ABSTRACT Patients with cancer harbor a significant oncogenic load, including circulating tumor DNA, extracellular vesicles, and microRNAs, which exhibit relative stability in biofluids. This review explores the theoretical ecotoxicological risks posed by the postmortem release of these tumor-derived biomolecules into the environment. Upon death, decomposition processes facilitate the release of this oncogenic material into soil and water, contributing to the formation of cadaver decomposition islands. We examine the environmental persistence of these molecules, drawing parallels to environmental DNA studies, which demonstrate that genetic material can persist for days to weeks under favorable conditions. The theoretical potential for passive transfection and lateral transfer of oncogenic DNA is considered through experimental models of cell-free DNA uptake by somatic cells and natural precedents of transmissible cancers. While the direct ecological risk is likely minimal because of rapid degradation and environmental barriers, this framework introduces the concept of “ecological oncology.” It highlights a potential, albeit speculative, feedback loop through which cancer-derived biomolecules may re-enter ecosystems, warranting interdisciplinary investigation into their ultimate environmental fate and theoretical ecological impact.
ABSTRACT Head-and-neck cancers comprise a heterogeneous group of malignancies arising from the mucosal linings of the oral cavity, sinonasal tract, pharynx, and larynx. Most patients present with locoregionally advanced disease and require multimodal treatment, including surgery, radiation, and chemotherapy. However, these treatments are frequently associated with significant toxicity, which may compromise oncological outcomes. Sarcopenia, characterized by a loss of skeletal muscle mass along with reduced muscle strength and function, is linked with functional impairment and adverse clinical outcomes. In patients with head-and-neck cancer, sarcopenia has emerged as an important prognostic factor associated with increased mortality, treatment-related complications, and reduced quality of life. It also influences treatment tolerance and response. Early identification of sarcopenia may aid in risk stratification and guide supportive care strategies to improve clinical outcomes in patients with head-and-neck cancer.
Background: Clinical utility of a single serum procalcitonin (PCT) measurement in patients with cancer presenting with a suspected infection episode remains uncertain. Objectives: The primary objective was to evaluate the diagnostic performance of PCT for bloodstream infection (BSI) and sepsis in patients with cancer. The secondary objective was to assess its ability to predict 14-day all-cause mortality. Materials and Methods: In this prospective observational study (May–July 2025), suspected infection episodes were defined as events in which blood cultures and serum PCT (ng/mL) were obtained, and antibiotics were initiated or escalated. Outcomes included BSI (positive blood culture for a pathogenic organism), probable sepsis (Δ sequential organ failure assessment [SOFA] score ≥2 with negative blood culture), and confirmed sepsis (Δ SOFA ≥2 with positive blood culture). Results: A total of 543 suspected infection episodes were identified in 468 patients. At a PCT cutoff of 0.5 ng/mL, sensitivity for BSI was 88.3% overall, 89.8% among patients already receiving antibiotics, and 83.3% in patients with neutropenia. At a cutoff of 30 ng/mL, specificity for BSI approached 90% across all groups. Receiver operating characteristic analysis demonstrated poor overall discrimination area under the receiver operating characteristic curve (AUC <0.7). On logistic regression analysis, PCT was not an independent predictor of 14-day all-cause mortality (odds ratio: 1.01; P, 0.132). Conclusion: While overall diagnostic performance of PCT was limited, extreme values (<0.5 ng/mL and >30 ng/mL) demonstrated clinically useful sensitivity and specificity for identifying BSI and confirmed bacterial sepsis in patients with cancer, including those with neutropenia.
Background: Childhood cancer and its treatment produce complex, multilayered effects across active treatment, maintenance, and survivorship phases. The focus of care has shifted toward early identification of difficulties related to biological functioning, somatic complaints, neurocognitive deficits, learning difficulties, emotion regulation, behavioral problems, and psychosocial functioning. Objectives: The primary objective was to develop a Multidimensional Comprehensive Screening Tool (MCOST) for children in maintenance and survivorship phases of cancer and the secondary objective was to evaluate its preliminary psychometric properties. Materials and Methods: A qualitative and cross-sectional design with purposive sampling was used. Following pretesting on 19 children, 59 participants [Male: 40 (67.8%); Mean age: 8.05 ± 1.94 years; Mean Social Quotient: 103.0 ± 12.31; 42 (71.2%) survivors] were included in the pilot. Tools used included the Vineland Social Maturity Scale (VSMS) for Social Quotient, Pediatric Quality of Life (PedsQL) for overall functioning, Mini-Mental Examination for Children (MMC) for cognitive deficits, and Child Behavior Checklist (CBCL) for behavioral issues. Results: MCOST comprises of 51 items across six domains on a 3-point Likert scale. It demonstrated excellent content validity (CVI > 0.90), no significant floor/ceiling effects, and strong internal consistency (α = 0.72 – 0.84). It showed good convergent validity with PedsQL, CBCL, MMC and reflected known-group validity across gender and treatment phase. Higher scores indicate higher deficits. Conclusion: MCOST exhibits strong preliminary psychometric properties and offers a unified alternative to multiple tools currently used by clinicians and researchers in pediatric oncology settings.
Background: Tongue is the most common subsite of oral cavity carcinoma in Bihar, and disease-free survival (DFS) depends upon multiple clinical and treatment-related factors. Objectives: The primary objective was to estimate the 3-year DFS of patients with oral tongue cancer from Bihar, India. The secondary objective was to identify prognostic factors associated with DFS and to assess whether surgical excision improves DFS. Materials and Methods: We conducted a cohort study of 515 newly diagnosed, biopsy-proven tongue cancer cases from Bihar who received treatment at Mahavir Cancer Sansthan and Research Center, Patna, between January 2020 and December 2020. Patients were clinically examined at 3-month intervals for 3 years. Results: Among 515 patients, 269 experienced disease recurrence during the study period. The overall median DFS was 13.6 months. DFS varied across stages and treatment groups, with lower survival in the non-surgical group and advanced stages. Recurrence was found to be significantly associated with treatment modality (P < 0.001), treatment default (P < 0.001), and clinical stage (P < 0.001). Conclusion: Surgical excision was associated with a lower risk of disease recurrence and improved DFS across all stages. Given that nearly half of the patients presented with advanced disease, effective awareness and early detection initiatives are needed to improve prognosis.
Background: Immune checkpoint inhibitors (ICIs) have transformed the management of several solid malignancies. Real-world data—particularly from low- and middle-income countries—remain limited and are essential to understand outcomes across heterogeneous patient populations. Objectives: Our primary objective was to assess overall survival (OS) in patients with solid tumors treated with immune checkpoint inhibitors. The secondary objective was to evaluate progression-free survival (PFS) and treatment-related toxicities. Materials and Methods: We retrospectively analyzed patients receiving immune checkpoint inhibitors (ICIs) in the Department of Radiation Oncology, All India Institute of Medical Sciences, Bhubaneswar, between 2017 and 2023. Data collected included demographics, comorbidities, prior treatments, use of radiotherapy, Programmed Death-Ligand 1 (PD-L1) status, line and type of immunotherapy, number of cycles received, treatment-related toxicities, disease progression, and survival outcomes. The Kaplan–Meier method was used to estimate OS and PFS, and survival differences were analyzed using the log-rank test. Results: Eighty-five patients were included. Head-and-neck squamous cell carcinoma was the most common malignancy (43 patients, 50.6%), followed by lung cancer (12 patients, 14.1%) and malignant melanoma (4 patients, 4.7%). With a median follow-up of 24 months (range: 1–35.5), the median OS was 24 months (95% CI: 12.5–35.5) and the median PFS was 19 months (95% CI: 12.5–25.4). Grade ≥3 treatment-related toxicities were observed in 8 patients (9.4%). Conclusion: This real-world analysis demonstrates that immune checkpoint inhibitors provide meaningful survival benefits with an acceptable toxicity profile, supporting their effective and feasible use in routine oncology practice in eastern India.
Background: The uptake of screening for three common cancers at the population level remains very low despite the implementation of nationwide screening for noncommunicable diseases in India. Objectives: The primary objective was to assess the cancer care cascade of a community health worker (CHW)-led population-based cancer education and screening strategy (PBES for oral, cervical, breast, and other cancers) in Assam, India, under a programmatic setting. The secondary objective was to identify the factors associated with the cancer care cascade of this initiative. Materials and Methods: In this cohort study, trained CHWs delivered PBES to all individuals aged ≥30 years during household visits. Symptom-positive individuals were referred to the health subcenter (HSC) for cancer screening by trained staff supervised by a medical officer. Individuals suspected of having cancer were referred from HSC to the tertiary cancer center (TCC) for diagnosis and treatment initiation. Results: Of the 48,233 individuals assessed, 24,915 (51.7%) were female, 33,287 (69.0%) were aged <50 years and 4,466 (9.3%) had at least one cancer-related symptom. Oral, cervical, breast, and other cancer site-related symptoms were observed in 2,790 (5.8%), 864 (3.5%), 151 (0.6%), and 953 (2.0%) individuals, respectively. A total of 96 individuals were diagnosed with cancer. The median durations between PBES and cancer diagnosis, and between diagnosis and treatment initiation, were 47 days and 56 days, respectively. Conclusion: The CHW-led PBES strategy is feasible in resource-limited settings. Future interventions must address dropouts and delays at the HSC and TCC levels.
Background: Neoadjuvant chemotherapy (NACT) plays a key role in treating locally advanced breast cancer. While pathological complete response (pCR) is a strong prognostic indicator, residual cancer burden (RCB) offers a more comprehensive assessment by quantifying residual disease. Objectives: The primary objective was to evaluate pathological response to NACT using the distribution of RCB and pCR across breast cancer receptor subtypes. The secondary objective was to examine the association between receptor subtype and the likelihood of achieving pCR or low RCB scores. Materials and Methods: This retrospective study analyzed 129 female patients with breast cancer treated with NACT and surgery between March 2024 and February 2025. Tumors were classified into four receptor subtypes: HR+/HER2-, HR+/HER2+, HR-/HER2+, and triple-negative breast cancer (TNBC). Clinicopathological variables were analyzed by receptor subtype and RCB class (RCB 0–III). Results: Overall pCR (RCB-0) was achieved in 45.8% (n = 59) of patients. The highest pCR rates were observed in HR-/HER2+ tumors (65.4%, n = 17) and TNBC (58.1%, n = 25). HR+/HER2- tumors demonstrated the lowest pCR rate (16.1%, n = 5) and the highest proportion of RCB-III (54.8%, n = 17), while HR+/HER2+ tumors showed an intermediate response. RCB distribution differed significantly across receptor subtypes (χ2: 37.74, P < 0.001). Conclusion: Breast cancer subtypes differ significantly in response to NACT. HR-/HER2+ and TNBC exhibit favorable responses, whereas HR+/HER2- subtypes are more resistant. Incorporation of RCB scoring into routine pathology reporting may enhance post-neoadjuvant risk stratification and guide personalized care.
Background: Penile carcinoma is a rare and aggressive malignancy with variable incidence and survival outcomes due to geographical and socioeconomic variation. Objectives: The primary objective was to study the clinical profile, treatment pattern, and surgical complications in patients with penile carcinoma. The secondary objectives were to evaluate disease-free and overall survival and to compare them with baseline characteristics. Materials and Methods: We reviewed the data of patients who were treated from January 2013 to December 2021 at Malabar Cancer Center - Postgraduate Institute of Oncology Sciences and Research (MCC-PGIOSR), Kerala. Clinicopathologic details were recorded. Survival outcomes were analyzed and compared with baseline characteristics. Results: During this period, 39 patients underwent radical surgery. The median follow-up period was 60 months. The median age was 62 years. The overall surgical complication rate was 71.8% (28/39), with 16 (41%) grade 1 and 2 and 12 (30.8%) grade 3 or above. Reoperations were required for 3 patients (7.7%) under general anesthesia for wound-related complications. Recurrence occurred in 8 patients (20.5%). The local, regional, and distant recurrence rates were 5.1%, 7.6%, and 7.6%, respectively. There were 11 deaths (28.2%). The 5-year overall survival was 64.2%, while the 4-year disease-free survival was 76.7% with median survival not reached. Conclusion: There was a trend toward earlier disease presentation and improved survival, reflecting growing awareness and improved access to tertiary healthcare in India. Continued efforts to optimize patient education and healthcare delivery are warranted. Refining the extent of inguinal and iliac lymphadenectomy remains important to minimize morbidity.
Background: Breast cancer incidence is rising in Latin America, with 17,018 cases reported in Colombia in 2022. Although predominant in women > 40 years, the disease is notably more aggressive in younger patients. Objectives: The primary objective was to compare health outcomes (stage at diagnosis, progression, and survival) between patients with breast cancer ≤ 40 and > 40 years. Secondary objectives included describing clinical characteristics, evaluating differences in recurrence, and comparing the one- and two-year overall survival by stage and molecular subtype. Materials and Methods: Sociodemographic and clinical data were collected from institutional records. Tumor stage was assigned using the TNM 8th edition, and molecular subtypes by immunohistochemistry. Group comparisons used the Chi-square or Fisher’s exact test for categorical variables and the Mann–Whitney U test for continuous variables. Survival was estimated with Kaplan–Meier curves and compared using the log-rank test. Results: Patients aged ≤ 40 years showed a higher prevalence of advanced-stage tumors (80%, n = 32 vs. 50.6%, n = 150), predominance of Luminal B subtype (70%, n = 28 vs. 48.3%, n = 143), and more frequent neoadjuvant chemotherapy (85.7%, n = 30 vs. 59.6%, n = 154). Overall survival was 92.1% at one year and 84.2% at two years, with a significant difference between early-stage (99.0%) and advanced cases (70.0%). Conclusion: Age modifies breast cancer presentation and early outcomes, with younger women demonstrating more aggressive clinical profiles. This emphasizes the need to strengthen early diagnostic pathways and ensure timely multidisciplinary management to mitigate progression in women aged ≤ 40 years.
Background: Crushing solid dosage forms is often required in patients with swallowing difficulties; however, the pharmacokinetic (PK) impact of this alteration is not well-studied. Objective: The primary objective was to compare the PK of crushed methotrexate tablets suspended in water versus whole tablets in patients with head-and-neck cancer. The secondary objective was to evaluate the effect of nasogastric/polyethylene glycol (PEG) tube administration on PK parameters. Materials and Methods: In this randomized crossover study, patients received methotrexate as either a crushed tablet in water or a whole tablet, followed by alternate formulation after 1-week washout. Serial blood samples were collected post-administration. PK parameters were derived using noncompartmental analysis in PUMAS. Bioequivalence was assessed using 90% confidence intervals (CIs) of the geometric mean ratio (GMR) for Cmax and area under the curve (AUC0-∞) with equivalence defined as 80%-125%. Results: Thirteen patients were enrolled; 11 completed both study periods. High interindividual variability (>40%) was observed for both formulations. Crushed tablets achieved Tmax approximately 16 minutes earlier. Mean Cmax and AUC0-∞ for whole versus crushed formulations were 447.04 ± 180.91 vs. 447.70 ± 224.71 ng/mL and 1704.29 ± 808.93 vs. 1907.47 ± 1012.24 ng.h/mL, respectively, with no statistical significance. The GMR for crushed versus whole tablets was 103.3% for Cmax and 112.2% for AUC0-∞. However, their 90% CIs (76%-139% for Cmax and 93%-134% for AUC0-∞) indicated lack of bioequivalence. Conclusion: Although not bioequivalent, crushed methotrexate tablets produced similar systemic exposure and a shorter Tmax. Despite high variability, crushed administration may be an acceptable PK alternative for patients unable to swallow tablets, without dose adjustment.
Background: This study aimed to evaluate whether the addition of an anti-vascular endothelial growth factor (VEGF) agent, axitinib, to oral metronomic chemotherapy and low-dose nivolumab could improve survival outcomes without increasing toxicities in patients with advanced, unresectable, or metastatic head-and-neck squamous cell carcinoma (HNSCC). Objectives: The primary objective was to assess overall survival (OS) with the addition of axitinib to triple metronomic chemotherapy and low-dose nivolumab in advanced, unresectable, recurrent, or metastatic HNSCC. Secondary objectives included progression-free survival (PFS), overall response rate (ORR), and adverse event (AE) assessment. Material and Methods: This retrospective study included 167 patients treated at the Department of Medical Oncology, Tata Memorial Hospital, Parel, Mumbai, between April 2022 and May 2024. Patients received oral metronomic chemotherapy (methotrexate, erlotinib, and celecoxib), axitinib, and low-dose nivolumab. OS and PFS were estimated using the Kaplan–Meier method, and AEs were graded as per CTCAE version 5.0. Results: The median OS was 7 months (95% confidence interval [CI]: 5.5–8.5), and the median PFS was 6.7 months (95% CI: 4.9–8.4). The ORR was 38%, including complete responses in nine patients. Grade ≥ 3 AEs occurred in 65.2% (n = 86), most commonly skin rash (18.2%, n = 24), hyponatremia (10.6%, n = 14), and transaminitis (9.8%, n = 13). Treatment-related toxicities led to dose interruptions or modifications in 36% (n = 48). Conclusion: The addition of axitinib to triple metronomic chemotherapy and low-dose nivolumab increased the rate of high-grade toxicities without demonstrating improvement in survival outcomes.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), established in April 1990, has released an updated version of its ICH E6 guidelines for Good Clinical Practice (GCP). This new version, ICH E6 (R3), replaces ICH E6 (R2) and introduces major changes promoting innovation across all stages of clinical trials, from planning to reporting. These updates enhance flexibility, inclusivity, risk management, and integration of modern technologies, ensuring ethical conduct and data integrity. Released in January 2025, E6 (R3) focuses on patient safety, advanced data management, transparency through public trial registration and result sharing, and more efficient, adaptable trial designs. At the same time, it presents challenges such as the need for comprehensive staff training and integration of digital health tools. We conducted a literature search using ScienceDirect, PubMed, and Google, along with ICH resources, to identify relevant publications. This narrative review, written in accordance with ICH GCP E6 (R3), emphasizes the key updates, including a risk-based approach that prioritizes patient safety and data quality, the use of electronic systems, decentralized and remote monitoring methods, and strengthened roles for investigators, sponsors, ethics committees, and regulators. Overall, ICH GCP E6 (R3) brings transformative changes that foster innovation at every phase of clinical trials. By promoting patient-centered approaches, fostering innovation, and reinforcing accountability, the guideline offers a framework for safer, faster, and more reliable trials. Effective implementation will depend on training, technological adaptation, and sustained collaboration among stakeholders.
Background: The staging workup for T3/T4 breast carcinoma requires multiple imaging sessions. Using 18F-FDG PET/CT (18F-fluorodeoxyglucose positron emission tomography/computed tomography) as a single modality may streamline diagnosis, reduce hospital visits, expedite treatment initiation, and facilitate early disease staging, improving overall patient management efficiency. Objectives: The primary objective was to determine whether PET/CT results in a higher stage assignment compared to conventional imaging (CI) in T3/T4 breast cancer. The secondary objectives were to compare the duration of workup and the number of radiology visits at Yenepoya Medical College, Mangalore, Karnataka, India. Materials and Methods: Forty-two women aged 18–70 years with biopsy-confirmed T3/T4 breast cancer underwent CI (contrast-enhanced computed tomography + bone scan) and PET/CT. Outcomes included differences in TNM staging, detection of metastases, and number of radiological visits. Results: PET/CT showed staging advancements for 21.4% (n = 9) and downgraded stage for 9.5% (n = 4) of cases. It detected distant metastases in 45.2% (n = 19) compared with 47.6% (n = 20) using CI, and identified more nodal involvement [N2/N3: 40.5% (n = 17) vs. 33.4% (n = 14)]. The mean workup duration was similar between PET/CT and CI (3.07 ± 1.2 days vs. 3.26 ± 0.66 days; P, 0.382). PET/CT required fewer radiological visits (1.24 ± 0.43 vs. 2.62 ± 0.66; P < 0.0001). Conclusion: PET/CT improved staging refinement in T3/T4 breast cancer and substantially reduced the hospital visits, while the overall workup duration remained similar. These findings support integrating it into the staging pathway for T3/T4 breast carcinoma.
Background: The role of induction chemotherapy (ICT) in locally advanced oropharyngeal and hypopharyngeal squamous cell carcinoma (SCC) remains debated, particularly in resource-limited settings. Objective: The primary objective was to evaluate the locoregional response to carboplatin- and paclitaxel-based ICT followed by concurrent chemoradiotherapy (CTRT) in patients with locally advanced oropharyngeal and hypopharyngeal SCC. The secondary objectives were to assess ICT-related adverse effects and 2-year disease-free survival and overall survival (OS). Materials and Methods: This retrospective cohort study included eligible patients who received carboplatin (AUC5) and paclitaxel (175 mg/m2) as ICT between January 2018 and December 2022. Locoregional response was categorized as complete, partial, stable, or progressive. Results: Among 97 patients, 83 (85.6%) were male and 69 (71.1%) were aged > 50 years. The oropharynx was the primary site in 60 (61.9%) patients. Of the total, 61 (62.9%) received ICT + CTRT, 22 (22.7%) received only ICT, and 14 (14.4%) received ICT followed by radiation therapy. Partial response at the primary site and neck was observed in 77 (79.4%) and 67 (69.1%) patients, respectively, while a complete response at the primary site was noted in 4 (4.1%). The median (interquartile range) OS was 16.7 (11.4) months. Grade 3-4 neutropenia, thrombocytopenia, and mucositis occurred in 20 (20.6%), 18 (18.6%), and 35 (36.1%) patients, respectively. Conclusion: The carboplatin- and paclitaxel-based ICT demonstrated efficacy and tolerability and may serve as a feasible alternative to conventional triple-drug ICT for locally advanced head-and-neck SCC in resource-constrained settings. Prospective studies are warranted to validate these findings.
Background: Despite advances in diagnostics and therapeutics, outcomes of head-and-neck cancer (HNC) remain dismal. Rural patients and their family caregivers (FCGs) face unique challenges that remain underexplored. Objectives: The primary objective was to study the clinicodemographic profile, treatment compliance, knowledge, perception (KP), attitude (AT), and health-related quality of life (HRQOL) of rural patients with HNC. The secondary objective was to study the psychosocial and financial impact of HNC on FCGs. Materials and Methods: In this prospective observational study (June 2019–January 2022), 210 newly diagnosed, nonmetastatic patients with HNC and their FCGs attending Dr. Vitthalrao Vikhe Patil Pravara Rural Hospital, Loni, were enrolled. Structured questionnaires captured demographics, substance abuse, KP, AT, and caregiver experiences. HRQOL was assessed using EORTC QLQ-C30 and QLQ-H and N43. Results: Most patients were rural residents (n = 167; 79.5%) and presented with locally advanced disease (n = 181, 86.2%), predominantly oral cavity cancers (n = 138, 65.7%). Substance abuse was reported by 200 patients (95.2%). Only 137 patients (65.2%) completed planned treatment; follow-up was often symptom-driven. HRQOL showed major impairment in financial, social, and emotional domains. Although the majority of the patients (n = 186/192, 96.9%) had government health insurance, out-of-pocket costs were substantial. More than half of FCGs reported adverse financial (n = 107, 50.9%) and social impacts (n = 165, 78.6%). Conclusion: Rural patients with HNC and their caregivers experience multifaceted clinical, psychosocial, and financial challenges that reduce compliance and HRQOL. Context-specific interventions are essential to improve awareness, support, and outcomes.
Background: Osimertinib benefits patients with non-small cell lung cancer (NSCLC), progressing on first-line epidermal growth factor receptor (EGFR) tyrosine-kinase-inhibitors (TKIs), but high cost restricts access in low- and middle-income countries (LMICs). We evaluated erlotinib rechallenge in this setting. Objectives: Primary objectives were to assess event-free survival (EFS) and overall survival (OS). Secondary objective was disease control rate (DCR) of erlotinib in EGFR-mutated metastatic NSCLC post-EGFR-TKIs. Materials and Methods: This retrospective study (2011–2024) at Cancer Institute, WIA, Chennai included patients with metastatic NSCLC and EGFR mutations progressed on prior TKIs and received erlotinib. Patients without EGFR mutations or with erlotinib exposure <1 week were excluded. Survival outcomes were estimated using the Kaplan-Meier method. Results: Of 32 patients [median age 52 years; 53.1% male (n = 17); 87.5% never-smokers (n = 28); 93.8% adenocarcinoma (n = 30)], common mutations were exon-19 deletion (n = 17, 53.1%) and exon-21 L858R (n = 8, 25.0%). Among 27 evaluable patients, 6 (22.2%) had partial-response, 8 (29.6%) had stable-disease, and 13 (48.2%) progressed (DCR 51.8%); median response duration was 246 days. Median EFS was 80 days (95% CI 34–125); exon-19 deletion patients had longer EFS (173 vs. 51 days, P, 0.008) than exon-21 L858R. Median OS was 247 days (95% CI: 103–391). Post-osimertinib EFS and OS were 63 and 157 days. Conclusion: This is the first report from India evaluating erlotinib rechallenge in EGFR-mutated NSCLC. These findings suggest that in LMICs, where osimertinib is inaccessible, erlotinib rechallenge represents a pragmatic and cost-effective treatment strategy warranting further investigation.
ABSTRACT Background: The addition of nimotuzumab to concurrent chemoradiotherapy (CTRT) has improved outcomes, including progression-free survival (PFS) and overall survival (OS) in human papilloma virus (HPV)-negative oropharyngeal cancers (OPC). Objectives: This study primarily assessed the cost-effectiveness of nimotuzumab plus CTRT versus CTRT alone in HPV(-) OPC in India by estimating the incremental cost-effectiveness ratio (ICER). The secondary objectives included comparing clinical outcomes, including life-years gained and quality-adjusted life years (QALYs), between the two strategies. Materials and Methods: A decision-tree model was developed in Microsoft Excel to assess the cost-effectiveness of nimotuzumab plus CTRT versus CTRT alone for HPV(-) OPC. Health states included locoregional control (LRC), adverse drug events (ADEs), and PFS. The model, from the Indian payer’s perspective, used a 2-year time horizon and applied a 3% annual discount rate. Primary outcomes were ICER and QALYs. Model robustness was confirmed through probabilistic sensitivity analysis (PSA). Results: In the base-case analysis, total costs and QALYs for nimotuzumab plus CTRT versus CTRT alone were ₹9,91,872 versus ₹8,75,180 and 1.262 versus 0.628, respectively. The incremental cost and QALY gain with nimotuzumab were ₹116,692 and 0.634, respectively. The ICER was ₹183,952 per QALY, well below the willingness-to-pay threshold of ₹300,000 per QALY, indicating cost-effectiveness. Net monetary benefit (NMB) and net health benefit (NHB) associated with nimotuzumab were ₹73,508 and 0.245, respectively. Conclusion: Nimotuzumab plus CTRT is a cost-effective option compared with CTRT alone for treating HPV(-) OPC in the Indian healthcare setting.
ABSTRACT Head-and-neck squamous cell carcinoma (HNSCC) remains a significant public health concern, particularly in India, where its incidence is disproportionately high due to risk factors such as tobacco and alcohol use. The updated guidelines for the management of HNSCC reflect a comprehensive review of current evidence and practices tailored to the Indian context. These emphasize a multidisciplinary approach and the integration of novel therapeutic modalities, including immune checkpoint inhibitors and metronomic chemotherapy. Enhanced diagnostic protocols and a focus on supportive care underscore the commitment to improving patient outcomes and quality of life. This update aims to provide healthcare professionals with clear, evidence-based recommendations that address the unique challenges faced by patients with HNSCC in India.
ABSTRACT Oropharyngeal cancer typically presents at a nonmetastatic stage and is mostly treated with curative intent. Although surgical options are available, they are often associated with significant functional and cosmetic morbidity, leading to a preference for nonsurgical modalities. The updated guidelines address the management of oropharyngeal squamous cell carcinoma in the Indian context, emphasizing the importance of a multidisciplinary approach. The guidelines detail diagnosis workflows, treatment protocols for early-stage and locally advanced cancers, and the role of human papillomavirus (HPV) status in guiding therapy. Special attention is given to emerging treatment deintensification strategies for HPV-associated cancers, aiming to optimize outcomes while minimizing treatment-related toxicity.
