To observe the clinical efficacy and safety of icotinib in the treatment of patients with recurrent mediastinal squamous cell carcinoma.
Patients with recurrent mediastinal squamous cell carcinoma were randomly divided into control group and treatment group using a random number table. Control group received docetaxel injection 75 mg·m-2, intravenous infusion, once every 3 weeks for 4 cycles; treatment group received icotinib 150 mg, orally, 3 times daily for 12 consecutive weeks. The clinical efficacy, disease control rate, progression-free survival, quality of life scores, physiological laboratory indicators and the incidence of adverse drug reactions were compared between the two groups.
A total of 105 patients were enrolled, 3 cases were excluded during the trial, leaving 52 participants in treatment group and 50 in control group. After treatment, the objective response rates (ORR) for treatment group and control group were 42.31% (22 cases /52 cases) and 32.00% (16 cases /50 cases); the disease control rates (DCR) were 76.92% (40 cases/52 cases) and 60.00% (30 cases/50 cases); the median progression-free survival (PFS) were 5.60 and 4.20 months; the median overall survival (OS) were 16.90 and 10.50 months; the overall health status were (72.61±13.96) and (63.62±16.94) points, respectively; the functional scale scores were (80.19±15.73) and (68.39±14.55) points, respectively; the symptom scale scores were (31.41±12.61) and (41.81±10.57) points, respectively; white blood cell count (WBC) were (2.31±1.50) and (4.45±1.00)×109 cell·L-1 ; neutrophil count (NEU) were (3.70±1.38) and (1.96±0.95)×109 cell·L-1; hemoglobin (Hb) were (119.39±17.40) and (109.98±14.04) g·L-1; platelet count (PLT) were (217.68±50.33) and (164.93±56.01)×109 cell·L-1. Compared with control group, the above indexes in treatment group all had significant differences (all P<0.05). The main adverse drug reactions in treatment group were rash, diarrhea and elevated transaminase; in control group were bone marrow suppression, alopecia, nausea and vomiting . There was no significant difference in the total incidence of adverse drug reactions between the two groups (82.69% vs. 90.00%, P>0.05). However, the incidence of grade 3-4 adverse drug reactions in treatment group was significantly lower than that in control group (11.54% vs. 30.00%, P<0.05).
Icotinib tablet is more effective than docetaxel injection in treating recurrent mediastinal squamous cell carcinoma, with less hematological toxicity, lower incidence of severe adverse reactions, and better safety profile.
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |