Concomitant chemoradiotherapy using low-dose weekly gemcitabine versus low-dose weekly paclitaxel in locally advanced head and neck squamous cell carcinoma: A phase III study

Medical Oncology

Volumn 29, Issue 1, 2012, Pages 279-284

  Halim, Amal Ahmed Fouad ^a   Wahba, Hanan Ahmed ^a   El Hadaad, Hend Ahmed ^a   Abo Elyazeed, Ahmed ^a  

^a MANSOURA UNIVERSITY   (Egypt)

Author keywords

Concomitant chemoradiotherapy; Gemcitabine; Head and neck cancer; Paclitaxel

Indexed keywords

CIMETIDINE; DEXAMETHASONE; DIPHENHYDRAMINE; GEMCITABINE; PACLITAXEL;

ACUTE TOXICITY; ADULT; ADVANCED CANCER; AGED; ANEMIA; ARTICLE; BLOOD TOXICITY; CANCER SURVIVAL; CHEMORADIOTHERAPY; CLINICAL PROTOCOL; CONTROLLED STUDY; DERMATITIS; DISEASE SEVERITY; DISTANT METASTASIS; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG TOLERABILITY; DYSPHAGIA; ENTERIC FEEDING; FEMALE; HEAD AND NECK SQUAMOUS CELL CARCINOMA; HUMAN; LOW DRUG DOSE; LUNG METASTASIS; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; NEUTROPENIA; OVERALL SURVIVAL; PARENTERAL NUTRITION; PHASE 3 CLINICAL TRIAL; PREMEDICATION; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RADIATION DERMATITIS; RADIATION SICKNESS; RANDOMIZED CONTROLLED TRIAL; SKIN TOXICITY; SUBCUTANEOUS TISSUE; TRACHEOSTOMY; TREATMENT FAILURE; TREATMENT OUTCOME; TREATMENT PLANNING; TREATMENT RESPONSE;

ADULT; AGED; ANTINEOPLASTIC AGENTS; CARCINOMA, SQUAMOUS CELL; CHEMORADIOTHERAPY; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; FEMALE; HEAD AND NECK NEOPLASMS; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; NEOPLASM GRADING; NEOPLASM STAGING; PACLITAXEL; YOUNG ADULT;

EID: 84864053366     PISSN: 13570560     EISSN: 1559131X     Source Type: Journal    
DOI: 10.1007/s12032-010-9811-x     Document Type: Article

References (42)

1. Argiris A, Karamouzis MV, Raben D, Ferris RL. Head and neck cancer. Lancet. 2008;371:1695-709. (Pubitemid 351671886)
2. Fu KK, Phillips TL, Silverberg IJ, Jacobs C, Goffinet DR, Chun C, et al. Combined radiotherapy and chemotherapy with belomycin and methotrexate for advanced inoperable head and neck cancer. J Clin Oncol. 1987;5:1410-8.
3. Gupta NK, Pointon RC, Wilkinson PM. A randomized clinical trial to compare radiotherapy with radiotherapy and methotexate given synchronously in head and neck cancer. Clin Radiol. 1987; 38:575-81.
4. Merlano M, Vitale V, Rossa R, Benasso M, Corvo R, Forastiere A, et al. Treatment of advanced squamous cell carcinoma of the head and neck with alternating chemotherapy and radiotherapy. N Eng J Med. 1992;237:1115-21.
5. Brizel DM, Albers ME, Fisher SR, Scher RL, Richtsmeier WJ, Hars V, et al. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Eng J Med. 1998;338:1798-804. (Pubitemid 28277960)
6. Calais G, Alfonsi M, Bardet E, Sire C, Germain T, Bergerot P, et al. Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced stage oro-pharynx carcinoma. J Natl Cancer Inst. 1999;91:2081-6. (Pubitemid 30019568)
7. Hafty BG, Son YH, Papec R, Sasaki CT, Weissberg JB, Fischer D, et al. Chemotherapy as an adjunct to radiation in the treatment of squamous cell carcinoma of the head and neck: results of the Yale mitomycin randomized trials. J Clin Oncol. 1997;15: 268-76. (Pubitemid 27020583)
8. Wendt TG, Grabenbauer GC, Rodel CM, Thiel HJ, Aydin H, Rohloff R, et al. Simultaneous radiochemotherapy versus radiotherapy alone in advanced head and neck cancer: a randomized multicenter trial. J Clin Oncol. 1998;16:1318-24. (Pubitemid 28175746)
9. Gandhi V, Huang P, Xu YZ, Heinemann V, Plunkett W. Metabolism and action of 2, 2-difluorodeoxycytidine: self-potentiation of cytotoxicity. Adv Exp Med Biol. 1991;309A: 125-30.
10. Plunkett W, Huang P, Xu YZ, Heinemann V, Grunewald R, Gandhi V. Gemcitabine: metabolism, mechanism of action, and self potentiation. Semin Oncol. 1995;22(Supp 11):3-10.
11. Plunkett W, Huang P, Gandhi V. Preclinical characteristics of gemcitabine. Anti-cancer Drugs. 1995;6(suppl 6):7-13. (Pubitemid 26014890)
12. 00-deoxycytidine. Int J Radiat Oncol Biol Phy. 1996;34: 867-72.
13. Hernandez P, Oivera P, Duenas-Gonzalez A, Pérez-Pastenes MA, Zárate A, Maldonado V, et al. Gemcitabine activity in cervical cancer cell lines. Cancer Chemother Pharmacol. 2001;48:488-92. (Pubitemid 33139871)
14. 00-deoxycytidine and radiation sensitization of human colon carcinoma cells. Cancer Res. 1994; 54:3218-23.
15. 00-difluorodeoxy cytidine against head and neck cancer. Cancer Res. 1991;51:211-4.
16. Joschko MA, Webster LK, Groves J, Yuen K, Palatsides M, Ball DL, et al. Enhancement of radiation induced regrowth delay by gemcitabine in a human tumor xenograft model. Radiat Oncol Invest. 1997;5:62-71. (Pubitemid 27323505)
17. Eisbruch A, Shewach DS, Urba S, Bradford CR, Littles JF, Teknos TN et al. Phase I trial of radiation concurrent with low-dose gemcitabine for head and neck cancer: high mucosal and pharyngeal toxicity. Proc Am Soc Clin Oncol. 1997;16:386a (Abstr 1377).
18. Aguilar-Ponce J, Granados-García M, Villavicencio V, Poitevin-Chacón A, Green D, Dueñas-González A, et al. Phase II trial of gemcitabine concurrent with radiation for locally advanced squamous cell carcinoma of the head and neck. Ann Oncol. 2004;15:301-7.
19. Schiff PB, Fant J, Howrwitz SB. Promotion of microtubule assembly in vitro by taxol. Nature. 1979;277:665-7. (Pubitemid 9114288)
20. Schiff PB, Horwitz SB. Taxol stabilizes microtubules in mouse fibroblast cells. Proc Natl Acad Sci USA. 1980;77:1561-5. (Pubitemid 10073801)
21. Terasima R, Tolmach LJ. X-ray sensitivity and DNA synthesis in synchronous populations of Hela cells. Science. 1963;140:490-2.
22. Milas L, Milas MM, Moson KA. Combination of taxanes with radiation: preclinical studies. Semin Radiat Oncol. 1999;9:12-26. (Pubitemid 29190407)
23. Elomaa L, Joensuu H, Kulmala J, Klemi P, Grénman R. Squa-mous cell carcinoma is highly sensitive to taxol, a possible new radiation sensitizer. Acta Otolaryngol (Stockh). 1995;115:340-4.
24. Leonard CE, Chan DC, Chou TC, Kumar R, Bunn PA. Paclitaxel enhances in vitro radiosensitivity of squamous carcinoma cell lines of the head and neck. Cancer Res. 1996;65:5198-204. (Pubitemid 26383036)
25. Rosenthal DI, Carbone DP. Taxol plus radiation for head and neck cancer. J Infus Chemoth. 1995;5:46-54.
26. Milas L, Hunter NR, Mason KA, Milross CG, Saito Y, Peters LJ. Role of reoxygenation in induction of enhancement of tumor radioresponse by paclitaxel. Cancer Res. 1995;55:3564-8.
27. Hoffmann W, Belka C, Schmidberger H, Budach W, Bochtler H, Hess CF, et al. Radiotherapy and concomitantly weekly 1-hour infusion of paclitaxel in the treatment of head and neck cancer: results from a phase I trial. Int J Radiat Oncol Biol Phys. 1997;38: 691-6. (Pubitemid 27310536)
28. Seif Eldein I, Ismail K, Hablas A, Hussein H, Elhamzawy H, Ramadan M editors. Cancer Egypt Gharbia, triennial report of 2000-2002, Gharbia Population-Based Cancer Registery. 1st ed. Tanta: El Meahy press; 2007. pp. 96-03.
29. Choeng N, Vores E. Expanding role of the medical oncologist in the management of head and neck cancer. CA Cancer J Clin. 2008;58:32-53.
30. Adelstein D, Rodriguez C. Current and emerging standards of concomitant chemoradiotherapy. Semin Oncol. 2008;35:211-20. (Pubitemid 351787694)
31. Bourhis J, Le Mâitre A, Baujat B, Audry H, Pignon JP. Individual patients' data meta-analysis in head and neck cancer. Curr Opin Oncol. 2007;19:188-94. (Pubitemid 46597476)
32. Eisbruch A, Shewach DS, Bradford CR, Littles JF, Teknos TN, Chepeha DB, et al. Radiation concurrent with gemcitabine for locally advanced head and neck cancer: a phase I trial and intra-cellular drug incorporation study. J Clin Oncol. 2001;19:792-9. (Pubitemid 32119095)
33. Hainsworth JD, Meluch AA, McClurkan S, Gray JR, Stroup SL, Burris HA 3rd, et al. Induction paclitaxel, carboplatin, and infusional 5-Fu followed by concurrent radiation therapy and weekly paclitaxel/carboplatin in the treatment of locally advanced head and neck cancer: a phase II trial of the Minnie Pearl Cancer Research Network. Cancer J. 2002;8:311-21.
34. Jain RK, Kirar P, Gupta G, Dubey S, Gupta SK, Goyal J. A comparative study of low dose weekly paclitaxel versus cisplatin with concurrent radiation in the treatment of locally advanced head and neck cancers. In J Cancer. 2009;46:50-3.
35. Trotti A, Bellm LA, Epstein JB, Frame D, Fuchs HJ, Gwede CK, et al. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systemic literature review. Radiother Oncol. 2003;66:253-62. (Pubitemid 36556043)
36. Hoffstetter S, Marchal C, Peiffert D, Luporsi E, Lapeyre M, Pernot M, et al. Treatment duration as a prognostic factor for local control and survival in epidermoid carcinoma of the ton-sillar region treated by combined external beam irradiation and brachytherapty. Radiother Oncol. 1997;45:141-8. (Pubitemid 27521086)
37. Tarnawski R, Fowler J, Skladowski K, Swierniak A, Suwiński R, Maciejewski B, et al. How fast is repopulation of tumor cells during the treatment gap? Int J Radiat Oncol Biol Phys. 2002; 54:229-36.
38. Suwinski R, Sowa A, Rutkowski T, Wydmanski J, Tarnawski R, Maciejewski B. Time factor in postoperative radiotherapy: a multivariate locoregional control analysis in 868 patients. Int J Radiat Oncol Biol Phys. 2003;56:399-412. (Pubitemid 36542899)
39. Langendijk JA, de Jong MA, Leemans CR, de Bree R, Smeele LE, Doornaert P, et al. Postoperative radiotherapy in squamous cell carcinoma of the oral cavity: the importance of the overall treatment time. Int J Radiat Oncol Biol Phys. 2003;57:693-700. (Pubitemid 37194295)
40. Lövey J, Koronczay K, Remenár E, Csuka O, Németh G. Radiotherapy and concurrent low-dose paclitaxel in locally advanced head and neck cancer. Radiother Oncol. 2003;68: 171-4. (Pubitemid 38367550)
41. Specenier PM, Van den Weyngaert D, Van Laer C, Weyler J, Van den Brande J, Huizing MT, et al. Phase II feasibility study of concurrent radiotherapy and gemcitabine in chemonaive patients with squamous cell carcinoma of the head and neck: long term follow up data. Ann Oncol. 2007;18:1856-60. (Pubitemid 350111572)
42. Chauhan A, Singh H, Sharma T, Manocha KK. Gemcitabine concurrent with radiation therapy for locally advanced head and neck carcinomas. Afr Health Sci. 2008;8:149-55.