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International Journal of Colorectal Disease
Published in: International Journal of Colorectal Disease 6/2006

01-09-2006 | Original Article

Adjuvant chemotherapy with folinic acid and 5-fluorouracil in patients with locally advanced rectal cancer previously treated by preoperative radiochemotherapy and curative tumor resection

Authors: Bert Hildebrandt, Beate Rau, Jürgen Löffel, Peter Wust, Annett Nicolaou, Johanna Gellermann, Philipp Le Coutre, Peter Neuhaus, Roland Felix, Klaus-Dieter Wernecke, Bernd Dörken, Hanno Riess

Published in: International Journal of Colorectal Disease | Issue 6/2006

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Abstract

Background and aims

The role of postoperative adjuvant chemotherapy in patients with rectal cancer pretreated by preoperative radiochemotherapy (RCT) and curative surgery is still poorly investigated.

Patients and methods

We pooled data from both arms of a phase III trial in which patients with locally advanced (T3/4) rectal cancer were randomized to preoperative RCT alone or combined with pelvic radio-frequency hyperthermia. After surgery, R0-resected patients were scheduled to adjuvant chemotherapy with four monthly courses of 50 mg folinic acid (FA) and gradually escalated 5-fluorouracil (5-FU, 350–500 mg/m2, days 1–5). Reasons preventing initiation of chemotherapy and treatment-related toxicities were evaluated. Patients’ characteristics and survival parameters were compared between the treated and untreated patient groups.

Results

Out of 93 patients, 73 (79%) started adjuvant chemotherapy, whereas 19 (21%) did not, mostly due to perioperative complications and refusal. Chemotherapy-related toxicities were mild to moderate in most cases, but—together with protracted postoperative complications—prevented the intended dose escalation of 5-FU in 71% of patients. Distant-failure-free (p=0.03) and overall survival (p=0.03) were improved in the chemotherapy group, although there was a negative selection of patients with unfavourable characteristics into the untreated patient group.

Interpretation/conclusion

Adjuvant chemotherapy using FA and 5-FU can be safely applied to the majority of patients with rectal cancer pretreated by RCT and surgery. Survival data are not suitable to allow far-reaching conclusions, but are in line with suggestions of a favourable effect of adjuvant chemotherapy in these patients.
Literature
1.
Douglas HO Jr, Moertel CG, Mayer RJ, Thomas PR, Lindblad AS, Mittleman A, Stablein DM, Bruckner HW (1986) Survival after postoperative combination treatment of rectal cancer (letter). N Engl J Med 315:1294–1295CrossRef
2.
GITSG (1985) Prolongation of the disease-free interval in surgically treated rectal carcinoma. Gastrointestinal Tumor Study Group. N Engl J Med 312:1465–1472CrossRef
3.
Krook JE, Moertel CG, Gunderson LL, Wieand HS, Collins RT, Beart RW, Kubista TP, Poon MA, Meyers WC, Mailliard JA et al (1991) Effective surgical adjuvant therapy for high-risk rectal carcinoma (see comments). N Engl J Med 324:709–715PubMedCrossRef
4.
NIH (1990) NIH consensus conference. Adjuvant therapy for patients with colon and rectal cancer. JAMA 264:1444–1450CrossRef
5.
Kapiteijn E, Marijnen CA, Nagtegaal ID, Putter H, Steup WH, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van Krieken JH, Leer JW, van de Velde CJ (2001) Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med 345:638–646PubMedCrossRef
6.
Kockerling F, Reymond MA, Altendorf-Hofmann A, Dworak O, Hohenberger W (1998) Influence of surgery on metachronous distant metastases and survival in rectal cancer. J Clin Oncol 16:324–329PubMed
7.
O’Connell MJ, Martenson JA, Wieand HS, Krook JE, Macdonald JS, Haller DG, Mayer RJ, Gunderson LL, Rich TA (1994) Improving adjuvant therapy for rectal cancer by combining protracted-infusion fluorouracil with radiation therapy after curative surgery. N Engl J Med 331:502–507PubMedCrossRef
8.
Swedish Rectal Cancer Trial (1997) Improved survival with preoperative radiotherapy in resectable rectal cancer. N Engl J Med 336:980–987CrossRef
9.
Sauer R, Becker H, Hohenberger W, Rodel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T et al (2004) Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med 351:1731–1740PubMedCrossRef
10.
Hyams DM, Mamounas EP, Petrelli N, Rockette H, Jones J, Wieand HS, Deutsch M, Wickerham L, Fisher B, Wolmark N (1997) A clinical trial to evaluate the worth of preoperative multimodality therapy in patients with operable carcinoma of the rectum: a progress report of National Surgical Breast and Bowel Project Protocol R-03. Dis Colon Rectum 40:131–139PubMedCrossRef
11.
Minsky BD (1999) Primary treatment of rectal cancer: present and future. Crit Rev Oncol Hematol 32:19–30PubMedCrossRef
12.
Minsky BD, Cohen AM, Kemeny N, Enker WE, Kelsen DP, Reichman B, Saltz L, Sigurdson ER, Frankel J (1992) Enhancement of radiation-induced downstaging of rectal cancer by fluorouracil and high-dose leucovorin chemotherapy. J Clin Oncol 10:79–84PubMed
13.
Minsky BD, Cohen AM, Kemeny N, Enker WE, Kelsen DP, Saltz L, Frankel J (1993) The efficacy of preoperative 5-fluorouracil, high-dose leucovorin, and sequential radiation therapy for unresectable rectal cancer. Cancer 71:3486–3492PubMedCrossRef
14.
Minsky B, Cohen A, Enker W, Kelsen D, Kemeny N, Ilson D, Guillem J, Saltz L, Frankel J, Conti J (1994) Preoperative 5-fluorouracil, low-dose leucovorin, and concurrent radiation therapy for rectal cancer. Cancer 73:273–280PubMedCrossRef
15.
Rau B, Wust P, Hohenberger P, Loffel J, Hunerbein M, Below C, Gellermann J, Speidel A, Vogl T, Riess H, Felix R, Schlag PM (1998) Preoperative hyperthermia combined with radiochemotherapy in locally advanced rectal cancer: a phase II clinical trial. Ann Surg 227:380–389PubMedCrossRef
16.
Riess H, Loffel J, Wust P, Rau B, Gremmler M, Speidel A, Schlag P (1995) A pilot study of a new therapeutic approach in the treatment of locally advanced stages of rectal cancer: neoadjuvant radiation, chemotherapy and regional hyperthermia. Eur J Cancer 31A:1356–1360PubMedCrossRef
17.
Hildebrandt B, Wust P, Rau B, Schlag PM, Riess H (2000) Regional hyperthermia in rectal cancer. Lancet 356:771–772PubMedCrossRef
18.
Wust P, Hildebrandt B, Sreenivasa G, Rau B, Gellermann J, Riess H, Felix R, Schlag PM (2002) Hyperthermia in combined treatment of cancer. Lancet Oncol 3:487–497PubMedCrossRef
19.
Grann A, Feng C, Wong D, Saltz L, Paty PP, Guillem JG, Cohen AM, Minsky BD (2001) Preoperative combined modality therapy for clinically resectable uT3 rectal adenocarcinoma. Int J Radiat Oncol Biol Phys 49:987–995PubMedCrossRef
20.
Chan AK, Wong AO, Langevin J, Jenken D, Heine J, Buie D, Johnson DR (2000) Preoperative chemotherapy and pelvic radiation for tethered or fixed rectal cancer: a phase II dose escalation study. Int J Radiat Oncol Biol Phys 48:843–856PubMed
21.
Porschen R, Bermann A, Loffler T, Haack G, Rettig K, Anger Y, Strohmeyer G (2001) Fluorouracil plus leucovorin as effective adjuvant chemotherapy in curatively resected stage III colon cancer: results of the trial adjCCA-01. J Clin Oncol 19:1787–1794PubMed
22.
Ahn JB, Shim KY, Jeung HC, Rha SY, Yoo NC, Kim NK, Roh JK, Min JS, Kim BS, Chung HC (2001) Monthly 5-days 5-fluorouracil and low-dose leucovorin for adjuvant chemotherapy in colon cancer. Cancer Lett 167:215–224PubMedCrossRef
Metadata
Title
Adjuvant chemotherapy with folinic acid and 5-fluorouracil in patients with locally advanced rectal cancer previously treated by preoperative radiochemotherapy and curative tumor resection
Authors
Bert Hildebrandt
Beate Rau
Jürgen Löffel
Peter Wust
Annett Nicolaou
Johanna Gellermann
Philipp Le Coutre
Peter Neuhaus
Roland Felix
Klaus-Dieter Wernecke
Bernd Dörken
Hanno Riess
Publication date
01-09-2006
Publisher
Springer-Verlag
Published in
International Journal of Colorectal Disease / Issue 6/2006
Print ISSN: 0179-1958
Electronic ISSN: 1432-1262
DOI
https://doi.org/10.1007/s00384-005-0054-9

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