodes and no use of rescue medication) rate. Main outcome measure Grades of nausea, vomiting, and drowsiness as per CTCAE v4.0. Results Data of 65 patients (median age: 48 years) who received mini-OPD regimen (median doses of cisplatin/patient: 4) was available. The CR rate was 55%. Considering all cycles together (217 weekly assessment points), "no nausea" target was attained in 125 (58%) assessments and "no vomiting" in 168 (77%). There were no significant side effects. Conclusions The mini-OPD regimen is an inexpensive, non-toxic and effective regimen for the prevention of CINV in patients receiving weekly cisplatin concurrent with pelvic radiotherapy.