Rituximab biosimilar for the treatment of diffuse large B-cell lymphoma: a phase 3 randomized study in India.

PURPOSE: Very few studies have demonstrated the rituximab biosimilarity in terms of efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity in patients with diffuse large B-cell lymphoma (DLBCL) in India. Therefore, we compared the efficacy, safety, pharmacokinetic, pharmacodynamic, and immunogenicity of our biosimilar rituximab with the reference rituximab (Ristova, Roche products [India] Pvt. Ltd) in patients with DLBCL in India. METHODS: A phase 3, randomized, assessor-blind, parallel-group, two-arm study was conducted across 28 sites in India. A total of 153 newly diagnosed DLBCL patients were randomized to receive either biosimilar rituximab or reference rituximab. The study drugs were administered at a dose of 375 mg/m2 by intravenous infusion every 3 weeks for six cycles. The primary end point was objective response rate (ORR) at the end of Cycle 6. Secondary end points included: pharmacokinetic, pharmacodynamics, immunogenicity, and safety assessment. RESULTS: The ORR at the end of Cycle 6 was 82.14% in the biosimilar rituximab and 85.71% in the reference rituximab group. The risk difference (90% CIs) was - 3.57 (- 14.80, 7.66). It met the non-inferiority margin of - 20%. The pharmacokinetic and pharmacodynamic parameters were comparable between the two treatment groups. The incidence rate of immunogenicity was very low and similar in both the treatment groups. The safety profile of both the treatments was comparable with no major difference in terms of nature, frequency and severity of TEAEs. CONCLUSION: The study demonstrated the biosimilarity between the biosimilar rituximab and the reference rituximab. Our biosimilar rituximab could add to the cost-effective treatment alternatives for patients with DLBCL in India.

Hypofractionated, palliative radiotherapy for advanced head and neck cancer.

BACKGROUND: A significant proportion of advanced stage head and neck cancer patients are incurable and have a limited life expectancy. This study reports a single institution experience with a hypofractionated radiotherapy regimen for palliation of loco-regionally advanced and incurable HNSCC. MATERIALS AND METHODS: Between 2000 and 2005, 110 patients of unresectable HNSCC were treated with a palliative radiotherapy (40Gy in 16 fractions). Distressing symptoms were assessed before treatment. Patients with good objective regression with acceptable toxicity received further escalation of dose till 50Gy. We made three strata to compare symptomatic improvement namely percentage relief <50%, between 50-75% and >75% as compared to baseline. RESULTS: Most common baseline distressing complaints were pain in 109 (99%) patients and dysphagia in 97 (88%) patients. Eleven patients (10%) had complete response (CR) and 80 (73%) patients had complete and partial response (PR). At completion of radiotherapy 26%, 57%, and 17% of patients had <50%, 50-75%, and >75% symptomatic relief, respectively. The overall PFS (defined as either complete disappearance of the disease or non-progression in the irradiated field) at 12 months was 55.1% (95% CI, 40.3%-69.9%). On multivariate analysis weight >50kg (p=0.049) and radiotherapy dose of more than 40Gy (p=0.012) were found to be significant for PFS. Acute and late reactions were acceptable. CONCLUSIONS: The hypofractionated radiotherapy regimen evaluated is an effective treatment modality for sustained symptoms relief with good response rates and acceptable toxicity.

Embryonal rhabdomyosarcoma of the biliary tree mimicking a choledochal cyst.

Embryonal rhabdomyosarcoma (ERMS) of biliary tree is a rare type of mesenchymal neoplasm diagnosed at surgery or by preoperative liver biopsy. We present a one year eight months old child who mimicked a choledochal cyst and was eventually treated with surgery, chemotherapy with IRS IV protocol and adjuvant postoperative radiotherapy to surgical bed with 6 MV photons to a dose of 5040 cGy in 28 fractions.

Recurrent episodes of hematuria: a rare presentation of leiomyosarcoma of prostate.

Leiomyosarcoma of the prostate is an extremely rare entity. Sarcomas account for about 1% of all malignant tumors and less than 5% of them arise from the genitourinary tract. Majority of patients present with urinary obstructive symptoms. The outcome is generally poor. Surgery with or without radiotherapy/chemotherapy forms the mainstay of treatment for patients with operable tumors. We report a patient presenting with recurrent episodes of hematuria.