| Objective: To prospectively observe the short term efficacy and toxic reaction of concurrent hypofractionated three-dimensional conformal radiotherapy and chemotherapy in patients with locally advanced non small cell lung cancer (LANSCLC), to assess the feasibility,validity and safety of the treatment method, meanwhile to evaluate the effect of consolidation chemotherapy.Methods: From Sep. 2009 to Oct. 2010 , 42 patients with LANSCLC had been enrolled for the trial.The median age was 67.5 years old (range from40 to 80 years old).There were 29 males and 13 females. Acording to AJCC in 2002 there were 28 patients with stageⅢA and 14 patients with stageⅢB. In the cases , there were 23 patients with squamous carcinoma and 19 with adeno carcinoma;12 patients with central type and 30 patients with peripheral type;17 patients with right lung and 25 patients with left lung;13 patients with 90 KPS scores,17 patients with 80 KPS scores and 12 patients with 70 KPS scores. All the patients were randomized into two groups :18 patients were treated with concurrent chemotherapy and hypofractionated radiotherapy ( treatment group) , while another 24 patients received treatment of concurrent conventional radiotherapy and chemotherapy (control group) . Image-guided there-dimensional conformal radiation therapy was used and no elective nodal irradiation was given. In treatment group the doses were delivered at 5Gy per fraction,5 fractions per week, to a total dose of 60Gy. And the dose of control group was delivered in 2Gy per fraction , 1 fraction every day with the total dose of 60~66 Gy. Concurrent chemotherapy regiment: paclitaxel liposome ( lipusu ) was given at 45mg/m2 by intravenous infusion (iv) on the first day of radiotherapy and once per week in two groups . The treatment group lasted for 3 weeks and the control group was for 6 weeks. After concurrent chemoradiotherapy consolidation chemotherapy ( paclitaxel liposome 135~ 175mg/m2 infused for 3 hours ,d1, combined with cisplatin(DDP) 20mg every day, d1~5, repeated at 21-day intervals )was given by 2~4 cycles . There were 30 minites before Lipusu and Dexamethasone 5 mg was administered intravenously to prevent hypersensitive reactions.All patients were treated routinely with antivomit drugs,hepatic protectant and nutritional support drugs to prevent toxic reactions.we would give leucocyte increasing agents by oral administration or injected hypodermicly G-CSF in time if leucocytopenia was discovered , and we would delay the chemotherapy if hemogram didn't recover within 3~5 days.Use the SPSS 13.0 statistical software.Constitution rate was tested byχ2 or Fisher test.The toxicity and short time effects were evaluated during and after the treatment between two groups.Results:1 The final follow-up date was on January 31, 2011. The follow -up rate was 100%, with median follow-up time of 9 months (4~16.5months). 42 patients all completed the concurrent chemoradiotherapy. There were 1 patients without consolidation chemotherapy in treatment group, 3 patients receiving 2 cycles of consolidation chemotherapy, 5 patients receiving 3 cycles and 9 patients with 4 cycles.While there were 4 patients with 2 cycles of consolidation chemotherapy in control group, 7 patients completing 3 cycles,11 patients completing 4 cycles and 2 patients without consolidation chemotherapy.2 The short term effects:One months later since the completion of concurrent chemoradiotherapy there were 3 patients(16.7%) reaching complete response, 12 patients (66.7%) reaching partial response and the overall response rate was 83.3%(15/18) in treatment group. In control group the efficany rate was 54.2% (13/24),with 2 patient(8.3%) reaching complete response, 11 patients (45.8%) reaching partial response, and was lower than the one of treatment group. The difference of the efficacy rate was statistically significant between two groups (P<0.05). 3 The toxic reactions:The acute toxicities were mainly bone marrow depression, radiation esophagitis and radiation pneumonitis.There were no serious acute toxic reactions of esophagus, heart,spinal cord and pneumonia.Serious allergic response, hepatic and renal function injuries didn't occur. The incidence rate of bone marrow depression was 72.2%(13/18) in treatment group, mainly with the leucocytopenia, 4 patients (22.2%) was grade 1, with 5 patients (27.8%) grade 2 , with 3 patients (16.7%) grade 3 and 1patients (5.6%) grade 4.There were another 5 patients (27.8%) with PLT decreasing atⅡ~Ⅲgrade, but chemoradiotherapy was not affected by treatment in time.The incidence rate of pneumonitis was 55.6%(10/18):3 patients (16.7%) were grade 1, 6 patients (33.3%) were grade 2,1 patients (5.6%) were grade 3 and no patient developed grade 4.The acute radiation esophagitis happened at 50%: 4patients(22.2%) with grade 1, 4 patients(22.2%) with grade 2 , 1 patients(5.6%) with grade 3 and no grade 4.The incidence rate of leucocytopenia in control group was 70.8%(17/24), with 7 patients(29.2%) grade 1, with 6 patients (25%) grade 2, with 3 patients (12.5%) grade 3 and 1 patients (4.2%) grade 4.The incidence rate of acute esophagitis was 45.8% : 6 patients(25%) were grade 1, 4 patients (16.7%) were grade 2 , 1 patients (4.2%) were grade 3 and no grade 4.The incidence rate of acute radiation pneumonitis was 50% : 6 patients(25%) with grade 1, 5 patients(20.8%) with grade 2 , 1 patients (4.2%) with grade 3 and no patients developed grade 4.The acute radiation injuries in treatment group were higher than the ones in control group,but the differences were no significances byχ2 tests between two groups (P>0.05).4 The effective rates before and after consolidation chemotherapy were respectively 82.4%(14/17) and 88.2% (15/17) in treatment group, the difference was not statistically significant by Fisher test (P>0.05); The effective rates were respectively 59.1% (13/22) and 63.6% (14/22) in control group. The difference was no statistically significance byχ2 test (P>0.05). And the effective rates were respectively 69.2%(27/39) and 74.4%(29/39) in the whole trial. The difference of overall effect was also no statistically significance byχ~2 test (P>0.05).Conclusions:1 The short effect of concurrent hypofractionated three dimensional conformal radiotherapy and paclitaxel liposome chemotherapy was higher than the one of concurrent three dimensional conformal conventional radiotherapy and chemotherapy.The treatment model can be one choose in LANSCLC for its better short efficiency.2 The acute toxicities of concurrent chemoradiotherapy in LANSCLC were mainly bone marrow depression, radiation esophagitis and radiation pneumonitis.The toxic reaction of the hypofractionated radiotherapy group was no more serious than the one of the conventional radiotherapy group.And the model of concurrent paclitaxel liposome chemotherapy and hypofractionated radiotherapy is safety and feasibility, for it can be better tolerated and administered.3 There was no signifcant difference in the effect rates before and after consolidation chemotherapy, and patients didn't benefit from it.The role of consolidation chemotherapy needs further research.
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