Treatment with nanosomal paclitaxel lipid suspension versus conventional paclitaxel in metastatic breast cancer patients - a multicenter, randomized, comparative, phase II/III clinical study.

Background: A novel nanosomal paclitaxel lipid suspension (NPLS), free from Cremophor EL (CrEL) and ethanol, was developed to address the solvent-related toxicities associated with conventional paclitaxel formulation. Objective: To evaluate the efficacy and safety of NPLS versus CrEL-based paclitaxel (conventional paclitaxel) in patients with metastatic breast cancer (MBC). Design: A prospective, open-label, randomized, multiple-dose, parallel, phase II/III study. Methods: Adult (18-65 years) female patients with MBC who had previously failed at least one line of chemotherapy were randomized (2:2:1) to NPLS 175 mg/m2 every 3 weeks (Q3W, n = 48, arm A), NPLS 80 mg/m2 every week (QW, n = 45, arm B) without premedication or conventional paclitaxel (Taxol®, manufactured by Bristol-Myers Squibb, Princeton, NJ, USA) 175 mg/m2 Q3W (n = 27, arm C) with premedication. In the extension study, an additional 54 patients were randomized (2:1) to arm A (n = 37) or arm C (n = 17). Results: Pooled data from the primary study and its extension phase included 174 patients. The primary endpoint was the overall response rate (ORR). As per intent-to-treat analysis, ORR was significantly better in the NPLS QW arm as compared to conventional paclitaxel [44.4% (20/45) versus 22.7% (10/44), (p = 0.04)]. An improvement in ORR with NPLS Q3W versus conventional paclitaxel arm [29.4% (25/85) versus 22.7% (10/44)] (p = 0.53) was observed. Disease control rates observed were improved with NPLS Q3W versus conventional paclitaxel Q3W (77.7% versus 72.7%, p = 0.66) and with NPLS QW versus conventional paclitaxel Q3W (84.4% versus 72.7%, p = 0.20), although not significant. A lower incidence of grade III/IV peripheral sensory neuropathy, vomiting, and dyspnea was reported with NPLS Q3W versus conventional paclitaxel Q3W arms. Conclusion: NPLS demonstrated an improved tumor response rate and a favorable safety profile versus conventional paclitaxel. NPLS 80 mg/m2 QW demonstrated a significantly better response versus conventional paclitaxel 175 mg/m2 Q3W. Trial registration: Clinical Trial Registry-India (CTRI), CTRI/2010/091/001344 Registered on: 18 October 2010 (https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MjEzNQ==&Enc=&userName=CTRI/2010/091/001344), CTRI/2015/07/006062 Registered on: 31 July 2015 (https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTE2Mjc=&Enc=&userName=CTRI/2015/07/006062).

Role of nanosomal paclitaxel lipid suspension (NPLS) in the treatment of patients with metastatic breast cancer (MBC) Why was the study done? Paclitaxel is a commonly used drug for the treatment of breast cancer. Conventional formulation of paclitaxel is known to cause side effects like injection site reactions. A newer formulation named NPLS was developed to overcome the limitations of the conventional paclitaxel. The current study was done to compare the safety and effectiveness of NPLS and conventional paclitaxel in patients with advanced breast cancer. What did the researchers do? The research team conducted a large study in multiple hospitals across India, involving women with advanced breast cancer who had experienced treatment failure with previous chemotherapy. A total of 174 patients were randomly assigned to receive either of the three treatment schedules: (1) NPLS every 3 weeks, (2) NPLS every week, (3) conventional paclitaxel every 3 weeks. What did the researchers find? The results showed that NPLS, in a weekly schedule, led to better tumor response rates compared to conventional paclitaxel given every 3 weeks. Additionally, NPLS demonstrated a favorable safety profile, as compared to conventional paclitaxel. What do the findings mean? These findings suggest that NPLS could be a promising alternative for women with advanced breast cancer. NPLS improved the response to treatment, with a better safety profile compared to conventional paclitaxel.

Penile metastasis from esophageal squamous carcinoma after curative resection.

The penis is an uncommon site of metastasis; with only about 300 cases reported in literature. The majority (75%) of primary tumors are located in the pelvis, and they arise from the genitourinary tract and rectum. We report on a patient with esophageal squamous carcinoma who underwent a curative resection and later developed metastatic nodules over the penis and perineum. We believe this is the first instance of this unusual presentation. He was offered palliation with weekly taxanes and had symptomatic relief with this regimen.

Clinico-investigative Profile Of Patients With Diabetic Foot In A Rural Tertiary Care Centre Of Maharashtra

Autism is childhood neuropsychiatric disorder despite exhibiting high heritability and has largely eluded efforts to identify specific genetic variants of biomarkers. This neuropsychiatric disorder is characterized by social and commu-nicative deficits and ritualistic-repetitive behaviour that are detectable in early childhood. It has been reported that some candidate genes has been found in autism children brains. The candidate genes include aspects of neurogene-sis, neuronal migration, maturation, differentiation, and degeneration. Some of researchers had reported the effects of the mutated and sufficiency of the candidate genes in autism brain which believed that might involved in the mechanism and causes deficit in social behaviour language impairment and repetitive behaviour. In this review, we will summarize the gene candidate which found in autism children brains and their effect of their cognitive function

Etiological Factors, Clinical Presentations And Treatment Outcome Of Cervical Lymphadenopathy: An Observational Descriptive Study

Aim: To study various etiological factors, clinical presentations of cervical lymphadenopathy. To study the manage-ment and outcome of cervical lymphadenopathy Method:Proper clinical history was first noted, local and systemic examination was performed and a clinical diagnosis was made. Gender wise distribution, presenting symptoms, site distribution, and treatment outcome were noted. Result:Gender wise distribution of male and female was 52%, and 48%, commonest site of primary in cases of metastatic Secondaries was tongue followed by oesophagus and thyroid. After proper diagnosis confirmed by Histopathology (biopsy), treatment constituted properly-Cases of Tubercular Lymphadenitis (49 cases) were Started on Anti-tubercular treatment, all were showed improvement in symptoms. Cases of Reactive lymphadenitis (26 cases) started on antibiotics, all recovered well. Among 14 Cases of Metastatic secondaries, 5 cases were given Chemotherapy/Radiotherapy after expert oncologist opinion out of which 3 showed improved symptoms and 2 were expired, 6 cases were operated out of which 5 showed improved symptoms and 1 expired post operatively, 3 cases were referred to specialized oncological and oncosurgical center for further man-agement. All 6 Lymphoma cases were started on chemotherapy after expert oncologist opinion showed improve-ment in symptoms. Conclusion:Commonest site of primary in cases of metastatic Secondaries was tongue followed by oesophagus and thyroid. Anti-tubercular treatment for tubercular lymphadenitis was highly satisfactory with im-provement in almost all patients. Surgery was restricted as an adjuvant to chemotherapy, as diagnostic biopsy, for treatment of abscess/sinuses and for a lymph nodes that do not resolve with chemotherapy. Non-tuberculous non-neoplastic lesions can be best managed by conservatively.

Bilateral synchronous spermatocytic seminoma: a rare case report from rural India and literature review.

Spermatocytic Seminoma is an unusual germ cell tumour known to arise from testis only. It is associated with good prognosis. Testicular tumours as such are uncommon in Asia as compared to western countries. In the literature only five cases of bilateral synchronous Spermatocytic Seminoma have been reported. Fifty years male patient presented to us with bilateral scrotal swelling and evaluation revealed neoplastic aetiology of bilateral testicular enlargement. Left side radical orchidectomy was performed initially which histopathologically revealed spermatocytic seminoma. Subsequently right side radical orchidectomy was performed after intra-op frozen section confirmation of neoplastic nature. Histopathology revealed same pathology as on left side. Immunohistochemistry of specimen from both testes was again conclusive of spermatocytic seminoma. We hereby report this rare case of Bilateral Synchronous Spermatocytic Seminoma. This is the first case report from entire Asian continent except for Japan.