No abstract

www.clinicaltrials.gov (NCT00824265).

Introduction:Febrile neutropenia (FN) is an oncological emergency. The choice of empiric therapy depends on the locally prevalent pathogens and their sensitivities, the sites of infection, and cost. The Infectious Diseases Society of America guidelines are being followed for the management of FN in India.Methods:This is a prospective observational study conducted at a tertiary care cancer centre from September 2012 to September 2014.Objectives:The objectives of this study were as follows: (1) To review the pattern of microbial flora, susceptibility pattern, and important clinical variables among bloodstream infections in febrile neutropenic patients with solid tumors and hematological malignancies. (2) As per the institutional protocol to periodically review the antibiotic policy and susceptibility pattern, and compare the findings with an earlier study done in our institute in 2010. This was a prospective study conducted from September 2012 to September 2014.Results:About 379 episodes of FN were documented among 300 patients. About 887 blood cultures were drawn. Of these, 137 (15%) isolates were cultured. Isolates having identical antibiograms obtained from a single patient during the same hospitalization were considered as one. Hence, 128 isolates were analyzed. About 74 (58%) cultures yielded Gram-negative bacilli, 51 (40%) were positive for Gram-positive cocci, and 3 (2%) grew fungi. Among Gram-negative organisms, Escherichia coli followed by Acinetobacter baumannii and Klebsiella pneumoniae accounted for 78% of the isolates. Among Gram-positive cocci, Staphylococcus species accounted for 84% of the isolates. We have noted a changing trend in the antibiotic sensitivity pattern over the years. Following the switch in empirical antibiotics, based on the results of the study done in 2010 (when the empirical antibiotics were ceftazidime + amikacin), the sensitivity to cefoperazone-sulbactam has plunged from about 80% to 60%%. Similar reduction in susceptibility was noted for piperacillin-tazobactam, imipenem, and meropenem. On the contrary, there was a marked increase in sensitivity to ceftazidime (50–76%). Based on these results, we have reverted to ceftazidime + amikacin as the empirical antibiotics.Conclusion:Every institute must have a regular revision of antibiotic policy based on periodic assessment of the clinical and microbiological profile in FN. This will combat antibiotic resistance.

Paclitaxel is widely used in the treatment of patients with metastatic breast cancer (MBC). Formulations of paclitaxel contain surfactants and solvents or albumin derived from human blood. The use of co-solvents such as polyoxyethylated castor oil is thought to contribute to toxicity profile and hypersensitivity reactions as well as leaching of plasticizers from polyvinyl chloride bags and infusion sets. Currently, nab-paclitaxel, an albumin-bound paclitaxel in nanometer range continues to be the preferred taxane formulation used in clinic. This study (CTRI/2010/091/001116) investigated the efficacy and tolerability of a polyoxyethylated castor oil- and albumin-free formulation of paclitaxel [paclitaxel injection concentrate for nanodispersion (PICN)] compared with nab-paclitaxel in women with refractory MBC. The current study was a multicenter, open-label, parallel-group, randomized, comparative phase II/III trial evaluating the efficacy and safety of PICN (260 mg/m2 [n = 64] and 295 mg/m2 [n = 58] every 3 weeks) compared with nab-paclitaxel (260 mg/m2 every 3 weeks [n = 58]) in women 18 and 70 years old with confirmed MBC. Overall response rate (ORR) was assessed with imaging every 2 cycles. An independent analysis of radiologic data was performed for evaluable patients. Progression-free survival (PFS) was a secondary efficacy measure. Independent radiologist-assessed ORRs in the evaluable population of women aged ≥70 years were 35, 49, and 43 % in the PICN 260 mg/m2, PICN 295 mg/m2, and nab-paclitaxel 260 mg/m2 arms, respectively. Median PFS in the evaluable population was 23, 35, and 34 weeks in the PICN 260 mg/m2, PICN 295 mg/m2, and nab-paclitaxel 260 mg/m2 arms, respectively. Adverse events occurred in similar proportions of patients across treatment arms. Hypersensitivity reactions were not frequently observed with the clinical use of PICN across the treatment cohorts. In women with metastatic breast cancer, PICN at 260 and 295 mg/m2 every 3 weeks was effective and well tolerated and showed similar tolerability compared with nab-paclitaxel 260 mg/m2 every 3 weeks. Statistically, significant differences were not observed in the PICN and nab-paclitaxel treatment arms for radiologist-assessed ORR or median PFS. The novel paclitaxel formulation, PICN, offers apart from efficacy, potential safety advantage of decreased use of corticosteroid pretreatment and the absence of the risk of transmission of blood product-borne disease.

Bone is an uncommon site of metastasis in patients with hepatocellular carcinoma (HCC), and often overlooked. We report two cases that had isolated bone metastasis; one of them had prolonged disease-free survival. The present series, along with the literature review, reinforces the idea that HCC should be considered in the differential diagnoses in patients presenting with metastases in bone. The presence of isolated bone metastases need not necessarily indicate poor prognosis, and all such patients need to be offered chemotherapy and at least one of the bone-directed therapies (either local radiation in cases of localized disease or bisphosphonates in the presence of extensive disease) as they may have a better outcome with therapy.

Introduction:Prolonged treatment, frequent administration of chemotherapy, antibiotics and blood products in cancer patients requires long term venous access. Central venous catheters (CVC) inserted into the subclavian vein or internal jugular vein, peripherally inserted central venous catheters (PICC) and chemoport (CP) are the commonly used central venous access devices (CVAD).Aim:This study was envisaged to review our experience of CVADs over a one year period and analyze the outcome with regard to catheter life, reasons for removal, complications, patient satisfaction and cost comparison between the CVAD types in the Indian setting.Settings and Design:This was a prospective, observational study carried out in a tertiary care cancer institute.Materials and Methods:180 CVADs placed in patients with hematological malignancies and solid tumors from January 2014 to December 2014 were included.Statistical Analysis Used:Data was analyzed using descriptive statistics, Mann Whitney U test. P <0.05 was taken as statistically significant.Results:180 CVADs were placed in 160 patients. The median catheter indwelling period was 76 days (16 days to 313 days) for CVC, 59 days (20days – 313 days) for PICC and 137 days (70 days – 258 days) for CP. 66 out of 160 patients developed complications (41.2%). 108 complication events were noted in 66 patients. There were 40 episodes of CRBSI. Out of the 68 mechanical complications, 37 were encountered during insertion of the CVAD and 31 were during the catheter indwelling period. Out of 160 patients, 138 (86.25%) were satisfied with the CVAD. The cost incurred for CVC/PICC (INR 4,480) was lower than that for CP (INR 24,150) and it was statistically significant (P < 0.0001). Our patients were highly satisfied with the CVAD.Conclusion:Use of CVC and PICC is a safe, reliable and cost saving way of administration of chemotherapy in developing countries. The incidence of complications and catheter loss was acceptable. Our patients were highly satisfied with the CVAD.

Treatment options for patients with small upper aerodigestive tracts squamous cell carcinoma (T1, T2) with advanced neck disease (N2, N3) is a topic that generates controversy in terms of thereuptic stratagies. We present the retrospective analysis of 109 patients treated, between 1991 and 2008, by "Neck dissection first approach" for N2, N3 neck node, followed by external beam radiotherapy (RT) with or without chemotherapy for the operated neck and the primary, deemed radiocurable. 94 patients completed the planned treatment and formed the material for this study. The primary (tumor) stage was as follows: T1 (29) and T2 (65) commonly arising from oropharynx; the neck nodes were predominantly N2a (n = 54), followed by N2b (n = 26) and N3 (n = 14) disease. Complete nodal clearence was achieved in 89 patients, with no major post operative complications. With a median follow up of 24 months disease free survival of 70% and overall survival of 61% at 5 years. Recurrence at primary site was noted predominantly with pyriform fossa tumors (n = 8), followed by base of tongue (n = 5) and were T2 lesions. Failure in the neck was seen in predominantly N3 nodes, R1 resection and failure to comply with adjuvant treatment. Neck dissection first approach is a valid treatment option that allows a good control of the disease in the neck, where it often fails if only RT is administered, along with preserving the pharyngolaryngeal function. Care should be excercised so that there should be no delay in initiating the RT following surgery.

Non-pulmonary metastases in osteosarcoma are increasingly recognized because of improved longevity in patients receiving modern treatment. One rare site of metastasis is the orbit, with only three cases reported so far. This report describes a 16-year-old male patient, who underwent above-knee amputation for right tibial osteosarcoma and later presented with a painful protrusion of the right eyeball and near-normal vision. The uncommon features in the present case are the site of metastasis and near-normal vision.