The Efficacy of Paxman Scalp Cooling System in Preventing Hair Loss in Breast Cancer Patients Receiving Chemotherapy in Western India - Multi-centre Retrospective Cohort Study.

Aim: Chemotherapy-induced alopecia (CIA) is the most common side effect of systemic treatment in breast cancer patients. Scalp cooling gained worldwide acceptance in preventing or mitigating CIA in patients undergoing chemotherapy. The objective of this study was to evaluate the efficacy and safety of the Paxman scalp cooling system (PSCS) in Indian breast cancer patients. Materials and Methods: This is a multi-centre, retrospective-observational study including patients registered from 1st March, 2019 to 30th April, 2021 undergoing chemotherapy for breast cancer by using PSCS. The primary end-point was the incidence of CIA after completing cycles of chemotherapy. Results: A total of 91 female patients were enrolled in the study, with a median age of 53 years (IQR: 44-62 years). The prevention of alopecia (grade 0 and grade I) was seen in 81%, while more than 50% hair loss (grade 2) was seen in 16.48% after completion of treatment. The univariate analysis results showed that CIA was significantly higher in patients who received anthracyclines (OR: 2.69; 95% CI: 1.04-6.958; P = 0.041) and in patients with a post-infusion cooling time of >150 minutes (OR: 8.409; 95% CI: 2.295-30.787; P = 0.001). The incidence of grade 2 (>50% hair loss) alopecia was 81.3% in patients <6 weeks and was 18.8% at >6 weeks of start of chemotherapy (P < 0.0001). No adverse events were reported in 71.4% of patients, and the most common adverse event was headache (18.7%). Conclusion: PSCS is an effective and well-tolerated treatment modality for preventing CIA among breast cancer patients undergoing chemotherapy.

A Real-World Molecular Epidemiological Study of Non-Small-Cell Lung Cancer (NSCLC) Patients from Western India.

Ashish JoshiBackground The molecular characterization of advanced non-small-cell lung cancer (NSCLC) has unveiled genomic alterations such as EGFR gene mutations, KRAS gene mutations, ROS1 gene rearrangements, EML4-ALK rearrangements, and altered MET signaling. The objective of this molecular epidemiological study was to report the clinical, pathological, and molecular profile of NSCLC patients from western India. Materials and Methods This real-world study of NSCLC patients was performed at a chemotherapy day-care center in western India. The clinical, pathological, and molecular data were collected from the patient's medical records after obtaining the Ethics Committee permission for the study. The study was conducted according to the ethical principles stated in the latest version of Helsinki Declaration, and the applicable guidelines for good clinical practice. Results A total of 182 (58.7%) men and 128 (41.3%) women with a median age of 63 years (range: 22-93 years) were included in the study. Of the total 310 patients, 195 (62.9%) were nonsmokers whereas 81 (26.1%) had a past history of smoking. EGFR , EML4-ALK Fusion Gene, KRAS , ROS1 gene rearrangement, and PD-L1 were positive in 42 (22.3%), 12 (9%), 2 (28.6%), 3 (12.5%), and 3 (25%) patients, respectively. One patient had concurrent EGFR mutation along with ROS1 gene rearrangement. Conclusion Oncogenic driver mutations are present in Indian NSCLC patients. Molecular testing should be performed for all patients of advanced NSCLC to identify those that can benefit from newer generation of targeted or immunotherapies.

Study of Efficacy and Toxicity of Capecitabine Maintenance After Response to Docetaxel, Cisplatin, and 5-Fluracil-Based Chemotherapy in Advanced Carcinoma Stomach.

BACKGROUND: Advanced gastric cancer is associated with poor survival despite chemotherapy. Maintenance chemotherapy has been successfully tried in lung cancer and colorectal cancers however there is scarce literature on maintenance therapy in advanced gastric cancer. We report a prospective non-randomized single-arm trial of capecitabine maintenance after response to docetaxel, cisplatin, and 5-Flurouracil-based chemotherapy. METHODS: 50 patients with advanced gastric cancer, who had achieved response or had stable disease after 6 cycles of Docetaxel, Cisplatin, and 5-Flurouracil (D 75 mg/m2, C 75 mg/m2, FU 750 mg/m2/d d1-d5, q3 weeks) chemotherapy were prospectively selected to receive maintenance chemotherapy with capecitabine (1000mg/ m2 bid d1-d14 q21 days) until progression. RESULTS: During the median follow-up period of 18 months all patients had progressed, however, there was no treatment-related death, the median time to tumor progression was 10.3 months, with grade 3 and 4 toxicities in 10-15% of patients, and treatment delays in 75% of patients. CONCLUSIONS: Our study has shown that maintenance chemotherapy with capecitabine post-first-line docetaxel, cisplatin, and 5-FU-based chemotherapy is effective and delays tumor progression. However, toxicity was a concern in our study which led to treatment-related delays but without any treatment-related death. Most patients continued therapy till progression.

Role of Circulating Tumor Cells in Determining Prognosis in Metastatic Breast Cancer.

Dinesh Chandra DovalBackground Circulating tumor cells (CTCs) in the peripheral blood may play a major role in the metastatic spread of breast cancer. This study was conducted to assess the role of CTCs to determine the prognosis in terms of survival in metastatic breast cancer patients. Methods This prospective study of 36 patients was conducted at the Hospital from April 2016 to May 2018. Details of each patient related to the demographic profile, tumor type, treatment, and follow-up information were recorded. The number of CTCs in the peripheral blood was measured by Celsee PREP 400 sample processing system and Celsee Analyzer imaging station. Results There was a positive correlation between the number of site of metastasis with number of CTCs ( p -value < 0.001). In the patients with clinical/partial response, a significant reduction in the number of CTCs after 1 month of therapy was observed ( p -value = 0.003). When the number of CTCs at baseline and 6 months were compared with the positron emission tomography response at 6 months, a statistically significant difference in CTCs in patients having partial response after 6 months was observed ( p -value = 0.001). On comparison with the responder groups, a statistically significant reduction in CTCs at baseline and 6 months was observed ( p -value = 0.001). Patients with CTCs less than 5 and more than or equal to 5 after 1 month of treatment had a mean progression-free survival of 11.1 months and 7.5 months ( p -value = 0.04) and a mean overall survival of 11.6 and 9.6 months ( p -value = 0.08), respectively. Conclusion Assessment of CTCs provides a more quantifiable response than radiographic evaluation and at a much earlier time point and is also a better predictor of survival.

Clinical and Epidemiological Profile of Elderly Hodgkin's Lymphoma in India.

Background Hodgkin's lymphoma (HL) is a curable malignancy that commonly involves the younger population. However, HL can rarely occur in the elderly population (≥60 years) and probably has different biology as compared to the younger counterparts. There was a paucity of data on the clinical and epidemiological profile of the elderly subset with HL in Indian patients who are misdiagnosed and empirically treated as tuberculosis. We have done an analysis of this subset of elderly patients who were registered at our institute. Methods A retrospective chart analysis of HL patients who presented to our center from 2008 to 2016 was conducted. Twenty-eight patients with HL of age ≥60 years were included in this study. Results Elderly HL comprised 18.67% of the total HL patients registered during this period. The majority were male patients, and the mean age of presentation was 65.9±5.6 years. A Charlson Comorbidity Index (CCI) of ≥2 was seen in 30.77% of the patients. Among these, 84.62% of the patients presented with advanced-stage disease, and 57.69% of the patients presented with B symptoms, which was significantly associated with a high-risk international prognostic score (IPS). Histology-wise, mixed cellularity classical Hodgkin's lymphoma (MCCHL) and nodular sclerosis classical Hodgkin's lymphoma (NSCHL) were equally represented (30.76%). Of the patients, 50% had extranodal disease, with the liver being the most frequent site involved. One patient each had bone marrow involvement and bulky disease. CD30, CD15, and CD20 positivity was seen in 84.61%, 50%, and 26.92% of cases, respectively. Conclusion Among elderly HL patients, males were more commonly represented than females, and patients more often presented with advanced disease and B symptoms and less often with bulky disease and mediastinal mass. Mixed cellularity classical HL is more common in the elderly subset, and significant comorbidities are present in a higher number of elderly HL patients.

Robust Protective Effect of COVID-19 Vaccination in India-Results of Survey in the Midst of Pandemic's Second Wave.

Introduction Our objective was to document the incidence of COVID-19 in vaccinated health care professionals and related personnel. Method We conducted an online survey to ascertain the incidence of COVID-19 symptoms, reverse transcriptase polymerase chain reaction (RT-PCR) positivity, effect on normal activity, need for anti-COVID-19 medication, hospitalization, and death among individuals who had completed both doses of COVID vaccination at least 2 weeks earlier. Results A total of 351 unique valid responses were received. Among the 340 people who had been vaccinated in India, 5% (17/340) had COVID-19 symptoms, 4.7% (16) became COVID-19 RT-PCR positive, 12 (3.5%) had sickness preventing normal daily activity, 2.65% (9) required anti-COVID-19 medication, and 1.18% (4) required hospitalization. Among family members living with the survey responders, the corresponding incidence was even lower. There was one death in this group. Discussion Being health care professionals, the responders would be at higher risk of daily exposure to COVID-19. Even in this high risk group, the vaccine efficacy is good. Vulture journalists should stop spreading fake news and misinformation that makes people hesitate taking the vaccine or be afflicted analysis paralysis. Every person who chooses to remain unvaccinated increases the risk for our entire community. We also need to follow universal precautions (wearing mask, physical distancing, handwashing) diligently without letting down our guard.

Adjuvant chemotherapy in uterine carcinosarcoma: Comparison of a doublet and a triplet chemotherapeutic regimen.

BACKGROUND: Uterine carcinosarcoma (UCS) is a rare and aggressive malignancy, and there are no existing standard guidelines for adjuvant therapy. Doublet chemotherapy regimens are most favored in adjuvant setting; however, given the early chances of distant recurrences, does a triple-drug adjuvant chemotherapy improve disease-free survival (DFS), remains to be seen. Our aim of the study is to compare and review different adjuvant regimens used in UCS. METHODS: Retrospective chart analysis included 37 optimally staged UCS patients. Each of them had either received paclitaxel plus carboplatin (PC) or paclitaxel, ifosfamide, and cisplatin (TIP). A toxicity analysis was charted as per common terminology criteria for adverse events (CTCAE) 4 criteria. A survival analysis was done by the Kaplan-Meier method, and log-rank test was used for comparison of two variables. RESULTS: Incidence of UCS was 4.1% and mean age (standard deviation) was 58.73 ± 6.3 (range 42 - 71) years. TIP and PC chemotherapies were given to 22 and 15 patients, respectively. Five-year DFS and overall survival for TIP versus PC were 38.2% versus 35.9% (P = 0.118) and 49% versus 50.3% (P = 0.306), respectively, and for Stage I, II versus Stage III was 78.8% versus 12.7%(P = 0.001) and 92.3% versus 34.2% (P = 0.002), respectively. However, in advanced disease (Stage III), there is a trend toward DFS advantage of triple-drug adjuvant regimen (Hazards ratio (HR) = 0.35, 95% confidence interval (CI) = 0.12-1.07). Grade 3 and 4 toxicities were seen in 54.5% patients of TIP chemotherapy group and in 13.3% patients of the PC chemotherapy (P = 0.012). CONCLUSION: Triple-drug adjuvant chemotherapy (TIP) confers no survival advantage over doublet chemotherapy (PC), and in turn, increases the grade 3/4 toxicity in the adjuvant setting of optimally staged UCS patients.

Role of Maintenance Gemcitabine in Advanced Carcinoma Gallbladder.

Objective The aim of this study is to investigate the effects of gemcitabine maintenance on progression-free survival (PFS) in patients with metastatic gallbladder cancer (GBC). Materials and Methods Sixty patients with unresectable or metastatic GBC having ongoing response to treatment with initial six cycles of gemcitabine and a platinum-based doublet chemotherapy were prospectively randomized on day 21 of the 6th cycle in 1:1 fashion to receive either maintenance gemcitabine 1 g/m 2 intravenously on day 1 and day 8 of three weekly cycle or observation. Survival analysis was performed using the Kaplan-Meier method and comparisons by the log-rank test. A p -value < 0.05 was considered as statistically significant. Results Of 60 patients, a total of 56 were available for final analysis. The median PFS was 4.7 months (3.1-6.3) in gemcitabine arm and 2.6 months (2.4-2.8) in observation arm, hazard ratio (HR) 0.196 (95% confidence interval [CI]: 0.1-0.39), p < 0.001. Median overall survival in gemcitabine arm was 12.4 months (9.15-15.6) as opposed to 9.9 months (8.29-11.5) in observation arm, HR 0.76 (95% CI: 0.43-1.35), p = 0.354. The grade 3 or 4 side effects in maintenance arm were transaminitis (17.9%), thrombocytopenia (17.8%), neutropenia (14.2%), and febrile neutropenia (7.1%). Conclusions Maintenance gemcitabine therapy in unresectable/metastatic GBC patients responding to first-line gemcitabine and platinum treatment contributes to increase PFS with minimal and manageable side effects.

Early oral cavity cancer: The prognostic factors and impact of adjuvant radiation on survival.

BACKGROUND: Early oral cavity cancer has good prognosis but recurrence in them is still not uncommon. There is no general consensus on the prognostic factors and adjuvant therapy that would have a significant impact on survival. METHODS: A retrospective analysis of early oral cavity cancer patients during the time period 2009-2017. The data regarding demographics, histopathological features, and recurrence patterns were collected and analyzed. RESULTS: Depth of invasion (DOI) was the most important prognostic factor among all the factors analyzed. Further analysis showed that addition of adjuvant radiotherapy for patients with DOI >5 mm did not show survival benefits (P = .73). Another subset analysis of patients with DOI >10 mm also did not show any survival advantage with adjuvant therapy P = .24. CONCLUSION: There is no benefit of adding adjuvant RT in patients with DOI > 5 mm or in patients who were upstaged to T3 based only on DOI.

Number of positive nodes - Current relevance in determining prognosis of oral cavity cancer after the recent AJCC staging update.

INTRODUCTION: Lymph node involvement and the number of positive nodes is a significant prognosticator in oral cavity cancers and current staging system does not incorporate it as an integral part. MATERIAL AND METHODS: This was a retrospective study of oral cavity cancer patients who were operated during the time period of 2009-2017. The data was collected and analysed to assess the impact of increase in the number of positive nodes on survival and its comparison of survival statistics to current AJCC staging. RESULTS: A total of 1431 patients were included in this study and 32.5% of these patients had a node positive disease. Nodal positivity was a significant prognosticator on multivariate analysis. Number of positive nodes was modelled with restricted cubic spline function and it showed progressive worsening of survival functions with increase in number. On Kaplan Meier analysis there was a better separation of curves when number of positive nodes was used and Akaike information criterion (AIC) showed that it was a better prognosticator than existing AJCC staging. CONCLUSION: Number of positive nodes is a significant prognosticator of prognosis and hence should be considered in the AJCC staging system.

Role of ADC values in assessing clinical response and identifying residual disease post-chemo radiation in uterine cervix cancer.

OBJECTIVES: To evaluate the role of apparent diffusion coefficient (ADC) values in assessing response after chemo-radiotherapy in cervix cancer and investigate the utility of ADC as a tool to identify residual disease, after the treatment completion. METHODS: A prospective study was done in 100 patients with histopathologically proven cancer of uterine cervix who were classified as either complete response (CR) or residual disease posttreatment. MRI was done pretreatment and after 6 weeks post-treatment with chemo-radiation. 53 patients among the cohort also underwent a fluoro-deoxy glucose positron-emission computed tomography (FDG-PET CT). ADC values, change in ADC values, and metabolic activity obtained from FDG-PET CT were correlated with clinical outcome, and statistical analysis was done to determine the better tool for assessing response evaluation between ADC and PET-CT. RESULTS: Residual lesions have notably lower ADC value than that of posttreatment changes. The mean ADC values of residual tumors: 1.26 ± 0.238 × 10-3 mm2/s and mean ADC values of lesions due to posttreatment changes: 1.540 ± 0.218 × 10-3 mm2/s (statistically significant difference between malignant and posttreatment lesions, P < 0.05). ADC has 67% sensitivity, 83% specificity, 35% positive predictive values (PPV), 95% negative predictive values (NPV), and 81% accuracy in differentiating residual disease from post treatment changes. PPV, NPV, sensitivity, and specificity with PET-CT were 93%, 89%, 98%, and 73%, respectively. PPV, NPV, sensitivity, and specificity of contrast MRI were 16%, 91%, 58%, and 59%, respectively. CONCLUSION: Diffusion imaging differentiates residual cervix malignancies from post treatment changes based on ADC values and can be a promising and evocative biomarker. Complimentary use of ADC and PET/CT may increase diagnostic confidence.

Frequency of T790M mutations after progression on epidermal growth factor receptor tyrosine kinase inhibitor in metastatic non-small cell lung cancer in Indian patients: real-time data from tertiary cancer hospital.

AIM: The aim of this study is to determine the incidence of T790M mutations after progression on epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) and median duration on TKI before progression on TKI. METHODS: Records of Rajiv Gandhi Cancer Institute and Research Centre, of patients who were diagnosed with metastatic adenocarcinoma of the lung and progressed on oral EGFR TKIs and underwent T790M mutation analysis in the last 6 months were retrospectively reviewed. The incidence of T790M positivity, sites of progression, and median duration of TKI treatment before progression was calculated. RESULTS: Among 31 patients, 10 patients have undergone rebiopsy, and 24 patients had undergone liquid biopsy by Droplet Digital polymerase chain reaction (ddPCR), and three patients had undergone both tests. Among all, the rate of T790M positivity was 54.8%. Among these 17 patients positive for T790M, seven patients were positive by biopsy, and 11 patients were positive by ddPCR. Among three patients who underwent both, one was positive by both. The most common site of progression among all patients is pleura, and 10% of patients progressed in brain post-TKI. Median progression-free survival on TKI before progression is 289.7 days, highest being 1290 days, and lowest 45 days. CONCLUSIONS: Exact incidence of T790M mutations after progression on TKI s in Asian population is not exactly known and requires large data, as incidence may be different than reported in the Western population. Rebiopsy and ddPCR help to determine the most common type of resistance after progression on TKI, for which effective targeted therapy is available.

Clinical outcome study of crizotinib in immunohistochemistry-proven echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase fusion gene among Indian patients with adenocarcinoma lung.

AIMS: The anaplastic lymphoma kinase (ALK) Break Apart FISH Probe Kit and Ventana anti-ALK (D5F3) CDx immunohistochemistry (IHC) assay are the Food and Drug Administration-approved companion diagnostic for targeted therapy with the ALK inhibitor crizotinib in lung cancers. The aim of this study was to assess the efficacy and safety of twice daily crizotinib tablet (250 mg) in IHC-proven echinoderm microtubule-associated protein-like 4 (EML4)-ALK fusion gene among Indian patients with adenocarcinoma lung in the routine clinical practice. SUBJECTS AND METHODS: Patients with nonsmall cell lung cancer (NSCLC), adenocarcinoma histology, whose tumors were found to be positive for EML4-ALK fusion gene using IHC, were considered for this study. IHC analysis was performed using a Ventana automated immunostainer (Benchmark XT). Detection was performed using Optiview DAB detection and amplification kit. RESULTS: A total of 25 NSCLC adenocarcinoma patients were included in the study. There were 14 (56%) women and 10 (44%) men with a median age of 53 years. All patients had Stage IV disease at the time of initiation of crizotinib therapy. One patient achieved complete response and 20 achieved response rate (PR) for an overall PR of 84%. The median progression-free survival (PFS) was 11.8 months and median overall survival (OS) was 20.6 months. Two (8%) patients experienced severe hepatotoxicity requiring permanent discontinuation of crizotinib therapy. CONCLUSIONS: A very high PR, PFS, and OS achieved in our study population indicates that IHC can accurately identify EML4 ALK fusion gene mutations in lung adenocarcinoma patients who are responsive to ALK inhibitors such as crizotinib. IHC should be considered as a cost-effective alternative to FISH, especially in low-resource countries.