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. MethodsWe 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-totreat 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 highe...

Background There is scant data from India on efficacy and safety of palbociclib and ribociclib in routine clinical practice. Methods This retrospective, observational, single institution study included patients with estrogen and/or progesterone receptor positive and human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancers, who received palbociclib or ribociclib with any partner endocrine therapy in any line of treatment between January 2016 and June 2019. Data were analyzed for progression-free survival (PFS), overall survival (OS) and toxicity. Results The study included 101 female patients with median age of 57 (IQR 48–62) years, of whom 80 (79.2%) were postmenopausal, 79 (78.2%) received palbociclib or ribociclib in second- or later-line treatment, 59 (58.4%) received fulvestrant and 41 (40.6%) received an aromatase inhibitor. In first-line treatment, at a median follow-up of 21.7 (0.5–41.9) months, median PFS and OS were 21.1 (95%CI 16.36-not estimable) months and not reached, respectively. In second- or later-line setting, at a median follow-up of 17.2 (0.5–43.7) months, median PFS and OS were 5.98 (95%CI 4.96–7.89) months and 20.2 (95%CI 14.1-not estimable) months, respectively. Grade 3–4 neutropenia and febrile neutropenia were seen in 45 (45.0%) and 9 (9.0%) patients, respectively while dose reduction was required in 32 (31.7%) patients. In multivariable Cox regression analysis, first-line setting (HR 0.49, 95%CI 0.25–0.97, p = 0.043) and ECOG performance status 1 (HR 0.43, 95%CI 0.20–0.91, p = 0.028) were significantly associated with PFS while only ECOG PS 1 was significantly associated (HR 0.04, 95%CI 0.008–0.206, p = 0.000) with OS. Conclusion Palbociclib and ribociclib, when used in routine clinical practice in first or subsequent lines of treatment, resulted in efficacy and toxicity outcomes in concordance with those expected from pivotal trials.

Background: Patients with cancer are at a higher risk of severe forms of coronavirus disease 2019 (COVID-19) and mortality. Therefore, widespread COVID-19 vaccination is required to attain herd immunity. Objectives: We aimed to evaluate the uptake of the COVID-19 vaccine in Indian patients with cancer and to collect information regarding vaccine hesitancy and factors that contributed to vaccine hesitancy. Materials and Methods: This was a questionnaire-based survey conducted between May 7, 2021 and June 10, 2021 in patients aged 45 years and over, with solid tumors. The primary end points of the study were the proportion of Indian patients with cancer aged 45 years and older who had not received the COVID-19 vaccine, and the reasons why these patients had not received the COVID-19 vaccine. Our secondary end points were the proportion of patients with a history of COVID-19 infection, and the proportion of the patients who had vaccine hesitancy. Additionally, we attempted to assess the factors that could impact vaccine hesitancy. Results: A total of 435 patients were included in the study. Of these, 348 (80%) patients had not received even a single dose of the COVID-19 vaccine; 66 (15.2%) patients had received the first dose, and 21 (4.8%) had received both the doses. Approximately half (47.1%) of the patients reported that they took the COVID-19 vaccine based on the advice from a doctor. The reasons for not taking the COVID-19 vaccine could be considered as vaccine hesitancy in 259 (77%) patients. The two most common reasons were fear in 124 (38%) patients (fear of side-effects and of the impact of the vaccine on the cancer/therapy) and lack of information in 87 (26.7%) patients. On the multivariate analysis, the two factors found to be significantly associated with vaccine hesitancy were a lower educational level (OR, 1.78; 95% CI, 1–3.17; P = 0.048) and a lack of prior advice regarding the COVID-19 vaccine (OR, 2.80; 95% CI, 1.73–4.53; P < 0.001). Conclusion: Vaccine hesitancy is present in over half of our patients, and the most common reasons are a fear of the vaccine impacting the cancer therapy, fear of side-effects, and lack of information. Widespread vaccination can only be attained if systematic programs for education and dissemination of information regarding the safety and efficacy of the COVID-19 vaccine are given as much importance as fortification of the vaccination supply and distribution system.