Biliary tract cancer treatment: 5,584 results from the Biliary Tract Cancer Statistics Registry from 1998 to 2004 in Japan

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1 J Heptoiliry Pncret Surg (2009) 16:1 7 DOI /s TOPICS Biliry trct cncer sttistics registry in Jpn Biliry trct cncer tretment: 5,584 results from the Biliry Trct Cncer Sttistics Registry from 1998 to 2004 in Jpn Shuichi Miykw Æ Shin Ishihr Æ Akihiko Horiguchi Æ Tdhiro Tkd Æ Msru Miyzki Æ Tkukzu Ngkw Received: 1 June 2008 / Accepted: 1 July 2008 / Pulished online: 26 Decemer 2008 Ó Springer 2008 Astrct Bckground/Purpose The results from the Jpnese Biliry Trct Cncer Sttistics Registry from 1988 to 1998 were reported in In the present study, we report here selectively summrized dt s n overview of the 2006 follow-up survey of the registered cses from 1998 to 2004 for informtion ering on prolems with the tretment of cncer of the iliry trct. Methods A totl of 5,584 ptients were registered from 1998 to The site of cncer ws the ile duct in 2,732 ptients, the gllldder in 2,067, nd the ppill of Vter in 785. Those cses were nlyzed with regrd to ptient survivl ccording to the extent of tumor invsion (), the extent of lymph node metstsis () nd the stge. Results The five-yer survivl rte fter surgicl resection ws 33.1% for ile duct cncer, 41.6% for gllldder cncer, nd 52.8% for cncer of the ppill of Vter. For hilr or superior ile duct cncer, the 5-yer survivl rte ws lower with n increse in the, nd f stge, except 3 vs. 4, 1 vs. 2 nd stge III vs. stge IV. For middle or distl ile duct cncer, the 5-yer survivl rte ws lower with increse in, nd f stge, except 2 vs. 3, 2 vs. 3, stge II vs. stge III nd stge III vs. stge IV. For gllldder cncer, the 5-yer survivl rte ws lower with increse in, nd f stge. For cncer of the ppill of Vter, the 5-yer survivl rte ws lower with increse in, nd f stge, except 1 vs. 2, 1 vs. 2, nd stge III vs. stge IV. Conclusions In the present study, the outcomes of surgicl tretment were etter thn tht of the previous report from Jpn nd foreign countries. The, nd stge of gllldder cncer re well defined. However, there were no significnt differences in some groups of those of ile duct cncer nd cncer of the ppill of Vter. Keyword Biliry trct cncer Sttistics registry 5-yer survivl of disese Lymph node metstsis Introduction S. Miykw (&) S. Ishihr A. Horiguchi Deprtment of Biliry nd Pncretic Surgery, Fujit Helth University, 1-98 Dengkugkuo, Kutsukke-cho, Toyoke, Aichi , Jpn e-mil: smiyk@fujit-hu.c.jp T. Tkd Deprtment of Surgery, Teikyo University, Tokyo, Jpn M. Miyzki Deprtment of Generl Surgery, Grdute School of Medicine, Chi, Jpn T. Ngkw Fukuno Hospitl, Nnto, Jpn To improve the surgicl results, the Jpnese Society of Biliry Surgery (JSBS) ws estlished in In 1987, the JSBS egn registrtion of iliry trct crcinoms s one of its projects in Jpn. In this project, the Society hs estlished guidelines for the tretment of cncer of the iliry trct sed on the extent of involvement t ech ntomicl site. Ngkw et l. [1] reported results from the Biliry Trct Cncer Sttistics Registry from 1988 to 1998 in Jpn. Therefter, the fifth Jpnese edition of the Jpnese Generl Rules for Biliry Trct Cncer [2], which ws trnslted in the second English edition [3], which ws pulished in In this edition, mjor revisions were mde for the degree of determinnts of tumor extension

2 2 J Heptoiliry Pncret Surg (2009) 16:1 7 nd T fctors, lymph node metstsis, nd stge clssifiction with regrd to descriptions for which evidence ws otined. In the present study, we nlyzed dt of the follow-up survey which performed in 2006 to the registered ptients of iliry trct cncer from 1998 to 2004 in Jpn for verifiction of the new version, nd for informtion ering on prolems with tretment of cncer of the iliry trct. Methods Ptients Cse registrtion is performed every yer. Follow-up survey is performed in lternte yers. A totl of 5,584 cses were registered for the 7 yers from 1998 to The site of cncer ws the ile duct in 2,732 cses, the gllldder in 2,067 cses, nd the ppill of Vter in 785 cses. Of ptients with ile duct cncer, 1,816 were mles nd 912 were femles, nd the mle-to-femle rtio ws 1.99:1. Among ptients with gllldder cncer, 861 were mles nd 1,201 were femles, with mle-to-femle rtio of 1:1.39. Among ptients with cncer of the ppill of Vter, 414 were mles nd 370 were femles, with mle-tofemle rtio of 1.12:1. In the cse of ile duct cncer, pek incidence occurred in ptients in their 60s to 70s. Gllldder cncer exhiited pek incidence in the 70s. Cncer of the ppill of Vter exhiited pek incidence in the 60s. Ptients tht hd complete stging nd follow-up informtion ville for survivl nlysis were 3,992 (71.5%). The most of insufficient dt were lost to follow-up. These cses were nlyzed in regrd to ptient survivl ccording to the primry tumor invsion, the stge of disese nd the extent of lymph node metstsis. The extent of tumors, including the clssifiction of lymph node metstsis, ws clssified cording to the fifth edition of Jpnese Generl Rules for Clssifiction of Biliry Trct Crcinom currently used in Jpn. The survivl rte ws clculted y the Kpln Meier method. Sttisticl nlysis ws performed using the logrnk test for survivl rte. P vlues less thn 0.05 were considered significnt. Results Outline of registered cses Tle 1 shows the rtes of resection, rtes of curtive resection, nd opertive deth rtes. Surgicl resections were performed in 70.2% of cses with ile duct cncer, 68.8% with gllldder cncer, nd 89.4% with cncer of the ppill of Vter. Curtive resection rtes were 68.1% in ile duct cncer, 68.7% in gllldder cncer, nd 93.0% in cncer of the ppill of Vter. Opertive mortlity ws 0.6%. Figure 1 shows survivl rte fter surgicl resection. Five-yer survivl rte ws 33.1% for ile duct cncer, 41.6% for gllldder cncer, nd 52.8% for cncer of the ppill of Vter. There were significnt differences etween sites of cncer. Survivl of ptients with resection ccording to site Gllldder cncer 1. Histologicl primry tumor invsion () nd lymph node metstsis () The degree of tumor invsion round the gllldder ws most frequently 2 (39.6%), followed y 4 (32.6%). Thus, 44.4% of ll cses were rted s 3 or higher. By degree of tumor invsion round the gllldder, 5-yer survivl rtes were 85.9% in 1 ptients, 56.1% in 2, 19.2% in 3, nd 14.1% in 4. There were significnt differences etween the four groups (Tle 2). After tumor resection, lymph node metstsis ws present in 38.7% of ll cses. Tle 2 shows prognosis in reltion to lymph node metstsis. The 5-yer survivl rte ws 60.3% for 0 ptients, 30.0% for 1, 16.8% for 2, nd 5.9% for 3. There were significnt differences etween the four groups. The f stge ws most frequently rted IV ptients (25.4%), followed y II (24.1%), IV (20.0%), I (16.2%), Tle 1 Registered cses of iliry trct cncer ( ) Tumor site Numer of registry cses Numer of complete dt Resection rte Curtive resection rte Deth rte Gllldder 2,067 1,590 (76.9%) 1,094 (68.8%) 752 (68.7%) 8 (0.7%) Bile duct 2,732 1,894 (69.3%) 1,299 (70.2%) 884 (68.1%) 7 (0.5%) Ppill of Vter (70.4%) 515 (89.4%) 479 (93.0%) 2 (0.4%) Totl 5,584 3,992 (71.5%) 2,908 (72.8%) 1,402 (72.7%) 17 (0.6%)

3 J Heptoiliry Pncret Surg (2009) 16: % % % % % 52.8% PV n= % GB n= % BD n= Fig. 1 Survivl of ptients with resection of gllldder cncer, ile duct cncer, nd cncer of the ppill of Vter. Percentges show 5- yer survivl rtes. There were significnt differences etween sites of cncer. BD versus GB, P = ; BD versus PV, P \ ; GB versus PV, P \ ; BD, ile duct cncer; GB, gllldder cncer; PV, cncer of ppill of Vter Tle 2 Survivl ccording to histologicl tumor invsion round the ile duct () nd histologicl lymph node metstsis () of gllldder cncer nd III (14.5%). Thus, 59.9% of ll cses were rted s f stge III or higher. Figure 2 shows prognosis in reltion to f stge. The 5-yer survivl rte ws 87.5% for f stge I ptients, 68.7% for f stge II, 41.8% for f stge III, 23.3% for f stge IV, nd 6.3% for f stge IV. There were significnt differences etween the five groups (Fig. 2) * * *,** ** * *, , There were significnt differences etween the four group There were significnt differences etween the four group * P \ ; ** P = ; P = ; P = Fig. 2 Survivl ccording to overll tumor stge (f stge) of gllldder cncer. There were significnt differences etween five f stges. * P \ Bile duct cncer Hilr or superior ile duct cncer 1. Histologicl tumor invsion round the ile duct () nd lymph node metstsis () The degree of tumor invsion round the ile duct ws most frequently 4 ptients (40.6%), followed y 2 (32.5%). By degree of tumor invsion round the ile duct, 5-yer survivl rtes were 66.6% in 1 ptients, 38.3% in 2, 26.0% in 3, nd 14.9% in 4 (Tle 3). Five-yer survivl rte decresed significntly s ecme higher, lthough the difference etween 3 nd 4 ws not significnt. After tumor resection, lymph node metstsis ws present in 40.2% of ll cses. Tle 3 shows prognosis in reltion to lymph node metstsis. The 5-yer survivl rte ws 38.2% for 0 ptients, 17.6% for 1, 10.2% for 2, nd 8.3% for 3. The five-yer survivl rte of ech group ws significntly lower with increse in extent of lymph node metstsis, except for lck of significnt difference etween 1 nd 2. The f stge ws most frequently rted IV ptients (31.7%), followed y III (23.5%), II (20.1%), IV (19.4%), nd I (5.3%). Thus, 48.8% of ll cses were rted s f stge IV or higher. Figure 3 shows prognosis in reltion to f stge. The 5-yer survivl rte ws 73.8% for f stge I ptients, 43.3% for f stge II, 30.5% for f stge III, 23.3% for f stge IV, nd 7.2% for f stge IV. The five-yer survivl rte decresed significntly s f stge ecme higher, lthough the difference etween f stges III nd IV ws not significnt.

4 4 J Heptoiliry Pncret Surg (2009) 16:1 7 Tle 3 Survivl ccording to histologicl tumor invsion round the ile duct () nd histologicl lymph node metstsis () of hilr or superior ile duct cncer * *,** ** There were significnt differences etween 1 nd 2 nd etween 2 nd 3 There were significnt differences etween 0 nd 1 nd etween 2 nd 3 * P = ; ** P = ; P \ ; P = Tle 4 Survivl ccording to histologicl tumor invsion round the ile duct () nd histologicl lymph node metstsis () of middle or distl ile duct cncer * * ** ** , There were significnt differences etween 1 nd 2 nd etween 3 nd 4 There were significnt differences etween 0 nd 1 nd etween 1 nd 2 * P = ; ** P = ; P = ; P = Middle or distl ile duct cncer % % % % % Fig. 3 Survivl ccording to overll tumor stge (f stge) of hilr or superior ile duct cncer. The five-yer survivl rte decresed significntly s f stge ecme higher, lthough the difference etween f stges III nd IV ws not significnt. * P = ; ** P = ; P = Histologicl tumor invsion round the ile duct () nd lymph node metstsis () The degree of tumor invsion round the ile duct ws most frequently 2 ptients (35.9%), followed y 4 (27.9%), 3 (27.0%). Thus, 54.9% of ll cses were rted s 3 or higher. By degree of tumor invsion round the ile duct, the 5-yer survivl rtes were 55.6% in 1 ptients, 36.2% in 2, 33.7% in 3, nd 20.8% in 4 (Tle 4). The five-yer survivl rte decresed significntly s ecme higher, lthough the difference etween 2 nd 3 ws not significnt. Tle 4 shows prognosis in reltion to lymph node metstsis. The 5-yer survivl rte ws 40.1% for 0 ptients, 23.4% for 1, 19.2% for 2, nd 18.1% for 3. The 5-yer survivl rte of ech group ws significntly lower with increse in extent of lymph node metstsis, except for lck of significnt difference etween 2 nd 3. The f stge ws most frequently rted III ptients (31.3%), followed y II (23.9%), IV (22.0%), IV (14.0%), nd I (8.9%). Thus, 67.3% of ll cses were rted s f stge III or higher. Figure 4 shows prognosis in reltion to f stge. The 5-yer survivl rte ws 59.5% in f stge I ptients, 39.3% in f stge II, 32.6% in f stge III, 29.6% in f stge IV, nd 9.7% in f stge IV. The 5-yer survivl rte decresed significntly s f stge ecme higher, lthough the differences etween f stges II nd III nd etween f stges III nd IV were not significnt. Cncer of the ppill of Vter 1. Histologicl tumor invsion () nd lymph node metstsis () The degree of tumor invsion round the ppill of Vter ws most frequently 3 ptients (37.7%), followed

5 J Heptoiliry Pncret Surg (2009) 16: % % % % % % % % % 54 0% Fig. 4 Survivl ccording to overll tumor stge (f stge) of middle or distl ile duct cncer. The 5-yer survivl rte decresed significntly s f stge ecme higher, lthough the differences etween f stges II nd III nd etween f stges III nd IV were not significnt. * P = ; ** P \ Tle 5 Survivl ccording to histologicl tumor invsion round the ile duct () nd histologicl lymph node metstsis () of cncer of the ppill of Vter * *, ** ** ** ** There were significnt differences etween 2 nd 3 nd etween 3 nd 4 There were significnt differences etween 0 nd 1 nd etween 2 nd 3 * P = ; ** P \ ; P = y 1 (27.4%), 2 (19.2%), 4 (15.7). By degree of tumor invsion round the ppill of Vter, 5-yer survivl rtes (Tle 5) were 74.1% in 1 ptients, 62.6% in 2, 49.5% in 3, nd 19.7% in 4. Five-yer survivl rte decresed significntly s ecme higher, lthough the difference etween 1 nd 2 ws not significnt. Tle 5 shows prognosis in reltion to lymph node metstsis. The 5-yer survivl rte ws 68.7% for 0 Fig. 5 Survivl ccording to overll tumor stge (f stge) of cncer of the ppill of Vter. The 5-yer survivl rte of ech f stge group ws significntly lower with n increse in f stge, except for the lck of significnt difference etween f stges II nd III. * P = ; ** P = ; P = ptients, 34.5% for 1, 30.9% for 2, nd 0% for 3. Thus, none of the ptients with 3 disese survived for 5 yers. The 5-yer survivl rte of ech group ws significntly lower with n increse in the extent of lymph node metstsis, except for lck of significnt difference etween 1 nd 2. The f stge ws the most frequently of rted III ptients (32.7%), followed y I (22.3%), IV (19.5%), II (14.6%), nd IV (11.0%). Figure 5 shows the prognosis in reltion to f stge. The 5-yer survivl rte ws 82.9% in f stge I ptients, 66.8% in f stge II, 49.9% in f stge III, 33.9% in f stge IV, nd 0% in f stge IV. Thus, none of the ptients with f stge IV disese survived for 5 yers. The 5-yer survivl rte of ech f stge group ws significntly lower with increse in f stge, except for the lck of significnt difference etween f stge II nd III. Discussion By two recent reports [4, 5] from the Ntionl Cncer Dtse (NCDB) nd Surveillnce, Epidemiology, nd End Results (SEER) dtse of Americ, the complete records were 70.7% nd 72.6%. In this study, ptients tht hd complete stging nd follow-up informtion ville for survivl nlysis were 3,992 (71.5%). Precision in our study ws pproximtely equl with these reports. The most of insufficient dt of our study were lost to follow-up. An effort to minimize loss of follow-up in ech institution is necessry to put up precision of registrtion dt.

6 6 J Heptoiliry Pncret Surg (2009) 16:1 7 In the previously report of Jpnese registry [1], the resection rte nd the curtive resection rte were 69.8% nd 37.7% for gllldder cncer, 67.0% nd 30.4% for ile duct cncer, nd 91.2% nd 78.5% for cncer of ppill of Vter. In this study, the resection rtes were higher thn those for ile duct cncer nd gllldder cncer, nd the curtive resection rtes were higher thn those for cncer of ll site of the iliry trct. Opertive mortlity decresed during the period etween 1988 to 1998 nd 1998 to 2004 from 1.7% to 0.6%, suggesting tht surgicl tretment for iliry trct cncer cn now e conducted very sfely. The 5-yer survivl rtes following resection were 7.1 point up in the ile duct cncer, 0.4 point down in gllldder cncer, nd 1.8 point up in mpullry cncer, compred with previous report of Jpnese registry. In this study, the survivl dt showed remrkle improvement in ll ptients with ile duct cncer who underwent resection. Previous survivl rtes of the gllldder cncer were 77% in stge I, 53% in stge II, 31% in stge III, nd 9% in stge IV, nd the survivl rtes showed more thn 10 points improvement in stge I IV in present study. In hilr or superior ile duct cncer, previous survivl rte were 47%, 30%, 19%, nd 12% in stge I to IV, nd lso, in this study, those showed remrkle improvement in stge I to IV. In middle or lower ile duct cncer, previous survivl rte were 54%, 33%, 20%, nd 15% in stge I to IV, nd in this study, those showed improvement of the points from 5.5 to 13 in stge I to IV. In cncer of ppill of Vter, previous survivl rte were 75%, 48%, 34%, nd 19% in stge I to IV, nd in this study, those showed remrkle improvement in stge I to IV. Foreign reports presenting dt on 100 or more cses include four reports on hilr or superior ile duct cncer ( cses ech) [6 9], four reports on middle nd distl ile duct cncer ( cses ech) [10 13], four reports on gllldder cncer ( cses ech) [14 17], nd eight reports on mpullry cncer ( cses ech) [18 26]. None of these reports ws superior to the present study in terms of scle of study. According to these reports, the five-yer survivl rte fter resection ws % for hilr or superior ile duct cncer, % for middle nd distl ile duct cncer, % for gllldder cncer, nd % for mpullry cncer. In the present study, the five-yer survivl rte fter resection ws 28.6% for hilr or superior ile duct crcinom, 32.7% for middle or distl ile duct cncer, 41.6% for gllldder cncer, nd 52.8% for mpullry cncer. Thus, five-yer survivl rtes fter resection were higher in the present study thn in those foreign reports in the hilr or superior ile duct cncer, the middle or distl ile duct cncer, nd the gllldder cncer. The outcome of tretment of mpullry cncer ws etter in two foreign studies thn in the present one. The est outcome (five-yer survivl rte: 68.0%) ws reported y Woo et l. in their nlysis of 163 cses [13]. According to their report, depth of invsion ws T2 or lower (s determined using criteri of the Americn Joint Committee on Cncer 6th edition) in 68% of ll cses nlyzed. In the present study, on the other hnd, cses with T3 or higher depth of invsion ccounted for 53.4% of ll cses. Thus, the percentge of dvnced cses ws higher in the present study thn in tht of Woo et l. [25]. This difference my ccount for the higher fiveyer survivl rte in their study. According to the report y Prk et l. [24], the five-yer survivl rte for 102 cses ws 57.0%. They excluded cses of periopertive deth when clculting this survivl rte. Our survivl rte, on the other hnd, ws clculted for the totl popultion including ptients who died periopertively. This difference in method of clcultion my explin the reltively poor outcome in our study. Compred to foreign studies, excluding those of Prk et l. [24] nd Woo et l. [25], the outcome in the present study ws fvorle. In the present study, the outcome of tretment ws etter thn reported previously from Jpn [1] nd foreign countries [6 23]. As to ppropriteness nd prolems of stge clssifiction, the fifth edition of the Jpnese Generl Rules for Biliry Trct Cncer mye not needed mjor revision. The,, nd stge in gllldder cncer re well defined. In the other site, clssifiction of those prognostic fctors is not controversilly, lthough there ws no significnt difference in survivl rtes etween those prognostic fctors. Further, detiled nlysis is needed to improve the T-ctegory, the lymph node groups, stge grouping nd the outcome of tretment of ile duct cncer nd cncer of the ppill of Vter. The prognosis of iliry trct cncer remins poor. Sophisticted dignostic skills nd tretment methods nd their ppliction re nturlly required to chieve etter tretment results for iliry trct cncer. The Clinicl Prctice Guidelines for the Mngement of Biliry trct nd Ampullry Crcinoms [26] ws pulished in The guideline consists of dignostic skills [27 29] nd tretment methods [30 34] nd their ppliction. The mngement of iliry trct cncer sed on this guideline cn expect improvement of tretment outcome. References 1. Ngkw T, Kyhr M, Iked S, Futkw S, Kkit A, Kwrd H, et l. Biliry trct cncer tretment: results from the Biliry Trct Cncer Sttistics Registry in Jpn. J Heptoiliry Pncret Surg. 2002;9: Jpnese Society of Biliry Surgery. Clssifiction of iliry trct crcinom. 5th Jpnese ed. Tokyo: Knehr; 2003.

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