Browsing by Author "Anuj Gupta"

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Real-world data on trastuzumab emtansine (TDM1) efficacy and safety: Results of a single-centre retrospective study of HER2-positive metastatic breast cancer patients
(Nature Research, 2025) Anuj Gupta; Bipinesh Sansar; Bal Krishna Mishra; Aqusa Khan; Arpita Singh; Arvind K. Upadhyay; Zachariah Chowdhury; Shashikant C.U. Patne; Mayank Tripathi; Shukla Shreya; Satyendra Narayan Singh; Lincoln Pujari; Prashanth Giridhar; Ankita Rungta Kapoor; Arvind Suresh; Somnath Dey; Kunal Ranjan Vinayak; Neha D. Singh; Amit Nanda Kumar; Ankita Pal; Akhil Kumar Kapoor
HER2-positive metastatic breast cancer (MBC) represents a challenging subtype of breast cancer, characterized by aggressive disease and poor clinical outcomes. Trastuzumab emtansine (TDM1), an antibody–drug conjugate combining trastuzumab and emtansine, has demonstrated efficacy in clinical trials as a second-line treatment for patients progressing after prior therapies. This study aims to provide real-world evidence on the efficacy and safety of TDM1 in HER2-positive MBC patients. A retrospective analysis was conducted on 70 HER2-positive MBC patients treated with TDM1 at our centre between January 2020 and December 2022. Clinical characteristics, progression-free survival (PFS), overall survival (OS), response rates, and toxicity were evaluated using hospital records. PFS and OS were calculated using Kaplan–Meier methods, and survival curves were compared with log-rank tests. The median age of patients was 47 years, with a majority presenting with advanced disease and prior treatment lines. The median PFS was 6.1 months (95% CI, 4.5–7.6), and the median OS was 14.4 months (95% CI, 10.2–18.0). The objective response rate was 75.7%, with 12.8% achieving a complete response and 62.8% a partial response. PFS was significantly longer in hormone receptor-positive patients compared to hormone receptor-negative patients (8.1 vs. 4.1 months, p = 0.035). Toxicity was manageable, with grade 3–4 adverse events including elevated transaminases (8.5%), thrombocytopenia (5.7%), and anemia (4.2%). The efficacy of TDM1 in this real-world cohort aligns with clinical trial data, though PFS and OS were somewhat lower compared to trials, likely due to the inclusion of patients with more extensive disease and prior treatments. Notably, TDM1 demonstrated activity against CNS metastases and a manageable safety profile, with higher incidence of hepatic and hematologic toxicities. Our study supports the use of TDM1 as a viable option for treating HER2-positive MBC in routine clinical practice, confirming its effectiveness and safety profile observed in clinical trials. © The Author(s) 2025.
Triple Oral Metronomic Chemotherapy Versus Chemotherapy of Physician Discretion After Failure of Platinum-Based Therapy in Advanced Head and Neck Cancer: A Phase III Randomized Study (METRO-CHASE Study)
(Lippincott Williams and Wilkins, 2025) Akhil Kumar Kapoor; Anuj Gupta; Bipinesh Sansar; Bal Krishna Mishra; Pooja K. Gupta; Arpita Singh; Arvind K. Upadhyay; Lakhan Kashyap; Ankita Pal; Amit Kumar; Sambit Swarup Nanda; Ashutosh Mukherji; Ankita Rungta Kapoor; Satyajit Pradhan; Aseem Mishra; Zachariah Chowdhury; Shashikant C.U. Patne; Ipsita Dhal; Neha Singh; Shukla Shreya; Satyendra Narayan Singh; Varun Shukla; M. V. Manikandan; Arvind Suresh; Shripad Dinanath Banavali; Somnath Dey; Kunal Ranjan Vinayak; Praveen Lakshman; Lokendra Gupta; Pratibha Gavel; Bhavesh P. Bandekar; Vijay Maruti Patil; Vanita Maria Noronha; Kumar P. Prabhash
PURPOSE Platinum-refractory advanced head and neck squamous cell carcinoma (HNSCC) has poor outcomes and limited treatment options, especially in resource-constrained settings. Triple oral metronomic chemotherapy (OMCT), involving low-dose continuous administration of chemotherapeutic agents, has shown promise in phase II studies but lacks evidence from randomized controlled trials. This study evaluated whether triple OMCT improves overall survival (OS) compared with chemotherapy of physician discretion (CPD). PATIENTS AND In this phase III randomized open-label study, 214 patients with advanced METHODS HNSCC who had previous platinum-based chemotherapy were randomly assigned 1:1 to receive either triple OMCT (arm A) with erlotinib, celecoxib, and methotrexate, or CPD (arm B). The primary end point was OS, with secondary end points including progression-free survival (PFS), quality of life (QOL), and safety. Kaplan-Meier and log-rank tests were used for OS and PFS, and Cox-proportional hazard models estimated hazard ratios. QOL was evaluated using European Organisation for Research and Treatment of Cancer QLQ-C30 and FACT H&N. RESULTS Median OS was 5 months in arm A and 3.1 months in arm B (hazard ratio [HR], 0.63 [95% CI, 0.47 to 0.83]; P 5 .00011). Median PFS was 4.8 months in arm A and 2.7 months in arm B (HR, 0.67 [95% CI, 0.52 to 0.87]; P < .0001). Previous treatment was a significant prognostic factor for OS, while age, tumor site, and previous treatment were significant for PFS. Triple OMCT improved global health status, physical functions, fatigue, and insomnia. It was well tolerated, with fewer grade 3 or higher adverse events than CPD (28.0% v 39.3%, P 5 .03). CONCLUSION Triple OMCT is an effective and safe treatment for advanced HNSCC after platinum-based chemotherapy. © 2025 by American Society of Clinical Oncology.