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Executing global clinical trials for cancer is a long, expensive, and complex undertaking. While selecting countries global studies, sponsors must consider several aspects including patient pool, quality of trained investigators, competing trials, availability of infrastructure, and financial investment versus returns. With a large, often treatment-naïve, and diverse patient pool, relatively low cost, good quality health care facilities in urban areas, and a robust and well-trained workforce, India offers several advantages for conducting oncology clinical trials. However, there remains challenges, including a shifting regulatory environment in recent decades. With the implementation of the New Drugs and Clinical Trial Rules in 2019, India's regulatory atmosphere seems to have stabilized. In this article, we present a review of the evolving clinical trial landscape in India, highlight the current regulatory scenario, and discuss the advantages and challenges of selecting India as a potential location for conducting global oncology clinical trials.

The real-world data on short course of immune checkpoint inhibitor (ICI) use are sparse and merit exploration. A multicentric observational study on the safety and efficacy of ICI in oncology patients between August 2014 and October 2020 involves 1011 patients across 13 centers in India. The median age was 59 (min 16-max 98) years with male preponderance (77.9%). The predominant cohort received short-course ICI therapy; the median number of cycles was 5 (95% confidence interval [CI] 1-27), and the median duration of therapy was 3 (95% CI 0.5-13) months. ICIs were used commonly in the second and third line setting in our study (66.4%, n = 671). Objective response rate (complete or partial response) was documented in 254 (25.1%) of the patients, 202 (20.0%) had stable disease, and 374 (37.0%) had progressive disease. The clinical benefit rate was present in 456 (45.1%). Among the patients whom ICI was stopped (n = 906), the most common reason for cessation of ICI was disease progression (616, 68.0%) followed by logistic reasons like financial constraints (234, 25.82%). With a median follow-up of 14.1 (95% CI 12.9-15.3) months, there were 616 events of progression and 443 events of death, and the median progression free survival and overall survival were 6.4 (95% CI 5.5-7.3) and 13.6 (95% CI 11.6-15.7) months, respectively, in the overall cohort. Among the immune-related adverse events, autoimmune pneumonitis (29, 3.8%) and thyroiditis (24, 2.4%) were common. Real-world multicentric Indian data predominantly with short-course ICI therapy have comparable efficacy/safety to international literature with standard ICI therapy., (© 2021 UICC.)

Malignant peripheral nerve sheath tumor (MPNST) is a type of soft tissue sarcoma arising from peripheral nerves. They can be found in isolation, but about half of the cases are associated with neurofibromatosis type 1 (NF1), an autosomal dominant genetic disorder. They usually arise from the nerve plexus in extremities and trunk. MPNSTs arising from the viscera or internal organs are very rare. We hereby report a rare case of sporadic MPNST arising from pleural surface in a middle-aged male. The diagnosis of such a rare entity involved multimodal investigations with consideration of wide differential diagnosis.

Objectives: To examine the epidemiology of microbiologically documented bacterial infection and the resistance pattern, among cancer patients undergoing treatment at RGCIRC, Delhi., Design and Setting: Retrospective observational study in which culture reports obtained over 1 year in 2013, were analyzed., Results: 13329 cultures were obtained over 1 year in 2013 and were analyzed. 23.6 % samples showed positive culture with majority being gram negative isolates (67.9 %). E. coli was the commonest gram negative isolate (49.4%) followed by klebsella (29.7%) and Staph. aureus was the commonest gram positive isolate. There was high incidence of ESBL in blood and urine (87.2% & 88.5%) and BLBLI were also high (78% & 83.9%). Carbapenem resistance was comparatively low (10%) and colistin sensitivity was quiet high (> 95%)., Conclusions: Prevalence of MRSA and VRE in our institute is very less, whereas prevalence of ESBLs and BLBLI isolates amongst gram negative infections is around 80%. Gram negative isolates had poor sensitivity to cephalosporins and fluoroquinolones.

The mean percentage of cells forming rosettes with 2-aminoethyl isothiouronium bromide-treated sheep erythrocytes (EAETRFC) in the peripheral blood of 10 horn cancer-affected cattle (40.05 +/- 2.91) was significantly low in comparison to the value in unaffected control animals (58.61 +/- 1.68). Immunotherapy with a saline phenol extract of allogeneic tumour tissue resulted in a gradual increase in the mean percentage of EAETRFC on each subsequent week. The increase was statistically significant from the second week onwards and on the sixth week, the percentage of EAETRFC in horn cancer affected cattle (56.80 +/- 1.38) closely approximated the value in unaffected controls.

Background Treatment of non-small cell lung cancer (NSCLC) has undergone a paradigm shift in the last decade with the advent of targeted therapy and immunotherapy. Anaplastic Lymphoma Kinase (ALK) rearrangement and Programmed Death-Ligand 1 (PD-L1) expression are important predictive biomarkers for response to targeted therapy and immunotherapy respectively. How these two biomarkers interplay with each other is yet to be determined. Various studies have tried to establish a relationship between PD-L1 expression in tumors and treatment outcomes in ALK rearranged NSCLC, with conflicting results. There is a paucity of data regarding this relationship from the Indian subcontinent. Methods PD-L1 expression was assessed in tissue samples of 58 patients with advanced ALK rearranged NSCLC treated between 2015 and 2018. PD-L1 expression was measured by immunohistochemistry using VENTANA PD-L1 (SP263) antibody on formalin-fixed paraffin-embedded specimens. The epidemiological profile of patients and the relationship between progression free survival (PFS) on small molecule ALK inhibitor and PD-L1 expression were noted. Results The median age was 47 years (range 25-72 years) and there were 25 males (50%). Most of the patients were never smokers (88%). Thirty-seven (63.7%) of tumors expressed PD-L1 (≥1%) and 13 (22.4%) tumors had a PD-L1 expression of ≥ 50%. All of the patients received crizotinib as first line ALK inhibitor. Of the 44 patients evaluable for treatment response there was no significant difference in PFS between PDL1 negative cohort (median PFS - 13.8 months, CI 6.2-21.3 months) and PDL1 positive cohort (median PFS 10.9 months, CI 6.5-15.2 months, P-0.81). No association was seen between PD-L1 expression and PFS when PD-L1 expression levels were stratified by median or quartiles. In the subgroup analysis, PFS was not significantly different between different patterns of PDL1 expression or intensity of staining. Conclusions In contrast to previous studies, we found a higher incidence of PD-L1 expression in patients with ALK rearranged advanced NSCLC. PFS on ALK inhibitors did not differ based on PD-L1 expression. However, this was a retrospective study in a limited number of patients. More prospective studies are needed to confirm our findings. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest. [ABSTRACT FROM AUTHOR]