Pharmacoepidemiology, Pharmacoeconomics, Pharmacovigilance, Oncology Pharmacy Practice, Drug utilization.
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Scopus Publications
Scopus Publications
A real-world study of the effectiveness and safety of low-dose immunotherapy in addition to oral metronomic chemotherapy in recurrent and metastatic head and neck squamous cell carcinoma Rushabh Kothari, Avinash Khadela, Gaurang Modi, Itesh Khatwani, Palak Bhatt, Vaishnavi Patel, Vraj B. Shah Journal of the Egyptian National Cancer Institute, 2026 The standard of care in recurrent/metastatic head and neck squamous cell carcinoma is Pembrolizumab with/without chemotherapy. However, these regimens are minimally affordable and accessible in resource-limited countries. Hence, immunotherapy is combined with oral metronomic chemotherapy in lower doses. Currently, the efficacy and safety of this regimen have been studied in platinum-refractory settings and not beyond them. Thus, we conducted a real-world study on the effectiveness of low-dose immunotherapy and metronomic chemotherapy in recurrent/metastatic head and neck cancer. This was a multicentre, real-world, prospective observational study. Recurrent/metastatic head and neck squamous cell carcinoma patients treated with palliative intent with an Eastern Cooperative Oncology Group performance status of 0–2 were recruited from three oncology centres. Patients received oral metronomic chemotherapy with IV nivolumab 20 mg once every 3 weeks. Patients received treatment until disease progression or unacceptable toxicities. The primary endpoints were Objective response rate, progression-free survival, and Overall survival. The secondary endpoint was safety. Moreover, subgroup analysis was also carried out among platinum sensitivity and the line of treatment. Overall, 123 patients were recruited (86% males and 35% females). The Objective response rate was 61.7% (95% CI, 53 to 70). The median overall survival and progression-free survival were 15.1 months (95% CI, 12.8–17.4) and 10.4 months (95% CI, 8.0-13.7), respectively. Moreover, the median overall survival was 15.9 (95% CI, 12.7 to 17.5) versus 8.0 months (95% CI, 3.4–12.6) (p < 0.01) and the median progression-free survival were 13.6 months (95% CI, 9.9–17.2) versus 5.0 months (95% CI, 2.2–7.8) (p < 0.01) for platinum sensitive and resistant subgroups respectively. The median OS were 15.1 months (95% CI, 12.7–17.5) versus 8.0 months (3.4–12.6) (p = 0.03), and the median PFS were 11.2 months (95% CI, 6.3–16.0) versus 6.0 months (95% CI, 2.7–9.3) (p = 0.07) for first and second-line subgroups, respectively. The most common adverse events were fatigue (63.4%), anemia (52.8%), mucositis (47.9%), and rashes (44.7%). This study demonstrated that adding low-dose immunotherapy to oral metronomic chemotherapy was effectively applicable and associated with manageable toxicities in a real-world setting for the management of R/M HNSCC. Furthermore, this regimen was associated with favourable survival outcomes and response rates in the platinum-sensitive and first-line treatment subgroups.
A Real-World Phase IV Superiority Trial and Cost-Effectiveness Analysis of the Addition of Low-Dose Nivolumab to Triple Metronomic Chemotherapy Compared to the Paclitaxel Carboplatin Regimen in Recurrent or Metastatic Head and Neck Cancer Patients Avinash Khadela, Rajsi Parikh, Jaydeep Vaghela, Yatra Chauhan, Vraj B. Shah, Rushabh Kothari, Manthan Merja Head and Neck, 2026 BackgroundLimited data are available regarding the comparison of low‐dose immunotherapy when added to oral metronomic chemotherapy with conventional induction chemotherapy regimens in recurrent/metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC).MethodsThis real‐world phase IV superiority trial recruited adult patients with R/M HNSCC being treated with palliative intent. Patients were assigned to TMC‐I or PC. The primary endpoints were median OS, PFS, ORR, and ICER, and the safety assessment was the secondary endpoint.ResultsA total of 154 patients were recruited: 78 in the TMC‐I arm and 76 in the PC arm. The median OS was 15.13 months (95% CI, 11.05–19.20) versus 9.8 months (95% CI, 7.50–12.09) (p < 0.01), and the median PFS was 11.20 months (95% CI, 5.43–16.96) versus 7.41 months (95% CI, 6.73–8.08) (p < 0.01) for the TMC‐I and PC arms, respectively. The ORR was 69.23% for TMC‐I and 31.57% for the PC arm, respectively. The ICER between both arms was 68 947.ConclusionA significant improvement in survival, tolerability, and reasonable cost‐effectiveness was observed with low‐dose immunotherapy when added to oral metronomic chemotherapy compared to conventional chemotherapy regimens.
Advanced Gene Therapy in the Clinical Management Vivek P. Chavda, Humzah Postwala, Yesha Shah, Disha Shah, Avinash Khadela, Xiang Chen Advances in Pharmaceutical Biotechnology Volume 2 Current Developments in Biopharmaceuticals, 2026 The human genome consists of a genetic code responsible for the transcription of the protein needed by cells for its living. These genes never get altered; however, it happens in certain cases which lead to serious disease conditions. Hence, gene therapy also called “living drug therapy” is administered to correct these gene altercations. After conducting 1700 clinical trials, the promise made by scientists decades ago about delivering a complete cure via gene therapy is worth exploring. Genes are mainly delivered to the subject through vectors, which include both viral and nonviral. A few problems associated with viral vector delivery such as immune reaction, off-target effect, and ineffective delivery have raised skepticism in the gene therapy process. However, with the joint effort of pharmaceutical industries and national institutes, controlling authorities have been established to monitor efficient vector preparation. In addition, with the discovery of nearly 12 gene therapy drugs for various conditions 386such as cancer, neurologic genetic disorders, and hereditary immune disorder have once again brought gene therapy into the public eye. This chapter here discusses the strategies, modes for gene delivery, CRISPR/ CAS9 technology and its use in gene therapy, clinical application, and the challenges of gene therapy.
Lesch–Nyhan syndrome in a female patient: exploring uncommon symptomatology Apeksha Merja, Avinash Khadela, Shruti Soni, Hetvi Bharadia, Vraj B. Shah Egyptian Journal of Neurology Psychiatry and Neurosurgery, 2025 Lesch–Nyhan syndrome is a disorder associated with the inadequacy of the hypoxanthine phosphoribosyl-transferase 1 enzyme, which plays a significant role in the purine salvage pathway that leads to urate overproduction and its range of neurological manifestations. The disease follows an X-linked recessive inheritance pattern, affecting males more commonly than females, who are asymptomatic carriers. Here, we discuss the case of a 12-year-old female with a history of self-mutilating behavior since childhood, who presented with complaints of persistent foul-smelling ulcers on the left foot, and a history of below-the-knee right foot amputation because of recurrent ulcers. This was followed by developmental delays, a low intelligence quotient, attention-deficit hyperactivity disorder, and an irritable and aggressive temperament. The patient was managed symptomatically, and prophylactic therapy was prescribed for foot infections. This case highlights the co-occurrence of Lesch–Nyhan syndrome with attention-deficit hyperactive disorder in a female patient, emphasizing the diagnosis and management of such patients, where the availability of resources is limited.
Unlocking the therapeutic potential of antibody–drug conjugates in targeting molecular biomarkers in non-small cell lung cancer Shruti Soni, Kaivalya Megha, Vraj B. Shah, Aayushi C. Shah, Shelly Bhatt, Manthan Merja, Avinash Khadela Journal of the Egyptian National Cancer Institute, 2025 Non-small cell lung cancer (NSCLC) is a prevalent and lethal malignancy worldwide, posing significant challenges to patient survival. Recent advancements in the field of oncology have introduced immunotherapy and targeted therapy as primary treatment modalities for NSCLC. However, the emergence of treatment resistance and relapse has impeded their long-term effectiveness. Antibody–drug conjugates (ADCs), a rapidly evolving class of anti-cancer agents, offer a promising solution to this issue by harnessing the specificity of monoclonal antibodies and the cytotoxic potency of drug payloads. ADCs have demonstrated notable potential in targeting both highly expressing and low-expressing malignant cells, with early-phase clinical trials yielding superior survival outcomes in NSCLC patients. This review comprehensively outlines the recent advancements in ADC-based strategies for managing NSCLC, supported by evidence from clinical trials. Additionally, the review delves into the oncogenic mechanisms of various biomarkers and offers insights into strategies for their detection in NSCLC patients. Lastly, a forward-looking perspective is provided to address the challenges associated with the utilization of ADCs in NSCLC therapy.
Emerging Role of Lenvatinib in Treating Platinum-Refractory Head and Neck Cancer in Resource-Limited Settings Avinash Khadela, Kashvy R. Morakhia, Nishra H. Shah, Vibha G. Kanjani, Rushabh Kothari, Manthan Merja Indian Journal of Medical and Paediatric Oncology, 2025 Lenvatinib, an oral multiple tyrosine kinase inhibitor, is currently being explored in the area of head and neck squamous cell carcinoma (HNSCC). Two-thirds of total patients are presented in the advanced stage leading to poor prognosis with conventional treatment. The addition of immunotherapy is the standard approach to it. However, in developing nations and resource-limited setups, affordability is the major concern. To encounter this, lenvatinib has become a novel cost-effective treatment for HNSCC. Lenvatinib targets a varied range of receptors including vascular endothelial growth factor receptor, platelet-derived growth factor receptor α, fibroblast growth factor receptor, KIT (stem cell factor receptor), and rearranged during transfection, all of which are involved in the pathogenesis of HNSCC leading to the establishment of its role in HNSCC. It inhibits angiogenesis in endothelial cells and proliferation in tumor cells. Instances of resistance were observed in monoreceptor targeting agents, which are also overcome by lenvatinib, leading to potent antitumor activity. Clinical studies are being conducted to establish the role of lenvatinib as a third-line therapy in HNSCC. In this review, we discuss the role of lenvatinib in resource-limited, platinum-refractory, and recurrent/metastatic HNSCC.
The Phenytoin Ataxia Enigma Unveiled “A Case Report’’ Avinash Khadela, Bhavarth Dave, Yatvi Premal, Nishi Patel, Devang Sadhwani Journal of Pharmacy Practice, 2025 Background: Phenytoin (PHT) has been approved for the treatment of epilepsy. It belongs to the category of medications with a limited therapeutic window and requires therapeutic drug monitoring (TDM). PTH has been observed to induce a variety of Adverse drug reactions (ADRs) including ataxia, dystonia, nystagmus, dyskinesia, etc. Phenytoin-induced ataxia is an uncommonly observed ADR of Phenytoin whose reports are extremely limited. Case: Herein, we present a case report of a 16-year-old Asian patient with a past history of epilepsy that was admitted to a tertiary care hospital due to the development of ataxia, giddiness, and vomiting when taking Phenytoin in addition to Oxcarbazepine, Clobazam, and Levetiracetam to treat seizures. On admission, Magnetic resonance imaging (MRI) findings revealed bilateral variable cerebrospinal fluid (CSF) lesions in the parieto-occipital region of the periventricular area (periventricular leukomalacia). Additionally, serum Phenytoin levels were observed to be in the toxic range (40 μg/mL) due to which physicians confirmed the ADR to be due to Phenytoin toxicity. Thus, the Phenytoin drug was discontinued in the patient gradually and he was continued on clobazam, oxcarbazepine, and brivaracetam which led to reversal of the ADR in the patient. Conclusion: In this case, ataxia resulted from Phenytoin overdose, as confirmed by MRI and serum tests suggesting that TDM of Phenytoin is essential to prevent ADRs. Given the scarcity of ataxia cases caused by Phenytoin, awareness is lacking within the scientific community. Our aim is to provide insights to promote better monitoring and patient-centered treatment outcomes for epileptic patients.
Assessing the effectiveness of gabapentin in paclitaxel-induced arthralgia, myalgia, and neuropathic pain: An observational, cohort study Prashantkumar Patel, Hemraj Singh Rajput, Khushboo Chavda, Smit Mistry, Sandesh Bhagat, Rajesh Hadia, Moinuddin Saiyed, Avinash Khadela Journal of Oncology Pharmacy Practice, 2025 Background and objectives Arthralgia, myalgia, and neuropathic pain are the most common side effects observed due to paclitaxel chemotherapy. The aim of this study was to investigate the prophylactic role, maintenance, remission, and re-occurrence of arthralgia, myalgia, and neuropathic pain post-gabapentin therapy. Methodology This study was conducted in the Department of Oncology, Dhiraj Hospital, Vadodara with a sample of 51 patients. Newly detected cancer patients who observed arthralgia, myalgia, and neuropathic pain due to paclitaxel were taken and a baseline pain assessment was done using the Common Terminology Criteria for Adverse Events (CTCAE) and painDETECT questionnaire. Gabapentin was given in the first cycle after symptoms appeared and prophylactic treatment was given in the subsequent three cycles and evaluation of pain was done post-gabapentin therapy to assess the symptomatic as well as prophylactic effect. Results At baseline, neuropathic pain score was 22.7 ± 3.6 which reduced to 0.01 ± 0.14 on subsequent follow-ups. Grade 2 arthralgia, myalgia, and neuropathic pain were more observed at baseline which reduces to Grade 0 in the third cycle. The difference in baseline and post-gabapentin therapy was statistically analyzed by conducting t-test which showed p-value <0.00001 and t-value was less than −2 which indicated a statistically significant result. Conclusion This study shows that gabapentin reduces neuropathic pain. Prophylactic usage of gabapentin was highly effective at bringing about quick pain relief when compared to symptomatic treatment. In further follow-ups, it was noted that gabapentin maintained the impact throughout the cycles.
Beyond the Surface: Sister Mary Joseph's Nodule in Metastatic Gallbladder Cancer: A Case Report and Review of Literature Avinash Khadela, Shruti Soni, Vraj B. Shah, Rushabh Kothari Indian Journal of Medical and Paediatric Oncology, 2025 Sister Mary Joseph's nodule (SMJN) is an umbilical nodule occurring because of metastasis of the abdomen and pelvic malignancies. It is a rare physical finding, reported in nearly 3% of patients with gastrointestinal or gynecological cancers. The majority of cases presents at a very advanced stage of the disease, and often results in dismal prognosis. Here, we report the case of a 54-year-old woman with metastatic gallbladder cancer, presenting with SMJN. The patient declined chemotherapeutic intervention following the cancer diagnosis and later arrived with an umbilical nodule, which was identified as SMJN. The patient was advised to take a gemcitabine-cisplatin regimen, but opted solely for palliative care and passed away within a few weeks of SMJN diagnosis. This case report emphasizes how an untreated malignancy can advance quickly and present as an unusual clinical sign. Drawing the attention of health care professionals to this clinical sign will eventually help in the early detection of disease progression and its management to improve survival outcomes.
Monitoring for recurrence: Follow-up care and surveillance Avinash Khadela, Mili Patel, Pooja Patel, Hitaishee Yagnik, Manthan Merja, Rushabh Kothari, Mehul R. Chorawala, Neha R. Raghani, Rakesh B. Patel Ovarian Cancer Disease Diagnosis and Treatment, 2025
Early detection matters: Screening and diagnostic tools Avinash Khadela, Jeel Trivedi, Sunayna Saluja, Isha Shah, Manthan Merja, Rushabh Kothari, Mehul R. Chorawala, Rajanikant Patel, Rakesh B. Patel Ovarian Cancer Disease Diagnosis and Treatment, 2025
Vaccine safety, efficacy, and ethical considerations Rashi Shukla, Krupa Vyas, Avinash Khadela, Lalitkumar K. Vora, Dharmendra Kumar Khatri Advanced Vaccination Technologies for Infectious and Chronic Diseases A Guide to Vaccinology, 2024
Current Perspectives in Dengue Hemorrhagic Fever Manish P. Patel, Vaishnavi M. Oza, Hemangi B. Tanna, Avinash D. Khadela, Praful D. Bharadia, Jayvadan K. Patel Rising Contagious Diseases Basics Management and Treatments, 2024
Phenytoin-induced dyskinesia: a case report Kashvi C. Shah, Nishi S. Patel, Paritosh Vasani, Avinash Khadela, Vivek P. Chavda, Lalitkumar Vora Journal of Medical Case Reports, 2023
Engineered exosomes for cancer theranostics: Next-generation tumor targeting Vivek P. Chavda, Vrashabh V. Sugandhi, Chandrakantsing V. Pardeshi, Rahul Jaywant Patil, Mit Joshi, Bhoomika Patel, Avinash Khadela, Rajashri Bezbaruah, Bedanta Bhattacharjee, Pankti C. Balar, Lalitkumar K. Vora Journal of Drug Delivery Science and Technology, 2023
