Background Anxiety and depression are common psychological symptoms in patients with advanced cancer and significantly affect quality of life. This study aimed to screen for depression and anxiety in patients with metastatic cancer receiving outpatient palliative care at a tertiary cancer centre in India. Methods A prospective observational study was conducted on 150 adult patients with metastatic disease and ECOG performance status 1–3 attending the palliative medicine outpatient department between August 2022 and October 2022. The Hospital Anxiety and Depression Scale (HADS), a validated 14-item instrument with two subscales (HADS-A and HADS-D), was used to screen for symptoms of anxiety and depression. Descriptive statistics, independent-samples t-test, and Pearson's correlation coefficient were used to analyse associations between anxiety/depression scores and gender, ECOG performance status, cancer diagnosis, and age. A p-value < 0.05 was considered statistically significant. Results A total of 150 patients (76 males, 74 females) were included, with a mean age of 49.19 ± 15.2 years. Anxiety (HADS-A ≥ 8) was observed in 33.9% and depression (HADS-D ≥ 8) in 42% of patients. Mean anxiety scores (8.75 vs 7.22, p = 0.009) and mean depression scores (9.48 vs 8.03, p = 0.015) were significantly higher in females than males. Anxiety and depression scores worsened with declining ECOG performance status. Patients with gastrointestinal malignancies had the highest mean anxiety scores, while those with primary brain tumours had the highest mean depression scores. A strong positive correlation between anxiety and depression scores was found across all parameters (r = 0.88–0.96). Conclusions Anxiety and depression symptoms are highly prevalent among metastatic cancer patients receiving outpatient palliative care. These findings highlight the need for a proactive approach to routine psychological screening and early intervention in palliative care settings to improve quality of life and overall patient care. Clinical trial number: Not applicable
Major head and neck oncologic surgeries cause significant systemic inflammation, with elevated CRP and IL-6. Vitamin C may help reduce perioperative inflammation and improve hemodynamic stability. In this double-blind study, 60 ASA I–II adults scheduled for elective head and neck cancer surgery with flap reconstruction were randomized to receive either intravenous vitamin C (Group C, n = 30; 1 g in 100 mL preoperatively, pre-incision, and before extubation/weaning) or placebo (saline, Group S, n = 30). Serum CRP and IL-6 were measured preoperatively and on postoperative days 1 (POD1) and 4 (POD4). The primary outcome was the serum CRP level on POD1, representing the early postoperative inflammatory response. Secondary outcomes included CRP on POD4, IL-6 levels at POD1 and POD4, vasopressor use, analgesic requirements, postoperative complications, and lengths of ICU and hospital stay. Baseline demographics and preoperative inflammatory markers were similar across groups. On POD1, the mean CRP and IL-6 levels were lower in the vitamin C group compared to placebo (CRP 7.6 ± 1.8 vs. 12.7 ± 6.5 mg/dL, p = 0.001; IL-6 43.3 ± 11.4 vs. 62.2 ± 21.5 pg/mL, p = 0.041). By POD4, these values showed no significant differences. No significant differences were observed in ICU stay, vasopressor use, analgesic requirements, or postoperative complications. However, hospital stay was significantly shorter in the vitamin C group. Perioperative vitamin C reduced early postoperative inflammatory markers, but the effect was transient. The shorter hospital stay observed in the vitamin C group requires confirmation in larger studies.
29 Background: Early integration of palliative care may modify quality of life (QoL) trajectories in cancer patients, but multivariate evidence on treatment response heterogeneity remains limited. Methods: Prospective RCT (N=110) allocating breast cancer patients to early best supportive care (n=56) or on-demand palliative care (n=54). Primary outcomes: Global Health Status (GHS) via EORTC QLQ-C30 and Total Symptom Distress Score (TSDS) via ESAS at baseline and 3-month follow-up. Analysis: Repeated Measures ANOVA, ANCOVA adjusting for baseline covariates, MANOVA on six functional domains, and sensitivity analyses (LOCF, worst-case, per-protocol). Cohen's d with 95% CI reported. Results: 94 patients (85.5%) completed 3-month assessments. Time x Group interactions were significant for GHS (F=4.47, p=0.037) and TSDS (F=4.87, p=0.030). ANCOVA: GHS +6.19 points (95% CI: 0.5-11.9, p=0.034); TSDS -7.14 points (95% CI: -9.1 to -5.1, p<0.001). MANOVA confirmed multivariate QoL restructuring (Pillai's Trace=0.307, F=6.42, p<0.001). Large effects for Social Functioning (d=1.21, p<0.001), medium for Physical Functioning (d=0.66, p=0.002) and Fatigue (d=-0.55, p=0.017). Reliable improvement (Jacobson-Truax): 44.6% vs 14.8% (p=0.003); clinical recovery: 39.3% vs 5.6% (p<0.001). See table. Conclusions: Early best supportive care integration produces statistically significant and clinically meaningful QoL improvements with heterogeneous treatment response patterns. Subgroup analyses suggest selective benefit for patients on active treatment and with shorter disease duration. Clinical trial information: CTRI/2021/06/034136. Primary and secondary outcome measures at 3-month follow-up. Outcome Intervention Control p-value Cohen's d GHS Change +23.2 ± 22.0 +14.7 ± 15.6 0.037 0.44 TSDS Change -28.3 ± 15.7 -21.1 ± 15.6 0.030 0.46 Social Functioning +25.5 ± 22.9 -3.9 ± 25.9 <0.001 1.21 Physical Functioning +18.4 ± 16.5 +6.8 ± 18.9 0.002 0.66 Fatigue -23.1 ± 22.9 -10.3 ± 23.2 0.017 -0.55
Background and aims:In India, where cancer incidence is rising, and healthcare infrastructure in tertiary care centers is strained, the outcomes of cancer patients requiring intensive care unit (ICU) care remain poorly understood. We aim to describe demographic, clinical, and survival data and to identify factors associated with mortality in non-elective medical admissions of critically ill cancer patients to ICU in a tertiary care hospital. Patients and methods:Retrospective observational study of non-elective medical admissions of critically ill adult cancer patients to the ICU with a diagnosis of solid organ or hematological malignancies between 1st January 2018 and 31st December 2022. Data regarding patient and neoplasm characteristics, ICU admission features, and outcomes were collected from medical records and ICU charts. Results:A total of 204 non-elective medical admissions of critically ill cancer patients to the ICU were analyzed. Hematological malignancies were documented in 53.9% patients. The main causes of admission to the ICU were febrile neutropenia (34.3%), respiratory failure (31.8%), sepsis (9.8%), and shock (7.8%). The mean length of ICU stay was 5.62 ± 5.67 days. Intensive care unit mortality was 52.94%. The most common cause of mortality was septic shock (53.7%). The need for invasive mechanical ventilation (IMV) [adjusted odds ratio (OR) 0.113; 95% confidence interval (CI) 15.98 (4.22-60.56), p < 0.001], use of vasopressors (adjusted OR 12.59; 95% CI: 3.45-45.94, p < 0.001), need for dialysis (adjusted OR 17.99; 95% CI: 1.97-164.45, p = 0.01), and tracheostomy (adjusted OR 0.15; 95% CI: 0.03-0.7, p = 0.016), were independent risk factors associated with higher ICU mortality. Conclusion:An increasing number of cancer patients require intensive care, and our study suggests that many of these patients have a reasonable chance of surviving their ICU stay. The in-ICU mortality of 52.94% was observed at our tertiary care center in India. Independent predictors of mortality included age, type of malignancy, treatment intent, need for early IMV, vasopressors, and dialysis in the ICU. How to cite this article:Sandill S, Mishra S, Garg R, Gupta N, Bharti SJ, Kumar V, et al. Outcomes of Cancer Patients Requiring Non-elective Medical Admission to the Intensive Care Unit of a Tertiary Care Center in India: A 5-year Retrospective Study. Indian J Crit Care Med 2026;30(1):13-18.
Background and Aims: Managing acute postsurgical pain following midline exploratory laparotomy in colorectal cancer patients involves various approaches, such as central neuraxial blockade, patient-controlled intravenous analgesia with opioids, and bilateral continuous paravertebral block. However, each of these modalities carries its disadvantages. The Quadratus Lumborum Block’s role in delivering adequate analgesia in abdominal surgical cases has recently gained prominence across different patient populations, including adults, pediatrics, and pregnant patients. This study aims to compare the analgesic and perioperative effects of continuous bilateral quadratus lumborum block [CQL (II)] (using the QL2 approach) with continuous epidural block [Epi]. Material and Methods: In this noninferiority randomized controlled trial, all eligible patients, aged 18 to 80 undergoing exploratory laparotomy for colorectal cancer surgery, falling within the American Society of Anesthesiologists (ASA) Physical Status Class I, II, and III, who voluntarily provided written informed consent were randomly assigned to the CQL (II) or the Epi group using computer-generated randomization. Due to the presence of invasive catheters, both patients and investigators could not be masked regarding group allocation. Separate anesthesiologists performed the block procedures, operating room anaesthesia management, and postoperative pain follow-up. Results: No significant disparities in age, height, weight, BMI, gender, and ASA physical status between the two groups. The upper limit of the 95% confidence interval (1.63) crosses the noninferiority margin (1.0), indicating that the NRS score at rest after 24 hours of surgery is inferior in the CQLII group compared to the Epi group. Among other postoperative outcomes, sleep quality (P value = 0.0015), patient satisfaction score (P value = 0.0000), total postoperative rescue fentanyl use (P value = 0.0005), and postoperative time for first activity out of bed (P value = 0.016) were significantly better in the Epi group. Conclusions: The continuous bilateral quadratus lumborum block failed to demonstrate noninferiority to the epidural block in providing similar NRS scores at rest at 24 hours and other postoperative outcomes.
Background and Aims: Thoracic paravertebral block (PVB) is the current gold standard technique for perioperative analgesia in breast surgeries. However, it has been associated with axillary sparing. Hence, we have attempted here to block the nerve supply of the entire chest wall with multiple nerve blocks given as the complete antethoracic block (CAB) and compared its analgesic efficacy with the PVB. Material and Methods: Seventy patients between 18 and 70 years, posted for modified radical mastectomy, were included and analyzed in this study. These patients were randomly allocated to group A or B to receive PVB or CAB, respectively. Thoracic paravertebral block was given to Group A patients with 25 ml of 0.5% ropivacaine. Complete antethoracic block was given with 60 ml of 0.2% ropivacaine. Duration of analgesia, postoperative pain scores, and patient satisfaction scores were noted. The statistical software STATA (version 14) was used for all statistical analyses. Results: The CAB group had a longer duration of analgesia than the PVB group, but noninferiority could not be established because the upper limit of the confidence interval (CI) exceeded both margins. Lower pain scores were recorded in the first 2 hours in the CAB group. There was no significant difference in terms of patient satisfaction between the two groups. Conclusions: CAB is a potential alternative technique for providing analgesia for breast surgeries and can be considered in breast surgeries where PVB is not feasible.
BACKGROUND:The choice of intrathecal local anesthetic influences discharge readiness and brachytherapy success. Evidence comparing hyperbaric bupivacaine, levobupivacaine, and ropivacaine is limited. METHODS:In this double-blind, randomized crossover study, 40 women undergoing three brachytherapy sessions received, in random order, intrathecal hyperbaric ropivacaine 0.5%, levobupivacaine 0.5%, or bupivacaine 0.75%, with ≥1 week between sessions. Sensory and motor block onset/duration, hemodynamic variables, and complications were monitored. Data were analyzed using two-way analysis of variance (ANOVA) and Chi-square tests. RESULTS:Ropivacaine produced the fastest sensory block (2.68 ± 0.20 min) versus levobupivacaine (2.72 ± 0.18 min) and bupivacaine (2.84 ± 0.22 min); the difference between ropivacaine and bupivacaine was -0.16 min (95% confidence interval (CI) -0.25 to -0.07). Sensory block lasted 57.2 ± 8.6, 58.5 ± 9.3, and 61.3 ± 7.7 min, respectively; ropivacaine shortened duration by 4.1 min versus bupivacaine (95%CI -7.7 to -0.5). Motor block onset was fastest with levobupivacaine (4.99 ± 0.50 min), followed by bupivacaine (5.41 ± 0.35 min) and ropivacaine (5.70 ± 0.25 min). Motor block lasted 60 ± 8.8, 62 ± 8.3, and 66 ± 5.0 min, respectively. Hypotension within 10 min occurred in 17.5%, 40%, and 85% with levobupivacaine, ropivacaine, and bupivacaine; tachycardia occurred in 15%, 35%, and 80%. CONCLUSIONS:All three agents provided effective spinal anesthesia for brachytherapy. Ropivacaine offered the shortest sensory/motor blocks; levobupivacaine afforded the most stable cardiovascular profile. Bupivacaine produced longer blocks but higher hypotension/tachycardia rates.
OBJECTIVE:To assess psychological distress and quality of life (QoL) among patients with non-small cell lung cancer (NSCLC) receiving chemotherapy and examine the relationship between distress and QoL across treatment cycles. METHODS:This prospective observational study enrolled 105 patients with NSCLC undergoing chemotherapy. Psychological distress was assessed using the Depression Anxiety Stress Scale-21 questionnaire, and QoL was evaluated using the WHO Quality of Life-BREF questionnaire at baseline (before chemotherapy) and after three and six cycles of chemotherapy. Linear mixed models with first-order autoregressive covariance were used to account for within-patient correlation. RESULTS:Psychological distress worsened over time, with anxiety and stress increasing significantly. QoL declined across all domains, with physical health scores decreasing from 57.99 to 46.71 and psychological health from 54.48 to 43.00. Regression analysis demonstrated an inverse relationship between distress and QoL, with distress explaining 41.74% of QoL variance at baseline and 44.01% at the final assessment. Patients in severe and extremely severe distress categories had a two times higher risk of experiencing a ≥10-point drop in QoL than those with mild or no distress. CONCLUSION:This prospective observational study confirms that patients with NSCLC receiving chemotherapy experience significant psychological distress and impaired QoL. Early identification and intervention are critical for improving patient outcomes, treatment adherence and quality of care. These findings highlight the need for integrated palliative care in NSCLC management.
Purpose Metastatic spinal cord compression (MSCC) is a debilitating complication of advanced malignancies, associated with immense physical and emotional distress. The aim of this study was to assess the trajectory of emotional well-being (primary outcome) and quality of life (QoL), functional status, and pain (secondary outcomes) over 30 days. Methods 106 MSCC patients were included in this prospective observational study. Assessments were done using the Hospital Anxiety and Depression Scale (HADS) for emotional well-being, EORTC QLQ-C30 for QoL, Karnofsky Performance Status (KPS) for functional status, and the numeric rating scale (NRS) for pain. These were conducted at baseline ( T 0 ), day 10 ( T 10 ), and day 30 ( T 30 ). Results The mean age of the participants was 54.1 years. A V-shaped pattern was observed in emotional well-being; improvement in HADS was noted from T 0 to T 10 ( P < 0.001), but they worsened by T 30 ( P < 0.01). Global health and functional domains of QoL ( P < 0.05) showed improvement, but these gains plateaued as fatigue and financial distress increased. Baseline correlation weakened over time between QoL and functional domains. At T 30 , the only domain that remained significantly associated with QoL was emotional functioning, underscoring its strong link to overall QoL. The pain decreased significantly by day 10. Conclusion MSCC affects the emotional well-being and QoL. Initial improvements in psychological symptoms is followed by an eventual decline. There is a paradox wherein, despite objective health deterioration there is subjective improvement in well-being. Hence, a multidisciplinary approach, involving psychological and rehabilitative support, becomes crucial for optimal patient-centred care.
Background and Aims:Frailty increases vulnerability to stressors, negatively impacting cancer outcomes. We evaluated the association between pre-operative frailty and post-operative outcomes in Indian patients undergoing major abdominal cancer surgery and explored ultrasound-based sarcopenia markers for frailty screening. Methods:Frailty was assessed using the Fried Frailty Phenotype. The primary outcome was hospital length of stay (LOS); secondary outcomes included severe complications (Clavien-Dindo III/IV), intensive care unit stay, and 30- and 90-day mortality. Pre-operative ultrasound-guided quadriceps thickness and rectus femoris cross-sectional area (CSA) were measured, and their cut-off values were derived via receiver operating characteristic (ROC) curves as screening parameters for pre-operative frailty. Results:Among 142 patients, 68 (47.8%) were frail. Frail patients had longer hospital stays {median 9 vs. 6 days; relative risk (RR) 1.20 [95% confidence interval (CI) 1.02 to 1.41]}; P = 0.031. On multivariate analysis, frailty {RR 1.16 [95% CI 1.03 to 1.31]}; P = 0.012 and American Society of Anesthesiologists physical status (ASA-PS) > III {RR 1.35 [95% CI 1.10 to 1.65]}; P = 0.004 independently predicted prolonged LOS. ROC analysis showed poor predictive ability of ultrasonography: {area under curve 0.591 [95% CI 0.497 to 0.685]}; P = 0.061 for body mass index-normalised quadriceps thickness; {0.613 [95% CI 0.519 to 0.707]}; P = 0.020 for rectus femoris CSA, which improved to {0.721 [95% CI 0.636 to 0.806]} with pre-operative anaemia. The diagnostic accuracy was 65.5% and 64.3%, respectively; the sensitivity/specificity for quadriceps was 78%/54%, and for rectus femoris, CSA was 50%/78%. DeLong's test showed no significant difference (P = 0.6). Conclusion:Frailty prolongs hospital stay but not complications or mortality. Ultrasound alone poorly predicts frailty. Combining pre-operative anaemia improves the predictive value of rectus femoris ultrasound assessment.
Breast cancer is the most common malignancy among women in India, with patients often experiencing high symptom burden and compromised quality of life (QoL). Despite evidence supporting early supportive care integration, significant implementation gaps persist in low- and middle-income countries (LMICs). This study addresses the lack of feasible intervention models for resource-constrained settings and inadequate characterization of mechanisms through which early supportive care improves outcomes—particularly symptom-specific contributions and financial burden reduction. This single-centre, randomised controlled trial at All India Institute of Medical Sciences, New Delhi, randomised 110 newly diagnosed adult female breast cancer patients (1:1) into intervention (early supportive care plus standard care) or control (standard care only) groups. Supportive care included symptom management, psychosocial counselling, and educational support. Outcomes were assessed at baseline and 3 months using EORTC QLQ-C30 and Edmonton Symptom Assessment Scale (ESAS). Statistical analyses included t-tests, multivariate regression, and mediation modelling. Both groups showed significant QoL improvement, but greater symptom reduction occurred in the intervention group (mean ± SD ESAS reduction: 30.69 ± 15.51 vs. 22.9 ± 15.99; p = 0.014). Fatigue and pain were significantly lower in the supportive care group (Cohen’s d = 0.55 [95
Enhanced Recovery After Surgery (ERAS) protocols reduce surgical stress and improve perioperative outcomes. Evidence supporting ERAS in head and neck oncology remains limited. This study evaluated the impact of a structured ERAS pathway on perioperative outcomes in adult patients undergoing head and neck cancer surgery. In this prospective quasi-experimental study, perioperative outcomes were compared in patients undergoing head and neck cancer surgery before and after implementation of an ERAS protocol at a tertiary care cancer centre. Adult patients received either conventional perioperative care (C-CAP; n = 115) or an ERAS pathway (E-CAP; n = 116). The primary outcome was length of hospital stay (LOHS). Secondary outcomes included intensive care unit (ICU) stay, postoperative complications (graded by the Clavien–Dindo classification), and 30-day readmission. Analysis of covariance (ANCOVA) adjusted for prespecified covariates. ERAS was associated with a significantly reduced LOHS (adjusted mean difference 2.48 days; 95 www.ctri.nic.in ) dated 30 March 2022.
This study investigates whether cancer-related stigma and pain among patients with advanced cancer influences their perceptions of receiving responsive care. We surveyed 2138 advanced cancer patients from 11 hospitals in eight Asian countries. Participants rated their most recent healthcare visit and a hypothetical patient’s experience described in vignettes concerning dignity, clarity of information, and involvement in decision-making. We used the vignettes to correct for differences in patients’ reporting behaviors. Overall, 39
BackgroundParents caring for children with cancer face substantial physical, emotional, social, and financial challenges, especially in low- and middle-income countries like India.ObjectiveIn this study, we aimed to assess caregiver burden and quality of life among parents of children with cancer in the Indian context, and to describe the socio-cultural and economic factors influencing these outcomes.MethodsIn this cross-sectional study, 200 primary caregivers of paediatric oncology patients were assessed using the Zarit Burden Interview (ZBI), WHOQoL-BREF, and the Multidimensional Scale of Perceived Social Support (MSPSS). Socio-demographic and clinical data were collected through interviews and review of medical records.ResultsThe median ZBI score was 66 (IQR 23.5), with 66% of caregivers experiencing severe burden. Caregiver burden was higher among mothers, caregivers with lower education, those unemployed, and those living in nuclear families. Burden negatively correlated with duration of illness (r = -0.75, P < 0.05) and quality of life across all domains. Perceived social support was low, particularly among caregivers living alone or in nuclear families.ConclusionsHigh caregiver burden and impaired quality of life were observed among caregivers in a resource-limited setting. Strengthening social support and implementing family-centred interventions may help reduce the burden and improve outcomes.
Objectives:Burnout is a significant occupational hazard among palliative care physicians, driven by the emotionally demanding and high-stress nature of their work. Despite its implications for physician well-being and patient care, limited data are available on burnout within Indian palliative care settings. This study aimed to assess the prevalence of burnout and explore associated demographic and occupational factors among palliative care physicians across India. Materials and Methods:A cross-sectional survey was conducted among 68 palliative care physicians across India using a non-probabilistic convenience sampling approach. Participants completed a semi-structured socio-demographic questionnaire along with the Copenhagen Burnout Inventory (CBI), which measures burnout across three domains: personal, work-related and client-related. Given the non-normal distribution of data, non-parametric statistical tests were employed for analysis. Results:The majority of physicians (85.3%) reported low overall burnout, whereas 10.3% experienced moderate burnout and 4.4% reported high burnout, based on established CBI cut-off scores. Notably, higher work-related and client-related burnout scores were observed among junior physicians and those practising in mixed-care settings. Engagement in regular physical activity was significantly associated with reduced overall burnout (P = 0.039), indicating its potential protective effect. Conclusion:Although most palliative care physicians in India demonstrated low levels of burnout, a significant minority exhibited moderate to high burnout-particularly in domains related to work and patient care. These findings highlight the need for targeted interventions aimed at improving institutional support, encouraging physical well-being and optimising work environments to mitigate burnout and enhance the sustainability of palliative care practice.
COVID-associated mucormycosis (CAM) is a severe fungal infection with lasting physical and psychological effects. This prospective cohort of 53 CAM patients evaluated symptom burden, depression (PHQ-9), anxiety (GAD-7), and quality of life (WHOQOL-BREF) at baseline, 6 months and 1 year. Facial pain (89%) and headache (87%) were the most common symptoms; depression improved significantly (PHQ-9: 9.7 to 5.4; p < 0.001), while anxiety initially declined but rose again at 1 year. Quality of life improved in physical and psychological domains, whereas social and environmental aspects remained unchanged. Persistent challenges such as dysphagia (33%), voice changes (27%) and appearance concerns (27%) underscore the need for integrated long-term mental health and rehabilitation strategies in CAM care.
BACKGROUND:Cancer-associated depression is a multifaceted condition that arises from the interplay of biological, psychological, and social factors in individuals diagnosed with cancer. Understanding this condition involves exploring how cancer and its treatments can precipitate depressive symptoms and the mechanisms behind this association. Chronic stress, inflammation, and immunological responses play a crucial role in the development of both cancer and depression. The objective of this review is to describe and synthesize information on the complex interactions between chronic stress, inflammation, immunological responses, and cancer development. Additionally, it aims to review existing evidence regarding mechanisms such as neurotransmitter imbalances, structural brain changes, and genetic predispositions as key contributors to depression in cancer patients. RECENT FINDINGS:A comprehensive literature search on Cancer-associated Depression was conducted in electronic databases, including APA PsycINFO, Medline, Google Scholar, Embase, PubMed, Scopus, and Web of Science. The research focused on understanding the potential relationship between stress-induced depression and cancer by examining neurochemical, anatomical, immunological, genetic, and psychological changes. The findings revealed a compilation of both quantitative and qualitative studies on depression in cancer patients. Evidence suggested a potential link between cancer-induced stress and depression, with increased levels of proinflammatory cytokines (such as IL-6) and dysregulation of neurotransmitters, including serotonin, contributing to the onset of depression. Furthermore, studies indicated that antidepressants, along with psychological interventions, were effective in managing depression among cancer patients. CONCLUSION:This narrative review provides insights into the importance of integrating oncology and mental health services to address the psychosocial needs of cancer patients. Future research should focus on the bidirectional interactions between stress and cancer, aiming to improve cancer care by incorporating mental health support. Addressing the mental health aspects of cancer treatment can significantly enhance patient outcomes and overall quality of life.
e13086 Background: Cyclin dependant kinase 4/6 inhibitors (CDKi), along with endocrine therapy (ET), is the first line management of metastatic hormone receptor-positive HR+/Her2 neu negative cancer. This study provides real world outcomes from a resource constrained setting with respect to treatment patterns and prognostic factors of patients with metastatic HR+ breast cancer treated with cyclin dependant kinase (CDKi). Methods: We conducted a retrospective cohort study of patients diagnosed with HR+ metastatic breast cancer and treated with CDK4/6 inhibitors at All India Institute of Medical Sciences, India. The primary end point of the study was progression-free survival (PFS) and the secondary endpoint was overall survival (OS), response rates and adverse events. Ovarian function suppression was administered as per institution protocol. Results: A total of 240 patients were included, with a median age of 48 (26-54) years. Out of 240 patients,119(50%) were postmenopausal. CDKi was used in 59.6% (n = 143) of the cases with de novo metastatic disease and in 27.9% (n = 67) with relapsed disease. The sites of metastases were skeletal (70.8%), liver (22.9%), central nervous system (5%), non-regional nodal (48.8%) and pulmonary (47.5%). Visceral crisis was present in 8.8% (n = 21) patients. In the whole cohort 199 (82.9%) patients received palbociclib, 35 (14.6%) received ribociclib and 6 (2.5%) received abemaciclib. The objective response rate (ORR) was 44.9% and the clinical benefit rate (CBR) was 86.7%. Complete response (CR) was seen in 13.8%, partial response was seen in 30.4% and stable disease in 41.7%. Amongst the patients who presented with visceral crisis, the response rates were similar to patients without visceral crisis. The median follow-up duration was 39.06 (0.3-127.83) months. The median PFS was 17.23 months(3.7-37.09 months) and the median OS was 56.8(6-58.37). There was no difference in OS with use of CDKi in first line versus second line (p = 0.275). Grade 3/4 toxicity was present in 59 (24.6%) patients and level 1 dose reduction was performed in 13.3% patients. The most common grade 3/4 toxicity was neutropenia (18.75%), thrombocytopenia (3.33%) and anemia (2.5%). Additionally, 3 patients had hepatic toxicity and 2 patients had QTc prolongation on ribociclib. Ki-67 ≥20% emerged as the only significant independent predictor of PFS (HR: 2.78, p = 0.03). The only significant factor having an impact on OS was number of metastatic sites more than 3 (HR: 6.98, p = 0.008). Conclusions: This represents the largest data of CDKi from the Indian subcontinent. The OS and PFS reported are similar to real-world studies even though the complete remission rates and adverse events were lower than western data which could be attributed to difference in tumor biology. There is no difference in survival with use of CDKi in first line versus subsequent lines.