Background: Concurrent chemoradiotherapy (CRT) with 5-fluorouracil (5-FU) and cisplatin (CDDP) are often associated with significant incidence of toxic effects in elderly patients with esophageal cancer. This phase I trial was designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of S-1, an oral 5-FU derivative, when given with radiotherapy in elderly patients. Methods:Patients who were age of 70 years or older with histologically confirmed esophageal cancer, and had an Eastern Cooperative Oncology Group (ECOG) score of 0-2 were eligible for this study. Radiotherapy was administered in 1.8 Gy fractions 5 times weekly to a total dose of 54 Gy. S-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and 80 mg/m 2 /day. Trial registration: NCT01175447 (ClinicalTrials.gov).Results: Twelve previously untreated patients were enrolled in this study. No grade 3 or 4 toxicity was observed in six patients treated at the 60 and 70 mg/m 2 dose levels. DLT was observed in four of six patients treated at the 80 mg/m 2 dose level. Two patients developed grade 3 esophagitis, one patient developed grade 3 esophagitis and pneumonitis, and one patient developed grade 3 thrombocytopaenia. Endoscopic complete response (CR) was observed in eight patients (66.7%). The median progression free survival (PFS) was 20 months and median overall survival was 29 months. Conclusions:The MTD of S-1 was 80 mg/m 2 , and the recommended dose (RD) for phase II studies was 70 mg/m 2 . This regimen was well tolerated and active in elderly patients with esophageal cancer, meriting further investigation in phase II studies. partially because of medical comorbidities and reduced functional reserve of organs (5-7). A population-based study of the National Cancer Registry in Ireland showed that, when compared with patients younger than 60 years of age, the likelihood for resection was significantly lower among older cohorts by 33%, 74% and 93% for patients aged 60-69, 70-79 and 80+, respectively (7).Chemoradiotherapy (CRT) has been accepted nowadays as the standard nonsurgical treatment for locally advanced esophageal cancer. The Radiation Therapy Oncology Group (RTOG) phase III intergroup trial RTOG 85-01 demonstrated that CRT with 5-fluorouracil (5-FU) and cisplatin (CDDP) provided a significant survival advantage over RT alone (8,9). However, the toxicity of CRT was substantial. 64% of patients treated with CRT experienced severe or life threatening adverse events comparing to 28% of patients treated with RT alone (9). And only 23% of patients enrolled in this study were over age 70, which brought a question about the suitability of CRT for elderly patients. Recently, several retrospective studies suggested that elderly patients with esophageal cancer may also benefit from CRT with 5-FU and CDDP (10-12). The clinical complete response (CR) rate was found at a range of 57.8-63.6% and survival time of 8.6-15.2 months. However, only 9-38.5% of patients finished the scheduled treatment because of the ...
BackgroundConcurrent chemoradiotherapy (CCRT) using conventional platinum-based doublets are often associated with significant incidence of toxic effects in elderly patients with esophageal cancer. We previously reported a phase I trial of CCRT using S-1, an oral 5-fluorouracil derivative, which yielded well safe and active outcomes.MethodsPatients with histologically confirmed esophageal cancer, who were age of 70 years or older with performance status (PS) score of 0-2 or age of 66 to 69 with PS score of 2, were eligible for this Phase II trial. Radiotherapy was delivered in 1.8 Gy per fraction to a total dose of 54 Gy. Concurrently, S-1 was administered at 70 mg/m2 on days 1–14 and 29–42. The primary end point was 2-year overall survival rate.ResultsThirty patients were enrolled, and 28 patients completed the full course of radiotherapy. No grade 4 toxicity or treatment-related death occurred. The grade 3 toxicities included esophagitis (16.7%), leucopoenia (13.3%), neutropenia (10%), anaemia (3.3%), pneumonitis (3.3%) and fatigue (3.3%). The median progression-free survival time and median survival time was 19 and 24 months, respectively. The 2-year overall survival rate was 45.1%, which exceeded the predefined threshold of 2-year OS 35% and met the primary end point of the study.ConclusionsThe results suggest that CCRT using S-1 is effective with mild toxicity in elderly patients with esophageal cancer. A phase III trial is needed to further evaluate this regimen.
activating EGFR mutation. Details of the 22 patients harboring the EGFR T790M mutation are listed in Table 1. The response rate to chemotherapy was 12.5% (best response; 1 PR, 4 SD and 3 PD) and the median time to progression (TTP) was 3.0 months. The response rate to EGFR TKIs treatment was 8.3% (best response; 1 PR, 3 SD and 8 PD), and the median TTP was 2.7 months. Three patients were treated with third generation EGFR TKIs (osimertinib or ASP 8237) and all achieved partial response (TTP; 33.3, 13.6 and 3.5 months, respectively). Conclusion: De novo EGFR T790M mutation is a rare event even in EGFR mutant NSCLC and associated with unfavorable clinical outcome to chemotherapy and EGFR TKIs.
Rationale: Human infection with Angiostrongylus cantonensis is uncommon and has only been sporadically reported in the literature. Patients infected with A cantonensis usually have a delayed diagnosis and sometimes a poor prognosis. Patient concerns: A 70-year-old woman presented to the respiratory department with complaints of headache, chest pain, myalgia, fatigue, and anorexia for 7 days. Diagnoses: Complete blood count showed eosinophilia. The serum was tested showing a positive finding of A cantonensis antibody. Cerebrospinal fluid was tested using high-throughput metagenomics analysis and 16 reads for A cantonensis were mapped. The patient was diagnosed with A cantonensis infection. Interventions: The patient received a 7-day course of albendazole and 4-day course of prednisone. Outcomes: When discharged from the hospital, the patient still suffered from fatigue and poor memory. Aminotransferase levels were high due to albendazole’s liver toxicity. In a post-discharge follow-up about 1 month later she had recovered completely both physically and mentally, and peripheral eosinophil count and aminotransferase levels were both normal. Lessons: Because the direct identification of parasites is difficult, high-throughput metagenomics analysis may provide a reliable alternative tool for the diagnoses of infection with A cantonensis . When albendazole is prescribed, caution must be taken with respect to its liver toxicity.
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