Summary Background There have been encouraging reports on transjugular intrahepatic portosystemic stent‐shunt (TIPSS) for Budd–Chiari syndrome (BCS). Long‐term data are lacking. Aim To assess long‐term outcomes and validate prognostic scores following TIPSS for BCS. Methods A single centre retrospective study. Patients underwent TIPSS using bare or polytertrafluoroethane (PTFE)‐covered stents. Results Sixty‐seven patients received successful TIPSS between 1996 and 2012 using covered (n = 40) or bare (n = 27) stents. Patients included had a Male: Female ratio of 21:46, and were characterised (mean ± s.d.) by age 39.9 ± 14.3 years, Model of end stage liver disease (MELD) 16.1 ± 7.0 and Child's score 8.8 ± 2.0. Seventy‐eight percent had haematological risk factors. Presenting symptoms were ascites (n = 61) and variceal bleeding (n = 6). Nine patients underwent hepatic vein dilatation or stenting prior to TIPSS. Mean follow‐up was 82 months (range 0.5–184 months). Fifteen percent had post‐TIPSS encephalopathy. Two have been transplanted. Primary patency rates (76% vs. 27%, P < 0.001) and shunt re‐interventions (22% vs. 100%, P < 0.001) significantly favoured covered stents. Secondary patency was 99%. Six‐, 12‐, 24‐, 60‐ and 120‐month survival was 97%, 92%, 87%, 80% and 72% respectively. Six patients had liver related deaths. Two patients developed hepatocellular carcinoma. The BCS TIPS PI independently predicted mortality in the whole cohort, but no prognostic score was a significant predictor of mortality after subgroup validation. Conclusions Long‐term outcomes following TIPSS for Budd–Chiari syndrome are very good. PTFE‐covered stents have significantly better primary patency. The value of prognostic scores is controversial. TIPSS should be considered as first line therapy in symptomatic patients in whom hepatic vein patency cannot be restored.

The Incidence of breast cancer has been steadily increasing in the last two decades, more so in urban areas of the sub-continent. Cancer ceters across the country have large numbers of patients being treated with multiple publications in this field. Inspite of paucity of prospective data and randomised clinical trials from India, there are large number of retrospective publications on various aspects of the disease including pathology, radiology, surgery, chemotherapy, radiation, palliative care and alternatitive treatment modalities. These published data provide an insight into the trends of breast cancer in the country and this comprehensive data review of Indian data will provide a basis for designing trials relevant to our population and planning health care.

Therapy was safe. The responses, time to treatment progression and survival are encouraging for patients with aggressive refractory disease.

Background The management of osteosarcoma is challenging especially in lower‐income and middle‐income countries, and there is an unmet need to evolve efficient and sustainable chemotherapy regimens. Methods We compared the outcomes in nonmetastatic osteosarcoma patients treated with three sequential non‐high‐dose methotrexate‐based combination chemotherapy protocols at a single tertiary care center over two decades. The first protocol, OGS‐99, involved dose‐intense, alternating dyads of three drugs: doxorubicin (Dox), cisplatin (CDDP), and ifosfamide (Ifo). The second protocol, OGS‐99 enhanced, included OGS‐99 drugs with etoposide and enhanced supportive care. The OGS‐12 protocol involved dose‐dense administration of eight sequential dyads of Dox, CDDP and Ifo, universal growth factor prophylaxis and targeted nutritional support. Event‐free survival (EFS), overall survival (OS), and toxicity were reported using a retrospective chart review in the OGS‐99 and OGS‐99 enhanced protocols and prospectively in the OGS‐12 protocol. Results A total of 41, 94, and 385 treatment‐naïve, consecutive, nonmetastatic patients with extremity osteosarcoma were treated with the OGS‐99 (2000–2005), OGS‐99 enhanced (2010), and OGS‐12 (2011–2016), respectively. At a median follow‐up of 19, 86, and 39 months, the five‐year EFS rates were 38%, 50%, and 62% in the OGS‐99, OGS‐99 enhanced, and OGS‐12, respectively. The corresponding rates of five‐year OS were nonevaluable, 60% and 77%, respectively, with acceptable rates of grade 3–4 toxicities: febrile neutropenia (40%), thrombocytopenia (36%), anemia (51%), and 1% deaths related to toxicity. Conclusions Sequential selection of an intelligent, dose‐dense chemotherapy regimen together with enhanced supportive care resulted in marked improvement in outcomes of nonmetastatic osteosarcoma and this “small steps—big changes” model deserves wider recognition and usage.

BCD-020 (Acellbia, rituximab biosimilar candidate) was shown to be highly similar to innovator rituximab (MabThera®/Rituxan®) in terms of its quality characteristics, in vitro biological activity, as well as toxicology and PK/PD characteristics in non-human primates. International multicenter comparative randomized open-label clinical study was carried out in a period from 2011 to 2013 and involved over 30 centers in Russia, Ukraine and India. Its methodology and design complies with current EMA guidelines on similar biological products containing monoclonal antibodies (EMA/CHMP/BMWP/403543/2010). 92 patients with follicular non-Hodgkin’s lymphoma, stage I-IV by Ann Arbor, or marginal zone lymphoma, stage I-IV by Ann Arbor, ECOG 0-2, who had at least 1 measurable lesion were enrolled. According to study protocol patients with secondary transformed B-cell lymphomas or with highly aggressive types of tumor, bulky disease, severe concomitant somatic disorders and some other conditions were excluded. If a patient had previous story of chemotherapy or radiation he could be included after at least 3 weeks post-treatment. Participation of patients who were previously treated with any kind of monoclonal antibodies was prohibited. After signing standard informed consent form and completion of 28-days screening period eligible patients underwent stratification in accordance to their prognostic risk (FLIPI or IPI) and previous treatment (naïve or pretreated). Subsequently patients were randomized (1:1) into 2 groups: 46 patients were included in the main group where Acellbia (rituximab biosimilar) was administered at a dose of 375 mg/m2 as a slow IV infusion on day 1, 8, 15 and 22; 46 patients were included in the reference group where MabThera was used at the same regimen. Use of any other medicines for the treatment of lymphoma was strictly prohibited. Efficacy was assessed on the basis of computed tomography and bone marrow evaluation which were performed 1 month after the completion of treatment. Median age of patients in each group was 57.5 years (main group [50.0-64.0], reference group [47.0-65.0]). Manageable comorbidities were reported in 50% of patients in the main group and 34.78% of patients in the reference group, p=0.2053. Comparative analysis of the prognostic risk factors confirmed the equivalence of study groups. The number of pretreated patients in both groups was equal – 8 individuals per group. Statistical analysis didn’t find any difference in overall response rate in general population of patients (39.52% patients in the main group vs. 36.57% patients in the reference group, p=0.8250), as well as in population of pretreated patients (28.6% vs 37.5% respectively, p=1.00) and in population of naïve patients (42.8% vs 39.4% respectively, p=1.00). The lower limit of the two-tailed 95% CI for difference in proportions of ORR was equal to -0.17 and exceeded the predefined non-inferiority margin -0.2, which confirmed non-inferiority of Acellbia to MabThera in terms of efficacy. Treatment-associated AE of any grade were reported in 21.74% patients in both arms, in the absence of statistically or clinically significant difference (p = 0.8005). There were 2 cases of CTCAE 4.03 grade 3-4 AEs in each group. PK and PD parameters were shown to be equivalent in both study groups. Thus, study results suggest that Acellbia has same efficacy and safety in patients with B-cell non-Hodgkin’s lymphoma. Disclosures Chernyaeva: JCS BIOCAD: Employment. Ivanov:JCS BIOCAD: Employment. Isaev:JCS BIOCAD: Employment.

The standard of care treatment for oral squamous cell carcinoma (OSCC) at present, consist of surgical resection followed by adjuvant radiotherapy and chemotherapy as indicated. Despite recent advances the overall prognosis remains guarded. Role of neoadjuvant chemotherapy is being explored with premise of reducing extent of surgical resection, improving loco-regional control and decreasing distant metastasis, thereby improving treatment outcomes by decreasing mortality and morbidity. However, indications of neoadjuvant chemotherapy in oral cancers are not clearly defined. Majority of studies have failed to demonstrate a significant benefit of neoadjuvant chemotherapy in terms of loco regional control and overall survival in resectable OSCC. In a select subset of patients with locally very advanced and unresectable OSCC, neoadjuvant chemotherapy has been shown to cause tumor shrinkage and improve resectability. These hypothesis generating findings of reduction in distant metastasis, improved resectability and functional outcome, however need further validation. In summary, the role of neoadjuvant chemotherapy for OSCC remains investigational and has a limited role outside clinical trial.

PURPOSE Escalated BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) improves overall survival (OS) in patients with Hodgkin lymphoma (HL) relative to ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) therapy. However, the associated higher cost and toxicity discourage clinicians from prescribing it. Identifying high-risk patients and administering escalated BEACOPP remains an effective strategy. We assessed the significance of interim positron emission tomography (iPET) scan after 2 cycles (iPET2) in identifying this high-risk subset. PATIENTS AND METHODS This cohort study used secondary data from 12 tertiary care centers in South India gathered over 10 years (2008-2018). OS, event-free survival (EFS), determinants of EFS, and complete response (CR) in iPET2 were assessed. RESULTS The study included 409 patients with HL (mean age, 34.5 years; male/female ratio, 1.4:1). The median duration of follow-up was 2.8 years. Of 409 patients, 63% underwent PET-based staging and 37% underwent computerized tomography (CT) staging. Stage IV (28.9%) and bone involvement (9.2%) were seen more often with PET than with CT staging (9.2% and 2%, respectively). Among 171 patients with iPET2 results, 24% did not achieve CR, and no factors were significantly associated. The 5-year EFS and OS rates of the entire cohort were 78% and 97%, respectively. The 5-year EFS and OS rates of patients with CR on iPET2 were 90% and 99%, respectively, whereas these were 65% and 100%, respectively, for patients not achieving CR. On univariable analysis, sex, stage, and iPET2 response significantly predicted inferior EFS. On multivariate analysis, only iPET2 response significantly predicted EFS ( P < .000). CONCLUSION Our study supports the use of PET for staging and iPET2 for response assessment. Nonachievement of CR on iPET2 indicates unfavorable outcome, and such patients may benefit from more intensive treatment.

Hyponatremia is a common and often under-recogonised clinical problem in oncologic practice. The recogonition of the cause of hyponatremia and initiation of appropriate and timely intervention can prevent morbidity and improve treatment tolerance. This drug review aims at discussing the currently approved oral vaptanagent Tolvaptan. Vaptans including Tolvaptan act as “aquaretic” agents cousing excretion of water while retaining the sodium. Administration of this agent for prescribed periods result in improvement of serum sodium levels. The drug can be used in many clinical situations resulting in hyponatremia including congestive heart failure, cirrhosis and syndrome of inappropriate ADH secretion (SIADH) including SIADH related to malignancies.