Neoadjuvant carboplatin and vinorelbine followed by chemoradiotherapy in locally advanced head and neck or oesophageal squamous cell carcinoma: A phase II study in elderly patients or patients with poor performance status

Background: The purpose of this study was to evaluate the efficacy and toxicity of neo-adjuvant carboplatin and vinorelbine followed by concomitant chemoradiotherapy in patients >= 70 years of age or with Karnofsky performance status (PS) 70-80, diagnosed with locally advanced head and neck (H&N) or oesophageal carcinoma. Patients and Methods: The treatment plan consisted of three courses of carboplatin AUC4 on day I and vinorelbine 25mg/m(2) on day I and 8, every 21 days, followed by chemoradiotherapy. Carboplatin 100 mg/m(2) was delivered weekly for the duration of the radiation therapy (70 Gy, 2 Gy/daily). Results: Thirtyfive patients with an average age of 68 years (range 42-85, 16 patients >= 70 years) were treated. Twenty-seven patients (77.1%) responded to neo-adjuvant chemotherapy (2 complete and 25 partial responses). Haematological toxicity was grade 3-4 in 13 patients (37.2%), while gastrointestinal toxicity was grade 3-4 in 20 patients (57.1%). All the patients completed the chemoradiotherapy plan, with grade 4 mucositis plus febrile neutropenia in 3 patients (8.5%). Median time to progression (TTP) was 10.2 months, with 31.5% of patients being alive at two years. Conclusion: The regimen of neoadjuvant carboplatin and vinorelbine followed by chemoradiotherapy is feasible and active in older (>= 70 years) or low PS (Karnofsky 70-80) patients, although toxicity is not negligible and long-term outcome remains poor.