康莱特加同步放化疗治疗局部晚期非小细胞肺癌的临床研究(英文)

Clinical study on concurrent chemoradiotherapy combined with Kanglaite injection in the treatment of regionally advanced unresectable non-small cell lung cancer

Objective: To evaluate the clinical effects and toxicity of concurrent chemoradiotherapy combined with Kan-glaite injection in the treatment of regionally advanced unresectable non-small cell lung cancer. Methods: 48 patients with regionally advanced unresectable non-small cell lung cancer were randomized to two groups, 25 patients in the combination group (concurrent chemoradiotherapy + Kanglaite) and 23 patients in the control group (concurrent chemoradiotherapy). The combination group received chemotherapy of vinorelbine (NVB) plus cisplatin (DDP) regimen, radiotherapy was given with conventional fraction in 2 Gy per fraction and five fractions per week concurrently. The total tumor doses were 56-60 Gy. Combined with Kanglaite injection 200 mL/d for twenty-one days for two courses in the combination group, the control group was chemoradiotherapy only. Effects and toxicities were evaluated according to the criteria of WHO. Results: The CR rates in the combination group and control group were 24.0% (6/25) and 13.0% (3/23), respectively (P > 0.05). Response (CR + PR) rates of combination group were 76.0 % (19/25) and 69.6% (16/23) in control group, P > 0.05. The incidence rates of grades 3-4 leukocytopenia, grades 3-4 digestive system (nausea and vomiting) and grades 3-4 esophagitis in the combination group and control group were 40.0% (10/25), 8.0% (2/25), 16.0% (4/25) and 69.6% (16/23), 34.8% (8/23), 43.5% (10/23), respectively (P < 0.05). KPS and body weight score significantly increased in combination group after the combined treatment, P < 0.05. Conclusion: Concurrent chemoradiotherapy combined with Kanglaite injection can relieve side effects of chemoradiotherapy in the treatment of regionally advanced unresectable non-small cell lung cancer, and improve quality of life. Kanglaite injection may increase effective rate of regionally advanced unresectable non-small cell lung cancer combined with concurrent chemoradiotherapy.

Objective： To evaluate the clinical effects and toxicity of concurrent chemoradiotherapy combined with Kanglaite injection in the treatment of regionally advanced unresectable non-small cell lung cancer. Methods： 48 patients with regionally advanced unresectable non-small cell lung cancer were randomized to two groups, 25 patients in the combination group （concurrent chemoradiotherapy ＋ Kanglaite） and 23 patients in the control group （concurrent chemoradiotherapy）. The combination group received chemotherapy of vinorelbine （NVB） plus cisplatin （DDP） regimen, radiotherapy was given with conventional fraction in 2 Gy per fraction and five fractions per week concurrently. The total tumor doses were 56-60 Gy. Combined with Kanglaite injection 200 mud for twenty-one days for two courses in the combination group, the control group was chemoradiotherapy only. Effects and toxicities were evaluated according to the criteria of WHO. Results： The CR rates in the combination group and control group were 24.0% （6/25） and 13.0% （3/23）, respectively （P 〉 0.05）. Response （CR ＋ PR） rates of combination group were 76.0 % （19/25） and 69.6% （16/23） in control group, P 〉 0.05. The incidence rates of grades 3-4 leukocytopenia, grades 3-4 digestive system （nausea and vomiting） and grades 3-4 esophagitis in the combination group and control group were 40.0% （10/25）, 8.0% （2/25）, 16.0% （4/25） and 69.6% （16/23）, 34.8% （8/23）, 43.5% （10/23）, respectively （P 〈 0.05）. KPS and body weight score significantly increased in combination group after the combined treatment, P 〈 0.05. Conclusion： Concurrent chemoradiotherapy combined with Kanglaite injection can relieve side effects of chemoradiotherapy in the treatment of regionally advanced unresectable non-small cell lung cancer, and improve quality of life. Kanglaite injection may increase effective rate of regionally advanced unresectable non-small cell lung cancer combined with concurrent chemoradiotherapy.