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.

Endoscopic Transcanal Myringoplasty-Smart Myringoplasty for Nex Gen ENT Surgeons: Our Experience.

Otolaryngology is one of the branch where endoscopes is being widely used nowadays to perform different surgeries. Ear surgeries are of special interest among the ENT surgeons. It has several advantages compared to the microscopes. 60 patients underwent endoscopic transcanal myringoplasty by the postgraduate residents under direct supervision of same consultants, using temporalis facia graft. The overall success rate in terms of graft uptake was 86.67% and the AB gap closure of < 10 dB in 63.3% of cases and 10-20 dB in 33.3%. Endoscopic myringoplasty was found to be equally effective, less morbid and very cost effective than the microscopic myringoplasty. This was applicable irrespective of the size of the perforation and condition of the middle ear (dry/wet) in our centre.

Conventional vs concomitant boost radiotherapy with concurrent cisplatin in advanced head and neck cancer.

AIM OF STUDY: To compare outcome of concomitant boost therapy (CBT) with conventional radiotherapy with cisplatin as a radiosensitizer in advanced head and neck cancer. SUBJECTS AND METHODS: Prospective comparative study was undertaken. Patients were assigned alternately to ArmA (conventional arm) and ArmB (CBT arm), 30 in each arm and total 60 patients were enrolled. RESULTS: Out of 30 patients in conventional Arm A, 13 had complete response (CR; 43.33%), 9 had partial response (PR; 30%), three patients (10%) had stable disease (SD), and five patients (16.66%) had progressive disease (PD). In arm B out of 30 patients, 18 patients (60%) had CR, five patients (16.66%) had partial response (PR), four patients (13.33%) showed SD, and three patients (10%) had PD. There was no statistically significant difference between the two arms for CR (P - value = 0.196). CONCLUSIONS: CBT can be used as an alternative to conventional RT in advanced head and neck cancers which minimize the total duration and the workload can be reduced. The locoregional control with CBT is comparable with the response of conventional RT.