Randomized trial of neoadjuvant cisplatin and fluorouracil versus carboplatin and fluorouracil in patients with stage IV-M0 head and neck cancer

Journal of Clinical Oncology

Volumn 13, Issue 6, 1995, Pages 1493-1500

  De Andrés, Luís ^a,b   Brunet, Joan ^a   López Pousa, Antonio ^a   Burgués, Joaquim ^a   Vega, Manuel ^a   Tabernero, Josep M ^a   Mesía, Ricard ^a   López, Juan J ^a  

^a Hospital Sant Pau   (Spain)

^b HOSPITAL CLÍNIC   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; CISPLATIN; DIPHENHYDRAMINE; FLUOROURACIL; METOCLOPRAMIDE;

ADULT; AGED; ARTICLE; BLOOD TOXICITY; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER SURVIVAL; CLINICAL TRIAL; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; HEAD AND NECK CANCER; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REGRESSION ANALYSIS; TREATMENT OUTCOME; VOMITING;

EID: 0029061853     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1995.13.6.1493     Document Type: Article

References (44)

1. Dimery IW, Hong WK: Overview of combined modality therapies for head and neck cancer. J Natl Cancer Inst 85:95-111, 1993
2. Forastiere AA: Chemotherapy of head and neck cancer. Ann Oncol 3:11-14, 1992 (suppl 3)
3. Strong EW, Jacobs C, Vikram B, et al: Adjuvant chemotherapy for advanced head and neck squamous carcinoma. Final report of the Head and Neck Contracts Program. Cancer 60:301-311, 1987
4. Brunin F, Rodriguez J, Jaulerry C, et al: Induction chemotherapy in advanced head and neck cancer: Preliminary results of a randomized trial. Acta Oncol 28:61-65, 1989
5. Forastiere AA, Metch B, Schuller DE, et al: Randomized comparison of cisplatin plus fluorouracil and carboplatin plus fluorouracil versus methotrexate in advanced squamous-cell carcinoma of the head and neck: A Southwest Oncology Group Study. J Clin Oncol 10:1245-1251, 1992
6. Veterans Affairs Laryngeal Cancer Study Group: Induction chemotherapy plus radiation compared with surgery plus radiation in patients with advanced laryngeal cancer. N Engl J Med 324:1685-1690, 1991
7. De Andrés L, Brunet J, López A, et al: Function preservation in stage III squamous laryngeal carcinoma: Results with an induction chemotherapy protocol. Proc Am Soc Clin Oncol 13:289, 1994 (abstr 937)
8. Pfister DG, Strong E, Harrison L, et al: Larynx preservation with combined chemotherapy and radiation therapy in advanced but resectable head and neck cancer. J Clin Oncol 9:850-854, 1991
9. Kish J, Drelichman A, Jacobs J, et al: Clinical trial of cis-platinum and 5-fluorouracil infusion as initial treatment of advanced squamous carcinoma of head and neck. Cancer Treat Rep 66:471-474, 1982
10. Rooney M, Kish J, Jacobs J, et al: Improved complete response rate and survival in advanced head and neck cancer after three course induction therapy with 120-hour infusion 5-FU and cisplatin. Cancer 55:1123-1128, 1985
11. Jacobs CH, Goffinet DR, Goffinet L, et al: Chemotherapy as a substitute for surgery in the treatment of advanced resectable head and neck cancer. A report from the Northern California Oncology Group. Cancer 60:1178-1183, 1987
12. De Andrés L, López A, Alba E, et al: Carboplatin, an active drug in advanced head and neck cancer. Cancer Treat Rep 70:1173-1176, 1986
13. Eisenberger M, Hornedo J, Silva S, et al: Carboplatin (NSC-241-240): An active platinum analog for the treatment of squamous-cell carcinoma of the head and neck. J Clin Oncol 4:1506-1509, 1986
14. Grégoire V, Beauduin M, Humblet Y, et al: A phase I-II trial of induction chemotherapy with carboplatin and fluorouracil in locally advanced head and neck squamous cell carcinoma: A report from the UCL-Oncology Group, Belgium. J Clin Oncol 9:1385-1392, 1991
15. Forastiere A, Natale RB, Takasugi BJ, et al: A phase I-II trial of Carboplatin and 5-fluorouracil combination chemotherapy in advanced carcinoma of the head and neck. J Clin Oncol 5:190-196, 1987
16. Kaasa S, Thorud E, Tausjø E, et al: Phase I/II study of carboplatin and 5-fluorouracil in patients with advanced head and neck carcinoma. Eur J Cancer 27:576-579, 1991
17. Volling P, Schröder M, Rauschning W, et al: Carboplatin: The better platinum in head and neck cancer. Arch Otolaryngol Head Neck Surg 115:695-698, 1989
18. Olver IN, Dalley D, Woods R, et al: Carboplatin and continuous infusion 5-fluorouracil for advanced head and neck cancer. Eur J Cancer Clin Oncol 25:173-176, 1989
19. Tepmongkol P, Panichevalux A, Skulchan V, et al: Neoadjuvant carboplatin and 5 fluorouracil combination chemotherapy and radiotherapy in the treatment of locally advanced head and neck cancer: Primary report. J Med Assoc Thai 74:658-668, 1991
20. Martin M, Gehanno P, Depondt P, et al: A phase III study: Induction carboplatin and 5-fluorouracil before locoregional treatment vs locoregional treatment alone in head and neck carcinomas. Proc Am Soc Clin Oncol 13:281, 1994 (abstr 906)
21. Aisner J, Sinibaldi V, Eisenberger M: Carboplatin in the treatment of squamous cell head and neck cancers. Semin Oncol 19:60-65, 1992 (suppl 2)
22. Gaver RC, Georege AM, Deeb G: In vitro stability, plasma protein binding and blood cell partioning of 14C-carboplatin. Cancer Chemother Pharmacol 20:271-276, 1987
23. Newellm DR, Siddik ZH, Gumbrell LA, et al: Plasma free platinum pharmacokinetics in patients treated with high dose carboplatin. Eur J Cancer Clin Oncol 25:1399-1405, 1987
24. Mitchel RB, Ratain MJ, Vogelzang NJ: Rationale and technical aspects, in Lokich JJ (ed): Cancer Chemotherapy by Infusion. Chicago, IL, Precept 1990, pp 3-34
25. Vokes EE, Ackland SP, Vogelzang NJ: Cisplatin, carboplatin and gallium nitrate, in Lokich JJ (ed): Cancer Chemotherapy by Infusion. Chicago, IL, Precept, 1990, pp 176-196
26. George SL: The required size and length of a phase III clinical trial, in Buyse ME, Staquet MJ, Sylvester RJ (eds): Cancer Clinical Trials: Methods and Practice. Oxford, United Kingdom, Oxford University, 1984, pp 287-310
27. McPherson K: Interim analysis and stopping rules, in Buyse ME, Staquet MJ, Sylvester RJ (eds): Cancer Clinical Trials: Methods and Practice. Oxford, United Kingdom, Oxford University, 1984, pp 407-422
28. Cox DR: The Analysis of Binary Data. London, United Kingdom, Methuen, 1970
29. Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457-481, 1958
30. Mantel N: Evaluation of survival data and two new rank order statistics rising in its consideration. Cancer Chemother Rep 50:163-170, 1966
31. Cox DR: Regression models and life tables. J R Stat Soc 34:187-220, 1972
32. Fountzilas G, Kosmidis P, Beer M, et al: Factors influencing complete response and survival in patients with head and neck cancer treated with platinum-based induction chemotherapy. Ann Oncol 3:553-558, 1992
33. Leyvraz S, Ohnuma T, Lassus M, et al: Phase I study of carboplatin in patients with advanced cancer, intermittent intravenous bolus, and 24-hour infusion. J Clin Oncol 3:1385-1392, 1985
34. Calvert AH, Newell DR, Gumbrell LA, et al: Carboplatin dosage: Prospective evaluation of a simple formula based on renal function. J Clin Oncol 7:1748-1756, 1989
35. Egorin MJ, Jodrell DI: Utility of individualized carboplatin dosing alone and in combination regimens. Semin Oncol 19:132-138, 1992 (suppl 2)
36. Thompson SW, Davis LE, Kornfield M, et al: Cisplatin neuropathy. Cancer 54:1269-1275, 1984
37. Cersosimo RJ: Cisplatin neurotoxicity. Cancer Treat Rev 16:195-211, 1989
38. Spaulding MB, Fischer SG, Wolf GT, et al: Tumor response, toxicity, and survival after neoadjuvant organ-preserving chemotherapy for advanced laryngeal carcinoma. J Clin Oncol 12:1592-1599, 1994
39. Gralla RJ: Antiemetic therapy, in De Vita VT, Hellman S, Rosenberg SA (eds): Cancer: Principles and Practice of Oncology. Philadelphia, PA, Lippincott, 1993, pp 2338-2348
40. Rosenthal DI, Pistenmaa DA, Glatsein E: A review of neoadjuvant chemotherapy for head and neck cancer: Partially shrunken tumours may be both leaner and meaner. Int J Radiat Oncol Biol Phys 28:315-320, 1994
41. Bosl GJ, Strong E, Harrison L, et al: Chemotherapy and the management of locally advanced squamous cell carcinoma of the head and neck: Role in larynx preservation, in De Vita VT, Hellman S, Rosenberg S (eds): Important Advances in Oncology 1991. Philadelphia, PA, Lippincott, 1991, pp 191-203
42. Neijt JP: Ovarian cancer: Rethinking prognostic factors and chemotherapy, in American Society of Clinical Oncology (ed): Educational Book 1994. Thirtieth Annual Meeting. Chicago, IL, American Society of Clinical Oncology, 1994, pp 214-220
43. Bajorin DF, Sarosdy MF, Pfister DG, et al: Randomized trial of etoposide and cisplatin versus etoposide and carboplatin in patients with good-risk germ cell tumors: A multiinstitutional study. J Clin Oncol 11:598-606, 1993
44. Horwich A, Sleijfer D, Fossa S, et al: A trial of carboplatin-based combination chemotherapy in good prognosis metastatic testicular non seminoma. Proc Am Soc Clin Oncol 13:231, 1994 (abstr 709)