Two hundred and fifty-one patients with stage iii and iv (uicc staging system) squamous cell cancers of the oral cavity, oropharynx, hypopharynx and larynx were assessed between january 1980 and december 1988 at westmead hospital. Of these, 50 patients received palliative treatment or were not treated and the remaining 201 patients received treatment with curative intent by various combinations of radiotherapy, surgery and chemotherapy. Thirty-nine operable cases were entered into a multimodality protocol initiated in april 1985, which consisted of induction chemotherapy (cisplatin 100mg/m2 i.v. day 1, 5-fluorouracil 1000mg/m2 per 24h i.v. days 1–5, q3w × 2) followed by surgery and postoperative radiotherapy. The median follow-up for all 251 patients was 57 months. Actuarial 3-year survival rate for all 201 patients receiving radical treatment was 48% (stage iii 66%. Stage iv 36%p < 0.001). Overall actuarial local and nodal control rates at 3 years were 67% and 69%. Thirty-two of 201 patients (16%) developed distant metastases at a median time of 11 months. Twenty-one patients (10%) had a previous or subsequent second primary cancer. In the group of 39 protocol patients, overall actuarial survival, local and nodal control rates are 68%, 77% and 73% at 3 years. A group of 22 ‘protocol’ patients was compared with a group of 22 patients treated prior to commencement of the protocol, matched as closely as possible on the basis of site, stage, age, sex and ecog status. Utilizing risk ratios, the protocol group was 4.14 times more likely to survive than the matched non-protocol group (p = 0.023). Nineteen patients were eligible for admission to the protocol but were not entered because their tumours were assessed to be of limited extent. This group received less extensive treatment and was analysed for actuarial survival (57%). Local control (66%) and nodal control (77%). Eight patients entered onto the protocol did not undergo surgery on the grounds of achieving a complete response (clinically or histologically) to induction chemotherapy. Local control was 3 of 8 patients (38%) and nodal control 2 of 8 patients (25%). Only two of these eight patients are alive, with a median follow-up of 12 months. Complications of all treatment modalities were acceptable. We conclude that survival rates in locally advanced head and neck cancer patients may be significantly improved by multimodality regimens and that less extensive treatments in patients responding favourably to chemotherapy may give inferior results. However, the limitations of a retrospective analysis based upon small patient numbers require that these findings are confirmed in properly conducted randomized prospective clinical trials. Chemotherapy currently remains an investigational modality in the treatment of locally advanced head and neck cancer.
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