BACKGROUND Some previous studies have shown that vinorelbine (VNB) is active in recurrent salivary gland tumors. METHODS Between April 1993 and April 1997, 36 patients in a Phase II randomized trial received either cisplatin, 80 mg/m2, on Day 1 plus VNB, 25 mg/m2, on Days 1 and 8 (every 3 weeks) (for a minimum of 3 cycles (Arm A [16 patients]), or VNB, 30 mg/m2/week, (for a minimum of 9 wks) (Arm B [20 patients]). There were 23 males and 13 females with a median age of 59 years (range, 20–74 years) and a median Eastern Cooperative Oncology Group performance status of 1 (range, 0–2). Four patients had been treated with prior surgery (S) or radiotherapy (RT), 27 patients had been treated with S plus RT, and 5 patients had been treated with S plus RT plus mitoxantrone. Eighteen patients had major salivary gland tumors, and 18 patients had minor salivary gland tumors; 9 patients had adenocarcinoma, 22 patients had adenoid cystic carcinoma, 1 patient had a malignant mixed carcinoma, 3 patients had undifferentiated carcinoma, and 1 patient had a mucoepidermoid carcinoma. The site of recurrence was local in (16 patients), local plus metastatic in 5 patients, and metastatic only in 15 patients. These characteristics were well balanced between the 2 arms. RESULTS In Arms A and B a complete response (CR) was noted in 3 patients (19%) and no patients, respectively; a partial response (PR) was noted in 4 patients (25%) and 4 patients (20%), respectively; no change was noted in 6 patients (37.5%) and 9 patients (45%), respectively; and progressive disease was noted in 3 patients (19%) and 7 patients (35%), respectively. The median duration of the CR was 15+ months (range, 6–27+ months) and for PR the median duration was 7.5 months (range, 3–11+ months) and 6 months (range, 3–9 months) in Arms A and B, respectively. Number of patients surviving > 12 months was 6 versus 1 in Arms A and B, respectively (P < 0.05). Grade 2–3 nausea and emesis was statistically higher (P < 0.001) in Arm A; there was no significant difference with regard to other side‐effects between the two treatment arms. CONCLUSIONS VNB is a drug with moderate activity in salivary gland malignancies. The combination of cisplatin plus VNB was found to be more active than VNB alone, with a good number of CRs and long‐term survivors reported in the current study. Cancer 2001;91:541–7. © 2001 American Cancer Society.

Objectives: In spite of aggressive surgery and high-dose radiotherapy, the long-term survival of patients with sinonasal cancer remains disappointing. In this paper, we report data from 179 consecutive cases treated in the Italian Piedmont region between 1996 and 2000 according to a fixed protocol. Methods: Clinical and pathological data and the following biological parameters were analyzed: microvessel density and growth fraction by CD31 and Ki-67 positivity, respectively, and immunohistochemical expression of vascular endothelial growth factor (VEGF). Results: The median follow-up period was 75 months (range 45–108 months). Median overall survival was 26 months; 2- and 5-year overall survival rates were 52 and 36%, respectively. Patients with T1-T2 adenocarcinoma and squamous cell cancers (SCC) had better median survival than those with other lesions (p < 0.05). Patients treated with surgery with or without radiotherapy had better survival (p < 0.01), while chemotherapy had a marginally favorable effect (p = 0.09). The type of surgery and radiotherapy dose had no impact on survival; in contrast, there was a strong association between Ki-67 expression and microvessel density and overall survival (p < 0.05 and p = 0.039, respectively), while VEGF-C was a prognostic factor in SCC patients only (p < 0.05). Conclusions: In sinonasal cancer, tumor stage and histology have a clear impact on survival; surgery with or without radiotherapy represents the main choice of treatment for such tumors. The efficacy of neoadjuvant and concomitant chemoradiotherapy needs to be further investigated. The proliferative index and angiogenesis show a major role in the natural history of this cancer.

Background: In head and neck cancer, the locoregional failure of patients with positive margins, vascular or perineural invasion, and extracapsular spread is high and results in poor survival. Objective: To assess the effect of adjuvant chemoradiotherapy in improving treatment outcomes among older patients with head and neck cancer. Methods: Forty patients undergoing radical surgery (median age, 73.5 years [range, 70-78 years]) were enrolled (35 men and 5 women; Eastern Cooperative Oncology Group performance status, grade 0-2). Disease sites included the oral cavity (10 patients), oropharynx (12 patients), hypopharynx (8 patients), and larynx (10 patients); pathological TNM classifications included T1 N2 (8 patients), T2 N1-2 (12 patients), T3 N0-2 (8 patients), and T4 N0-2 (12 patients), with the following poor prognostic factors: positive margins (6 patients), vascular invasion (14 patients), neural invasion (16 patients), and extracapsular spread (26 patients). All patients were treated with carboplatin (30 mg/m 2 on days 1-5 of weeks 1, 3, and 5) concomitant with radiotherapy (54.0 Gy to all risk volumes plus 10.0 Gy to high-risk volumes; 5 daily fractions of 1.8 Gy each per week). Results: No grade 4 toxicity was observed. Grade 3 toxicity included mucositis (10 patients), neutropenia (6 patients), dermatitis (2 patients), and thrombocytopenia (1 patient). The radiotherapy dose administered was 52.0 Gy to all risk volumes plus 10.0 Gy to high-risk volumes. Thirty-two patients (80%) received 3 cycles, 6 (15%) received 2 cycles, and 2 (5%) received 1 cycle. Three-year survival was as follows: disease-free survival, 58%; overall survival, 64%; and local control, 79%. Conclusions: Adjuvant chemoradiotherapy may be successful in fit older patients. The results of adjuvant chemoradiotherapy were better than those observed in a comparable group treated with radiotherapy alone and were similar to those observed in a younger group with the same poor prognostic factors treated with adjuvant carboplatin plus radiotherapy.

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The local control rate for these tumors remains low. The prognosis depends on localization, tumor stage and treatment modality. Three-dimensional conformal radiotherapy reduces the risk on optical pathways but does not modify outcome.

Concomitant chemoradiotherapy followed by adjuvant chemotherapy in advanced unresectable undifferentiated parotid carcinoma is feasibile and well tolerated. The high percentage of long-lasting CR is encouraging.

The combination has a good palliative role as third-line chemotherapy in recurrent undifferentiated nasopharyngeal cancer.

Concomitant chemoradiotherapy is the most effective treatment of unresectable head and neck cancer. Docetaxel and carboplatin are two active drugs that potentiate radiotherapy. Thirty patients (median age = 56 years; median Eastern Cooperative Oncology Group performance status = 1) received radiotherapy (70 Gy, 2 Gy/d, 5 d/wk) concurrent with carboplatin AUC 0.3 to 0.5 on day 1-5, weeks 1, 3, 5, 7, and docetaxel 15 to 25 mg/m2 on day 4 of weeks 2, 4, and 6. Site of unresectable squamous cell carcinoma was as follows: oropharynx, 41%; hypopharynx, 27%; oral cavity, 16%; and larynx, 16%. Stage was III in 13% and IV in 87%. In 11 patients, pharmacokinetic parameters were evaluated. Acute G4 toxicity was as follows: neutropenia, 20%; mucositis, 33%. We had the following acute G3 toxicities: mucositis, 40%; neutropenia, 37%; dermatitis, 23%; and anemia, 13%. The maximum tolerated dosage was area under the curve 0.5 for carboplatin and 20 mg/m2 for docetaxel. Median radiotherapy dose was 69 Gy, and 175 out of 210 courses (83%) were administered. At the end of the treatment, we had 20 complete responses (CR) (67%), 9 partial responses (30%), and 1 no change (3%). After radial neck dissection, 2 patients achieved a CR (overall CR = 73%). After a median follow-up of 2.5 years, we had a 3-year local progression-free survival of 85%, failure-free survival of 69%, and overall survival of 60%. A significant increase of Cmax of carboplatin concentration was noted at the beginning of weeks 3, 5, and 7. Total plasma platinum raises during each course of 5 days of carboplatin without reaching a steady state. Carboplatin, docetaxel, and concomitant conventional radiotherapy is a feasible and effective treatment of unresectable head and neck cancer. The concurrent administration of two drugs does not alter pharmacokinetic drug behavior compared with single-agent data.