| ObjectiveTo investigate the clinical efficacy, safety and tolerability of etoposide soft capsulesfor second-line monotherapyof elderly patients with extensive-disease small cell lung cancer(ED-SCLC).Methods39 elderly patients withED-SCLC were treated as the research objectfrom January 2012 to January 2014.All patients were recrudesced after the end of first-line treatmentfor three months at least. All patients were treated with etoposide soft capsules for oral,70 mg/m2, once a day,7 days for a period, and 21 days for a period of each treatment cycle. The repeat treatment had beencontinued until the condition deteriorated, or the patients could not tolerate the side effects, or the patient refused treatment. The efficacy and safety of drug use were evaluated during two cycles at least. The follow-up period was 1 years after the death of the patient or the end of the treatment. The complete clinical data of patients were retrospectively analyzed. The short-term effect (complete remission, partial remission, stable, progress) was evaluated according to the evaluation criteria of solid tumor. The determination of toxicity and adverse reactions were based on the national cancer institution common terminology criteria. Progress-free survival (PFS), overall survival (OS), clinical benefit rate (DCR) and total response rate (ORR) in patients were observed and analyzed.Results1 General information:There were 25 male and 14 female in the clinical research, and the ratio for male to female was 1.79:1. The average age of 39 cases was 72.6±9.31 years, and the median age was 73 years. There were 33.33% of patients with BMI<18.5 kg/m2,51.28% of cases with ECOG score of 0-1. The complications of underlying disease of patients were cardiovascular disease, hypertension, cerebrovascular disease, COPD, diabetes and low blood sodium. The smoking, tumor history, family history of cancer, the longest diameter of tumors≥5cmand classic ED-SCLC of histopathological classification of patients were 69.23%,5.13%,15.38%,7.69% and 97.44%,respectively.The metastatic sites of the tumor were mainly bone, lung, liver, adrenal gland and lymph nodes.58.97% of the patients had recurrence time of 3-6 months,41.03% more than 6 months. There were 17.95%patients with pleural effusion,84.62% patients with elevated tumor markers NSE.There were 35.90%, 17.95%,46.15% and 56.41% patients of LDH, CRP, FIB and D-D increased, and 38.46%,28.21% and 15.38% patients of CD3+ CD4+, CD3+ CD8+ and CD4+ CD8+ decreased, respectively.There were 61.54% patients in the first-line treatment with etoposide, and 38.46% patients in the first-line treatment of thoracic radiotherapy.2Recent efficacy:39 patients were followed up, and there was 1 patient with chemotherapy cycle died after 4 weeks into the group. The patients of CR, PR, SD and PD were 0 case (0.0%),12 cases (31.6%),12 cases (31.6%) and 14 cases (36.8%), respectively. ORR was 31.6%, DCR was 63.2%. The median OS was 7.3 months and 95% of the confidence interval was 6.93-7.67 months. The PFS was 2.8 months, and the 95% confidence interval was 2.66-2.94 months.3Influencing factors analysis:It was the significantly negative correlation between the OS of patients with ED-SCLCwith the risk factors ofage≥75 years old, ECOG score≥2 points, metastatic site (bone, lung and liver), recurrence time≥3monthsand<6 months, high level of LDH in serum and no thoracic radiotherapy in first-line treatment.It was the significantly negative correlation between the PFS of patients with ED-SCLC with the risk factors of age≥75 years old, ECOG score>2 points, complications (diabetes and low blood sodium),smoking, bone metastases, high level of LDH in serum and no thoracic radiotherapy in first-line treatment.4 Toxicity and adverse reactions:No one died due to the toxicity and adverse reactions. The main toxicity and adverse reactions were myelosuppression, gastrointestinal toxicity, hair loss, liver function abnormalities, and so on. All patients had different degrees of oral mucosal inflammation, neutrophil decrease, platelet decreaseand AST increased.The main of the gastrointestinal toxicity were oral mucosal inflammation,nausea, vomiting, appetite loss, nausea and diarrhea predominant, and most of patients were remised after symptomatic treatment. Patients were tolerated the adverse reactions of abnormal liver function and renal function, hair loss and fatigue. There was no significant effect on the course of treatment.Conclusion1The ORR and DCR were 31.6% and 63.2% in the treatment of etoposidc soft capsulesfor second-line monotherapyof elderly patients with ED-SCLC.The median OS was 7.3 months and the PFS was 2.8 months.2It was the significantly influences between the survival of patients with ED-SCLC with age, ECOG score, bone metastases, theetoposideand thoracic radiotherapy in first-line treatment.It is good for prognosis whose age<75, good physical condition, no bone metastasis, normal level of LDH in serum and no thoracic radiotherapy in first-line treatment.3The toxicity and adverse reactions were myelosuppression, gastrointestinal toxicity, hair loss and abnormal liver function in the treatment of etoposide soft capsulesfor second-line monotherapyof elderly patients with ED-SCLC. All the toxicity and adverse reactions could be tolerated, and the treatment had better security. |
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