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1 [ ] 95 (n=45) (n=50) 3 4~6(PFS) (OS)75.6% 86.0%(P 0.05) 94.7% 95.2% (P 0.05) CA19-9(P 0.01) (P 0.05) 20 PFS OS (P 0.05) 48.9% 56.0% 11.1% 20.0% (P 0.05) 3 4 PFS OS [ ] [ ] R735.9 [ ] A [ ] (2016) [DOI] /j.issn Clinical observation of cyberknife therapy combined with TS-1 in treatment of local advanced pancreatic cancer ZHANG Xin-hong, KANG Jing-bo, NIE Qing, XU Yun-ke, YAN Xiao-mei, ZHANG Jia-yue, ZHAN Xiao-yu Department of Radiotherapy Oncology and Integrative Oncology, Navy General Hospital of PLA, Beijing , China [Abstract] Objective To evaluate the effect and toxicity of cyberknife therapy combined with titanium silicalite-1 (TS-1) in treatment of local advanced pancreatic cancer (LAPC). Methods Ninety-five patients with LAPC were divided into two groups: cyberknife group (control group, n=45) received cyberknife therapy only, and combination group (n=50) received cyberknife therapy combined with TS-1. The adjuvant chemotherapy was performed 3 weeks after radiotherapy, and lasted for 4-6 cycles continuously. The effect, side effect, progression-free survival (PFS) and overall survival (OS) were recorded. Results In cyberknife group and combination group, the objective response rates (ORR, CR+PR) were 75.6% and 86.0% (P<0.05) respectively, the pain relief rates were 94.7% and 95.2% (P>0.05) respectively. The indexes of total bilirubin and CA19-9 were significantly improved in the both groups after than before treatment with statistical significance (P<0.01), but there was no significant difference between the two groups (P>0.05). In the median follow-up time of 20 months, the median PFS was 10.1 and 11.2 months and the median OS was 15.5 and 16.7 months in cyberknife and combination group, respectively (P>0.05). The incidences of digestive tract adverse reaction and myelosuppression in cyberknife group and combination group were 48.9% and 56.0%, 11.1% and 20.0%, respectively (P>0.05). There was no grade 3-4 serious adverse reaction. Conclusion Cyberknife combined with TS-1 is effective and safe for patients with LAPC, may improve local control rate, effective rate, PFS and OS. [Key words] pancreatic neoplasm; cyber knife; TS-1 [1] 2% /10 [ ] [ ] ( ) 10%~15% 6 5 5% [2] [3-4]

2 Med J Chin PLA, Vol. 41, No. 10, October 1, PET/CT (CA19-9 ) [5] (KPS) ~ ( 6 4 ) CA % 95 (n=45) (n=50) [n(%)] Tab. 1 Clinical characteristics of the 95 patients with locally advanced pancreatic cancer [n(%)] Item Gender Cyberknife radiosurgery (n=45) Combined therapy (n=50) Male 27(60) 29(58) Female 18(40) 21(42) Age (year) 70 28(62.2) 35(70) 70 17(37.8) 15(30) KPS score Stage 80 12(26.7) 12(24) 80 33(73.3) 38(76) A 28(62.2) 30(60) B 17(37.8) 20(40) Position Pancreas head 25(55.6) 25(50) Pancreatic body tail 20(44.4) 25(50) CA19-9 Normal 4(8.9) 4(8) Abnormal 41(91.1) 46(92) Symptom Abdominal pain 38(84.4) 42(84) Jaundice 14(31.1) 15(30) Anorexia 36(80.0) 38(76) Combined therapy comprises cyberknife radiosurgery and TS SR S ( Acc uray ) X 1mm 6MV 6 CT 1.5mm CT (gross tumor volume GT V ) PET/CT MRI GTV 5~8mm (planning target volume PTV) 95%PTV (30~45Gy) 4~7 65%~84% 2 0.5~1.0h 2 95 Tab. 2 Parameters of Cyberknife treatment for 95 patients with pancreatic cancer Parameters Range (x±s) Gross tumor volume (ml) ( ) Dose (Gy) 30-45( ) Isodose curve (%) 65-84( ) Fraction (f ) 4-7( ) BED (Gy, / =10) ( ) GTV coverage rate (%) ( ) Conformal index ( ) New conformal index ( ) Homogeneity index ( ) Beam ( ) mg 2 /d 1~14d 21d 3 4~6 CA19-9 CT 1.3 (visual analogue scale/score VAS) VAS 3 [6]

3 CT MRI PET/ CT 3 2 CT WHO (CR) (PR) (SD) (PD) CR+PR (ORR) RTOG 1~ (PFS) (OS) 1.4 SPSS 16.0 (%) χ 2 x±s t (OS) Kaplan-Meier Log-rank P % 75.6%(34/45) 86.0%(43/50) (P 0.05) (85.0%) 8 (10.0%) 3~7d 4d 4 (5%) 94.7%(36/38) 95.2%(40/42) (P 0.05) CA19-9 (P 0.01) (P ) 3 CA19-9 (x±s) Tab. 3 Comparison of the levels of TBIL and CA19-9 between Cyberknife and combination group (x±s) Index Total bilirubin ( mol/l) Cyberknife radiosurgery (n=45) Combined therapy (n=50) Pre-treatment Post-treatment (1) (1) CA19-9 (U/ml) Pre-treatment Post-treatment (1) (1) TBIL. Total bilirubin. (1)P<0.01 compared with post-treatment % 20.0% (P=0.102) 48.9% 56.0% (P=0.192) ~30 20 (PFS) (P 0.05) (OS) (P 0.05) % 60.0%(P 0.05) 3 50%~60% [7-9] X 1mm 12~15Gy 3~6 45Gy ( / =10) 80~120Gy [10] % % [11] 75% % 20% [12] 5-FU 5-FU 1 (5.6 vs 4.4 ) [13] 5-FU [14] 5-FU

4 Med J Chin PLA, Vol. 41, No. 10, October 1, S DNA G 2 M (5-Fu ) ( 5-Fu ) ( 5-Fu ) [15] 43.75% 19.35% % 25.8% [16] 79.1% 45.8% ASCO SBRT 13.0~ % [17-20] 94.7% 95.2% 4d CA19-9 WHO 86.0% 75.6% (P 0.05) % 55.6%(P 0.05) % 56.0% 20.0% 11.1% [1] Han XL, Zhang TP, Zhao YP. Comprehensive diagnosis and treatment of pancreatic cancer[ J]. Chin J Pract Intern Med, 2012, 32(3): [,,. [ J]., 2012, 32(3): ] [2] Xia TY, Kang JB. Stereotactic body radiation therapy with body Gamma Knife[M]. Beijing: People's Medical Publishing House, [,. [M]. :, ] [3] Yoshida K, Kuramitsu Y, Murakami K, et al. Proteomic differential display analysis for TS-1-resistant and -sensitive pancreatic cancer cells using two-dimensional gel electrophoresis and mass spectrometry[ J]. Anticancer Res, 2011, 31(6): [4] Li S, Zhou ZG, Gao JB, et al. Efficacy of CT-guided implantation of 125 I seeds combined with S-1 in treatment of pancreatic cancer in elderly patients[ J]. J Zhengzhou Univ (Med Sci), 2015, 50(2): [,,,. CT 125 I [ J]. ( ), 2015, 50(2): ] [5] Ni QX, Yu XJ, Liu L. Discussion for the clinical definition of pancreatic cancer in China[ J]. China Oncol, 2012, 22(2): [,,,. [ J]., 2012, 22(2): ] [6] Zanoli G, Stromqvist B, Jonsson B. Visual analog scales for interpretation of back and leg pain intensity in patients operated for degenerative lumbar spine disorders[ J]. Spine (Phila Pa 1976), 2001, 26(21): [7] Wu TY, Zhang JQ, Liu YL, et al. Effect of stereotactic radiation therapy combined with Gemcitabine in treatment of locally advanced pancreatic cancer[ J]. Cancer Res Clin, 2012, 24: [,,,. [ J]., 2012, 24: ] [8] Kothari N, Saif MW, Kim R. First-line treatment for advanced pancreatic cancer[ J]. JOP, 2013, 14: [9] Abreu MR, Vilar E, Arús ER, et al. Trends in digestive cancer mortality. Cuba [ J]. Eur J Public Health, 2013, 23: [10] Shen ZT, Wu XH, Li B, et al. Clinical outcomes of CyberKnife radiosurgery treatment in locally advanced pancreatic cancer[ J]. China Oncol, 2012, 22(8): [,,,. [ J]., 2012, 22(8): ] [11] Jung YH, Choi HS, Cheon YK, et al. An experience of cyberknife treatment in pat ients w ith advanced pancreat icobilliar y malignancy[ J]. Korean-J-Gastroenterol, 2011, 58(5): [12] Das P, Wolff RA. Concurrent capecitabine and upper abdominal radiation therapy is well tolerated[ J]. Radiat Oncol, 2006, 1: 41. [13] Heinemann V, Boeck S, Hinke A, et al. Meta analysis of randomized trials: Evaluation of benefit from gemcitabine- based combination chemotherapy applied in advanced pancreatic cancer[ J]. BMC Cancer, 2008, 8: 82. [14] Wu LL, Lou WH, Zeng ZC, et al. Phase trial of low S-1 concurrent with radiotherapy in patients with locally advanced or recurrent pancreatic cancer[ J]. Shanghai Med, 2011, 34(5): [,,,. [ J].,

5 , 34(5): ] [15] Tai YY, Chen P, Xu T, et al. Three-dimensional conformal radiation therapy (3DCRT) combined with TS-1 for treatment locally advanced pancreatic cancer[ J]. Chin J Clin Oncol Rehabil, 2011, 18(5): [,,,. [ J]., 2011, 18(5): ] [16] Zhang S, Shan GY, Liu XA, et al. Clinical study on the efficacy of S-1 combined with three-dimensional conformal radiotherapy in treatment of patients with advanced pancreatic cancer[ J]. Chin J Cancer Prev Treat, 2012, 19(12): [,,,. [ J]., 2012, 19(12): ] [17] G o rovets D, Sa i f M W, Hu b er K, e t al. Novel t reat m ent approaches for locally advanced pancreatic cancer[ J]. JOP, 2014, 15(2): [18] Pol lom EL, A lagappan M, Chan C, et al. Outcomes and toxicity of SBRT for patients with unresectable pancreatic adenocarcinoma[ J]. J Clin Oncol, 2014, 32(Suppl 3): 317. [19] Moningi S, Raman SP, Dholakia AS, et al. Stereotactic body radiation therapy for pancreatic cancer: single institutional experience[ J]. J Clin Oncol, 2014, 32(Suppl 3): 328. [20] Gurka MK, Kim CM, Haddad NG, et al. Stereotactic body radiation therapy (SBRT) combined with chemotherapy for locally advanced pancreatic adenocarcinoma[ J]. J Clin Oncol, 2014, [Epubahead of print]. ( ) ( )

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