An Audit of Systemic Therapy in Medullary Carcinoma Thyroid.

There is a paucity of evidence of the impact of sorafenib on MCT and it is the preferred therapy used in India. We decided to do an audit of all patients of MCT who were referred to us for systemic therapy. The objective of this exercise was to identify the treatment pattern, outcomes, and adverse events with therapy in MCT. Baseline demographics (age, gender, ECOG PS, comorbidities, habits), tumor details (site of metastasis), previous treatment details, clinical features at metastasis (symptomatic or asymptomatic), the pattern of treatment, adverse events (CTCAE version 4.02), date of progression, date of death and status, and follow-up were extracted from the rare tumor database and electronic medical records. Out of 75 patients referred for therapy for MCT, 47 (62.7%) patients were considered for immediate tyrosine kinase inhibitors as they had symptomatic status and 28 (37.3%) patients were kept on observation due to the asymptomatic nature of the disease. Out of the 28 patients, 15 (53.6%, n = 28) patients were subsequently started on TKI while in 13 (46.4%, n = 28) patients observation was continued. In the overall cohort, the median PFS was 18.9 months (95% CI 11.9-29.9) and OS was 26.6 months (95% CI 14.4-39.0). Among variables tested, only female gender had an impact on PFS (hazard ratio = 0.364 95% CI 0.148-0.895; P = 0.028) and the absence of lung metastasis had a positive impact on OS (hazard ratio = 0.443 95% CI 0.207-0.95; P = 0.037). Most commonly used TKI was sorafenib (n = 61) and sunitinib in 1 patient. The most common adverse events with TKI were palmo-plantar dysesthesia (50, 80.6%) and oral mucositis (25, 40.2%). The strategy of treating symptomatic MCT and observing in asymptomatic MCT is associated with reasonable PFS and OS. Sorafenib is the most commonly used TKI in our setup and provides similar outcomes as globally.

Audit of Demographics, Treatment Patterns and Outcomes of Differentiated Thyroid Cancers Treated with Tyrosine Kinase Inhibitors.

The real-world patterns of TKI use in differentiated thyroid cancer (DTC) are largely governed by the accessibility and financial feasibility of the patient with more sorafenib use compared to lenvatinib. There are limited data available on the toxicity profile, safety and tolerance of sorafenib and lenvatinib in DTC. Hence, we audited our practice on DTC. This is a retrospective single-centre analysis of patients with DTC who were referred to the Department of Medical Oncology for systemic therapy. Baseline demographics (age, sex, ECOG PS, comorbidities, substance use), tumour details (site of metastasis), previous treatment details, clinical features at metastasis (symptoms), the pattern of treatment, adverse events and outcomes including progression and death were extracted. There were 67 patients with DTC referred for systemic therapy; the median age was 56 (33-81) with a male preponderance (55.6%). The most common reason to start TKI therapy was radioactive iodine (RAI) cumulative dose > 600 milliCurie, followed by low iodine uptake in the RAI low-dose scan done at progression. The most common TKI used in the first line was sorafenib in 56 (83.6%) patients followed by lenvatinib in 9 (13.4%) patients. Papillary thyroid carcinoma was the most common histology (51, 76.1%), and the rest were follicular carcinoma (16, 23.9%). With a median follow-up of 36 months, the median PFS was 13.2 months (95% CI 10.4-16.0). The median OS was 18.8 months (95% CI 10.0-27.6). Among variables tested, no factors had a significant impact on the PFS or OS. The most common adverse events were hand-foot syndrome (54, 80.5%), diarrhoea (23, 33.3%) and transaminitis (24, 34.4%). The pattern of care of patients with RAI-refractory DTC is TKI therapy, especially sorafenib and lenvatinib in the real-world settings with comparable efficacy and safety profile compared to international literature.

The role of chemotherapy in patients with small cell lung cancer and poor performance status.

BACKGROUND: There are limited data on the role of chemotherapy in patients with small cell lung cancer (SCLC) and poor performance status (PS). METHODS: This was a retrospective analysis of a prospective observational study in patients with SCLC and PS 3 or 4. We recorded the initial therapy, symptom improvement, response rate, overall survival (OS), and the impact of various factors on OS. RESULTS: From June 2010 to August 2019, we enrolled 234 patients; 185 (79%) with PS 3 and 49 (21%) PS 4. Initial therapy was best supportive care (BSC) in 49 patients (21%), standard full dose chemotherapy in 31 (13%), and attenuated chemotherapy in 154 (66%). In 89% patients treated with attenuated chemotherapy, symptom-relief occurred at a median of 3 days (IQR, 1-7). Grade 3 and higher toxicities developed in 60% patients treated with initial attenuated chemotherapy, commonly hyponatremia in 39%, neutropenia in 16%, anemia in 11%, and infection in 10%. Grade 3 and higher toxicities as a result of standard chemotherapy occurred in 89% patients treated with upfront standard full dose chemotherapy compared to 69% of patients who received initial attenuated chemotherapy with subsequent treatment escalation. Overall, there were 6 (2.6%) toxic deaths. The response rate to chemotherapy was 77%. The median OS of the patients who received any chemotherapy was significantly longer at 6 months (95% CI, 4.8-7.2) compared to 1 month (95% CI, 0.4-1.6 months) in patients who were managed with BSC, p < 0.001; hazard ratio, 0.39 (95% CI, 0.27-0.56). The disease stage, lactate dehydrogenase level, and receipt of chemotherapy significantly impacted survival. CONCLUSION: Chemotherapy prolongs survival in patients with SCLC and poor PS. Administering an initial attenuated chemotherapy regimen followed by standard full-dose chemotherapy when the PS improves may lower toxicity and improve tolerance.

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.

Efficacy and Safety of Induction Chemotherapy in Esophageal Cancer with Airway Involvement.

PURPOSE: Esophageal cancer with tracheobronchial involvement (TBI) has a poor prognosis. Radical therapy carries the risk of inducing tracheoesophageal fistula (TEF) and treatment-related mortality. Induction chemotherapy followed by reassessment for radical therapy may decrease morbidity and improve outcome. METHODS: This is a retrospective analysis of esophageal cancer patients with TBI who received induction chemotherapy. Airway involvement was defined as bronchoscopic appearance of a bulge into the lumen, restricted or immobile mucosa, frank infiltration, TEF, or stridor, which was clinically due to airway obstruction from the esophageal lesion. RESULTS: Eighty-three patients were included over 5 years; 97.6 % had squamous histology. All patients received taxane and platinum combination induction chemotherapy; 90.5 % of patients received chemotherapy without dose delays, and 77.8 % patients did not require a dose reduction or modification. The 31.7 % patients had a clinically significant ≥grade 3 toxicity. The objective response rate was 67 % among the patients who underwent restaging scans following induction chemotherapy; 79.5 % of the patients could receive radical intent therapy, either concurrent chemoradiotherapy, or radiation alone, or surgery in one patient. The TEF complication rate was 6 % during the course of therapy. At a median follow-up of 28 months in surviving patients, the estimated median PFS was 8 months (95 % CI 5.5-10.5) and the estimated median OS was 17 months (95 % CI 5.6-28.4). Patients who received radical therapy had a significantly better PFS and OS, p = 0.000. CONCLUSIONS: Induction chemotherapy may improve the outcome of patients with esophageal cancer involving the airway and may help select patients for curative treatment and lower the risk of TEF development.

Clinical Outcome in Definitive Concurrent Chemoradiation With Weekly Paclitaxel and Carboplatin for Locally Advanced Esophageal and Junctional Cancer.

There are little data on the efficacy and safety of taxane/platinum with definitive radiotherapy (RT) for esophageal/GEJ cancer. This article is a retrospective analysis of patients who received weekly paclitaxel 50 mg/m(2) and carboplatin AUC 2 with radical definitive RT for locally advanced esophageal/GEJ cancer. Between February 2011 and July 2014, 179 patients were included. The median age was 54 years. Ninety-two percent of patients had squamous histology. Mean RT dose was 58.7 Gy in 32 fractions over 53 days, with mean of six chemotherapy cycles. Fifty-six percent of patients developed ≥grade 3 acute toxicities, commonly febrile neutropenia (12%) and infection (11%); ≥grade 3 laboratory abnormalities included hyponatremia (38%), leukopenia (49%), neutropenia (27%), and anemia (16%). Twelve percent of patients developed ≥grade 3 chronic toxicity. Fatal toxicities included six during CRT, eight within 30 days of completing CRT, and three chronic. Radiologic response was 49% (CR 5.6%, PR 43%). Follow-up endoscopy showed remission in 53% and residual disease in 14%. At a median follow-up of 28 months, median PFS was 11 months (95% CI: 8-13.9), median OS was 19 months (95% CI: 15.4-22.6), and estimated 1-year, 2-year, and 3-year survivals were 70%, 47%, and 39%, respectively. Weekly paclitaxel-carboplatin concurrently with definitive RT is efficacious with manageable toxicity. [The trial was registered with the Clinical Trials Registry-India (CTRI), registration number: CTRI/2014/07/004776.].