Synchronous radiotherapy and chemotherapy with cisplatin in the management of locally advanced or recurrent head and neck cancer.

A synergism between cisplatin and radiotherapy has been demonstrated in in vitro and in vivo studies. To improve the locoregional control of disease and the survival rate in patients affected by locally advanced or recurrent squamous cell carcinoma of the head and neck, we planned a Phase II study of concurrent radiotherapy, 2 Gy for 5 days every week for a total dose of 60-70 Gy with cisplatin 80 mg/m2 every 21 days for 2 or 3 doses (on days 1, 21, 42). Fifty-one patients were entered in the study; 48 were evaluable for response and toxicity; 18 (37.5%) had untreated Stage III disease; 25 (52%) had Stage IV disease; 5 (10.5%) had recurrent disease. The complete response rate in Stage III-IV patients was 63% (27 of 43) with 95% confidence limits from 48 to 77% (+/- 14.5%). In the group of five patients with recurrent disease, only one (20%) achieved a complete response. In patients with Stage III-IV disease, a significantly higher complete response rate was observed for those younger than 58.5 years (p = 0.05). The overall estimated 1- and 2-year survival was 59% and 37%, respectively, and a significantly better survival was observed in complete responders compared to partial responses or patients with stable disease (p = 0.037). Disease-free survival was 46% and 36% at 1 and 2 years, respectively. Distant failure occurred only in 12.5% of the patients. Overall, the treatment was well tolerated, and only three patients refused to complete the planned therapy. Gastrointestinal and hematological toxicity were the most common side effects. Data from present trial were compared with that of 50 patients with comparable characteristics treated with radiotherapy alone from 1985 to 1987 as a historical control. The complete response rate, the disease-free survival, and the overall survival appear to be better in the patients treated with chemoradiotherapy. It was concluded that the combination of chemoradiotherapy in patients with Stage III-IV head and neck squamous cell carcinoma is an effective and safe treatment with an apparent better locoregional control than radiotherapy alone. Survival results need to be evaluated in a Phase III randomized trial.

Simultaneous cis-platinum and radiotherapy in inoperable or locally advanced squamous cell carcinoma of the head and neck.

A synergism between cis-platinum (CDDP) and radiotherapy (RT) has been demonstrated both in culture systems and in clinical studies. On the above basis, we planned, in patients with locally advanced or unresectable squamous cell carcinoma of the head and neck, a concomitant treatment with CDDP 80 mg/m2 i.v. every 3 weeks for three doses (days 1, 21 and 42) and RT in the primary and in the neck nodes bilaterally, for a total dose of 60-70 Gy. Thirty-five untreated patients with poor prognosis unresectable stage II and stages III-IV disease were entered in the study and 32 were evaluable. Complete response (CR) rate was 75% (24/32) with 95% confidence limits from 60 to 90% (+/- 15%): 8 cases (25%) achieved a partial response, for an overall response rate of 100%. A significantly higher CR rate and a longer survival rate was observed in patients with good performance status (PS = 90-100) and stages II-III. The overall estimated 2-year survival is 46%; 59% for patients who obtained a CR versus 0% for those who achieved only a partial response. Overall the treatment was well tolerated and gastrointestinal and hematologic toxicities were the most common side effects. In conclusion, the combination of CDDP plus RT is a very effective and safe treatment and we recommend such an approach in head and neck squamous cell carcinoma, particularly in those patients with good PS and with unresectable stage II or stage III disease.

[Cranio-facial resections]. / Resezioni cranio-facciali.

Four basic steps should be considered in craniofacial tumor surgery: dismantling and re-assembling of preservable bone structures to reach the tumor; en bloc resection of the "box" in malignancies (i.e., the unaffected boundaries surrounding and including the tumor), internal rigid fixation and, reconstruction by using whenever possible regional structures. In benign tumors and so-called pseudotumors, the treatment is total removal and immediate reconstruction of all structures, including the bone. The primary goal of craniofacial surgery for malignancies is to create an entrance to the box that is to be resected. This necessitates the dismantling and reassembly of some uninvolved skeletal structures. Among these are the nose, the maxilla, the nose and maxilla en bloc, the nose and the maxilla bilaterally to the mandible. The introduction of internal rigid fixation by using plates and screws has facilitated the realignment of the pedicled bone fragments in a correct position. After cranial base resection, the communication between neuro- and splanchno-cranium must be closed with viable flaps. Many techniques have been described. The horizontal forehead flap is certainly effective but results in a significant secondary defect. Where there is an orbital resection en bloc with the cranial base, the temporalis muscle flap is effective in providing vascularized coverage and simultaneously obliterating the orbital cavity. The galeal frontal flap is versatile and easy to use. It has been used to cover anterior and lateral defects with good results. The orbit is another area that requires immediate reconstruction so that there is no resulting external defect. The temporalis muscle flap, with or without a skin island, can be used to repair it. Distant flaps can likewise be used. If the resection includes the maxilla, reconstruction of the defect can be performed immediately, or it can be delayed. The authors prefer to use the temporalis muscle flap if it has not already been used. On the basis of 10 years of experience in craniofacial surgery the following conclusions can be drawn: 1. Craniofacial surgery is not a single concept. Therefore, the surgeon who deals with facial tumors involving the cranial base must have expertise in the entire field. Oncology must be part of his basic biological education. 2. Complications functional and aesthetic consequences are minimal if some basic principles are applied, both in the resection and the primary reconstructive phase. 3. In the past few years, surgical techniques have been modified and improved considerably, resulting in an operation that combines an excellent approach, oncological resection, low postoperative morbidity, good aesthetic results and improved prognosis.