CQ2 化学療法
CQ2-3切除不能膵癌に対して推奨される化学療法の投与期間は何か?
エビデンス
化学療法は一般的には長期に継続することにより,蓄積毒性が出現し,治療効果が減弱する傾向が認められる。適切な投与期間は,投与する薬剤や癌腫により異なると考えられており,切除不能膵癌に対するゲムシタビン塩酸塩の投与期間について検証した。
切除不能膵癌に対するゲムシタビン塩酸塩の投与期間を明らかにすることを目的とする研究報告はみられなかった。ゲムシタビン塩酸塩と他の治療を比較した大規模なランダム化比較試験では,これまで全て,病態が明らかに進行するまで,または継続が困難な有害事象が発現するまで治療が継続され,有用性が検証されていることから1)〜23)(レベルⅡ),現時点ではこれらと同様な投与期間を設定することが推奨される。
引用文献
- 1)
- Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first─line therapy for patients with advanced pancreas cancer:a randomized trial. J Clin Oncol 1997;15:2403─2413.
- 2)
- Bramhall SR, Rosemurgy A, Brown PD, Bowry C, Buckels JA;Marimastat Pancreatic Cancer Study Group. Marimastat as first─line therapy for patients with unresectable pancreatic cancer:a randomized trial. J Clin Oncol 2001;19:3447─3455.
- 3)
- Moore MJ, Hamm J, Dancey J, Eisenberg PD, Dagenais M, Fields A, Hagan K, Greenberg B, Colwell B, Zee B, Tu D, Ottaway J, Humphrey R, Seymour L;National Cancer Institute of Canada Clinical Trials Group. Comparison of gemcitabine versus the matrix metalloproteinase inhibitor BAY 12─9566 in patients with advanced or metastatic adenocarcinoma of the pancreas:a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 2003;21:3296─3302.
- 4)
- Cheverton P, Friess H, Andras C, Salek T, Geddes C, Bodoky G, Valle J, Humblet Y. Phase III results of exatecan (DX─8951f) versus gemcitabine (Gem) in chemotherapy─nave patients with advanced pancreatic cancer (APC). J Clin Oncol 2004;22:abstr 4005.
- 5)
- Gansauge F, Ramadani M, Pressmar J, Gansauge S, Muehling B, Stecker K, Cammerer G, Leder G, Beger HG. NSC─631570 (Ukrain) in the palliative treatment of pancreatic cancer. Results of a phase II trial. Langenbecks Arch Surg 2002;386:570─574.
- 6)
- Berlin JD, Catalano P, Thomas JP, Kugler JW, Haller DG, Benson AB 3rd. Phase III study of gemcitabine in combination with fluorouracil versus gemcitabine alone in patients with advanced pancreatic carcinoma:Eastern Cooperative Oncology Group Trial E2297. J Clin Oncol 2002;20:3270─3275.
- 7)
- Riess H, Helm A, Niedergethmann M, Schmidt─Wolf I, Moik M, Hammer C, Zippel K, Weigang─Khler K, Stauch M, Oettle H. A randomised, prospective, multicenter, phase III trial of gemcitabine, 5─fluorouracil (5─FU), folinic acid vs. gemcitabine alone in patients with advanced pancreatic cancer. J Clin Oncol 2005;23:abstr 4009.
- 8)
- Herrmann R, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schuller J, Saletti P, Bauer J, Figer A, Pestalozzi B, Khne CH, Mingrone W, Stemmer SM, Tmas K, Kornek GV, Koeberle D, Cina S, Bernhard J, Dietrich D, Scheithauer W;Swiss Group for Clinical Cancer Research;Central European Cooperative Oncology Group. Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer:a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group. J Clin Oncol 2007;25:2212─2217.
- 9)
- Cunningham D, Chau I, Stocken D, Davies C, Dunn J, Valle J, Smith D, Steward W, Harper P, Neoptolemos J. Phase III randomised comparison of gemcitabine (GEM) versus gemcitabine plus capecitabine (GEM─CAP) in patients with advanced pancreatic cancer. 13th European Cancer Conference (ECCO) 2005;abstr 617.
- 10)
- Oettle H, Richards D, Ramanathan RK, van Laethem JL, Peeters M, Fuchs M, Zimmermann A, John W, Von Hoff D, Arning M, Kindler HL. A phase III trial of pemetrexed plus gemcitabine versus gemcitabine in patients with unresectable or metastatic pancreatic cancer. Ann Oncol 2005;16:1639─1645.
- 11)
- Colucci G, Giuliani F, Gebbia V, Biglietto M, Rabitti P, Uomo G, Cigolari S, Testa A, Maiello E, Lopez M. Gemcitabine alone or with cisplatin for the treatment of patients with locally advanced and/or metastatic pancreatic carcinoma:a prospective, randomized phase III study of the Gruppo Oncologia dell’Italia Meridionale. Cancer 2002;94:902─910.
- 12)
- Heinemann V, Quietzsch D, Gieseler F, Gonnermann M, Schneks H, Rost A, Neuhaus H, Haag C, Clemens M, Heinrich B, Vehling─Kaiser U, Fuchs M, Fleckenstein D, Gesierich W, Uthgenannt D, Einsele H, Holstege A, Hinke A, Schalhorn A, Wilkowski R. Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer. J Clin Oncol 2006;24:3946─3952.
- 13)
- Louvet C, Labianca R, Hammel P, Lledo G, Zampino MG, Andr T, Zaniboni A, Ducreux M, Aitini E, Taeb J, Faroux R, Lepere C, de Gramont A;GERCOR;GISCAD. Gemcitabine in combination with oxaliplatin compared with Gemcitabine alone in locally advanced or metastatic pancreatic cancer:results of a GERCOR and GISCAD phase III trial. J Clin Oncol 2005;23:3509─3516.
- 14)
- Poplin E, Levy DE, Berlin J, Rothenberg ML, O’Dwyer PJ, Cella D, Mitchell E, Alberts S, Benson A III. Phase III trial of gemcitabine (30─minute infusion) versus gemcitabine (fixed─dose─rate infusion [FDR]) versus gemcitabine+oxaliplatin (GEMOX) in patients with advanced pancreatic cancer (E6201). J Clin Oncol 2006:abstr 4004.
- 15)
- Rocha Lima CM, Green MR, Rotche R, Miller WH Jr, Jeffrey GM, Cisar LA, Morganti A, Orlando N, Gruia G, Miller LL. Irinotecan plus gemcitabine results in no survival advantage compared with gemcitabine monotherapy in patients with locally advanced or metastatic pancreatic cancer despite increased tumor response rate. J Clin Oncol 2004;22:3776─3783.
- 16)
- Stathopoulos GP, Syrigos K, Aravantinos G, Polyzos A, Papakotoulas P, Fountzilas G, Potamianou A, Ziras N, Boukovinas J, Varthalitis J, Androulakis N, Kotsakis A, Samonis G, Georgoulias V. A multicenter phase III trial comparing irinotecan─gemcitabine (IG) with gemcitabine (G) monotherapy as first─line treatment in patients with locally advanced or metastatic pancreatic cancer. Br J Cancer 2006;95:587─592.
- 17)
- Abou─Alfa GK, Letourneau R, Harker G, Modiano M, Hurwitz H, Tchekmedyian NS, Feit K, Ackerman J, De Jager RL, Eckhardt SG, O’Reilly EM. Randomized phase III study of exatecan and gemcitabine compared with gemcitabine alone in untreated advanced pancreatic cancer. J Clin Oncol 2006;24:4441─4447.
- 18)
- Bramhall SR, Schulz J, Nemunaitis J, Brown PD, Baillet M, Buckels JA. A double─blind placebo─controlled, randomised study comparing gemcitabine and marimastat with gemcitabine and placebo as first line therapy in patients with advanced pancreatic cancer. Br J Cancer 2002;87:161─167.
- 19)
- Van Cutsem E, van de Velde H, Karasek P, Oettle H, Vervenne WL, Szawlowski A, Schoffski P, Post S, Verslype C, Neumann H, Safran H, Humblet Y, Perez Ruixo J, Ma Y, Von Hoff D. Phase III trial of gemcitabine plus tipifarnib compared with gemcitabine plus placebo in advanced pancreatic cancer. J Clin Oncol 2004;22:1430─1438.
- 20)
- Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, Au HJ, Murawa P, Walde D, Wolff RA, Campos D, Lim R, Ding K, Clark G, Voskoglou─Nomikos T, Ptasynski M, Parulekar W;National Cancer Institute of Canada Clinical Trials Group. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer:a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 2007;25:1960─1966.
- 21)
- Kindler HL, Niedzwiecki D, Hollis D, Oraefo E, Schrag D, Hurwitz H, McLeod HL, Mulcahy MF, Schilsky RL, Goldberg RM, Cancer and Leukemia Group B. A double─blind, placebo─controlled, randomized phase III trial of gemcitabine (G) plus bevacizumab (B) versus gemcitabine plus placebo (P) in patients (pts) with advanced pancreatic cancer (PC):A preliminary analysis of Cancer and Leukemia Group B (CALGB). J Clin Oncol 2007:abstr 4508.
- 22)
- Philip PA, Benedetti J, Fenoglio─Preiser C, Zalupski M, Lenz H, O’Reilly E, Wong R, Atkins J, Abruzzese J, Blanke C. Phase III study of gemcitabine [G] plus cetuximab [C] versus gemcitabine in patients [pts] with locally advanced or metastatic pancreatic adenocarcinoma [PC]:SWOG S0205 study. J Clin Oncol 2007:abstr 4509.
- 23)
- Reni M, Cordio S, Milandri C, Passoni P, Bonetto E, Oliani C, Luppi G, Nicoletti R, Galli L, Bordonaro R, Passardi A, Zerbi A, Balzano G, Aldrighetti L, Staudacher C, Villa E, DiCarlo V. Gemcitabine versus cisplatin, epirubicin, fluorouracil, and gemcitabine in advanced pancreatic cancer:a randomised controlled multicentre phase III trial. Lancet Oncol 2005;6:369─376.
検索式
- (1)
- 医中誌
- CQ2─1 局所進行切除不能膵癌に対し,化学療法単独による治療は推奨されるか?
- CQ2─2 遠隔転移を有する膵癌に対して推奨される一次化学療法は何か?
- CQ2─3 切除不能膵癌に対して推奨される化学療法の投与期間は何か?
- CQ2─4 切除不能膵癌に対して推奨される二次化学療法は何か?
- (4つのCQをまとめて検索した)
- ①
- 検索年限 出版年2004/7/4〜2007/4/30
- ②
- 検索日 2007/5/21
- ③
- 検索式
- #1
- (膵臓腫瘍/TH or 膵臓腫瘍/AL) or (膵囊胞/TH or 膵囊胞/AL) or (膵管癌/TH or 膵管癌/AL) or (膵臓腫瘍/TH or 膵臓癌/AL) and (PT=会議録除く)
- #2
- (薬物療法/TH or 薬物療法/AL) or (薬物療法/TH or 化学療法/AL) or (抗腫瘍剤/TH or 抗腫瘍剤/AL) or (腫瘍多剤併用療法/TH or 混合抗腫瘍剤/AL) or (抗腫瘍剤/TH or 抗癌剤/AL) and (PT=会議録除く)
- #3
- #1 and #2
- #4
- #3 and (PT=原著論文 RD=メタアナリシス,ランダム化比較試験,準ランダム化比較試験,比較研究)
- ④
- 検索件数51件
- (2)
- PubMed
- ①
- 検索年限 出版年2004/7/4〜2007/4/30
- ②
- 検索日 2007/5/21
- ③
- 検索式
- #1
- pancreatic neoplasms/dt Limits:Entrez Date from 2004/07/04 to 2007/04/30, Humans, English, Japanese
- #2
- meta─analysis[pt] or randomized controlled trial[pt] or controlled clinical trial[pt] or clinical trial[pt]
- #3
- antineoplastic agents or 5─fluorouracil or 5─FU or gemcitabine or cisplatin or leucovorin or mytomycin C or doxorubicin or paclitaxel or cytarabine or cyclophosphamide or docetaxel or irinotecan or S─1 or capecitabine or topotecan or UFT or (tagafur and uracil)
- #4
- #1 and #2 and #3
- #5
- administration and dosage
- #6
- #4 and #5
- ④
- 検索件数107件