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© 2004 Oxford University Press
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Randomized Phase III Trial of Neoadjuvant Chemotherapy in Head and Neck Cancer: 10-Year Follow-Up
Affiliations of authors: Radiotherapy Department (PLZ, AG), Otorinolaryngology Department (CM, AF), Medical Oncology Department (AO), Ospedale Ca' Foncello, Treviso, Italy; Medical Oncology Department (AP, MGG), Radiotherapy Department (CAM), Ospedale Civile, Venezia, Italy; Otorinolaryngology Department (GC, MCDM), Radiotherapy Department (LL, LT), Oncology Department (VCS), Medical Oncology Department (GLP), Ospedale Civile, Padova, Italy; Otorinolaryngology Department (FB), Ospedale di Trecenta, Trecenta, Italy; Otorinolaryngology Department (FL), Ospedale di Monselice, Monselice, Italy; Radiotherapy Department (AB), Ospedale di Belluno, Belluno, Italy; Radiotherapy Department (AJ), Ospedale di Legnago, Legnago, Italy
Correspondence to: Adriano Paccagnella, MD, Medical Oncology Department, SS Giovanni and Paolo Hospital, Campo S Giovanni e Paolo, 30100 Venice, Italy (e-mail: adriano.paccagnella{at}ulss12.ve.it)
In 1986, we initiated a multicenter, randomized trial to compare induction chemotherapy with cisplatin and 5-fluorouracil followed by locoregional treatment (surgery and radiotherapy or radiotherapy alone) with locoregional treatment alone in patients with head and neck squamous cell carcinoma. Here we report the long-term results of the trial. A total of 237 patients with nonmetastatic stage III or IV head and neck carcinoma were randomly assigned to receive four cycles of neoadjuvant chemotherapy followed by locoregional treatment (group A) or locoregional treatment alone (group B). Among all patients, overall survival at 5 and 10 years was 23% (95% confidence interval [CI] = 15.3% to 30.9%) and 19% (95% CI = 11.6% to 26.4%), respectively, for those in group A and 16% (95% CI = 9.6% to 23.4%) and 9% (95% CI = 3.5% to 14.7%), respectively, for those in group B (P = .13). Among operable patients, we observed no difference between group A and group B in overall survival at 5 and 10 years (group A, 31% [95% CI = 14.9% to 47.3%] and 22.7% [95% CI = 7.1% to 38.3%], respectively; group B, 43.3% [95% CI = 25.6% to 61.0%] and 14.2% [95% CI = 0.1% to 28.3%], respectively; P = .73). Among inoperable patients, overall survival at 5 and 10 years was 21% (95% CI = 12.3% to 30.1%) and 16% (95% CI = 7.7% to 23.9%), respectively, for group A and 8% (95% CI = 1.5% to 12.3%) and 6% (95% CI = 0.1% to 9.1%), respectively, for group B (log-rank P = .04). Four cycles of neoadjuvant chemotherapy is a promising approach for treating patients with inoperable advanced head and neck cancer but not for treating patients with operable disease.
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Editorial about this Article
- Is There a New Role for Induction Chemotherapy in the Treatment of Head and Neck Cancer?
- Arlene A. Forastiere
J Natl Cancer Inst 2004 96: 1647-1649.[Extract] [Full Text] [PDF]
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