A prospective multicenter phase II study evaluating multimodality treatment of patients with peritoneal carcinomatosis arising from appendiceal and colorectal cancer: The COMBATAC trial

BMC Cancer

Volumn 13, Issue , 2013, Pages

  Glockzin, Gabriel ^a   Rochon, Justine ^b   Arnold, Dirk ^c   Lang, Sven A ^a   Klebl, Frank ^a   Zeman, Florian ^a   Koller, Michael ^a   Schlitt, Hans J ^a   Piso, Pompiliu ^a,d  

^a UNIVERSITY HOSPITAL REGENSBURG   (Germany)

^b UNIVERSITY OF HEIDELBERG   (Germany)

^c UNIVERSITY OF FREIBURG   (Germany)

^d Saint John of God Hospital Regensburg   (Germany)

Author keywords

Cetuximab; Colorectal cancer; Cytoreductive surgery; HIPEC; Perioperative chemotherapy; Peritoneal carcinomatosis

Indexed keywords

CETUXIMAB; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; K RAS PROTEIN; OXALIPLATIN;

APPENDIX CANCER; ARTICLE; CANCER PATIENT; CANCER REGRESSION; CARCINOMATOUS PERITONITIS; CLINICAL EFFECTIVENESS; COLORECTAL CANCER; CYTOREDUCTIVE SURGERY; FEASIBILITY STUDY; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY; HYPERTHERMIC THERAPY; MAJOR CLINICAL STUDY; MORBIDITY; MULTICENTER STUDY; MULTIMODALITY CANCER THERAPY; OPEN STUDY; OVERALL SURVIVAL; PERIOPERATIVE PERIOD; PHASE 2 CLINICAL TRIAL; PREOPERATIVE PERIOD; PROGRESSION FREE SURVIVAL; PROSPECTIVE STUDY; QUALITY OF LIFE;

ADENOCARCINOMA; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; APPENDICEAL NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CHEMOTHERAPY, CANCER, REGIONAL PERFUSION; COLORECTAL NEOPLASMS; DIGESTIVE SYSTEM SURGICAL PROCEDURES; DISEASE-FREE SURVIVAL; FEASIBILITY STUDIES; GERMANY; HUMANS; HYPOTHERMIA, INDUCED; METASTASECTOMY; PERITONEAL NEOPLASMS; PROSPECTIVE STUDIES; PROTO-ONCOGENE PROTEINS; QUALITY OF LIFE; RAS PROTEINS; RESEARCH DESIGN; SAMPLE SIZE; TIME FACTORS; TREATMENT OUTCOME;

EID: 84873389017     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-13-67     Document Type: Article

References (81)

1. Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin 2011, 61(2):69-90. 10.3322/caac.20107, 21296855.
2. Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010, 127(12):2893-2917. 10.1002/ijc.25516, 21351269.
3. Glehen O, Osinsky D, Cotte E, Kwiatkowski F, Freyer G, Isaac S, Trillet-Lenoir V, Sayag-Beaujard AC, Francois Y, Vignal J, et al. Intraperitoneal chemohyperthermia using a closed abdominal procedure and cytoreductive surgery for the treatment of peritoneal carcinomatosis: morbidity and mortality analysis of 216 consecutive procedures. Ann Surg Oncol 2003, 10(8):863-869. 10.1245/ASO.2003.01.018, 14527903.
4. Russell AH, Tong D, Dawson LE, Wisbeck W. Adenocarcinoma of the proximal colon. Sites of initial dissemination and patterns of recurrence following surgery alone. Cancer 1984, 53(2):360-367. 10.1002/1097-0142(19840115)53:2<360::AID-CNCR2820530232>3.0.CO;2-U, 6690020.
5. Willett CG, Tepper JE, Cohen AM, Orlow E, Welch CE. Failure patterns following curative resection of colonic carcinoma. Ann Surg 1984, 200(6):685-690. 10.1097/00000658-198412000-00001, 1250581, 6508395.
6. Schott A, Vogel I, Krueger U, Kalthoff H, Schreiber HW, Schmiegel W, Henne-Bruns D, Kremer B, Juhl H. Isolated tumor cells are frequently detectable in the peritoneal cavity of gastric and colorectal cancer patients and serve as a new prognostic marker. Ann Surg 1998, 227(3):372-379. 10.1097/00000658-199803000-00009, 1191275, 9527060.
7. Carmignani CP, Sugarbaker TA, Bromley CM, Sugarbaker PH. Intraperitoneal cancer dissemination: mechanisms of the patterns of spread. Cancer Metastasis Rev 2003, 22(4):465-472. 10.1023/A:1023791229361, 12884919.
8. Ceelen WP, Bracke ME. Peritoneal minimal residual disease in colorectal cancer: mechanisms, prevention, and treatment. Lancet Oncol 2009, 10(1):72-79. 10.1016/S1470-2045(08)70335-8, 19111247.
9. Stewart JH, Shen P, Levine EA. Intraperitoneal hyperthermic chemotherapy for peritoneal surface malignancy: current status and future directions. Ann Surg Oncol 2005, 12(10):765-777. 10.1245/ASO.2005.12.001, 16132375.
10. Sadeghi B, Arvieux C, Glehen O, Beaujard AC, Rivoire M, Baulieux J, Fontaumard E, Brachet A, Caillot JL, Faure JL, et al. Peritoneal carcinomatosis from non-gynecologic malignancies: results of the EVOCAPE 1 multicentric prospective study. Cancer 2000, 88(2):358-363. 10.1002/(SICI)1097-0142(20000115)88:2<358::AID-CNCR16>3.0.CO;2-O, 10640968.
11. Jayne DG, Fook S, Loi C, Seow-Choen F. Peritoneal carcinomatosis from colorectal cancer. Br J Surg 2002, 89(12):1545-1550. 10.1046/j.1365-2168.2002.02274.x, 12445064.
12. Schmoll HJ, Van Cutsem E, Stein A, Valentini V, Glimelius B, Haustermans K, Nordlinger B, van de Velde CJ, Balmana J, Regula J, et al. ESMO consensus guidelines for management of patients with colon and rectal cancer. A personalized approach to clinical decision making. Ann Oncol 2012, 23(10):2479-2516. 10.1093/annonc/mds236, 23012255.
13. Falcone A, Ricci S, Brunetti I, Pfanner E, Allegrini G, Barbara C, Crino L, Benedetti G, Evangelista W, Fanchini L, et al. Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the Gruppo Oncologico Nord Ovest. J Clin Oncol 2007, 25(13):1670-1676. 10.1200/JCO.2006.09.0928, 17470860.
14. Arnold D, Seufferlein T. Targeted treatments in colorectal cancer: state of the art and future perspectives. Gut 2010, 59(6):838-858. 10.1136/gut.2009.196006, 20551469.
15. de Gramont A, Figer A, Seymour M, Homerin M, Hmissi A, Cassidy J, Boni C, Cortes-Funes H, Cervantes A, Freyer G, et al. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 2000, 18(16):2938-2947.
16. Giacchetti S, Perpoint B, Zidani R, Le Bail N, Faggiuolo R, Focan C, Chollet P, Llory JF, Letourneau Y, Coudert B, et al. Phase III multicenter randomized trial of oxaliplatin added to chronomodulated fluorouracil-leucovorin as first-line treatment of metastatic colorectal cancer. J Clin Oncol 2000, 18(1):136-147.
17. Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 2000, 355(9209):1041-1047. 10.1016/S0140-6736(00)02034-1, 10744089.
18. Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, Maroun JA, Ackland SP, Locker PK, Pirotta N, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med 2000, 343(13):905-914. 10.1056/NEJM200009283431302, 11006366.
19. Tournigand C, Andre T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, et al. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 2004, 22(2):229-237.
20. Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004, 350(23):2335-2342. 10.1056/NEJMoa032691, 15175435.
21. Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts S. Randomized controlled trial of reduced-dose bolus fluorouracil plus leucovorin and irinotecan or infused fluorouracil plus leucovorin and oxaliplatin in patients with previously untreated metastatic colorectal cancer: a North American Intergroup Trial. J Clin Oncol 2006, 24(21):3347-3353. 10.1200/JCO.2006.06.1317, 16849748.
22. Fuchs CS, Marshall J, Barrueco J. Randomized, controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: updated results from the BICC-C study. J Clin Oncol 2008, 26(4):689-690. 10.1200/JCO.2007.15.5390, 18235136.
23. Fuchs CS, Marshall J, Mitchell E, Wierzbicki R, Ganju V, Jeffery M, Schulz J, Richards D, Soufi-Mahjoubi R, Wang B, et al. Randomized, controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: results from the BICC-C Study. J Clin Oncol 2007, 25(30):4779-4786. 10.1200/JCO.2007.11.3357, 17947725.
24. Saltz LB, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol 2008, 26(12):2013-2019. 10.1200/JCO.2007.14.9930, 18421054.
25. Hecht JR, Mitchell E, Chidiac T, Scroggin C, Hagenstad C, Spigel D, Marshall J, Cohn A, McCollum D, Stella P, et al. A randomized phase IIIB trial of chemotherapy, bevacizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer. J Clin Oncol 2009, 27(5):672-680. 10.1200/JCO.2008.19.8135, 19114685.
26. Tebbutt NC, Wilson K, Gebski VJ, Cummins MM, Zannino D, van Hazel GA, Robinson B, Broad A, Ganju V, Ackland SP, et al. Capecitabine, bevacizumab, and mitomycin in first-line treatment of metastatic colorectal cancer: results of the Australasian Gastrointestinal Trials Group Randomized Phase III MAX Study. J Clin Oncol 2010, 28(19):3191-3198. 10.1200/JCO.2009.27.7723, 20516443.
27. Stathopoulos GP, Batziou C, Trafalis D, Koutantos J, Batzios S, Stathopoulos J, Legakis J, Armakolas A. Treatment of colorectal cancer with and without bevacizumab: a phase III study. Oncology 2010, 78(5-6):376-381.
28. Douillard JY, Siena S, Cassidy J, Tabernero J, Burkes R, Barugel M, Humblet Y, Bodoky G, Cunningham D, Jassem J, et al. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study. J Clin Oncol 2010, 28(31):4697-4705. 10.1200/JCO.2009.27.4860, 20921465.
29. Tabernero J, Van Cutsem E, Diaz-Rubio E, Cervantes A, Humblet Y, Andre T, Van Laethem JL, Soulie P, Casado E, Verslype C, et al. Phase II trial of cetuximab in combination with fluorouracil, leucovorin, and oxaliplatin in the first-line treatment of metastatic colorectal cancer. J Clin Oncol 2007, 25(33):5225-5232. 10.1200/JCO.2007.13.2183, 18024868.
30. Borner M, Koeberle D, Von Moos R, Saletti P, Rauch D, Hess V, Trojan A, Helbling D, Pestalozzi B, Caspar C, et al. Adding cetuximab to capecitabine plus oxaliplatin (XELOX) in first-line treatment of metastatic colorectal cancer: a randomized phase II trial of the Swiss Group for Clinical Cancer Research SAKK. Ann Oncol 2008, 19(7):1288-1292. 10.1093/annonc/mdn058, 18349029.
31. Arnold D, Hohler T, Dittrich C, Lordick F, Seufferlein T, Riemann J, Woll E, Herrmann T, Zubel A, Schmoll HJ. Cetuximab in combination with weekly 5-fluorouracil/folinic acid and oxaliplatin (FUFOX) in untreated patients with advanced colorectal cancer: a phase Ib/II study of the AIO GI Group. Ann Oncol 2008, 19(8):1442-1449. 10.1093/annonc/mdn150, 18441330.
32. Cartwright T, Kuefler P, Cohn A, Hyman W, Berger M, Richards D, Vukelja S, Nugent JE, Ruxer RL, Boehm KA, et al. Results of a phase II trial of cetuximab plus capecitabine/irinotecan as first-line therapy for patients with advanced and/or metastatic colorectal cancer. Clin Colorectal Cancer 2008, 7(6):390-397. 10.3816/CCC.2008.n.052, 19036692.
33. Van Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pinter T, Lim R, Bodoky G, et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 2009, 360(14):1408-1417. 10.1056/NEJMoa0805019, 19339720.
34. Bokemeyer C, Bondarenko I, Makhson A, Hartmann JT, Aparicio J, de Braud F, Donea S, Ludwig H, Schuch G, Stroh C, et al. Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer. J Clin Oncol 2009, 27(5):663-671. 10.1200/JCO.2008.20.8397, 19114683.
35. Tol J, Koopman M, Cats A, Rodenburg CJ, Creemers GJ, Schrama JG, Erdkamp FL, Vos AH, van Groeningen CJ, Sinnige HA, et al. Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer. N Engl J Med 2009, 360(6):563-572. 10.1056/NEJMoa0808268, 19196673.
36. Maughan TS, Adams RA, Smith CG, Meade AM, Seymour MT, Wilson RH, Idziaszczyk S, Harris R, Fisher D, Kenny SL, et al. Addition of cetuximab to oxaliplatin-based first-line combination chemotherapy for treatment of advanced colorectal cancer: results of the randomised phase 3 MRC COIN trial. Lancet 2011, 377(9783):2103-2114. 10.1016/S0140-6736(11)60613-2, 3159415, 21641636.
37. Tveit KM, Guren T, Glimelius B, Pfeiffer P, Sorbye H, Pyrhonen S, Sigurdsson F, Kure E, Ikdahl T, Skovlund E, et al. Phase III trial of cetuximab with continuous or intermittent fluorouracil, leucovorin, and oxaliplatin (Nordic FLOX) versus FLOX alone in first-line treatment of metastatic colorectal cancer: the NORDIC-VII study. J Clin Oncol 2012, 30(15):1755-1762. 10.1200/JCO.2011.38.0915, 22473155.
38. Saltz LB, Meropol NJ, Loehrer PJ, Needle MN, Kopit J, Mayer RJ. Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. J Clin Oncol 2004, 22(7):1201-1208. 10.1200/JCO.2004.10.182, 14993230.
39. Jonker DJ, O'Callaghan CJ, Karapetis CS, Zalcberg JR, Tu D, Au HJ, Berry SR, Krahn M, Price T, Simes RJ, et al. Cetuximab for the treatment of colorectal cancer. N Engl J Med 2007, 357(20):2040-2048. 10.1056/NEJMoa071834, 18003960.
40. Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A, Bets D, Mueser M, Harstrick A, Verslype C, et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 2004, 351(4):337-345. 10.1056/NEJMoa033025, 15269313.
41. Van Cutsem E, Kohne CH, Lang I, Folprecht G, Nowacki MP, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Tejpar S, et al. Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J Clin Oncol 2011, 29(15):2011-2019. 10.1200/JCO.2010.33.5091, 21502544.
42. Bokemeyer C, Cutsem EV, Rougier P, Ciardiello F, Heeger S, Schlichting M, Celik I, Kohne CH. Addition of cetuximab to chemotherapy as first-line treatment for KRAS wild-type metastatic colorectal cancer: pooled analysis of the CRYSTAL and OPUS randomised clinical trials. Eur J Cancer 2012, 48(10):1466-1475. 10.1016/j.ejca.2012.02.057, 22446022.
43. Peeters M, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, Andre T, Chan E, Lordick F, Punt CJ, et al. Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. J Clin Oncol 2010, 28(31):4706-4713. 10.1200/JCO.2009.27.6055, 20921462.
44. Franko J, Shi Q, Goldman CD, Pockaj BA, Nelson GD, Goldberg RM, Pitot HC, Grothey A, Alberts SR, Sargent DJ. Treatment of colorectal peritoneal carcinomatosis with systemic chemotherapy: a pooled analysis of north central cancer treatment group phase III trials N9741 and N9841. J Clin Oncol 2012, 30(3):263-267. 10.1200/JCO.2011.37.1039, 3269953, 22162570.
45. Klaver YL, Simkens LH, Lemmens VE, Koopman M, Teerenstra S, Bleichrodt RP, de Hingh IH, Punt CJ. Outcomes of colorectal cancer patients with peritoneal carcinomatosis treated with chemotherapy with and without targeted therapy. Eur J Surg Oncol 2012, 38(7):617-623. 10.1016/j.ejso.2012.03.008, 22572106.
46. Elias D, Lefevre JH, Chevalier J, Brouquet A, Marchal F, Classe JM, Ferron G, Guilloit JM, Meeus P, Goere D, et al. Complete cytoreductive surgery plus intraperitoneal chemohyperthermia with oxaliplatin for peritoneal carcinomatosis of colorectal origin. J Clin Oncol 2009, 27(5):681-685. 10.1200/JCO.2008.19.7160, 19103728.
47. Lee DH, Oh SY, Lee YR, Huh SJ, Yoon HH, Kim SH, Lee S, Lee JH, Kim Y, Kim HJ, et al. A phase II study of modified FOLFOX4 for colorectal cancer patients with Peritoneal Carcinomatosis. Cancer Res Treat 2011, 43(4):225-230. 10.4143/crt.2011.43.4.225, 3253864, 22247707.
48. Sugarbaker PH, Cunliffe WJ, Belliveau J, de Bruijn EA, Graves T, Mullins RE, Schlag P. Rationale for integrating early postoperative intraperitoneal chemotherapy into the surgical treatment of gastrointestinal cancer. Semin Oncol 1989, 16(4 Suppl 6):83-97.
49. Sugarbaker PH. New standard of care for appendiceal epithelial neoplasms and pseudomyxoma peritonei syndrome?. Lancet Oncol 2006, 7(1):69-76. 10.1016/S1470-2045(05)70539-8, 16389186.
50. Dedrick RL. Theoretical and experimental bases of intraperitoneal chemotherapy. Semin Oncol 1985, 12(3 Suppl 4):1-6.
51. Flessner MF, Dedrick RL, Schultz JS. A distributed model of peritoneal-plasma transport: analysis of experimental data in the rat. Am J Physiol 1985, 248(3 Pt 2):F413-F424.
52. Speyer JL, Collins JM, Dedrick RL, Brennan MF, Buckpitt AR, Londer H, DeVita VT, Myers CE. Phase I and pharmacological studies of 5-fluorouracil administered intraperitoneally. Cancer Res 1980, 40(3):567-572.
53. Sugarbaker PH, Stuart OA, Carmignani CP. Pharmacokinetic changes induced by the volume of chemotherapy solution in patients treated with hyperthermic intraperitoneal mitomycin C. Cancer Chemother Pharmacol 2006, 57(5):703-708. 10.1007/s00280-005-0074-8, 16096789.
54. Elias D, Matsuhisa T, Sideris L, Liberale G, Drouard-Troalen L, Raynard B, Pocard M, Puizillou JM, Billard V, Bourget P, et al. Heated intra-operative intraperitoneal oxaliplatin plus irinotecan after complete resection of peritoneal carcinomatosis: pharmacokinetics, tissue distribution and tolerance. Ann Oncol 2004, 15(10):1558-1565. 10.1093/annonc/mdh398, 15367418.
55. Elias D, Bonnay M, Puizillou JM, Antoun S, Demirdjian S, El OA, Pignon JP, Drouard-Troalen L, Ouellet JF, Ducreux M. Heated intra-operative intraperitoneal oxaliplatin after complete resection of peritoneal carcinomatosis: pharmacokinetics and tissue distribution. Ann Oncol 2002, 13(2):267-272. 10.1093/annonc/mdf019, 11886004.
56. Gonzalez-Moreno S, Gonzalez-Bayon LA, Ortega-Perez G. Hyperthermic intraperitoneal chemotherapy: Rationale and technique. World J Gastrointest Oncol 2010, 2(2):68-75. 10.4251/wjgo.v2.i2.68, 2999165, 21160924.
57. Sugarbaker PH. Laboratory and clinical basis for hyperthermia as a component of intracavitary chemotherapy. Int J Hyperthermia 2007, 23(5):431-442. 10.1080/02656730701455318, 17701534.
58. Issels RD. Hyperthermia adds to chemotherapy. Eur J Cancer 2008, 44(17):2546-2554. 10.1016/j.ejca.2008.07.038, 18789678.
59. Verwaal VJ, Bruin S, Boot H, van Slooten G, van Tinteren H. 8-year follow-up of randomized trial: cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy in patients with peritoneal carcinomatosis of colorectal cancer. Ann Surg Oncol 2008, 15(9):2426-2432. 10.1245/s10434-008-9966-2, 18521686.
60. Verwaal VJ, van Ruth S, de Bree E, van Sloothen GW, van Tinteren H, Boot H, Zoetmulder FA. Randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy and palliative surgery in patients with peritoneal carcinomatosis of colorectal cancer. J Clin Oncol 2003, 21(20):3737-3743. 10.1200/JCO.2003.04.187, 14551293.
61. Elias D, Delperro JR, Sideris L, Benhamou E, Pocard M, Baton O, Giovannini M, Lasser P. Treatment of peritoneal carcinomatosis from colorectal cancer: impact of complete cytoreductive surgery and difficulties in conducting randomized trials. Ann Surg Oncol 2004, 11(5):518-521. 10.1245/ASO.2004.09.008, 15123461.
62. Mahteme H, Hansson J, Berglund A, Pahlman L, Glimelius B, Nygren P, Graf W. Improved survival in patients with peritoneal metastases from colorectal cancer: a preliminary study. Br J Cancer 2004, 90(2):403-407. 10.1038/sj.bjc.6601586, 2409568, 14735184.
63. Glehen O, Kwiatkowski F, Sugarbaker PH, Elias D, Levine EA, De Simone M, Barone R, Yonemura Y, Cavaliere F, Quenet F, et al. Cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for the management of peritoneal carcinomatosis from colorectal cancer: a multi-institutional study. J Clin Oncol 2004, 22(16):3284-3292. 10.1200/JCO.2004.10.012, 15310771.
64. Glockzin G, Ghali N, Lang SA, Agha A, Schlitt HJ, Piso P. Peritoneal carcinomatosis. Surgical treatment, including hyperthermic intraperitoneal chemotherapy. Chirurg 2007, 78(12):1100-1110. 10.1007/s00104-007-1419-0, 17992490.
65. Hompes D, D'Hoore A, Van Cutsem E, Fieuws S, Ceelen W, Peeters M, Van der Speeten K, Bertrand C, Legendre H, Kerger J. The treatment of peritoneal carcinomatosis of colorectal cancer with complete cytoreductive surgery and hyperthermic intraperitoneal peroperative chemotherapy (HIPEC) with oxaliplatin: a Belgian multicentre prospective phase II clinical study. Ann Surg Oncol 2012, 19(7):2186-2194. 10.1245/s10434-012-2264-z, 22395983.
66. Pilati P, Mocellin S, Rossi CR, Foletto M, Campana L, Nitti D, Lise M. Cytoreductive surgery combined with hyperthermic intraperitoneal intraoperative chemotherapy for peritoneal carcinomatosis arising from colon adenocarcinoma. Ann Surg Oncol 2003, 10(5):508-513. 10.1245/ASO.2003.08.004, 12794016.
67. Glehen O, Cotte E, Schreiber V, Sayag-Beaujard AC, Vignal J, Gilly FN. Intraperitoneal chemohyperthermia and attempted cytoreductive surgery in patients with peritoneal carcinomatosis of colorectal origin. Br J Surg 2004, 91(6):747-754. 10.1002/bjs.4473, 15164446.
68. Shen P, Hawksworth J, Lovato J, Loggie BW, Geisinger KR, Fleming RA, Levine EA. Cytoreductive surgery and intraperitoneal hyperthermic chemotherapy with mitomycin C for peritoneal carcinomatosis from nonappendiceal colorectal carcinoma. Ann Surg Oncol 2004, 11(2):178-186. 10.1245/ASO.2004.05.009, 14761921.
69. Quenet F, Claus C, Roca L, Gauthey A, Essissen M, Ychou M, Rouanet P, Saint-Aubert B. Complete cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for peritoneal carcinomatosis from digestive tract cancer--New management with oxaliplatin plus irinotecan: a feasibility study in 37 patients. J Clin Oncol 2008, 26. suppl; abstr 4084.
70. Glehen O, Gilly FN. Quantitative prognostic indicators of peritoneal surface malignancy: carcinomatosis, sarcomatosis, and peritoneal mesothelioma. Surg Oncol Clin N Am 2003, 12(3):649-671. 10.1016/S1055-3207(03)00037-1, 14567023.
71. Jacquet P, Sugarbaker PH. Clinical research methodologies in diagnosis and staging of patients with peritoneal carcinomatosis. Cancer Treat Res 1996, 82:359-374. 10.1007/978-1-4613-1247-5_23, 8849962.
72. Glockzin G, Schlitt HJ, Piso P. Peritoneal carcinomatosis: patients selection, perioperative complications and quality of life related to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. World J Surg Oncol 2009, 7(1):5. 10.1186/1477-7819-7-5, 2639355, 19133112.
73. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009, 45(2):228-247. 10.1016/j.ejca.2008.10.026, 19097774.
74. Younan R, Kusamura S, Baratti D, Cloutier AS, Deraco M. Morbidity, toxicity, and mortality classification systems in the local regional treatment of peritoneal surface malignancy. J Surg Oncol 2008, 98(4):253-257. 10.1002/jso.21057, 18726887.
75. Fayers PM. Interpreting quality of life data: population-based reference data for the EORTC QLQ-C30. Eur J Cancer 2001, 37(11):1331-1334. 10.1016/S0959-8049(01)00127-7, 11435060.
76. Schwarz R, Hinz A. Reference data for the quality of life questionnaire EORTC QLQ-C30 in the general German population. Eur J Cancer 2001, 37(11):1345-1351. 10.1016/S0959-8049(00)00447-0, 11435063.
77. Koller M, Lorenz W. Quality of life: a deconstruction for clinicians. J R Soc Med 2002, 95(10):481-488. 10.1258/jrsm.95.10.481, 1279172, 12356967.
78. Dworak O, Keilholz L, Hoffmann A. Pathological features of rectal cancer after preoperative radiochemotherapy. Int J Colorectal Dis 1997, 12(1):19-23. 10.1007/s003840050072, 9112145.
79. Rubinstein LV, Korn EL, Freidlin B, Hunsberger S, Ivy SP, Smith MA. Design issues of randomized phase II trials and a proposal for phase II screening trials. J Clin Oncol 2005, 23(28):7199-7206. 10.1200/JCO.2005.01.149, 16192604.
80. Lawless JF. Statistical Models and Methods for Lifetime Data (Wiley Series in Probability & Mathematical Statistics) 1982, New York: John Wiley & Sons.
81. Glockzin G, von Breitenbuch P, Schlitt HJ, Piso P. Treatment-related morbidity and toxicity of CRS and oxaliplatin-based HIPEC compared to a mitomycin and doxorubicin-based HIPEC protocol in patients with peritoneal carcinomatosis: A matched-pair analysis. J Surg Oncol 2012, 12(1):356.