Phase I trial of neoadjuvant concurrent chemoradiotherapy with S-1 and weekly irinotecan in locally advanced rectal cancer

Radiotherapy and Oncology

Volumn 87, Issue 3, 2008, Pages 361-366

  Choi, Hye Jin ^a   Kim, Nam Kyu ^a   Keum, Ki Chang ^a   Cheon, Seong Ha ^a   Shin, Sang Jun ^a   Baik, Seung Hyuk ^a   Choen, Jae Hee ^a   Rha, Sun Young ^a   Roh, Jae Kyung ^a   Jeung, Hei Cheul ^a   Chung, Hyun Cheol ^a   Ahn, Joong Bae ^a  

^a Yonsei University College of Medicine   (South Korea)

Author keywords

Irinotecan; Neoadjuvant; Rectal cancer; S 1

Indexed keywords

5 CHLORO 2,4 DIHYDROXYPYRIDINE PLUS OXONATE POTASSIUM PLUS TEGAFUR; IRINOTECAN;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ARTICLE; BLOOD TOXICITY; BRAIN INFARCTION; CANCER LOCALIZATION; CANCER RADIOTHERAPY; CANCER SURGERY; CLINICAL ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; DIARRHEA; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG TOLERABILITY; FEMALE; HUMAN; HUMAN TISSUE; MALE; NEUTROPENIA; PATIENT COMPLIANCE; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; RECTUM CANCER;

ADENOCARCINOMA; ADULT; AGED; ANTINEOPLASTIC AGENTS, PHYTOGENIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COMBINED MODALITY THERAPY; DRUG COMBINATIONS; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOADJUVANT THERAPY; OXONIC ACID; RADIATION-SENSITIZING AGENTS; RADIOTHERAPY DOSAGE; RADIOTHERAPY, HIGH-ENERGY; RECTAL NEOPLASMS; TEGAFUR;

EID: 46549084526     PISSN: 01678140     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.radonc.2008.04.001     Document Type: Article

References (29)

1. Enker W.E., Thaler H.T., Cranor M.L., and Polyak T. Total mesorectal excision in the operative treatment of carcinoma of the rectum. J Am Coll Surg 181 (1995) 335-346
2. Quirke P., Durdey P., Dixon M.F., and Williams N.S. Local recurrence of rectal adenocarcinoma due to inadequate surgical resection. Histopathological study of lateral tumour spread and surgical excision. Lancet 2 (1986) 996-999
3. Kapiteijn E., Marijnen C.A., Nagtegaal I.D., Putter H., Steup W.H., Wiggers T., et al. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med 345 (2001) 638-646
4. Sauer R., Becker H., Hohenberger W., Rodel C., Wittekind C., Fietkau R., et al. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med 351 (2004) 1731-1740
5. Bosset J.F., Calais G., Mineur L., Maingon P., Radosevic-Jelic L., Daban A., et al. Enhanced tumorocidal effect of chemotherapy with preoperative radiotherapy for rectal cancer: preliminary results - EORTC 22921. J Clin Oncol 23 (2005) 5620-5627
6. Bosset J.F., Collette L., Calais G., Mineur L., Maingon P., Radosevic-Jelic L., et al. Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med 355 (2006) 1114-1123
7. Douillard J.Y., Cunningham D., Roth A.D., Navarro M., James R.D., Karasek P., et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 355 (2000) 1041-1047
8. Saltz L.B., Cox J.V., Blanke C., Rosen L.S., Fehrenbacher L., Moore M.J., et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med 343 (2000) 905-914
9. Boscia R.E., Korbut T., Holden S.A., Ara G., and Teicher B.A. Interaction of topoisomerase I inhibitors with radiation in cis-diamminedichloroplatinum(II)-sensitive and -resistant cells in vitro and in the FSAIIC fibrosarcoma in vivo. Int J Cancer 53 (1993) 118-123
10. Levine E.L., Gollins S., Susnerwala S., Haylock B., Saunders M., Myint S., et al. Phase I/II study of irinotecan (CPT 11) 5-fluorouracil and concurrent radiotherapy in the treatment of T3-T4 locally advanced inoperable rectal cancer. Proc Am Soc Clin Oncol 22 (2003) 345
11. Shirasaka T., Shimamato Y., Ohshimo H., Yamaguchi M., Kato T., Yonekura K., et al. Development of a novel form of an oral 5-fluorouracil derivative (S-1) directed to the potentiation of the tumor selective cytotoxicity of 5-fluorouracil by two biochemical modulators. Anticancer Drugs 7 (1996) 548-557
12. Kawahara M., Furuse K., Segawa Y., Yoshimori K., Matsui K., Kudoh S., et al. Phase II study of S-1, a novel oral fluorouracil, in advanced non-small-cell lung cancer. Br J Cancer 85 (2001) 939-943
13. Sakata Y., Ohtsu A., Horikoshi N., Sugimachi K., Mitachi Y., and Taguchi T. Late phase II study of novel oral fluoropyrimidine anticancer drug S-1 (1 M tegafur-0.4 M gimestat-1 M otastat potassium) in advanced gastric cancer patients. Eur J Cancer 34 (1998) 1715-1720
14. Shirao K., Ohtsu A., Takada H., Mitachi Y., Hirakawa K., Horikoshi N., et al. Phase II study of oral S-1 for treatment of metastatic colorectal carcinoma. Cancer 100 (2004) 2355-2361
15. Nakata E., Fukushima M., Takai Y., Nemoto K., Ogawa Y., Nomiya T., et al. S-1, an oral fluoropyrimidine, enhances radiation response of DLD-1/FU human colon cancer xenografts resistant to 5-FU. Oncol Rep 16 (2006) 465-471
16. Kim J.S., Cho M.J., Song K.S., and Yoon W.H. Preoperative chemoradiation using oral capecitabine in locally advanced rectal cancer. Int J Radiat Oncol Biol Phys 54 (2002) 403-408
17. Jeung H.C., Rha S.Y., Kim H.K., Lim H.Y., Kim S., Kim S.Y., et al. Multi-institutional phase II study of S-1 monotherapy in advanced gastric cancer with pharmacokinetic and pharmacogenomic evaluations. Oncologist 12 (2007) 543-554
18. Dworak O., Keilholz L., and Hoffmann A. Pathological features of rectal cancer after preoperative radiochemotherapy. Int J Colorectal Dis 12 (1997) 19-23
19. Roh M.S., Colangelo L., and Wieand S. Response to preoperative multimodality therapy predicts survival in patients with carcinoma of the rectum. Proc Am Soc Clin Oncol 22 (2004) 246s
20. Hartley A., Hooper A.T., and Bassi R. Pathological complete response following pre-operative chemoradiotherapy in rectal cancer: analysis of phase II/III trials. Br J Radiol 78 (2005) 934-938
21. Gollins S.W., Myint S., Levine E., Morris J., Haylock B., Susnerwala S., et al. Phase I study of radiotherapy (RT) plus concurrent irinotecan (CPT-11) and capecitabine (CAP) as preoperative downstaging treatment for locally advanced inoperable rectal cancer. Proc Am Soc Clin Oncol 23 (2005) 16s
22. Hofheinz R.D., von Gerstenberg-Helldorf B., Wenz F., Gnad U., Kraus-Tiefenbacher U., Muldner A., et al. Phase I trial of capecitabine and weekly irinotecan in combination with radiotherapy for neoadjuvant therapy of rectal cancer. J Clin Oncol 23 (2005) 1350-1357
23. Klautke G., Kuchenmeister U., Foitzik T., Ludwig K., Prall F., Klar E., et al. Concurrent chemoradiation with capecitabine and weekly irinotecan as preoperative treatment for rectal cancer: results from a phase I/II study. Br J Cancer 94 (2006) 976-981
24. Sato T., Kokuba Y., Koizumi W., Hayakawa K., Okayasu I., and Watanabe M. Phase I trial of neoadjuvant preoperative chemotherapy with S-1 and irinotecan plus radiation in patients with locally advanced rectal cancer. Int J Radiat Oncol Biol Phys 69 (2007) 1442-1447
25. Hoff P.M., Janjan N., Saad E.D., Skibber J., Crane C., Lassere Y., et al. Phase I study of preoperative oral uracil and tegafur plus leucovorin and radiation therapy in rectal cancer. J Clin Oncol 18 (2000) 3529-3534
26. de la Torre A., Ramos S., Valcarcel F.J., Candal A., Regueiro C.A., Romero J., et al. Phase II study of radiochemotherapy with UFT and low-dose oral leucovorin in patients with unresectable rectal cancer. Int J Radiat Oncol Biol Phys 45 (1999) 629-634
27. Yasui M., Ikeda M., Sekimoto M., Yamamoto H., Takemasa I., Ueda T., et al. Preliminary results of phase I trial of oral uracil/tegafur (UFT), leucovorin plus irinotecan and radiation therapy for patients with locally recurrent rectal cancer. World J Surg Oncol 4 (2006) 83
28. Yamada Y., Yasui H., Goto A., Arai T., Ura T., Hamaguchi T., et al. Phase I study of irinotecan and S-1 combination therapy in patients with metastatic gastric cancer. Int J Clin Oncol 8 (2003) 374-380
29. Glynne-Jones R., Dunst J., and Sebag-Montefiore D. The integration of oral capecitabine into chemoradiation regimens for locally advanced rectal cancer: how successful have we been?. Ann Oncol 17 (2006) 361-371