Effect of interval (7 or 11 weeks) between neoadjuvant radiochemotherapy and surgery on complete pathologic response in rectal cancer: A multicenter, randomized, controlled trial (GRECCAR-6)

Journal of Clinical Oncology

Volumn 34, Issue 31, 2016, Pages 3773-3780

  Lefevre, Jérémie H ^a   Mineur, Laurent ^g   Kotti, Salma ^a   Rullier, Eric ^h   Rouanet, Philippe ⁱ   De Chaisemartin, Cécile ^j   Meunier, Bernard ^k   Mehrdad, Jafari ^l   Cotte, Eddy ⁿ   Desrame, JéRome ^o   Karoui, Mehdi ^b   Benoist, Stéphane ^p   Kirzin, Sylvain ^q   Berger, Anne ^c   Panis, Yves ^r   Piessen, Guillaume ^m   Saudemont, Alain ^m   Prudhomme, Michel ^s   Peschaud, Frédérique ^t   Dubois, Anne ^u   Loriau, JéRome ^d   Tuech, Jean Jacques ^v   Meurette, Guillaume ^w   Lupinacci, Renato ^e   Goasgen, Nicolas ^f   Parc, Yann ^b   Simon, Tabassome ^a   Tiret, Emmanuel ^a   more..

^a HÔPITAL SAINT ANTOINE   (France)

^b PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^c HÔPITAL EUROPÉEN GEORGES POMPIDOU   (France)

^d SAINT JOSEPH HOSPITAL   (France)

^e GROUPE HOSPITALIER DIACONESSES CROIX SAINT SIMON   (France)

^f Hopital des Diaconesses   (France)

^g Sainte Camille Institut   (France)

^h HÔPITAL SAINT ANDRÉ   (France)

ⁱ CENTRE VAL D AURELLE   (France)

^j ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE   (France)

^k RENNES UNIVERSITY HOSPITAL   (France)

^l CENTRE OSCAR LAMBRET   (France)

^m Centres Hospitaliers Univ Grenoble   (France)

ⁿ CENTRE HOSPITALIER LYON SUD   (France)

^o Private Hospital Jean Mermoz   (France)

^p BICÊTRE HOSPITAL   (France)

^q CHU PURPAN   (France)

^r BEAUJON HOSPITAL   (France)

^s DEPARTMENT OF NEUROLOGY   (France)

^t HÔPITAL AMBROISE PARÉ   (France)

^u UNIVERSITY HOSPITAL OF CLERMONT FERRAND   (France)

^v ROUEN UNIVERSITY HOSPITAL   (France)

^w HÔTEL DIEU   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CAPECITABINE; FLUOROURACIL; ANTINEOPLASTIC AGENT;

ADJUVANT CHEMORADIOTHERAPY; ADULT; AGED; ANASTOMOSIS LEAKAGE; ANUS SPHINCTER; ARTICLE; CONTROLLED STUDY; DISTANT METASTASIS; FEMALE; HUMAN; HUMAN TISSUE; LOCAL EXCISION; LYMPH NODE METASTASIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIMODALITY CANCER THERAPY; OPEN STUDY; PHASE 3 CLINICAL TRIAL; POSTOPERATIVE COMPLICATION; POSTOPERATIVE ILEUS; PRIORITY JOURNAL; RADIATION DOSE; RANDOMIZED CONTROLLED TRIAL; RECTUM CANCER; SCAR; TIME TO TREATMENT; TOTAL MESORECTAL EXCISION; TREATMENT RESPONSE; VEIN THROMBOSIS; CHEMORADIOTHERAPY; CLINICAL TRIAL; DISEASE FREE SURVIVAL; MIDDLE AGED; NEOADJUVANT THERAPY; RADIOTHERAPY DOSAGE; RECTUM TUMOR; REMISSION; TIME FACTOR; TREATMENT OUTCOME;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAPECITABINE; CHEMORADIOTHERAPY; DISEASE-FREE SURVIVAL; FEMALE; FLUOROURACIL; HUMANS; MALE; MIDDLE AGED; NEOADJUVANT THERAPY; RADIOTHERAPY DOSAGE; RECTAL NEOPLASMS; REMISSION INDUCTION; TIME FACTORS; TREATMENT OUTCOME;

EID: 84993965575     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2016.67.6049     Document Type: Article

References (38)

1. van Gijn W, Marijnen CA, Nagtegaal ID, et al: Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: 12-year follow-up of the multicentre, randomised controlled TME trial. Lancet Oncol 12:575-582, 2011
2. Sauer R, Liersch T, Merkel S, et al: Pre-operative versus postoperative chemoradiotherapy for locally advanced rectal cancer: Results of the German CAO/ARO/AIO-94 randomized phase III trial after a median follow-up of 11 years. J Clin Oncol 30: 1926-1933, 2012
3. Yeo SG, Kim DY, Kim TH, et al: Pathologic complete response of primary tumor following preoperative chemoradiotherapy for locally advanced rectal cancer: Long-term outcomes and prognostic significance of pathologic nodal status (KROG 09-01). Ann Surg 252:998-1004, 2010
4. Francois Y, Nemoz CJ, Baulieux J, et al: Influence of the interval between preoperative radiation therapy and surgery on downstaging and on the rate of sphincter-sparing surgery for rectal cancer: The Lyon R90-01 randomized trial. J Clin Oncol 17: 2396, 1999
5. Bujko K: Timing of surgery following preoperative therapy in rectal cancer: there is no need for a prospective randomized trial. Dis Colon Rectum 55: e31, 2012; author reply e31-32
6. Suit HD, Gallager HS: Intact tumor cells in irradiated tissue. Arch Pathol 78:648-651, 1964
7. Moore HG, Gittleman AE, Minsky BD, et al: Rate of pathologic complete response with increased interval between preoperative combined modality therapy and rectal cancer resection. Dis Colon Rectum 47:279-286, 2004
8. Tulchinsky H, Shmueli E, Figer A, et al: An interval. 7 weeks between neoadjuvant therapy and surgery improves pathologic complete response and disease-free survival in patients with locally advanced rectal cancer. Ann Surg Oncol 15:2661-2667, 2008
9. Kalady MF, de Campos-Lobato LF, Stocchi L, et al: Predictive factors of pathologic complete response after neoadjuvant chemoradiation for rectal cancer. Ann Surg 250:582-589, 2009
10. Petrelli F, Coinu A, Lonati V, et al: A systematic review and meta-analysis of adjuvant chemotherapy after neoadjuvant treatment and surgery for rectal cancer. Int J Colorectal Dis 30:447-457, 2015
11. Tran CL, Udani S, Holt A, et al: Evaluation of safety of increased time interval between chemo-radiation and resection for rectal cancer. Am J Surg 192:873-877, 2006
12. Lefevre JH, Parc Y, Tiret E: Increasing the interval between neoadjuvant chemoradiotherapy and surgery in rectal cancer. Ann Surg 262:e116, 2015
13. Lefevre JH, Rousseau A, Svrcek M, et al: A multicentric randomized controlled trial on the impact of lengthening the interval between neoadjuvant radiochemotherapy and surgery on complete pathological response in rectal cancer (GRECCAR-6 trial): Rationale and design. BMC Cancer 13:417, 2013
14. Rullier A, Laurent C: Recommendations for clinical practice. Therapeutic choices for rectal cancer. What quality criteria are important for surgical excision of rectal cancer? [Article in French] Gastroenterol Clin Biol 31 Spec No 1:1S34-51, 1S91-95, 2007
15. Dworak O, Keilholz L, Hoffmann A: Pathological features of rectal cancer after preoperative radio-chemotherapy. Int J Colorectal Dis 12:19-23, 1997
16. Rödel C, Martus P, Papadoupolos T, et al: Prognostic significance of tumor regression after preoperative chemoradiotherapy for rectal cancer. J Clin Oncol 23:8688-8696, 2005
17. Clavien PA, Barkun J, de Oliveira ML, et al: The Clavien-Dindo classification of surgical complications: Five-year experience. Ann Surg 250:187-196, 2009
18. Dindo D, Demartines N, Clavien PA: Classification of surgical complications: A new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240:205-213, 2004
19. Bosset JF, Collette L, Calais G, et al: Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med 355:1114-1123, 2006
20. Hiotis SP, Weber SM, Cohen AM, et al: Assessing the predictive value of clinical complete response to neoadjuvant therapy for rectal cancer: An analysis of 488 patients. J Am Coll Surg 194:131-135, 2002; discussion 135-136
21. de Campos-Lobato LF, Geisler DP, da Luz Moreira A, et al: Neoadjuvant therapy for rectal cancer: The impact of longer interval between chemoradiation and surgery. J Gastrointest Surg 15:444-450, 2011
22. Evans J, Tait D, Swift I, et al: Timing of surgery following preoperative therapy in rectal cancer: The need for a prospective randomized trial? Dis Colon Rectum 54:1251-1259, 2011
23. Armitage P: Interim analysis in clinical trials. Stat Med 10:925-935, 1991; discussion 936-937
24. Habr-Gama A, Perez RO, Proscurshim I, et al: Interval between surgery and neoadjuvant chemo-radiation therapy for distal rectal cancer: Does delayed surgery have an impact on outcome? Int J Radiat Oncol Biol Phys 71:1181-1188, 2008
25. Probst CP, Becerra AZ, Aquina CT, et al: Extended intervals after neoadjuvant therapy in locally advanced rectal cancer: The key to improved tumor response and potential organ preservation. J Am Coll Surg 221:430-440, 2015
26. Lim SB, Choi HS, Jeong SY, et al: Optimal surgery time after preoperative chemoradiotherapy for locally advanced rectal cancers. Ann Surg 248: 243-251, 2008
27. Jeong DH, Lee HB, Hur H, et al: Optimal timing of surgery after neoadjuvant chemoradiation therapy in locally advanced rectal cancer. J Korean Surg Soc 84:338-345, 2013
28. Rödel C, Liersch T, Becker H, et al: Preoperative chemoradiotherapy and postoperative chemotherapy with fluorouracil and oxaliplatin versus fluorouracil alone in locally advanced rectal cancer: Initial results of the German CAO/ARO/AIO-04 randomised phase 3 trial. Lancet Oncol 13:679-687, 2012
29. Gérard JP, Azria D, Gourgou-Bourgade S, et al: Comparison of two neoadjuvant chemoradiotherapy regimens for locally advanced rectal cancer: Results of the phase III trial ACCORD 12/0405-Prodige 2. J Clin Oncol 28:1638-1644, 2010
30. Roh MS, Colangelo LH, O'Connell MJ, et al: Preoperative multimodality therapy improves diseasefree survival in patients with carcinoma of the rectum: NSABP R-03. J Clin Oncol 27:5124-5130, 2009
31. Bujko K, Nowacki MP, Nasierowska-Guttmejer A, et al: Long-term results of a randomized trial comparing preoperative short-course radiotherapy with preoperative conventionally fractionated chemo-radiation for rectal cancer. Br J Surg 93:1215-1223, 2006
32. Schmoll HJ: Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin versus capecitabine alone in locally advanced rectal cancer: Disease-free survival results at interim analysis. J Clin Oncol 32, 2014 (suppl; abstr 3501)
33. Rullier A, Laurent C, Vendrely V, et al: Impact of colloid response on survival after preoperative radiotherapy in locally advanced rectal carcinoma. Am J Surg Pathol 29:602-606, 2005
34. Shia J, McManus M, Guillem JG, et al: Significance of acellular mucin pools in rectal carcinoma after neoadjuvant chemoradiotherapy. Am J Surg Pathol 35:127-134, 2011
35. Bhatti AB, Akbar A, Khattak S, et al: Impact of acellular mucin pools on survival in patients with complete pathological response to neoadjuvant treatment in rectal cancer. Int J Surg 12:1123-1126, 2014
36. Quirke P, Steele R, Monson J, et al: Effect of the plane of surgery achieved on local recurrence in patients with operable rectal cancer: A prospective study using data from the MRC CR07 and NCIC-CTG CO16 randomised clinical trial. Lancet 373:821-828, 2009
37. Musters GD, Buskens CJ, Bemelman WA, et al: Perineal wound healing after abdominoperineal resection for rectal cancer: A systematic review and meta-analysis. Dis Colon Rectum 57:1129-1139, 2014
38. Garcia-Aguilar J, Chow OS, Smith DD, et al: Effect of adding mFOLFOX6 after neoadjuvant che-moradiation in locally advanced rectal cancer: A multicentre, phase 2 trial. Lancet Oncol 16:957-966, 2015