Neoadjuvant chemotherapy consisting of cisplatin and continuous infusions of bleomycin and 5-fluorouracil for advanced head and neck cancer. The need for a new stratification for stage IV (MO) disease

Abstract

A Phase II study of cisplatin (100 mg/m2 on day 1 and bleomycin (15 mg intravenous push day 1) followed by 5 days of continuous intravenous infusions of 5‐fluorouracil (5‐FU) (650 mg/m2/d) and bleomycin (16 mg/m2/d) repeated at 21‐day intervals was performed in 54 previously untreated patients with nonmetastatic (MO), locoregionally advanced head and neck squamous cell carcinoma (SCC). The aim of this study was to increase the complete response rate to chemotherapy and to identify prognostic factors that may influence local control and disease‐free survival. From April 1986 until August 1988, 5 patients with Stage III and 49 with Stage IV (International Union Against Cancer‐American Joint Committee on Cancer 1986 [UICC‐AJCC]) disease received this regimen. Thirty (61%) patients with Stage IV disease had bulky nodal disease (9 N2c and 21 N3) and 29 (53%) had T4 primary lesions. The response rate was 59% (95% confidence interval, 47% to 71%) and the complete response rate to chemotherapy was 13% (95% confidence interval, 0% to 26%). The response rate was greatly influenced by tumoral volume and performance status (PS). The complete response rate to chemotherapy was 40% for patients with Stage III disease (2 of 5 patients) versus 10% for patients with Stage IV disease (5 of 49 patients; P = 0.02). The response rate for patients with Stage III disease was 100% (5 of 5 patients) versus 55% for patients with Stage IV disease (27 of 49 patients; P = 0.14). For patients with Stage IV bulky nodal disease (N2c‐N3), the response rate was 43% (13 of 30 patients) and the complete response rate to chemotherapy was 3% (1 of 30 patients) versus 68% (13 of 19 patients; P = 0.13) and 21% (4 of 19 patients; P = 0.07), respectively, for patients with Stage IV less than N2b disease. The local control rate after definitive therapy was 100% for patients with Stage III disease, 70% (17 of 24 patients) for patients with Stage IV less than N2b disease, and 17% (5 of 30 patients) for patients with bulky nodal disease (P = 0.0005). As of February 1991, with a median follow‐up time of 38 months (range, 30 to 53 months), 4 of 5 patients with Stage III disease and 7 of 19 patients with Stage IV less than N2b disease were alive with no evidence of disease (37%) versus 0 of 30 patients with bulky nodal disease (P = 0.001). In advanced head and neck SCC, the variations in the complete response rate to chemotherapy, the obtaining of local control, and the success of multimodality treatment depend on tumoral volume, especially nodal tumoral volume. The differences between Stages III and IV, and within the Stage IV category for greater than N2c‐N3 disease, point to the need for a better definition of prognostic groups in future trials. Cancer 68:2109–2119.

Outcomes in Squamous Cell Carcinoma with Advanced Neck Disease

“…In treating patients with advanced head and neck cancer, there has been a recent trend away from surgery towards chemotherapy and/or radiotherapy thereby improving tumour response rates and disease control whilst attempting to achieve organ preservation. [6][7][8][9][10][11][12] Ahmed et al 6 used concomitant chemoradiotherapy and surgical salvage for N3 nodal disease. Intra-arterial cisplatin and radiotherapy was given with surgical salvage for patients with N3 nodal disease.…”

“…From these studies, it has been suggested that large volume lymph node metastasis is unlikely to be cured by radiotherapy or by chemoradiotherapy alone. 8,9 Given these results, it is uncertain how this group of patients should be managed and whether aggressive surgery still has arole. Results for neck recurrence in advanced neck disease have been controversial in the literature.…”

Efficacy of Concomitant Chemoradiation and Surgical Salvage for N3 Nodal Disease Associated With Upper Aerodigestive Tract Carcinoma

“…Recondo et al 26 investigated the effects of treating advanced head and neck cancer patients with neoadjuvant cisplatin, continuous intravenous bleomycin, and 5‐FU. An overall response rate of 43% was reported for patients with N2C‐N3 disease, and the 3‐year survival was reported to be below 15%.…”

Prognostic value of the sixth edition of the UICC's TNM classification and stage grouping for oral cancer

“…Firstly, from 1987 (third edition), nodal status was measured as nodal size instead of fixation or mobility. Secondly, until 1997, stages I, II, and III defined a limited number of categories, whereas stage IV comprised multiple categories from T4N0M0 to T4N3M1, which led to a very limited prognostic value of the UICC group staging system 12, 13. In attempts to achieve a higher level of discrimination among categories than in the UICC stage classification, various models using the same T and N data have been described 3,10,12,14–16.…”