Effective management Alopecia totalis by Ayurveda - A case report.

Alopecia areata (AA) is a T-cell-mediated autoimmune illness characterized by intermittent, non-scarring hair loss, Alopecia totalis(AT) is a type of AA characterized by total hair loss on the face and scalp. Unfortunately, it is projected that 10-15 % of people with AA will advance to total hair loss on the scalp (AT) or hair loss on the scalp and body Alopecia Universalis (AU) only 10 % of patients with AT/AU recover completely. Treatment for severe AA is often unsatisfactory. The most popular AT/AU therapy techniques were topical steroid application and oral steroid administration. We present a case of Alopecia totalis that was treated with cupping therapy and ayurvedic treatments such as Punarnava Mandoor, manjistadi Kashaya, asanadi gana Kashaya, purnachandrodaya rasa, a churna combo, and Malatyadi and Dhurdhurapatradi taila for external application over scalp. The treatment's effectiveness is due to the synergistic action of all the herbs and the immunostimulant activity of cupping.

The prevalence of cognitive impairment in older Indian persons with cancer and brain metastases.

Background: Older patients with cancer are more vulnerable to the effects of cognitive impairment affecting their functional status, quality of life, compliance to treatment and ultimately survival. Cancer-related cognitive impairment may be due to the cancer itself or due to the treatment of cancer. There are no data regarding the prevalence of cognitive impairment in older persons with cancer and brain metastasis. Methods: This retrospective analysis was conducted on a prospectively collected data set of patients who attended the geriatric oncology clinic at a tertiary care comprehensive cancer centre in India from June 2018 to July 2021. Patients aged 60 years and above with malignancy were included. Cognition was assessed with the mini-mental status examination (MMSE); the Hindi MMSE was used for illiterate patients. A score of ≤23 on the MMSE was considered abnormal. Correlation between the presence of cognitive impairment and brain metastasis was tested using the chi-square test. Results: A total of 597 patients were included, of which 462 (77.4%) were male. The median age was 69 years (range: 60-100 years). All patients had solid tumours; 244 (40.9%) had lung, 189 (31.7%) had gastrointestinal and 75 (12.6%) had head and neck malignancies. Forty-one (6.9%) patients had brain metastases, of which 10 (24.4%) had solitary, 30 (73.2%) had multiple lesions and 1 (2.4%) had leptomeningeal metastases. Cognitive impairment was noted in 11 (26.8%) of the 41 patients with brain metastases and 91 (16.4%) of the 556 patients without brain metastases. There was no significant correlation between the presence of brain metastases and cognitive impairment, p = 0.086. Conclusion: Older persons with cancer and brain metastases were not found to have a higher occurrence of cognitive impairment than those without brain metastases in this study. The next step is to understand whether older persons with brain metastases are at a higher risk for cognitive decline as a result of therapeutic interventions such as cranial radiotherapy and chemotherapy.

Optimizing Postoperative Adjuvant Therapy in Elderly Patients with Newly Diagnosed Glioblastoma: Single-Institution Audit of Clinical Outcomes from a Tertiary-Care Comprehensive Cancer Center in India.

BACKGROUND: There is lack of consensus regarding optimal adjuvant therapy in elderly glioblastoma (GBM). We have been treating elderly (≥60 years) GBM patients with normofractionated or hypofractionated radiotherapy (RT) plus temozolomide (TMZ) based on Karnofsky performance status (KPS). Herein we report clinical outcomes in this cohort treated at our institute using this approach. METHODS: Medical records of elderly GBM patients (≥60 years) treated between 2013 and 2017 with either normofractionated RT (59.4-60 Gy/30-33 fractions/6-6.5 weeks) or hypofractionated RT (35 Gy/10 fractions/2 weeks) plus TMZ were reviewed retrospectively. Outcomes of interest included progression-free survival (PFS), overall survival (OS), and ≥grade 3 myelotoxicity. Time-to-event outcomes were analyzed with Kaplan-Meier methods, compared using log-rank test, and reported as point estimates with 95% confidence interval (CI). RESULTS: The normofractionated cohort (n = 126) was characterized by a higher proportion of patients younger than age 65 years, KPS ≥70, methylated O6-methylguanine DNA methyltransferase (MGMT), and receiving adjuvant TMZ including extended adjuvant TMZ (>6 cycles) compared with the hypofractionated cohort (n = 20), confirming selection bias. At a median follow-up of 13 months, 1-year Kaplan-Meier estimates of PFS and OS were 43% (95% CI: 36%-52%) and 56% (95% CI: 48%-64%), yielding median PFS and OS of 11.0 months and 13.1 months, respectively. Higher KPS, methylated MGMT, normofractionated RT, and extended adjuvant TMZ emerged as favorable prognostic factors. TMZ was well tolerated with a low risk of ≥grade 3 myelotoxicity. CONCLUSIONS: Our single-institution clinical audit confirms poor survival in elderly GBM with suboptimal performance status but demonstrates acceptably fair outcomes in patients with preserved KPS comparable with the nonelderly cohort.

Clinical Audit of Survival Outcomes and Prognostic Factors in Adolescents and Adults with Medulloblastoma.

Purpose: Medulloblastomas, comprising 20%-25% of all primary brain tumors in children are much rarer in adulthood. Disease biology varies substantially across different age groups; however, owing to rarity, adults with medulloblastoma are traditionally treated using pediatric protocols. This is a retrospective audit of adolescent and adult medulloblastoma from a comprehensive cancer center. Methods: Data regarding demography, clinical presentation, imaging characteristics, histopathological features, molecular profiling, risk stratification, treatment details, and outcomes were retrieved from medical records. All time-to-event outcomes were analyzed using Kaplan-Meier method and compared with the log-rank test. Univariate and multivariate analysis of relevant prognostic factors was done with p value <0.05 being considered statistically significant. Results: A total of 162 patients ≥15 years of age with medulloblastoma were included. The median age was 25 years (range: 15-59 years) with leptomeningeal metastases seen in 31 (19%) patients at initial diagnosis. Following surgery, patients were treated with appropriate risk-stratified adjuvant therapy comprising of craniospinal irradiation plus boost with or without systemic chemotherapy. At a median follow-up of 50 months, 5-year Kaplan-Meier estimates of progression-free survival and overall survival were 53.5% and 59.5%, respectively. The addition of adjuvant systemic chemotherapy did not impact upon survival in standard-risk medulloblastoma. High-risk (HR) disease and anaplastic histology emerged as significant and independent predictors of poor survival on multivariate analysis. Conclusion: Medulloblastoma is a rare tumor in adolescents and adults with key differences in disease biology and resultant outcomes compared with the pediatric population. Contemporary management comprising maximal safe resection followed by appropriate risk-stratified adjuvant therapy provides acceptable survival outcomes.

Prospective Phase II Open-Label Randomized Controlled Trial to Compare Mandibular Preservation in Upfront Surgery With Neoadjuvant Chemotherapy Followed by Surgery in Operable Oral Cavity Cancer.

PURPOSE: The objective of this study was to explore the potential role and safety of neoadjuvant chemotherapy (NACT) in tumor shrinkage and resultant mandibular preservation in oral cancers compared with conventional surgical treatment. METHODS: This study was a single-center, randomized, phase II trial of treatment-naive histologically confirmed squamous cell carcinoma of the oral cavity with cT2-T4 and N0/N+, M0 (American Joint Committee on Cancer, seventh edition) stage, necessitating resection of the mandible for paramandibular disease in the absence of clinicoradiologic evidence of bone erosion. The patients were randomly assigned (1:1) to either upfront surgery (segmental resection) followed by adjuvant treatment (standard arm [SA]) or two cycles of NACT (docetaxel, cisplatin, and fluorouracil) at 3-week intervals (intervention arm [IA]), followed by surgery dictated by postchemotherapy disease extent. All patients in the IA received adjuvant chemoradiotherapy, and patients in the SA were treated as per final histopathology report. The primary end point was mandible preservation rate. The secondary end points were disease-free survival and treatment-related toxicity. RESULTS: Sixty-eight patients were enrolled over 3 years and randomly assigned to either SA (34 patients) or IA (34 patients). The median follow-up was 3.6 years (interquartile range, 0.95-7.05 years). Mandibular preservation was achieved in 16 of 34 patients (47% [95% CI, 31.49 to 63.24]) in the IA. The disease-free survival (P = .715, hazard ratio 0.911 [95% CI, 0.516 to 1.607]) and overall survival (P = .747, hazard ratio 0.899 [95% CI, 0.510 to 1.587]) were similar in both the arms. Complications were similar in both arms, but chemotherapy-induced toxicity was observed in the majority of patients (grade III: 14, 41.2%; grade IV: 11, 32.4%) in the IA. CONCLUSION: NACT plays a potential role in mandibular preservation in oral cancers with acceptable toxicities and no compromise in survival. However, this needs to be validated in a larger phase III randomized trial.

Distress Screening in Head and Neck Cancer Patients Planned for Cancer-Directed Radiotherapy.

OBJECTIVE/HYPOTHESIS: To estimate the prevalence of baseline clinically significant distress (distress score ≥ 4) in head and neck cancer patients planned and treated with radical intent radiotherapy using the National Comprehensive Cancer Network Distress Thermometer (DT) and assess factors predictive of distress. STUDY DESIGN: Cross-sectional study. METHODS: This was a cross-sectional study evaluating distress in 600 head and neck cancer patients undergoing radiation therapy. The DT was used to screen patients for distress at baseline before radiotherapy. RESULTS: The median distress score of the entire cohort was 4 interquartile range (IQR) (IQR: 3-5), and 340 patients (56.7%) had clinically significant distress. On univariate analysis, the causal factors predictive of distress were low socioeconomic status (P = .04), presence of proliferative growth at presentation (P = .008), site of the tumor (oral cavity, P = .02), comorbidity (P = .04), and presence of Ryle's tube or tracheostomy tube at baseline (P = .01). Low socioeconomic status was significant (P = .04) on multivariate analysis for high levels of distress. CONCLUSIONS: Among head and neck cancer patients, 56% of patients had clinically significant baseline distress, and patients with low socioeconomic status had high distress. There is a need for interventions to mitigate distress. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:2023-2029, 2021.

Low-cost oral metronomic chemotherapy versus intravenous cisplatin in patients with recurrent, metastatic, inoperable head and neck carcinoma: an open-label, parallel-group, non-inferiority, randomised, phase 3 trial.

BACKGROUND: Regimens for palliation in patients with head and neck cancer recommended by the US National Comprehensive Cancer Network (NCCN) have low applicability (less than 1-3%) in low-income and middle-income countries (LMICs) because of their cost. In a previous phase 2 study, patients with head and neck cancer who received metronomic chemotherapy had better outcomes when compared with those who received intravenous cisplatin, which is commonly used as the standard of care in LMICs. We aimed to do a phase 3 study to substantiate these findings. METHODS: We did an open-label, parallel-group, non-inferiority, randomised, phase 3 trial at the Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India. We enrolled adult patients (aged 18-70 years) who planned to receive palliative systemic treatment for relapsed, recurrent, or newly diagnosed squamous cell carcinoma of the head and neck, and who had an Eastern Cooperative Oncology Group performance status score of 0-1 and measurable disease, as defined by the Response Evaluation Criteria In Solid Tumors. We randomly assigned (1:1) participants to receive either oral metronomic chemotherapy, consisting of 15 mg/m2 methotrexate once per week plus 200 mg celecoxib twice per day until disease progression or until the development of intolerable side-effects, or 75 mg/m2 intravenous cisplatin once every 3 weeks for six cycles. Randomisation was done by use of a computer-generated randomisation sequence, with a block size of four, and patients were stratified by primary tumour site and previous cancer-directed treatment. The primary endpoint was median overall survival. Assuming that 6-month overall survival in the intravenous cisplatin group would be 40%, a non-inferiority margin of 13% was defined. Both intention-to-treat and per-protocol analyses were done. All patients who completed at least one cycle of the assigned treatment were included in the safety analysis. This trial is registered with the Clinical Trials Registry-India, CTRI/2015/11/006388, and is completed. FINDINGS: Between May 16, 2016, and Jan 17, 2020, 422 patients were randomly assigned: 213 to the oral metronomic chemotherapy group and 209 to the intravenous cisplatin group. All 422 patients were included in the intention-to-treat analysis, and 418 patients (211 in the oral metronomic chemotherapy group and 207 in the intravenous cisplatin group) were included in the per-protocol analysis. At a median follow-up of 15·73 months, median overall survival in the intention-to-treat analysis population was 7·5 months (IQR 4·6-12·6) in the oral metronomic chemotherapy group compared with 6·1 months (3·2-9·6) in the intravenous cisplatin group (unadjusted HR for death 0·773 [95% CI 0·615-0·97, p=0·026]). In the per-protocol analysis population, median overall survival was 7·5 months (4·7-12·8) in the oral metronomic chemotherapy group and 6·1 months (3·4-9·6) in the intravenous cisplatin group (unadjusted HR for death 0·775 [95% CI 0·616-0·974, p=0·029]). Grade 3 or higher adverse events were observed in 37 (19%) of 196 patients in the oral metronomic chemotherapy group versus 61 (30%) of 202 patients in the intravenous cisplatin group (p=0·01). INTERPRETATION: Oral metronomic chemotherapy is non-inferior to intravenous cisplatin with respect to overall survival in head and neck cancer in the palliative setting, and is associated with fewer adverse events. It therefore represents a new alternative standard of care if current NCCN-approved options for palliative therapy are not feasible. FUNDING: Tata Memorial Center Research Administration Council. TRANSLATIONS: For the Hindi, Marathi, Gujarati, Kannada, Malayalam, Telugu, Oriya, Bengali, and Punjabi translations of the abstract see Supplementary Materials section.

A cross-sectional audit of distress in patients undergoing adjuvant therapy or follow-up in central nervous system malignancies.

BACKGROUND: Unaddressed high distress leads to noncompliance with treatment, negatively affects quality of life, and may also have a negative impact on the prognosis of cancer patients. Patients with brain tumors have higher levels of distress than the general population and hence we hypothesize that even routine visits during adjuvant treatment or follow-up are likely to be stressful. This analysis was performed to identify the incidence of distress and factors affecting it. METHODS: This was an audit of 84 consecutive patients seen in an adult neuro-medical oncology outpatient department who were either receiving adjuvant chemotherapy or were on follow-up. Distress screening with the National Comprehensive Cancer Network (NCCN) distress thermometer was performed. Patients in whom distress was scored as 4 or above were considered as having high distress. Descriptive statistics and logistic regression analysis were performed to identify factors affecting distress. RESULTS: The median age of the cohort was 40 years (interquartile range, 28.3 to 50 years). Actionable distress defined as a distress score of 4 or more was seen in 52 patients (61.9%, 95% CI 51.2% to 71.5%). Presence of physical deficit (odds ratio [OR] = 3.412, P = .020) and treatment under the private category (OR = 5.273, P = .003) had higher odds of having high distress. CONCLUSION: A high proportion of brain tumor patients either on adjuvant chemotherapy or on follow-up have high distress levels that need to be addressed even during follow-up.

Distress Management in Patients With Head and Neck Cancer Before Start of Palliative Chemotherapy: A Practical Approach.

PURPOSE: This study reports the incidence of distress, the factors associated with distress, and a practical strategy to resolve distress in patients with head and neck cancer who are starting palliative chemotherapy. METHODS: Adult patients with head and neck cancer planned for palliative chemotherapy underwent distress screening before the start of treatment as part of this single-arm prospective study. Patients who had a distress score > 3 on the National Comprehensive Cancer Network (NCCN) distress thermometer were counseled initially by the clinician. Those who continued to have high distress after the clinician-led counseling were referred to a clinical psychologist and were started on palliative chemotherapy. After counseling, distress was measured again. The relation between baseline distress and compliance was tested using Fisher's exact test. RESULTS: Two hundred patients were enrolled, and the number of patients with high distress was 89 (44.5% [95% CI, 37.8% to 51.4%]). The number of patients who had a decrease in distress after clinician-led counseling (n = 88) was 52 (59.1% [95% CI, 48.6% to 68.8%]) and after psychologist-led counseling (n = 32) was 24 (75.0% [95% CI, 57.6% to 72.2%]; P = .136). Compliance rates did not differ between the patients with or without a high level of distress at baseline (74.2% v 77.4%, P = .620). CONCLUSION: The incidence of baseline distress is high in patients awaiting the start of palliative chemotherapy. It can be resolved in a substantial number of patients using the strategy of clinician-led counseling, with additional referral to a clinical psychologist as required. Patients with a greater number of emotional problems usually require psychologist-led counseling.

Phase III randomized trial comparing intravenous to oral iron in patients with cancer-related iron deficiency anemia not on erythropoiesis stimulating agents.

AIM: We aimed to find the optimal route of iron supplementation in patients with malignancy and iron deficiency (true or functional) anemia not receiving erythropoiesis stimulating agents (ESA). METHODS: Adult patients with malignancy requiring chemotherapy, hemoglobin (Hb) <12 g/dL and serum ferritin <100 mcg/mL, transferrin saturation <20% or hypochromic red blood cells >10% were randomized to intravenous (IV) iron sucrose or oral ferrous sulfate. The primary endpoint was change in Hb from baseline to 6 weeks. Secondary endpoints included blood transfusion, quality of life (QoL), toxicity, response and overall survival. RESULTS: A total of 192 patients were enrolled over 5 years: 98 on IV arm and 94 on oral arm. Median age was 51 years; over 95% patients had solid tumors. The mean absolute increase in Hb at 6 weeks was 0.11 g/dL (standard deviation [SD]: 1.48) in IV arm and -0.16 g/dL (SD: 1.36) in oral arm, P = 0.23. Twenty-three percent patients on IV iron and 18% patients on oral iron had a rise in Hb of ≥1 g/dL at 6 weeks, P = 0.45. Thirteen patients (13.3%) on the IV iron arm and 14 patients (14.9%) on the oral arm required blood transfusion, P = 1.0. Gastrointestinal toxicity (any grade) developed in 41% patients on IV iron and 44% patients on oral iron, P = 1.0. 5 patients on IV iron and none on oral iron had hypersensitivity, P = 0.06. QoL was not significantly different between the two arms. CONCLUSION: IV iron was not superior to oral iron in patients with malignancy on chemotherapy and iron deficiency anemia.