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 â¥70 years of age or with Karnofsky performance status (PS) 70-80, diagnosed with locally advanced head and neck (H&N...

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Published in:	Anticancer research Vol. 28; no. 2B; pp. 1383 - 1388
Main Authors:	KOUSSIS, Haralabos, SCOLA, Annamaria, LORA, Ornella, BOTTIN, Raffaele, MARIONI, Gino, DONACH, Martin, JIRILLO, Antonio, BERGAMO, Francesca, TONELLO, Stefano, BASSO, Umberto, KARAHONTZITIS, Paraskevi, CHIARION-SILENI, Vanna, PASETTO, Lara, RUOL, Alberto, LOREGGIAN, Lucio
Format:	Journal Article
Language:	English
Published:	Attiki International Institute of Anticancer Research 01-03-2008
Subjects:	Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Carboplatin - administration & dosage Carboplatin - adverse effects Carcinoma, Squamous Cell - drug therapy Carcinoma, Squamous Cell - pathology Carcinoma, Squamous Cell - radiotherapy Esophageal Neoplasms - drug therapy Esophageal Neoplasms - pathology Esophageal Neoplasms - radiotherapy Esophagus Female Gastroenterology. Liver. Pancreas. Abdomen Head and Neck Neoplasms - drug therapy Head and Neck Neoplasms - pathology Head and Neck Neoplasms - radiotherapy Humans Male Medical sciences Middle Aged Neoadjuvant Therapy Neoplasm Staging Survival Rate Tumors Vinblastine - administration & dosage Vinblastine - adverse effects Vinblastine - analogs & derivatives Antineoplastic agent Performance evaluation Esophageal disease Esophagus squamous cell carcinoma Chemoradiotherapy Esophagus cancer Neoadjuvant treatment oesophageal cancer Alkaloid Cancerology Phase II trial Head and neck ENT disease Antimitotic Platinum II Complexes Human Malignant tumor poor performance status Carboplatin Digestive diseases Head and neck cancer Locally advanced stage Elderly Vinorelbine Cancer
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Summary:	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 â¥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 1 and vinorelbine 25mg/m 2 on day 1 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: Thirty-five patients with an average age of 68 years (range 42-85, 16 patients â¥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 neo-adjuvant carboplatin and vinorelbine followed by chemoradiotherapy is feasible and active in older (â¥70 years) or low PS (Karnofsky 70-80) patients, although toxicity is not negligible and long-term outcome remains poor.
ISSN:	0250-7005 1791-7530