Chemoradiation with raltitrexed and oxaliplatin in preoperative treatment of stage II-III resectable rectal cancer: Phase I and II studies

International Journal of Radiation Oncology Biology Physics

Volumn 60, Issue 1, 2004, Pages 139-148

  Gambacorta, Maria Antonietta ^a   Valentini, Vincenzo ^a   Coco, Claudio ^a   Morganti, Alessio Giuseppe ^a   Smaniotto, Daniela ^a   Miccichè, Francesco ^a   Mantini, Giovanna ^a   Barbaro, Brunella ^a   Garcia Vargas, Jose E ^b   Magistrelli, Paolo ^a   Picciocchi, Aurelio ^a   Cellini, Numa ^a  

^a CATHOLIC UNIVERSITY   (Italy)

^b ASTRAZENECA   (United Kingdom)

Author keywords

Oxaliplatin; Raltitrexed; Rectal carcinoma; Tomudex

Indexed keywords

CHEMORADIATION; OXALIPLATIN;

CARCINOGENS; CHEMOTHERAPY; DIAGNOSIS; PATHOLOGY; SURGERY; TUMORS;

RADIOTHERAPY;

OXALIPLATIN; RALTITREXED;

ADULT; AGED; ALOPECIA; ANEMIA; ANUS SPHINCTER; ARTICLE; BLOOD TOXICITY; CANCER ADJUVANT THERAPY; CANCER RADIOTHERAPY; CANCER STAGING; CANCER SURGERY; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYSTITIS; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SCREENING; DYSESTHESIA; FEMALE; GAMMA IRRADIATION; GASTROINTESTINAL TOXICITY; HUMAN; LEUKOPENIA; LIVER TOXICITY; MALE; MAXIMUM TOLERATED DOSE; NEPHROTOXICITY; NEUROTOXICITY; NEUTROPENIA; OTOTOXICITY; PARESTHESIA; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PREOPERATIVE CARE; PRIORITY JOURNAL; PROCTITIS; RECTUM CARCINOMA; SKIN TOXICITY; THROMBOCYTOPENIA; TREATMENT WITHDRAWAL;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COMBINED MODALITY THERAPY; FEMALE; FLUOROURACIL; HUMANS; MALE; MIDDLE AGED; NEOPLASM STAGING; ORGANOPLATINUM COMPOUNDS; QUINAZOLINES; RADIOTHERAPY DOSAGE; RECTAL NEOPLASMS; THIOPHENES;

EID: 4444375375     PISSN: 03603016     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijrobp.2004.01.051     Document Type: Article

References (47)

1. Jackman A.L., Taylor G.A., Gibson W., et al. ICI D1694, a quinazoline antifolate thymidylate synthase inhibitor that is a potent inhibitor of L1210 tumor cell growth in vitro and in vivo A new agent for clinical study. Cancer Res. 51:1991;5579-5586
2. Jackman A.L., Calvert A.H. Folate-based thymidylate synthase inhibitors as anticancer drugs. Ann Oncol. 6:1995;871-881
3. Teicher B.A., Ara G., Chen Y.N., et al. Interaction of Tomudex with radiation in vitro and in vivo. Int J Oncol. 13:1998;437-442
4. Mamenta E.L., Poma E.E., Kaufmann W.K., et al. Enhanced replicative bypass of platinum-DNA adducts in cisplatin-resistant human ovarian carcinoma cell lines. Cancer Res. 54:1994;3500-3505
5. Pendyla L., Creaven P.J., Shah G., et al. In vitro cytotoxicity studies of oxaliplatin in human tumor cell lines. Proc Am Cancer Res. 32:1991;410
6. Martoni A., Mini E., Pinto C., et al. Oxaliplatin plus raltitrexed in the treatment of patients with advanced colorectal cancer A phase II study. Anticancer Res. 23:2003;687-691
7. Schull B., Scheithauer W. Raltitrexed and oxaliplatin in colorectal cancer In vitro and in vivo study of a synergistic cytostatic combination. Acta Med Austriaca. 29:2002;124-131
8. Neri B., Doni L., Fulignati C., et al. Raltitrexed plus oxaliplatin as a first-line chemotherapy in metastatic colorectal carcinoma A multicentric phase II trial. Anticancer Drugs. 13:2002;719-724
9. Seitz J.F., Bennouna J., Paillot B., et al. Multicenter non-randomized phase II study of raltitrexed (Tomudex) and oxaliplatin in non-pretreated metastatic colorectal cancer patients. Ann Oncol. 13:2002;1072-1079
10. Cascinu S., Graziano F., Ferrau F., et al. Raltitrexed plus oxaliplatin (TOMOX) as first-line chemotherapy for metastatic colorectal cancer A phase II study of the Italian Group for the Study of Gastrointestinal Tract Carcinomas (GISCAD). Ann Oncol. 13:2002;716-720
11. Scheithauer W., Kornek G.V., Schuell B., et al. Second-line treatment with oxaliplatin + raltitrexed in patients with advanced colorectal cancer failing fluoropyrimidine/leucovorin-based chemotherapy. Ann Oncol. 12:2001;709-714
12. Douillard J, Michel P, Gamelin E, et al. Raltitrexed ('Tomudex') plus oxaliplatin: An active combination for first-line chemotherapy in patients with metastatic colorectal cancer [Abstract]. Proc Am Soc Clin Oncol 2000;19:250a
13. UICC International Union Against Cancer. TNM classification of malignant tumours. 4th ed, 2nd revision:1992;Springer-Verlag, Berlin
14. Valentini V., Doglietto G.B., Morganti A.G., et al. Pre-operative chemoradiation with raltitrexed ('Tomudex') for T2/N+ and T3/N+ rectal cancers A phase I study. Eur J Cancer. 37:2001;2050-2205
15. Arbuck S.G. Workshop on phase I study design. Ninth NCI/EORTC New Drug Development Symposium. Amsterdam, March 12, 1996. Ann Oncol. 7:1996;567-573
16. Capirci C., Polico C., Mandoliti G. Dislocation of small bowel volume within box pelvic treatment fields, using new "up down table" device. Int J Radiat Oncol Biol Phys. 51:2001;465-473
17. International Commission on Radiation Units and Measurements. ICRU report 50: Prescribing, recording and reporting photon beam therapy. 1993;ICRU, Bethesda
18. International Commission on Radiation Units and Measurements. ICRU report 62: Prescribing, recording and reporting photon beam therapy (supplement to ICRU report 50). 1999;ICRU, Bethesda
19. Machover D., Schwarzenberg L., Goldschmidt E., et al. Treatment of advanced colorectal and gastric adenocarcinomas with 5-FU combined with high-dose folinic acid A pilot study. Cancer Treat Rep. 66:1982;1803-1807
20. Miller A.B., Hoogstraten B., Staquet M., et al. Reporting results of cancer treatment. Cancer. 47:1981;207-214
21. Perez C.A., Brady L.W. Overview. Perez C.A., Brady L.W. Principles and practice of radiation oncology. 2nd ed:1992;1-62 Lippincott, Philadelphia
22. Marano P., Barbaro B., De Franco A., et al. The experience of diagnostic and therapeutic integration in rectal cancer Preliminary notes. Radiol Med (Torino). 84:1992;261-273
23. Valentini V., Coco C., Cellini N., et al. Pre-operative chemoradiation for extraperitoneal T3 rectal cancer Acute toxicity, tumor response, and sphincter preservation. Int J Radiat Oncol Biol Phys. 40:1998;1067-1075
24. Mandard A.M., Dalibard F., Mandard J.C., et al. Pathologic assessment of tumor regression grade after pre-operative chemoradiotherapy of esophageal carcinoma Clinicopathologic correlations. Cancer. 73:1994;2680-2686
25. Tepper J.E., O'Connell M.J., Petroni G.R., et al. Adjuvant postoperative fluorouracil-modulated chemotherapy combined with pelvic radiation therapy for rectal cancer Initial results of Intergroup 0114. J Clin Oncol. 15:1997;2030-2039
26. Krook J.E., Moertel C.G., Gunderson L.L., et al. Effective surgical adjuvant therapy for high-risk rectal carcinoma. N Engl J Med. 324:1991;709-715
27. O'Connell M.J., Martenson J.A., Wieand H.S. Improving adjuvant therapy for rectal cancer by combining protracted-infusion fluorouracil with radiation therapy after curative surgery. N Engl J Med. 331:1994;502-507
28. Dewit L. Combined treatment of radiation and cisdiamminedichloroplatinum (II) A review of experimental and clinical data. Int J Radiat Oncol Biol Phys. 13:1987;403-426
29. Douple E.B., Richmond R.C. Radiosensitization of hypoxic tumor cells by cis- and trans-dichlorodiammineplatinum (II). Int J Radiat Oncol Biol Phys. 13:1979;1369-1372
30. Begg A.C., van der Kolk P.J., Dewit L., et al. Radiosensitization by cisplatin of RIF 1 tumour cells in vitro. Int J Radiat Oncol Biol Relat Phys Stud Chem Med. 50:1986;871-884
31. Chari R.S., Tyler D.S., Anscher M.S., et al. Pre-operative radiation and chemotherapy in the treatment of adenocarcinoma of the rectum. Ann Surg. 221:1995;778-786
32. Alvarez M.V., Cobreros G., Heras A., et al. Studies on cis-dichlorodiammineplatinum (II) as a radiosensitizer. Br J Cancer. 37:1978;68-72
33. Valentini V., Coco C., Cellini N., et al. Pre-operative chemoradiation with cisplatin and 5-fluorouracil for extraperitoneal T3 rectal cancer Acute toxicity, tumor response, sphincter preservation. Int J Radiat Oncol Biol Phys. 45:1999;1175-1184
34. Machover B., Diaz-Rubio E., de Gramont A., et al. Two consecutive phase II studies of oxaliplatin (L-OHP) for treatment of patients with advanced colorectal carcinoma who were resistant to previous treatment with fluoropyrimidines. Ann Oncol. 7:1996;95-98
35. Raymond E., Djeloul S., Buquet-Fagot C., et al. Oxaliplatin (LOHP) and cisplatin (CDDP) in combination with 5-FU specific thymidilate synthase (TS) inhibitors (AG337, ZD1694), and topoisomerase I (Topo-I) inhibitors (SN38, CPT-11) in human colonic, ovarian, and breast cancer. [Abstract] Proc Am Assoc Cancer Res. 37:1996;291
36. Hess S., Blackstock W. Oxaliplatin In vitro and in vivo evidence of its radiation sensitizing activity. Preclinical observation relevant to ongoing clinical trials. [Abstract] Proc Am Assoc Cancer Res. 41:2000;53
37. Blackstock W., Tepper J.E., Case D.L., et al. In vitro and in vivo radiosensitization of colon cancer cells by cis-[(1R,2R)-1-2-cuclohexanediamine- N,N′] [oxalato(2-)-OO] platinum (oxaliplatin). [Abstract] Int J Mol Med. 10:(Suppl. 1):2002;S68
38. Cividalli A., Ceciarelli F., Livdi E., et al. Radiosensitization by oxaliplatin in a mouse adenocarcinoma Influence of treatment schedule. Int J Radiat Oncol Biol Phys. 52:2002;1092-1098
39. McMullen K.P., Blackstock A.W. Chemoradiation with novel agents for rectal cancer. Clin Colorectal Cancer. 2:2002;24-30
40. Freyer G., Bossard N., Romestaing P., et al. Addition of oxaliplatin to continuous fluorouracil, 1-folinic acid, and concomitant radiotherapy in rectal cancer The Lyon R 97-03 phase I trial. J Clin Oncol. 19:2001;2433-2438
41. Gérard J.P., Chapet O., Nemoz C., et al. Pre-operative concurrent chemoradiotherapy in locally advanced rectal cancer with high-dose radiation and oxaliplatin-containing regimen The Lyon R0-04 phase II trial. J Clin Oncol. 21:2003;1119-1124
42. Shumate C.R., Rich T.A., Skibber J.M., et al. Pre-operative chemotherapy and radiation therapy for locally advanced primary and recurrent rectal carcinoma A report of surgical morbidity. Cancer. 7:1993;3690-3696
43. Grann A., Minsky B.D., Cohen A.M., et al. Preliminary results of pre-operative 5-fluorouracil, low-dose leucovorin, and concurrent radiation therapy for clinically resectable T3 rectal cancer. Dis Colon Rectum. 40:1997;515-522
44. Garcia-Vargas J.E., Sahmoud T., Smith M.P., et al. Qualitative and chronological assessment of toxicities during treatment with raltitrexed ('Tomudex') in 861 patients Implications for patient management. [Abstract] Eur J Cancer. 35:(Suppl. 4):1999;S72
45. Minsky B.D., Conti J.A., Huang Y., et al. Relationship of acute gastrointestinal toxicity and the volume of irradiated small bowel in patients receiving combined modality therapy for rectal cancer. J Clin Oncol. 13:1995;1409-1416
46. James R., Price P., Valentini V. Raltitrexed (Tomudex) concomitant with radiotherapy as adjuvant treatment for patientswith rectal cancer Preliminary results of phase I studies. Eur J Cancer. 35:(Suppl. 1):1999;S19-S22
47. Vecchio F.M., Valentini V., Padula G., et al. A pathologic score system after pre-operative combined modality therapy as a predictor of metastases-free-survival in the management of rectal carcinoma. [Abstract] Int J Radiat Oncol Biol Phys. 54:(Suppl. 2):2002;1083